Treating psychiatrists in the outpatient mood disorders program of the Warneford Hospital, University of Oxford, Oxford, UK and Oxford Health Foundation NHS Trust approached patients under their care who met the following eligibility criteria: (i) age 16 years or older; (ii) a diagnosis of bipolar I (BD-I) or bipolar II (BD-II) disorder; (iii) in regular follow-up care with the psychiatrist; (iv) not in simultaneous psychotherapy with another provider; (v) not in an acute episode of mania or mixed illness; and (vi) willing to use mobile phone text messaging or Web form e-mail. Written informed consent was obtained prior to the first FIMM session. This study was approved by the Local Research Ethics Committee.
Development of FIMM
We sought to design a brief treatment that would be practicable in most community health centers. As a first step, we undertook a survey of 31 principal investigators and therapists who took part in one of 14 published randomized trials of psychotherapy for BD published before 2008 (17
). We coded the treatment elements that were present in all or most forms of manual-based therapy, and elements that were characteristic of certain treatments more than others. The results are summarized in . We were struck by the greater commonalities than differences among the treatment models, at least as reported by the clinicians who administered them.
Table 1 Common and specific elements of psychosocial treatments for bipolar disorder (17)
We developed the FIMM manual to include all eight common elements. Specific elements, such as behavioral activation exercises (i.e., pleasant events scheduling), were incorporated when patients had depressive symptoms and were experiencing significant social withdrawal. Written psychoeducational materials and homework assignments were given throughout the program.
The intervention was first developed in a 14-case open trial (Pilot I), with ongoing iteration and refinement, and informed by qualitative data gathered from patients on using the True Colours
system and their experiences in working with the facilitators (18
). Development took place in formal, multidisciplinary meetings and local supervision meetings of a research team at Oxford University (the OXTEXT team) and during weekly or biweekly internet supervision sessions involving the facilitators and the clinical supervisor (DJM). Changes or refinements to the intervention were then tested in a second open trial (Pilot II) with five new participants.
The four female facilitators who administered the experimental treatment in Pilots I and II were ages 24, 25, 26, and 56. Two had Psychology Bachelor’s degrees, one a Masters degree, and one a D.Phil. None had formal clinical qualifications or professional registration as a therapist. All worked at the Oxford University Department of Psychiatry and had variable durations of research experience with clinical populations (1.5, 3.0, 3.5, and 15 years). The first author (DJM) and two senior psychiatrists (JRG and GMG), who specialize in BD, trained the facilitators in administering FIMM in an initial three-day workshop. Training included lectures, videotaped examples, and role-playing of various treatment scenarios with coaching on effective responses. Over the next six months, the clinical supervisor provided biweekly supervision to the facilitators in a group setting using the electronic videoconferencing system Skype and e-mail.
True Colours system for monitoring mood
To be eligible for this pilot study, potential participants needed to be enrolled in the True Colours system and to have completed at least one month of mood monitoring before undertaking FIMM. The latter criterion over-selected for patients who were compliant with the texting procedures and perhaps, treatment in general. However, many such patients were markedly symptomatic and these symptoms became a focus for determining the short term outcome of the FIMM intervention.
The True Colours mood monitoring system, which uses text or e-mail messages (by patient preference) and validated self-rating scales of mood, was developed by clinicians and software engineers at the University of Oxford. Weekly text or e-mail messages from a central mobile phone prompt participants to complete weekly ratings on the five-item Altman Self-Rating Mania (ASRM) scale (19
) and the 16-item Quick Inventory of Depressive Symptoms–Self Report (QIDS-SR) scale (20
). Participants who used the text messaging option responded to text prompts with the letter ‘A’ indicating they were replying to the ASRM, or with the letter ‘Q’ indicating they were replying to the QIDS-SR, and then with a sequence of digits (5 for the ASRM, 16 for the QIDS-SR) corresponding to item responses. Rather than receiving the scale questions in each text message, the participants were supplied with wallet-sized versions of the rating scales with instructions on how to complete the ratings. For example, a participant completing the QIDS-SR would receive a text prompt, look at his or her rating card, and reply to the prompt ‘Q’ with numerical ratings for each of the 16 items (e.g., Q0330200001101111). If the participant’s text message response contained errors (e.g., too few responses, scores out of range), the system sent a reply requesting that the participant resubmit his or her responses. If the participant did not reply at all when first prompted, a reminder message was sent the following day and then again on a third day. If the third message did not prompt a response, the system did not send any more reminders and charted a ‘nonresponse’, but prompts were sent on subsequent weeks.
