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1.  Predictors of Change in Quality of Life in Older Adults with Generalized Anxiety Disorder 
International psychogeriatrics / IPA  2014;27(7):1207-1215.
Background
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.
Methods
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.
Results
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.
Conclusions
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.
doi:10.1017/S1041610214002567
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.
doi:10.1080/15402002.2012.755125
PMCID: PMC3690155  PMID: 23470116
Bad dreams; older adults; anxiety; GAD; CBT
4.  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.
doi:10.1177/0145445513477420
PMCID: PMC3872091  PMID: 23447103
5.  The Peaceful Mind Program: A Pilot Test of a CBT-Based Intervention for Anxious Patients with Dementia 
Objectives
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).
Design
Pilot randomized controlled trial including assessments at baseline, 3 and 6 months
Setting
Houston, TX
Participants
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.
Intervention
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.
Measurements
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
Results
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.
Conclusions
Results support that Peaceful Mind is ready for future comparative clinical trials.
doi:10.1016/j.jagp.2013.01.007
PMCID: PMC3411894  PMID: 23567399
anxiety; dementia; cognitive behavioral therapy; self-ratings; proxy ratings
6.  Improving recognition of late life anxiety disorders in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition: observations and recommendations of the Advisory Committee to the Lifespan Disorders Work Group 
Background
Recognition of the significance of anxiety disorders in older adults is growing. The revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM) provides a timely opportunity to consider potential improvements to diagnostic criteria for psychiatric disorders for use with older people. The authors of this paper comprise the Advisory Committee to the DSM5 Lifespan Disorders Work Group, the purpose of which was to generate informative responses from individuals with clinical and research expertise in the field of late-life anxiety disorders.
Methods
This paper reviews the unique features of anxiety in later life and synthesizes the work of the Advisory Committee.
Results
Suggestions are offered for refining our understanding of the effects of aging on anxiety and other disorders (e.g., mood disorders) and changes to the DSM5 criteria and text that could facilitate more accurate recognition and diagnosis of anxiety disorders in older adults. Several of the recommendations are not limited to the study of anxiety but rather are applicable across the broader field of geriatric mental health.
Conclusions
DSM5 should provide guidelines for the thorough assessment of avoidance, excessiveness, and comorbid conditions (e.g., depression, medical illness, cognitive impairment) in anxious older adults.
doi:10.1002/gps.2752
PMCID: PMC4048716  PMID: 21773996
aging; anxiety; geriatric mental health; DSM-V; older adult; later life
7.  Implementing brief cognitive behavioral therapy in primary care: A pilot study 
ABSTRACT
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.
doi:10.1007/s13142-013-0248-6
PMCID: PMC4041920  PMID: 24904701
Primary care; Hybrid effectiveness-implementation designs; Cognitive behavioral therapy; Veterans; Anxiety; Depression
8.  Treating late-life GAD in primary care: An effectiveness pilot study 
Objective
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.
Method
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).
Results
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.
Conclusion
Preliminary results suggest adapted CBT can effectively reduce worry. The piloted modifications can provide acceptable and feasible evidence-based care.
doi:10.1097/NMD.0b013e31828e0fd6
PMCID: PMC3644354  PMID: 23588228
cognitive behavioral therapy; generalized anxiety disorder; primary care; older adults; mental health
9.  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.
