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author:("kunin, Mark")
1.  Predictors of Change in Quality of Life in Older Adults with Generalized Anxiety Disorder 
International psychogeriatrics / IPA  2014;27(7):1207-1215.
Quality of life (QOL) is lower in older adults with generalized anxiety disorder (GAD). QOL generally improves following cognitive-behavioral treatment for GAD. Little is known, however, about additional variables predicting changes in QOL in older adults with GAD. This study examined predictors of change in QOL among older participants in a randomized clinical trial of cognitive behavioral thera for GAD, relative to enhanced usual care.
Hierarchical multilevel mixed-model analyses were used to examine inter-individual and intra-individual factors that predicted QOL over time. Predictors were categorized into treatment, personal and clinical characteristics.
QOL improved over time, and there was significant variability between participants in change in QOL. Controlling for treatment condition, baseline general self-efficacy, baseline social support, within-person variation in worry and depression and average levels of depression across different time points predicted changes in QOL.
QOL has increasingly been used as an outcome measure in treatment outcome studies to focus on overall improvement in functioning. Attention to improvement in symptoms of depression and worry, along with psychosocial variables, such as social support and self-efficacy, may help improve QOL in older adults with GAD.
PMCID: PMC4502441  PMID: 25497362
generalized anxiety disorder; quality of life; predictors; older adults
2.  Bad Dream Frequency in Older Adults with Generalized Anxiety Disorder: Prevalence, Correlates, and Effect of Cognitive Behavioral Treatment for Anxiety 
Behavioral sleep medicine  2013;12(1):10.1080/15402002.2012.755125.
This study investigated the relation between generalized anxiety disorder (GAD) and frequency of bad dreams in older adults. A secondary analysis from a randomized clinical trial comparing cognitive behavioral therapy for anxiety (CBT) to enhanced usual care (EUC), it assessed bad dream frequency at baseline, post-treatment (3 months), and 6, 9, 12 and 15 months. Of 227 participants (mean age = 67.4), 134 met GAD diagnostic criteria (CBT = 70, EUC = 64), with the remaining 93 serving as a comparison group. Patients with GAD had significantly more bad dreams than those without, and bad dream frequency was significantly associated with depression, anxiety, worry, and poor quality of life. CBT for anxiety significantly reduced bad dream frequency at post-treatment and throughout follow-up compared to EUC.
PMCID: PMC3690155  PMID: 23470116
Bad dreams; older adults; anxiety; GAD; CBT
3.  The Peaceful Mind Manual: A Protocol for Treating Anxiety in Persons with Dementia 
Behavior modification  2013;37(5):10.1177/0145445513477420.
Anxiety disorders are highly prevalent among individuals with dementia and have a significant negative impact on their lives. Peaceful Mind is a form of Cognitive-Behavioral Therapy for anxiety in persons with dementia. The Peaceful Mind manual was developed, piloted and modified over 2 years. In an open trial and a small randomized, controlled trial, it decreased anxiety and caregiver distress. The treatment meets the unique needs of individuals with dementia by emphasizing behavioral rather than cognitive interventions, slowing the pace, limiting the material to be learned, increasing repetition and practice, using cues to stimulate memory, including a friend or family member in treatment as a coach, and providing sessions in the home. The manual presented here includes modules that teach specific skills, including awareness, breathing, calming self-statements, increasing activity, and sleep management, as well as general suggestions for treatment delivery.
PMCID: PMC3872091  PMID: 23447103
4.  Psychotherapy in the Veterans Health Administration: Missed Opportunities? 
Psychological services  2008;5(4):320-331.
Informed by data on the dose-response effect, the authors assessed use of psychotherapy in the Veterans Health Administration (VA). The authors identified 410,923 patients with newly diagnosed depression, anxiety, or posttraumatic stress disorder using VA databases (October 2003 through September 2004). Psychotherapy encounters were identified by Current Procedural Terminology codes for the 12 months following patients’ initial diagnosis. Psychotherapy was examined for session exposure received within the 12-month follow-up period and time (in days) between diagnosis and treatment. Of the cohort, 22% received at least one session of psychotherapy; 7.9% received four or more sessions; 4.2% received eight or more sessions; and 2.4% received 13 or more sessions. Delays between initial mental health diagnosis and initiation of care averaged 57 days. Patient variables including age, marital status, income, travel distance, psychiatric diagnosis, and medical-illness burden were significantly related to receipt of psychotherapy. Treatment delays and general underuse of psychotherapy services are potential missed opportunities for higher-quality psychotherapeutic care in integrated health care settings.