Participants who preferred the e-mail option received an e-mail prompt contained a Web link to open the same questionnaires. The default system sent prompts for entry every seven days. Data were stored on a central computer in the form of raw ASRM and QIDS-SR scores for each week of the study, as well as graphically, to display mood fluctuations over time. Graphical charts were sent on a weekly basis to the participant, the facilitator, and the treating psychiatrist.
The QIDS-SR is a 16-item measure of depression severity which covers the nine DSM-IV-TR (21
) symptoms related to the diagnosis of major depressive disorder. Participants were asked to rate each symptom on a 0–3 scale covering the previous seven days. Depression scores on the QIDS-SR correspond to five levels of severity: none: 0–5; mild: 6–10; moderate: 11–15; severe: 16–20; very severe: 21–27. Scores < 6 typically indicate euthymia. The QIDS-SR has established psychometric properties for rating depressive symptom severity in individuals with major depressive disorder (22
) and BD (23
). It does not purport to distinguish between dysthymic and major depressive mood states.
Participants rated the frequency and severity of their mania-related symptoms over the course of the previous week on five individual ASRM scales that each ranged from 0–4. Total ASRM scores range from 0–20, where scores of ≥ 6 indicate significant manic or hypomanic symptoms. The ASRM has established psychometric properties for detecting mania among bipolar patients (19
) and is sensitive to treatment effects among patients with severe and psychotic manic or mixed episodes (23
Because scale items do not measure the duration or functional impairment associated with symptoms, the ASRM does not distinguish between mania and hypomania. ASRM scores were used as continuous variables in order to examine the weekly severity of (hypo)manic symptoms. In a prior study using True Colours, dimensional QIDS-SR and ASRM scores distinguished between BD-I and BD-II patients and between male and female patients over an average of 36 weeks (15
Trends in QIDS-SR and Altman scores over the 120-day study period were estimated using linear mixed models, with random effects for subject and trend over time, and an unstructured variance-covariance matrix for the random effects (24
). Models were fit in Stata v11.2 using restricted maximum likelihood. Normality of residuals and random effects were checked graphically, as were the linearity of the effects.
Daily adaptation of True Colours mood monitoring
A limitation of any weekly mood rating system is that daily fluctuations in mood – often indicating emergent signs of an episode – are lost when averaging across a number of days (25
). In developing FIMM, we experimented with a more fine grained system of daily mood monitoring. The system was based on an analogue study in which people at high behavioral risk for BD provided daily mood ratings within an experience sampling framework (16
During the first psychoeducation session, participants were invited to supplement their weekly QIDS-SR and ASRM ratings with daily mood and sleep monitoring, which involved responding to two additional daily text messages or e-mails. One message asked participants to rate five moods (irritable, anxious, depressed, elated, energetic) on a scale of 1 (not at all) to 7 (very much) in terms of how they had felt in the previous 24 hours. The second message, sent at either 10 am or 12 noon asked participants to report their bedtime and the number of hours they had slept the previous night. If participants did not respond to the messages, or their response was not understood by the system they were sent another text message or e-mail prompting them to re-send their scores. Following the method piloted by Malik et al. (16
), graphic charts of patients’ responses over the previous seven days were drawn and used in the sessions to make links between mood and sleep variability and as a prompt for participants to recall associated stressors in the prior week (see example in ). Daily mood monitoring was no longer required after the psychoeducation sessions had ended.