doi:10.1016/j.evalprogplan.2013.01.003
PMCID: PMC3594523  PMID: 23434724
Primary Care; Psychotherapy; Generalized Anxiety Disorder; Older Adults; Treatment Satisfaction; Adherence; Expectancies; Social Support
10.  Multisystemic Therapy for Child Non-Externalizing Psychological and Health Problems: A Preliminary Review 
Multisystemic therapy (MST) is effective for decreasing or preventing delinquency and other externalizing behaviors and increasing prosocial or adaptive behaviors. The purpose of this project was to review the literature examining the efficacy of MST for other child psychological and health problems reflecting non-externalizing behaviors, specifically difficulties related to child maltreatment, serious psychiatric illness [Serious psychiatric illness was defined throughout the current review paper as the “presence of symptoms of suicidal ideation, homicidal ideation, psychosis, or threat of harm to self or others due to mental illness severe enough to warrant psychiatric hospitalization based on the American Academy of Child and Adolescent Psychiatry (Level of care placement criteria for psychiatric illness. American Academy of Child and Adolescent Psychiatry, Washington, DC, 1996) level of care placement criteria for psychiatric illness” (Henggeler et al. in J Am Acad Child Psy 38:1331–1345, p. 1332, 1999b). Additionally, youth with “serious emotional disturbance (SED)” defined as internalizing and/or externalizing problems severe enough to qualify for mental health services in public school who were “currently in or at imminent risk of a costly out-of-home placement” (Rowland et al. in J Emot Behav Disord 13:13–23, pp. 13–14, 2005) were also included in the serious psychiatric illness category.], and health problems (i.e., obesity and treatment adherence for diabetes). PubMed, Web of Science, MEDLINE, and PsycINFO databases; Clinicaltrials.gov; DARE; Web of Knowledge; and Cochrane Central Register of Controlled Trials were searched; and MST developers were queried to ensure identification of all relevant articles. Of 242 studies identified, 18 met inclusion criteria for review. These were combined in a narrative synthesis and critiqued in the context of review questions. Study quality ratings were all above mean scores reported in prior reviews. Mixed support was found for the efficacy of MST versus other treatments. In many cases, treatment effects for MST or comparison groups were not sustained over time. MST was efficacious for youth with diverse backgrounds. No studies discussed efficacy of MST provided in different treatment settings. Four studies found MST more cost-effective than a comparison treatment, leading to fewer out-of-home placements for youth with serious psychiatric illness or lower treatment costs for youth with poorly controlled diabetes.
doi:10.1007/s10567-012-0127-6
PMCID: PMC3800084  PMID: 23385370
Multisystemic; Treatment; Internalizing; Maltreatment; Health problems
11.  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.
doi:10.1016/j.janxdis.2012.11.001
PMCID: PMC3578141  PMID: 23270995
worry; anxiety; elders; dementia; self-ratings; proxy ratings
12.  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.
doi:10.1016/j.psychres.2012.03.045
PMCID: PMC3401329  PMID: 22503380
Pittsburgh Sleep Quality Index; psychometrics; generalized anxiety disorder; elderly; cognitive behavioral therapy
13.  A Randomized Controlled Trial of Telephone-Delivered Cognitive-Behavioral Therapy for Late-life Anxiety Disorders 
Objectives
Older adults face a number of barriers to receiving psychotherapy, such as a lack of transportation and access to providers. One way to overcome such barriers is to provide treatment by telephone. The purpose of this study was to examine the effects of cognitive behavioral therapy delivered by telephone (CBT-T) to older adults diagnosed with an anxiety disorder.
Design
Randomized controlled trial.
Setting
Participants' homes.
Participants
Sixty participants ≥ 60 years of age with a diagnosis of Generalized Anxiety Disorder, Panic Disorder, or Anxiety Disorder Not Otherwise Specified.
Intervention
CBT-T vs. information-only comparison.
Measurements
Co-primary outcomes included worry (Penn State Worry Questionnaire) and general anxiety (State Trait Anxiety Inventory). Secondary outcomes included clinician-rated anxiety (Hamilton Anxiety Rating Scale), anxiety sensitivity (Anxiety Sensitivity Index), depressive symptoms (Beck Depression Inventory), quality of life (SF-36), and sleep (Insomnia Severity Index). Assessments were completed prior to randomization, immediately upon completion of treatment, and 6 months after completing treatment.
Results
CBT-T was superior to information-only in reducing general anxiety (ES = 0.71), worry (ES = 0.61), anxiety sensitivity (ES = 0.85), and insomnia (ES = 0.82) at the post-treatment assessment; however, only the reductions in worry were maintained by the 6 month follow-up assessment (ES = 0.80).
Conclusions
These results suggest that CBT-T may be efficacious in reducing anxiety and worry in older adults, but additional sessions may be needed to maintain these effects.
doi:10.1097/JGP.0b013e31822ccd3e
PMCID: PMC3407971  PMID: 22828172
anxiety; cognitive-behavioral therapy; elderly; Generalized Anxiety Disorder; Panic Disorder; telephone-delivered psychotherapy
14.  Psychometric Properties of a Structured Interview Guide for the Rating for Anxiety in Dementia (RAID-SI) 
Aging & mental health  2012;16(5):592-602.
OBJECTIVES
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.
METHOD
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.
RESULTS
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.