PMCID: PMC4145407  PMID: 25177213
psychotherapy; mental health; depression; anxiety; posttraumatic stress disorder
Depression and anxiety  2014;31(8):653-661.
Despite their high rates of depression, homebound older adults have limited access to evidence-based psychotherapy. The purpose of this paper was to report both depression and disability outcomes of telehealth problem-solving therapy (tele-PST via Skype video call) for low-income homebound older adults over 6 months postintervention.
A 3-arm randomized controlled trial compared the efficacy of tele-PST to in-person PST and telephone care calls with 158 homebound individuals who were aged 50+ and scored 15+ on the 24-item Hamilton Rating Scale for Depression (HAMD). Treatment effects on depression severity (HAMD score) and disability (score on the WHO Disability Assessment Schedule [WHODAS]) were analyzed using mixed-effects regression with random intercept models. Possible reciprocal relationships between depression and disability were examined with a parallel-process latent growth curve model.
Both tele-PST and in-person PST were efficacious treatments for low-income homebound older adults; however the effects of tele-PST on both depression and disability outcomes were sustained significantly longer than those of in-person PST. Effect sizes (dGMA-raw) for HAMD score changes at 36 weeks were 0.68 for tele-PST and 0.20 for in-person PST. Effect sizes for WHODAS score changes at 36 weeks were 0.47 for tele-PST and 0.25 for in-person PST. The results also supported reciprocal and indirect effects between depression and disability outcomes.
The efficacy and potential low cost of tele-delivered psychotherapy show its potential for easy replication and sustainability to reach a large number of underserved older adults and improve their access to mental health services.
PMCID: PMC4122624  PMID: 24501015
depression; disability; tele-psychotherapy; homebound older adults
6.  The Peaceful Mind Program: A Pilot Test of a CBT-Based Intervention for Anxious Patients with Dementia 
To assess feasibility and to conduct a preliminary evaluation of outcomes following Peaceful Mind, a CBT-based intervention for anxiety in dementia, relative to usual care (UC).
Pilot randomized controlled trial including assessments at baseline, 3 and 6 months
Houston, TX
32 outpatients diagnosed with mild (47%) or moderate (53%) dementia receiving care through outpatient clinics at the Veterans Affairs medical center, Baylor College of Medicine, Harris County Hospital District and community day centers for dementia, and their collaterals, who spent at least 8 hours a week with them.
Peaceful Mind included up to 12 weekly in-home sessions (mean = 8.7, SD = 2.27) during the initial 3 months and up to eight brief telephone sessions (mean = 5.4, SD = 3.17) during months 3 to 6, involving self-monitoring for anxiety, deep breathing, and optional skills (coping self-statements, behavioral activation and sleep management). Patients learned skills, and collaterals served as coaches. In UC, patients received diagnostic feedback; and providers were informed of inclusion status.
Neuropsychiatric Inventory-Anxiety subscale, Rating Anxiety in Dementia scale, Penn State Worry Questionnaire-Abbreviated, Geriatric Anxiety Inventory, Geriatric Depression Scale, Quality of Life in Alzheimer’s disease, Patient Health Questionnaire, Client Satisfaction Questionnaire
Feasibility was demonstrated with regard to recruitment, attrition, and treatment characteristics. At 3 months, clinicians rated patients receiving Peaceful Mind as less anxious, and patients rated themselves as having higher quality of life; collaterals reported less distress related to loved ones’ anxiety. Although significant positive effects were not noted in other outcomes or at 6-month follow-up, the pilot nature of the trial prohibits conclusions about efficacy.
Results support that Peaceful Mind is ready for future comparative clinical trials.
PMCID: PMC3411894  PMID: 23567399
anxiety; dementia; cognitive behavioral therapy; self-ratings; proxy ratings
7.  Implementing brief cognitive behavioral therapy in primary care: A pilot study 
Effective implementation strategies are needed to improve the adoption of evidence-based psychotherapy in primary care settings. This study provides pilot data on the test of an implementation strategy conducted as part of a multisite randomized controlled trial examining a brief cognitive-behavioral therapy versus usual care for medically ill patients in primary care, using a hybrid (type II) effectiveness/implementation design. The implementation strategy was multifaceted and included (1) modular-based online clinician training, (2) treatment fidelity auditing with expert feedback, and (3) internal and external facilitation to provide ongoing consultation and support of practice. Outcomes included descriptive and qualitative data on the feasibility and acceptability of the implementation strategy, as well as initial indicators of clinician adoption and treatment fidelity. Results suggest that a comprehensive implementation strategy to improve clinician adoption of a brief cognitive-behavioral therapy in primary care is feasible and effective for reaching high levels of adoption and fidelity.