OXTEXT Psychoeducation Mood and Sleep Chart (example).
The sections below describe the five-session FIMM protocol administered to patients in both pilot trials. A facilitator’s manual was used to guide the content of each session, alongside a range of handouts and worksheets for participants to complete during and between sessions.
The treatments offered in the two pilots differed in several ways. First, in Pilot I, patients were invited to take part in six weekly sessions, with Session 5 designated as a personalized, ‘free-form’ session to address comorbid disorders or longstanding interpersonal problems that were outside of the psychoeducational agenda. These typically included anxiety disorders, substance or alcohol abuse, chronic low self-esteem, relationship problems, or work or family conflicts. The rationale for placing this session just prior to the final session was that novel strategies for mood management might be revealed in a personalized session and would inform the mood management plan finalized in the sixth session. However, it quickly became clear that one session was not enough to address these issues adequately. Moreover, novice therapists were often not prepared to explore interpersonal problems in depth. Thus, in Pilot II, the personalized session was omitted such that the protocol was reduced to five sessions. Patients in both pilots were given referral information regarding additional specialized services for associated problems (e.g., CBT for anxiety disorders, couple therapy).
Second, in Pilot II a shared written agenda (in the form of summary bullet points) for each session was added to help the facilitator and patient develop a collaborative session plan and stay on track. A patient workbook was added to increase the involvement of patients during and between sessions. Paralleling the facilitator’s manual, it contained the handouts and worksheets for each session with a brief outline of each topic and its relevance to managing moods. This manual provided a greater structure for discussions of daily and weekly mood fluctuations, environmental triggers, and preventative strategies.
Involvement of caregivers
Although the content and format of FIMM sessions were organized primarily for the individual, participants were encouraged to invite a caregiver (spouse, parent or close friend) to sessions. Caregivers assisted the patient in identifying early warning signs of significant mood changes, risk and protective factors (e.g., one caregiver said to her husband, a teacher: ‘your mood starts changing when the school year starts, and then it changes again during Christmas’), or response strategies to use in emergency situations (e.g., agreeing to call the physician if the patient had escalating signs of mania; avoiding discussing certain ‘hot topics’ when the patient was unstable). Generally, the facilitator did not examine the history or current manifestations of couple or family relationship problems unless these problems clearly impeded the development of a mood-management plan (for example, a husband’s resentment of his wife’s reminders to take his medications). In such cases, the facilitator assisted the couple or family in developing alternative strategies that were less likely to ignite conflicts (for example, encouraging the patient to develop his own system for remembering medicines). Contact between the facilitator and caregiver was kept to a minimum between sessions. The facilitator made clear that FIMM did not replace couple or family therapy, and provided referrals as needed.
Session one: identifying the relapse signature
Facilitators began by ‘joining’ and expressing interest in the patient as a person (26
). This included a brief discussion of the patient’s own goals for treatment, how the goals of psychoeducation could be adjusted to mesh with these goals, and a preview of the sessions to follow. Facilitators explained that the major objective of psychoeducation was to develop a mood management plan to curtail the severity or reduce the duration of new mood episodes. The plan, consisting of a description of early warning signs, eliciting stressors, and possible prevention or emotion regulation techniques, would be built on a week by week basis and finalized in the last session.
First, the facilitator reviewed with the patient his or her prior manic and depressive episodes, with a focus on the sequential development of symptoms: which came first, second, and third and constituted the likely prodromal signature of new recurrences. Signatures could be quite different for mania (e.g., decreased sleep duration) and depression (e.g., rumination, inactivity). When caregivers participated, they were asked to recount their perceptions of how the patient’s prior episodes had developed.