CONCLUSION
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.
doi:10.1080/13607863.2011.644518
PMCID: PMC3371288  PMID: 22372475
dementia; anxiety; clinical interview; assessment; Rating for Anxiety in Dementia
15.  Development and Pilot Testing of a Standardized Training Program for a Patient-Mentoring Intervention to Increase Adherence to Outpatient HIV Care 
AIDS Patient Care and STDs  2012;26(3):165-172.
Abstract
Although peer interventionists have been successful in medication treatment-adherence interventions, their role in complex behavior-change approaches to promote entry and reentry into HIV care requires further investigation. The current study sought to describe and test the feasibility of a standardized peer-mentor training program used for MAPPS (Mentor Approach for Promoting Patient Self-Care), a study designed to increase engagement and attendance at HIV outpatient visits among high-risk HIV inpatients using HIV-positive peer interventionists to deliver a comprehensive behavioral change intervention. Development of MAPPS and its corresponding training program included collaborations with mentors from a standing outpatient mentor program. The final training program included (1) a half-day workshop; (2) practice role-plays; and (3) formal, standardized patient role-plays, using trained actors with “real-time” video observation (and ratings from trainers). Mentor training occurred over a 6-week period and required demonstration of adherence and skill, as rated by MAPPS trainers. Although time intensive, ultimate certification of mentors suggested the program was both feasible and effective. Survey data indicated mentors thought highly of the training program, while objective rating data from trainers indicated mentors were able to understand and display standards associated with intervention fidelity. Data from the MAPPS training program provide preliminary evidence that peer mentors can be trained to levels necessary to ensure intervention fidelity, even within moderately complex behavioral-change interventions. Although additional research is needed due to limitations of the current study (e.g., limited generalizability due to sample size and limited breadth of clinical training opportunities), data from the current trial suggest that training programs such as MAPPS appear both feasible and effective.
doi:10.1089/apc.2011.0248
PMCID: PMC3326443  PMID: 22248331
16.  Characteristics of Generalized Anxiety Disorder in Patients With Dementia 
Background
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.
Methods
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.
Results
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.
Conclusions
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.
doi:10.1177/1533317511426867
PMCID: PMC3252749  PMID: 22062223
Generalized anxiety disorder; dementia; anxiety symptoms; dementia symptoms; differential diagnosis for generalized anxiety disorder/dementia
17.  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.
doi:10.1097/NMD.0b013e31822feda6
PMCID: PMC3187557  PMID: 21964278
GAD; older adults; treatment response; quality of life
18.  Innovations in research for treatment of late-life anxiety 
Aging & mental health  2011;15(7):811-821.
Objectives
While psychosocial interventions for late-life anxiety show positive outcomes, treatment effects are not as robust as in younger adults. To date, the reach of research has been limited to academic and primary care settings, with homogeneous samples. The current review examines recently funded and ongoing late-life anxiety research that uses innovative approaches to reach unique patient populations and tailor treatment content and delivery options to meet the unique needs of older adults.
Method
A systematic search was conducted using electronic databases of funded clinical trials to identify ongoing psychosocial intervention studies targeting older adults with anxiety. The principal investigators of the studies were contacted for study details and preliminary data, if available. In some cases, the principal investigators of identified studies acted as referral sources in identifying additional studies.
Results
Eleven studies met inclusion criteria and represented three areas of innovation: new patient groups, novel treatment procedures, and new treatment delivery options. Studies and their associated theoretical bases are discussed, along with preliminary results reported in published papers or conference presentations.
Conclusion
Psychosocial intervention trials currently in progress represent promising new strategies to facilitate engagement and improve outcomes among unique subsets of older adults with anxiety. Continued investigation of evidence-based treatments for geriatric anxiety will allow greater understanding of how best to tailor the interventions to fit the needs of older adults.
doi:10.1080/13607863.2011.569487
PMCID: PMC3163048  PMID: 21702723
psychosocial treatment; late life anxiety; generalized anxiety disorder; older adults; review
19.  Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness-implementation design 
Background
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.
Methods
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.
Conclusions
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 http://www.clinicaltrials.gov/ct2/show/NCT01149772
doi:10.1186/1748-5908-7-64
PMCID: PMC3503767  PMID: 22784436
Primary care; Hybrid effectiveness-implementation designs; Cognitive behavioral therapy; Mental health; Veterans; Anxiety; Depression
20.  Cognitive Behavior Therapy for Generalized Anxiety Disorder Among Older Adults in Primary Care: A Randomized Clinical Trial 
Jama  2009;301(14):1460-1467.