PMCID: PMC4041920  PMID: 24904701
Primary care; Hybrid effectiveness-implementation designs; Cognitive behavioral therapy; Veterans; Anxiety; Depression
8.  Predictors of Inpatient Utilization among Veterans with Dementia 
Dementia is prevalent and costly, yet the predictors of inpatient hospitalization are not well understood. Logistic and negative binomial regressions were used to identify predictors of inpatient hospital utilization and the frequency of inpatient hospital utilization, respectively, among veterans. Variables significant at the P < 0.15 level were subsequently analyzed in a multivariate regression. This study of veterans with a diagnosis of dementia (n = 296) and their caregivers found marital status to predict hospitalization in the multivariate logistic model (B = 0.493, P = 0.029) and personal-care dependency to predict hospitalization and readmission in the multivariate logistic model and the multivariate negative binomial model (B = 1.048, P = 0.007, B = 0.040, and P = 0.035, resp.). Persons with dementia with personal-care dependency and spousal caregivers have more inpatient admissions; appropriate care environments should receive special care to reduce hospitalization. This study was part of a larger clinical trial; this trial is registered with NCT00291161.
PMCID: PMC4058849  PMID: 24982674
9.  Treating late-life GAD in primary care: An effectiveness pilot study 
To increase sustainability of Cognitive Behavior Therapy (CBT) in primary care for late-life anxiety, we incorporated non-expert counselors, options for telephone meetings, and integration with primary care clinicians.
This open trial examines the feasibility, satisfaction and clinical outcomes of CBT delivered by experienced and non-experienced counselors for older adults with generalized anxiety disorder (GAD). Clinical outcomes assessed worry (Penn State Worry Questionnaire), GAD (Generalized Anxiety Disorder Severity Scale), and anxiety (Beck Anxiety Inventory and Structured Interview Guide for Hamilton Anxiety Scale).
Following 3 months of treatment, Cohen’s d effect sizes for worry and anxiety ranged from .48 to .78. Patients treated by experienced and non-experienced counselors had similar reductions in worry and anxiety, although treatment outcomes were more improved on the Beck Anxiety Inventory for experienced therapists.
Preliminary results suggest adapted CBT can effectively reduce worry. The piloted modifications can provide acceptable and feasible evidence-based care.
PMCID: PMC3644354  PMID: 23588228
cognitive behavioral therapy; generalized anxiety disorder; primary care; older adults; mental health
10.  Behavioral health coaching for rural veterans with diabetes and depression: a patient randomized effectiveness implementation trial 
Depression and diabetes cause significant burden for patients and the healthcare system and, when co-occurring, result in poorer self-care behaviors and worse glycemic control than for either condition alone. However, the clinical management of these comorbid conditions is complicated by a host of patient, provider, and system-level barriers that are especially problematic for patients in rural locations. Patient-centered medical homes provide an opportunity to integrate mental and physical health care to address the multifaceted needs of complex comorbid conditions. Presently, there is a need to not only develop robust clinical interventions for complex medically ill patients but also to find feasible ways to embed these interventions into the frontlines of existing primary care practices.
This randomized controlled trial uses a hybrid effectiveness-implementation design to evaluate the Healthy Outcomes through Patient Empowerment (HOPE) intervention, which seeks to simultaneously address diabetes and depression for rural veterans in Southeast Texas. A total of 242 Veterans with uncontrolled diabetes and comorbid symptoms of depression will be recruited and randomized to either the HOPE intervention or to a usual-care arm. Participants will be evaluated on a host of diabetes and depression-related measures at baseline and 6- and 12-month follow-up. The trial has two primary goals: 1) to examine the effectiveness of the intervention on both physical (diabetes) and emotional health (depression) outcomes and 2) to simultaneously pilot test a multifaceted implementation strategy designed to increase fidelity and utilization of the intervention by coaches interfacing within the primary care setting.
This ongoing blended effectiveness-implementation design holds the potential to advance the science and practice of caring for complex medically ill patients within the constraints of a busy patient-centered medical home.
Trial registration
Behavioral Activation Therapy for Rural Veterans with Diabetes and Depression: NCT01572389.