Facilitators explained that mood episodes come about due to interactions between genetic vulnerabilities, biological vulnerabilities, individual behaviors (e.g., substance abuse), and environmental stressors. They explained that mood fluctuations could include subsyndromal mood swings as well as fully syndromal episodes, and that stressors could include episodic events (e.g., losses) or chronic environmental strains (e.g., ongoing family conflict). Patients were asked for examples of environmental factors or individual risk behaviors that appeared to play a role in past episodes (examples included ‘arguments with my wife,’ ‘missing a lot of sleep because of studying,’ or ‘drinking too much’).
Toward the end of session one, facilitators explained the procedure for tracking daily moods:
“Monitoring your mood and sleep every day may give us both insight into how much your moods tend to fluctuate and what factors in your life are associated with these fluctuations. Every day you will receive one text/e-mail message at some point between 4 pm and 5 pm asking you about your daily mood. Please text or e-mail us and tell us to what degree over the last 24 hours you have experienced each of the following five moods on a scale of 1 (not at all) to 7 (very much): Irritable, Anxious, Depressed, Elated, and Energetic.
Every morning you will also receive a separate text/e-mail message about your sleep the previous night. It will arrive at either 10 am or 12 noon. Please send a text or e-mail stating what time you went to bed last night. Finally, inform us of the number of hours you slept (to the nearest half hour).”
The facilitator then assisted the patient in registering for daily mood and sleep monitoring and practicing responding to the texts on his or her mobile phone or via e-mail on a local computer.
Session two: reviewing risk and protective factors
Facilitators began by reviewing the daily mood ratings and weekly (i.e., QIDS-SR, ASRM) symptom scale results from the previous week, emphasizing the link between mood changes and eliciting stressors. Then, they introduced the theme of the second session:
“We believe that individuals are better able to manage their mood swings when they can identify risk and protective factors. Risk factors and protective factors are those things that increase or decrease your chances of getting sick or having mood swings.”
Patients identified risk factors (e.g., substance or alcohol abuse, chaotic sleep habits) and protective factors (e.g., supportive family relationships, medication adherence, following strict sleep/wake habits) in their prior illness history. This discussion built on the themes introduced in the first session. For each risk factor, the facilitator asked the patient what she/he had learned about the relevance of the factor to his or her illness management (e.g., “So what have you concluded about your sleep/wake cycle?” “Any ideas of how your family could be more helpful when you’re depressed?”). Once again, input from caregivers on observations about risk or protective factors was solicited. The session concluded with a homework assignment – filling in a Risk and Protective Factors summary handout – and the instruction to continue with daily and weekly mood monitoring.
Session three: daily rhythm and sleep/wake regulation
This session emphasized the key role of regular daily routines and sleep/wake cycles in the course of BD (10
). At this stage, the patient had contributed two weeks of daily mood and sleep data via the True Colours monitoring system. Facilitators examined the mood and sleep charts with patients to identify the nature of any irregularities. These relationships generally fell into one of the following categories: (i) decreased sleep associated with increases in energy, elation, or irritability in the subsequent days; (ii) increased sleep associated with worsening depression or irritability; or (iii) changes in mood preceding changes in sleep.
Patients were asked to discuss any major or minor stressors that might have been associated with changes in mood or sleep. If family members or friends were present, they often added observations of their own (e.g., “she seemed agitated by the tax forms she was going to fill out the next day;” “when he starts ruminating he just sleeps and keeps to himself”
). The facilitator then suggested strategies for normalizing sleep/wake and daily rhythms: (i) getting up/going to bed at the same time every weekday and on weekends; (ii) having a one-hour wind-down time before bed; (iii) avoiding caffeine or stimulants late in the day; (iv) exercising (a minimum of four hours before bedtime); (v) eating at regular times; (vi) using self-relaxation or meditation exercises; (vii) and asking assistance from family members in maintaining sleep routines (28
). At the end of the session, patients were asked to make a list of sleep management strategies to practice, and to keep a log of which activities contributed to sleep problems in the forthcoming week, so that these activities could be examined in relation to daily mood ratings.