Context
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. .
Objective
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).
Intervention
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).
Results
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).
Conclusion
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.
doi:10.1001/jama.2009.458
PMCID: PMC3328789  PMID: 19351943
21.  Early Response to Psychotherapy and Long-term Change in Worry Symptoms in Older Adults with Generalized Anxiety Disorder 
Objectives
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.
Design
Substudy of larger randomized controlled trial
Setting
Family medicine clinic and large multi-specialty health organization in Houston, TX, between March 2004 and August 2006
Participants
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.
Intervention
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)
Measurements
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.
Results
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.
Conclusions
Early symptom reduction is associated with long-term outcomes after psychotherapy in older adults with GAD.
doi:10.1097/JGP.0b013e3181f18061
PMCID: PMC3058752  PMID: 21427643
psychotherapy; generalized anxiety disorder; older adults
22.  The involvement of multiple caregivers in cognitive-behavior therapy for anxiety in persons with dementia 
Aging & mental health  2011;15(3):291-298.
Objectives
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.
Method
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.
Results
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.
Conclusions
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.
doi:10.1080/13607860903493374
PMCID: PMC3086554  PMID: 21491216
cognitive-behavioral therapy; anxiety; dementia
23.  The Roles of Social Support and Self-efficacy in Physical Health's Impact on Depressive and Anxiety Symptoms in Older Adults 
Physical illness may precipitate psychological distress among older adults. This study examines whether social support and self-efficacy moderate the associations between physical health and depression and anxiety. Predictions were tested in 222 individuals age 60 or older presenting for help with worry. Physical health was assessed through self-report (subjective) and physical diagnoses (objective). Objective physical health did not have a significant association with depression or anxiety. Worse subjective physical health was associated with increased somatic anxiety, but not with depression or worry. The relationship between subjective physical health and depressive symptoms was moderated by self-efficacy and social support. As predicted, when self-efficacy was low, physical health had its strongest negative association with depressive symptoms such that as physical health improved, depressive symptoms also improved. However, the moderation effect was not as expected for social support; at high levels of social support, worse physical health was associated with increased depressive affect.
doi:10.1007/s10880-010-9211-6
PMCID: PMC3053526  PMID: 21110074
elderly; depression; anxiety; social support; self-efficacy; physical health
24.  Peaceful Mind: An Open Trial of Cognitive-Behavioral Therapy for Anxiety in Persons With Dementia 
International psychogeriatrics / IPA  2010;22(6):1012-1021.
Background
Anxiety has a high prevalence among individuals with dementia, and it has a significant negative impact on their functioning; yet intervention studies are lacking. We developed Peaceful Mind, a cognitive-behavioral intervention for persons with dementia. In this article, we describe the intervention and results of an open trial evaluating the feasibility and utility of the intervention and assessment procedures.
Methods
Peaceful Mind is implemented over a period of 3 months in the participant's home with involvement of a caregiver or “collateral.” Dyads are followed for an additional 3 months via telephone. An assortment of simplified skills is offered, including self-awareness, breathing, behavioral activation, calming thoughts, and sleep skills.
Results
Nine participants were enrolled, eight completed the 3-month assessment, and seven completed the 6-month assessment. Overall, participants and collaterals were satisfied with the intervention and reported that they benefited in terms of anxiety, depression, and collateral distress.
Conclusions
A randomized controlled trial would help determine whether this promising new treatment has a statistically significant impact on anxiety in this population.
doi:10.1017/S1041610210000694
PMCID: PMC3071800  PMID: 20550745
CBT; caregiver; intervention; home
25.  Feasibility and Acceptability of Bibliotherapy and Telephone Sessions for the Treatment of Late-life Anxiety Disorders 
Clinical gerontologist  2010;33(1):62-68.
This article describes the development of Biblio and Telephone Therapy or BTT, a cognitive-behavioral treatment program for late-life anxiety disorders. Although studies have examined bibliotherapy for the treatment of late-life depression, none have studied it as a format for treating late-life anxiety. The application of this treatment to 4 older adults with Generalized Anxiety Disorder (GAD) and/or Panic Disorder (PD) is described and benefits, advantages and limitations are discussed.
doi:10.1080/07317110903344968
PMCID: PMC2909126  PMID: 20661315

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