PMCID: PMC4045905  PMID: 24774351
Behavioral medicine; Diabetes mellitus; Depression; Veterans’ health
11.  Predictors of treatment satisfaction among older adults with anxiety in a primary care psychology program 
Increasing numbers of patients are treated in integrated primary care mental health programs. The current study examined predictors of satisfaction with treatment in patients from a randomized clinical trial of late-life generalized anxiety disorder (GAD) in primary care. Higher treatment satisfaction was associated with receiving CBT rather than enhanced usual care. Treatment credibility, treatment expectancies, social support, and improvements in depression and anxiety symptoms predicted higher treatment satisfaction in the total sample. In the CBT group, only credibility and adherence with treatment predicted satisfaction. This suggests that older patients receiving CBT who believe more strongly in the treatment rationale and follow the therapist’s recommendations more closely are likely to report satisfaction at the end of treatment. In addition, this study found that adherence mediated the relationship between treatment credibility and treatment satisfaction. In other words, patients’ perceptions that the treatment made sense for them led to greater treatment adherence which then increased their satisfaction with treatment.
PMCID: PMC3594523  PMID: 23434724
Primary Care; Psychotherapy; Generalized Anxiety Disorder; Older Adults; Treatment Satisfaction; Adherence; Expectancies; Social Support
12.  Mental Health Service Use Among Depressed, Low-Income Homebound Middle-Aged and Older Adults 
Journal of aging and health  2013;25(4):638-655.
This study examined previous mental health service use among low-income homebound middle-aged and older adults who participated in a study testing the feasibility and efficacy of telehealth problem-solving therapy for depression.
The sample consisted of 188 homebound adults aged 50 years or older. Data on mental health service use were collected at baseline. We used multivariable logistic regression analysis to examine correlates of different types of outpatient service use within the preceding 12 months.
Of the subjects, 56% reported mental health service use. Of the users, 80% had made at least one primary care mental health visit, 21% had visited a psychiatrist, and 25% had received counseling. Higher depressive symptom severity scores were positively associated with a psychiatrist visit only.
The need to improve low-income homebound older adults’ access to psychotherapy was clearly evident.
PMCID: PMC3971526  PMID: 23584592
mental health; frailty; geriatrics
13.  A controlled trial of Partners in Dementia Care: veteran outcomes after six and twelve months 
“Partners in Dementia Care” (PDC) tested the effectiveness of a care-coordination program integrating healthcare and community services and supporting veterans with dementia and their caregivers. Delivered via partnerships between Veterans Affairs medical centers and Alzheimer’s Association chapters, PDC targeted both patients and caregivers, distinguishing it from many non-pharmacological interventions. Hypotheses posited PDC would improve five veteran self-reported outcomes: 1) unmet need, 2) embarrassment about memory problems, 3) isolation, 4) relationship strain and 5) depression. Greater impact was expected for more impaired veterans. A unique feature was self-reported research data collected from veterans with dementia.
Methods and Findings
Five matched communities were study sites. Two randomly selected sites received PDC for 12 months; comparison sites received usual care. Three structured telephone interviews were completed every 6 months with veterans who could participate.
Of 508 consenting veterans, 333 (65.6%) completed baseline interviews. Among those who completed baseline interviews, 263 (79.0%) completed 6-month follow-ups and 194 (58.3%) completed 12-month follow-ups. Regression analyses showed PDC veterans had significantly less adverse outcomes than those receiving usual care, particularly for more impaired veterans after 6 months, including reduced relationship strain (B = −0.09; p = 0.05), depression (B = −0.10; p = 0.03), and unmet need (B = −0.28; p = 0.02; and B = −0.52; p = 0.08). PDC veterans also had less embarrassment about memory problems (B = −0.24; p = 0.08). At 12 months, more impaired veterans had further reductions in unmet need (B = −0.96; p < 0.01) and embarrassment (B = −0.05; p = 0.02). Limitations included use of matched comparison sites rather than within-site randomization and lack of consideration for variation within the PDC group in amounts and types of assistance provided.
Partnerships between community and health organizations have the potential to meet the dementia-related needs and improve the psychosocial functioning of persons with dementia.
Trial Registry
PMCID: PMC3978714  PMID: 24764496
14.  Concordance of Self- and Proxy-Rated Worry and Anxiety Symptoms in Older Adults with Dementia 
Journal of anxiety disorders  2012;27(1):125-130.