Session four: the role of medications and substance/alcohol abuse
Facilitators reviewed with the patient the medications in his or her regimen and asked the patient to discuss any concerns or misgivings he or she had about them. For example, some patients were confused as to why they were being treated with an atypical antipsychotic agent, despite having no psychotic symptoms. Patients’ or caregivers’ beliefs about medications (e.g., “I think they’re a crutch,” “I’ll eventually be able to go off of all of them”) were discussed and gently challenged if they were based on misinformation. The burden of side effects was acknowledged and, where appropriate, patients were offered advice on how to approach discussions or questions about medication with their psychiatrists. Facilitators assisted patients in developing plans to keep track of pills taken each day and to remember to refill prescriptions.
For a subset of patients, session four focused on substance or alcohol abuse. Generally, facilitators took a didactic stance, explaining that substances can worsen mood symptoms, and mood symptoms can increase the drive toward substances. The role of substance misuse in the patient’s prior manic or depressive episodes was reviewed. Caregivers were often helpful in providing examples that had been forgotten by the patient. Homework focused on keeping track of substance use during the forthcoming week so that the linkage between drinking, drug abuse, mood swings, and sleep disturbance could be clarified (see example).
Session five: finalizing the mood management plan
The goal of the final session was to generate a written summary of the patient’s early warning signs, risk and protective factors, and behavioral and/or pharmacological strategies to undertake when symptoms escalated. The patient was encouraged to share the plan with the treating psychiatrist and any caregivers who had not attended, and to update it as new information (i.e., responses to medication adjustments) became available. Participants discussed obstacles to putting the plan into practice. For the three months following the final session, facilitators scheduled biweekly and then monthly half-hour phone calls to check in with the patient and determine whether s/he had been implementing the plan.
Treatment fidelity ratings
The FIMM supervisor (DJM) listened to approximately 50% of the audiotaped sessions for each case. He applied fidelity ratings using a modified version of the Therapy Competence and Adherence Scale (TCAS) (29
) consisting of 21 Likert-type (range: 1–7) items covering various domains of clinician behavior: (i) effective provision of psychoeducation; (ii) explaining the mood monitoring strategies; (iii) assignment of homework; (iv) exploring prodromal symptoms; (v) developing prevention plans; and (vi) problem-solving about sleep/wake monitoring. The scales also covered nonspecific factors (rapport and alliance-building skills, pacing, session command, taking a didactic stance, addressing patients’ emotional reactions to the material) and proscribed strategies (e.g., psychoanalytic interpretations). For the present study, an overall one to seven score summarizing facilitators’ fidelity across domains was derived for each session. Inter-rater reliability for TCAS items ranged from 0.74 to 0.98 (intraclass rs, p’s < 0.001).
Bipolar Mood Management Questionnaire (BMMQ)
We developed the BMMQ (available from the corresponding author) to measure change in knowledge and behavior relevant to self-care in BD, and to guide the focus of the FIMM by establishing gaps in the patients’ knowledge base. The questionnaire comprised 20 items, such as ‘I know which early symptoms show that I am at risk of mood elevation’ or ‘At least one other person knows about my relapse prevention plan and its contents’. Patients rated their level of agreement with each statement on scales ranging from 0 = disagree through 1 = disagree a little, 2 = neither agree nor disagree, 3 = agree a little, and 4 = agree. Patients completed the questionnaire immediately prior to each of the five treatment sessions.
Cronbach’s alpha was calculated from week 1 data to assess internal consistency; values between 0.70 and 0.90 were regarded as optimal. Week 1 questionnaire data were compared with data from the last available questionnaire (either week 5 or week 6). When week 1 data were missing, the next observation was carried back, and when final week data were missing, the last observation was carried forward. The mean and standard deviation (SD) of the total knowledge score and the individual item scores were calculated at the first and last weeks. A pairwise t-test was conducted to determine the statistical significance of the change in total scores.