We compared the psychometric performance of two validated self-report anxiety- symptom measures when rated by people with dementia versus collaterals (as proxies). Forty-one participants with mild-to-moderate dementia and their respective collaterals completed the Geriatric Anxiety Inventory, the Penn State Worry Questionnaire-Abbreviated, and a structured diagnostic interview. We used descriptive and nonparametric statistics to compare scores according to respondent characteristics. Receiver operating characteristic (ROC) curves were calculated to establish the predictive validity of each instrument by rater type against a clinical diagnosis of an anxiety disorder. Participant and collateral ratings performed comparably for both instruments. However, collaterals tended to give more severe symptom ratings, and the best-performing cut-off scores were higher for collaterals. Our findings suggest that people with mild-to-moderate dementia can give reliable self-reports of anxiety symptoms, with validity comparable to reports obtained from collaterals. Scores obtained from multiple informants should be interpreted in context.
PMCID: PMC3578141  PMID: 23270995
worry; anxiety; elders; dementia; self-ratings; proxy ratings
15.  The Pittsburgh Sleep Quality Index in Older Primary Care Patients with Generalized Anxiety Disorder: Pyschometrics and Outcomes Following Cognitive Behavioral Therapy 
Psychiatry research  2012;199(1):24-30.
The Pittsburgh Sleep Quality Index (PSQI) is a widely used, comprehensive self-report measure of sleep quality and impairment, which has demonstrated good psychometric properties within various populations, including older adults. However, the psychometric properties of the PSQI and its component scores have not been evaluated for older adults with generalized anxiety disorder (GAD). Additionally, changes in PSQI global or component scores have not been reported following cognitive-behavioral treatment (CBT) of late-life GAD. This study examined (1) the psychometric properties of the PSQI within a sample of 216 elderly primary care patients age 60 or older with GAD who were referred for treatment of worry and/or anxiety; as well as (2) response to CBT, relative to usual care, for 134 patients with principal or coprincipal GAD. The PSQI demonstrated good internal consistency reliability and adequate evidence of construct validity. Those receiving CBT experienced greater reductions in PSQI global scores at post-treatment, relative to those receiving usual care. Further, PSQI global and domain scores pertaining to sleep quality and difficulties falling asleep (i.e., sleep latency and sleep disturbances) demonstrated response to treatment over a 12-month follow-up period. Overall, results highlight the usefulness of the PSQI global and component scores for use in older adults with GAD.
PMCID: PMC3401329  PMID: 22503380
Pittsburgh Sleep Quality Index; psychometrics; generalized anxiety disorder; elderly; cognitive behavioral therapy
16.  Psychometric Properties of a Structured Interview Guide for the Rating for Anxiety in Dementia (RAID-SI) 
Aging & mental health  2012;16(5):592-602.
The Rating Anxiety in Dementia (RAID; Shankar et al, 1999)is a clinical rating scale developed to evaluate anxiety in persons with dementia. This report explores the psychometric properties and clinical utility of a new structured interview format of the RAID (RAID-SI), developed to standardize administration and scoring based on information obtained from the patient, an identified collateral, and rater observation.
The RAID-SI was administered by trained master’s level raters. Participants were 32 persons with dementia who qualified for an anxiety treatment outcome study. Self-report anxiety, depression, and quality of life measures were administered to both the person with dementia and a collateral.
The RAID-SI exhibited adequate internal consistency reliability and inter-rater reliability. There was also some evidence of construct validity as indicated by significant correlations with other measures of patient-reported and collateral-reported anxiety, and non-significant correlations with collateral reports of patient depression and quality of life. Further, RAID-SI scores were significantly higher in persons with an anxiety diagnosis compared to those without an anxiety diagnosis.
There is evidence that the RAID-SI exhibits good reliability and validity in older adults with dementia. The advantage of the structured interview format is increased standardization in administration and scoring, which may be particularly important when RAID raters are not experienced clinicians.
PMCID: PMC3371288  PMID: 22372475
dementia; anxiety; clinical interview; assessment; Rating for Anxiety in Dementia
17.  Characteristics Associated with Inpatient Versus Outpatient Status in Older Adults with Bipolar Disorder 
This is an exploratory analysis of ambulatory and inpatient services utilization by older persons with type I bipolar disorder experiencing elevated mood. The association between type of treatment setting and the person’s characteristics is explored within a framework that focuses upon predisposing, enhancing, and need characteristics.
Baseline assessments were conducted with the first 51 inpatients and 49 outpatients 60 years of age and older, meeting criteria for type I bipolar disorder, manic, hypomanic, or mixed episode enrolled in the geriatric bipolar disorder study (GERI-BD) study. We compared participants recruited from inpatient versus outpatient settings in regard to the patients’ predisposing, enabling, and need characteristics.
Being treated in an inpatient rather than an outpatient setting was associated with the predisposing characteristic of being non-Hispanic caucasian (odds ratio [OR]: 0.1; P = .005) and past history of treatment with first-generation antipsychotics (OR: 6.5; P < .001), and the need characteristic reflected in having psychotic symptoms present in the current episode (OR: 126.08; P < .001).
Ethnicity, past pharmacologic treatment, and current symptom severity are closely associated with treatment in inpatient settings. Clinicians and researchers should investigate whether closer monitoring of persons with well-validated predisposing and need characteristics can lead to their being treated in less costly but equally effective ambulatory rather than inpatient settings.
PMCID: PMC3623950  PMID: 22467848
bipolar disorder; geriatric; hospitalization; mania
18.  Relationship between depressive symptom severity and emergency department use among low-income, depressed homebound older adults aged 50 years and older 
BMC Psychiatry  2012;12:233.
Previous research found a high prevalence of depression, along with chronic illnesses and disabilities, among older ED patients. This study examined the relationship between depressive symptom severity and the number of ED visits among low-income homebound older adults who participated in a randomized controlled trial of telehealth problem-solving therapy (PST).
The number of and reasons for ED visits were collected from the study participants (n=121 at baseline) at all assessment points—baseline and 12- and 24-week follow-ups. Depressive symptoms were measured with the 24-item Hamilton Rating Scale for Depression (HAMD). All multivariable analyses examining the relationships between ED visits and depressive symptoms were conducted using zero-inflated Poisson regression models.
Of the participants, 67.7% used the ED at least once and 61% of the visitors made at least one return visit during the approximately 12-month period. Body pain (not from fall injury and not including chest pain) was the most common reason. The ED visit frequency at baseline and at follow-up was significantly positively associated with the HAMD scores at the assessment points. The ED visit frequency at follow-up, controlling for the ED visits at baseline, was also significantly associated with the HAMD score change since baseline.
The ED visit rate was much higher than those reported in other studies. Better education on self-management of chronic conditions, depression screening by primary care physicians and ED, and depression treatment that includes symptom management and problem-solving skills may be important to reduce ED visits among medically ill, low-income homebound adults.
Trial registration Identifier: NCT00903019
PMCID: PMC3557139  PMID: 23267529
Homebound older adults; Depression; Emergency department
19.  Characteristics of Generalized Anxiety Disorder in Patients With Dementia 
Overlap of cognitive and anxiety symptoms (i.e., difficulty concentrating, fatigue, restlessness) contributes to inconsistent, complicated assessment of generalized anxiety disorder (GAD)in persons with dementia.
Anxious dementia patients completed a psychiatric interview, the Penn State Worry Questionnaire-Abbreviated, and the Rating for Anxiety in Dementia scale. Analyses to describe the 43 patients with and without GAD included the Wilcoxon Mann-Whitney two-sample test, Fisher’s exact test. Predictors of GAD diagnosis were identified using logistic regression.
Those with GAD were more likely to be male, have less severe dementia and endorsed more worry, and anxiety compared to patients without GAD. Gender, muscle tension and fatigue differentiated those with GAD from those without GAD.
Although this study is limited by a small sample, it describes clinical characteristics of GAD in dementia, highlighting the importance of muscle tension and fatigue in recognizing GAD in persons with dementia.
PMCID: PMC3252749  PMID: 22062223
Generalized anxiety disorder; dementia; anxiety symptoms; dementia symptoms; differential diagnosis for generalized anxiety disorder/dementia
20.  Treatment Response for Late-Life Generalized Anxiety Disorder: Moving Beyond Symptom-Based Measures 
Response to treatment for late-life generalized anxiety disorder has been defined by a variety of methods, all based on statistically significant reductions in symptom severity. However, it is unknown whether these improvements in symptom severity are associated with meaningful differences in everyday functioning. The current study used four methods to define response to treatment for 115 primary care patients, age 60 and older, with a principal or co-principal diagnosis of generalized anxiety disorder. The methods examined included percent improvement, reliable change index and minimal clinically significant differences. Agreement among classification methods and their associations with general and mental health related quality of life were assessed. Results indicated moderate agreement among symptom-based classification methods and significant associations with measures of quality of life.
PMCID: PMC3187557  PMID: 21964278
GAD; older adults; treatment response; quality of life
21.  Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness-implementation design 
Despite the availability of evidence-based psychotherapies for depression and anxiety, they are underused in non-mental health specialty settings such as primary care. Hybrid effectiveness-implementation designs have the potential to evaluate clinical and implementation outcomes of evidence-based psychotherapies to improve their translation into routine clinical care practices.
This protocol article discusses the study methodology and implementation strategies employed in an ongoing, hybrid, type 2 randomized controlled trial with two primary aims: (1) to determine whether a brief, manualized cognitive behavioral therapy administered by Veterans Affairs Primary Care Mental Health Integration program clinicians is effective in treating depression and anxiety in a sample of medically ill (chronic cardiopulmonary diseases) primary care patients and (2) to examine the acceptability, feasibility, and preliminary outcomes of a focused implementation strategy on improving adoption and fidelity of brief cognitive behavioral therapy at two Primary Care-Mental Health Integration clinics. The study uses a hybrid type 2 effectiveness/implementation design to simultaneously test clinical effectiveness and to collect pilot data on a multifaceted implementation strategy that includes an online training program, audit and feedback of session content, and internal and external facilitation. Additionally, the study engages the participation of an advisory council consisting of stakeholders from Primary Care-Mental Health Integration, as well as regional and national mental health leaders within the Veterans Administration. It targets recruitment of 320 participants randomized to brief cognitive behavioral therapy (n = 200) or usual care (n = 120). Both effectiveness and implementation outcomes are being assessed using mixed methods, including quantitative evaluation (e.g., intent-to-treat analyses across multiple time points) and qualitative methods (e.g., focus interviews and surveys from patients and providers). Patient-effectiveness outcomes include measures of depression, anxiety, and physical health functioning using blinded independent evaluators. Implementation outcomes include patient engagement and adherence and clinician brief cognitive behavioral therapy adoption and fidelity.
Hybrid designs are needed to advance clinical effectiveness and implementation knowledge to improve healthcare practices. The current article describes the rationale and challenges associated with the use of a hybrid design for the study of brief cognitive behavioral therapy in primary care. Although trade-offs exist between scientific control and external validity, hybrid designs are part of an emerging approach that has the potential to rapidly advance both science and practice.
Trial registration
NCT01149772 at
PMCID: PMC3503767  PMID: 22784436
Primary care; Hybrid effectiveness-implementation designs; Cognitive behavioral therapy; Mental health; Veterans; Anxiety; Depression
22.  Cognitive Behavior Therapy for Generalized Anxiety Disorder Among Older Adults in Primary Care: A Randomized Clinical Trial 
Jama  2009;301(14):1460-1467.
Cognitive behavior therapy (CBT) is effective for late-life generalized anxiety disorder (GAD), but, only pilot studies have been conducted in primary care, where older adults most often seek treatment. .
To examine effects of CBT relative to enhanced usual care (EUC) in older adults with GAD in primary care.
Design, Setting, and Participants
A randomized clinical trial with 134 older adults (mean age, 66.9 years) recruited from March 2004 to August 2006 in two primary care settings. Treatment was provided for 3 months; assessments were conducted at baseline, post-treatment (3 months), and over a 12-month follow-up (6, 9, 12, and 15 months).
CBT (n = 70) was conducted in the primary care clinics. Treatment included education and awareness, relaxation training, cognitive therapy, exposure, problem-solving skills training, and behavioral sleep management. Patients assigned to EUC (n = 64) received biweekly calls to ensure patient safety and provide minimal support.
Main Outcome Measures
Primary outcomes included worry severity (Penn State Worry Questionnaire) and GAD severity (GAD Severity Scale).. Secondary outcomes included anxiety (Hamilton Anxiety Rating Scale, Beck Anxiety Inventory), coexistent depressive symptoms (Beck Depression Inventory II), and physical/mental health quality of life (SF-12).
CBT significantly improved worry severity [45.6; 95% CI 44.4 to 47.8; vs. 54.4; 95% CI 51.4 to 57.3; p < .0001), depressive symptoms (10.2; 95% CI 8.5 to 11.9; vs. 12.8; 95% CI 10.5 to 15.1; p = .02), and general mental health (49.6; 95% CI 47.4 to 51.8; vs. 45.3; 95% CI 42.6 to 47.9; p=.008) compared with EUC. . According to intent-to-treat analyses, response rates defined according to worry severity were higher following CBT than EUC at 3 months (40.0% [28/70] vs. 21.9% [14/64], p = .02).
Compared to EUC, CBT resulted in greater improvement in worry severity, depressive symptoms, and general mental health for older patients with GAD in primary care.
PMCID: PMC3328789  PMID: 19351943
23.  Early Response to Psychotherapy and Long-term Change in Worry Symptoms in Older Adults with Generalized Anxiety Disorder 
To determine the association of early and long-term reductions in worry symptoms after cognitive behavioral therapy for generalized anxiety disorder (GAD) in older adults.
Substudy of larger randomized controlled trial
Family medicine clinic and large multi-specialty health organization in Houston, TX, between March 2004 and August 2006
Patients (N=76) 60 years or older with a principal or coprincipal diagnosis of GAD, excluding those with significant cognitive impairment, bipolar disorder, psychosis or active substance abuse.
Cognitive behavioral therapy, up to 10 sessions over 12 weeks, or enhanced usual care (regular, brief telephone calls and referrals to primary care provider as needed)
Penn State Worry Questionnaire (PSWQ) administered by telephone at baseline, 1 month (mid-treatment), 3 months (post-treatment), and at 3-month intervals through 15 months (1-year follow-up). We used binary logistic regression analysis to determine the association between early (1-month) response and treatment responder status (reduction of more than 8.5 points on the PSWQ) at 3 and 15 months. We also used hierarchical linear modeling to determine the relationship of early response to the trajectory of score change after post-treatment.
Reduction in PSWQ scores after the first month predicted treatment response at post-treatment and follow-up, controlling for treatment arm and baseline PSWQ score. The magnitude of early reduction also predicted the slope of score change from post-treatment through the 15-month assessment.
Early symptom reduction is associated with long-term outcomes after psychotherapy in older adults with GAD.
PMCID: PMC3058752  PMID: 21427643
psychotherapy; generalized anxiety disorder; older adults
24.  The involvement of multiple caregivers in cognitive-behavior therapy for anxiety in persons with dementia 
Aging & mental health  2011;15(3):291-298.
Peaceful Mind, a cognitive-behavioral therapy for treating anxiety in persons with dementia, is a promising new treatment currently under investigation. This article reports results of our examination of a modification of the treatment protocol in two cases that included multiple caregivers in treating two persons with dementia.
Two case presentations of the benefits and challenges of including multiple caregivers in treatment are discussed. Treatment outcome data for these cases were collected as part of a larger investigation of Peaceful Mind.
The involvement of multiple collaterals resulted in several benefits, including increased family communication, as well as increased opportunities for the practice of new skills. These cases have also presented unique challenges requiring alterations in therapy structure and attention to issues of family conflict.
Including multiple collaterals in cognitive-behavioral therapy for treating anxiety in persons with dementia is feasible and may be beneficial in maximizing treatment gains and increasing the family’s investment in therapy.
PMCID: PMC3086554  PMID: 21491216
cognitive-behavioral therapy; anxiety; dementia
25.  Self-reported antidepressant use among depressed, low-income homebound older adults: class, type, correlates, and perceived effectiveness 
Brain and Behavior  2012;2(2):178-186.
Little research has been done on the use of antidepressants among homebound older adults, especially low-income homebound older adults, and their perceptions of the effectiveness of their medication. The purposes of this study were to examine self-reported use of antidepressants among depressed homebound older adults, class and type of antidepressants used, individual-level correlates of antidepressant use, and users’ perceptions of the effectiveness of antidepressants. Data on self-reported use of antidepressants were obtained as part of a feasibility study of short-term telehealth problem-solving therapy for depressed low-income homebound adults (n = 162) aged 50 or older. The 24-item Hamilton Rating Scale for Depression (HAMD) was used to assess depression severity. The findings show that about half of the study participants were taking antidepressants, with 26.6% of those on antidepressants rating their medications very effective and 21.5% rating them effective. Female gender was positively, but older age and being Black/African American were negatively associated with the likelihood of antidepressant use. Perceived effectiveness of antidepressants was negatively associated with older age and the HAMD score. The findings suggest that personalized approaches to depression management may be needed in subgroups of depressed older adults, including culturally tailored medication counseling in Black/African-American older adults.
PMCID: PMC3345360  PMID: 22574284
Antidepressant; depression; homebound adults; perceived effectiveness

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