None listed
Conditions
Brief summary
While medication is considered the first line of treatment in BD, there is increasing evidence that the course of BD can be further modified by interventions targeted at the social and environmental context. Most people with BD are discharged within 4-6 months there is a sub-group who spend years on community mental health service caseloads because they do not respond to medication, may have a rapid cycling form of the disorder and/or do not recover from mood episodes. There are no formal adjunctive therapies available for BD in usual practice. SRT is a clinical adaptation of Interpersonal and Social Rhythm Therapy (IPSRT) (Frank 2005). It is based on the stress-vulnerability model. Design This study is an open-label trial of SRT for patients under the care of community mental health services with treatment resistant BPD. The aim of the study is to examine whether SRT is effective in stabilizing social rhythms in patients with treatment resistant BD. Participants Twenty patients will be recruited from community mental health services for 12 weeks of SRT as an adjunct to their usual care. Participants will remain under the care of mental health services but will have weekly one-hour SRT sessions. Primary hypothesis: Following 12 sessions of SRT and 6 months from baseline patients will demonstrate improved mood symptoms. Secondary hypotheses: Following 12 weeks of SRT patients will have: o Improvement in quality of life o Improvement in social rhythm stability o Improvement in level of functioning Measurement: • Mood symptoms will be measured using The Longitudinal Interval Follow-up Evaluation (LIFE) (Keller et al. 1987) at baseline and 6 months to determine the occurrence of episodes of hypomania, major depressive disorder or mania. • Stability in social rhythms will be measured using the Social Rhythm Matrix (Monk et al. 1991). This is a daily self-report of social rhythm activities: sleep, eating, activities. Stability will be measured as < 45-minute discrepancy between the times of target and actual social rhythms. Stability is defined as a score indicating that all social rhythms have been occurring within a 45-minute window over the final 2 weeks of SRT. • Quality of life will be measured using QoL-BD (Michalak and Murray 2010) a validated measure for those with BD. • Level of functioning will be measured using The Functioning Assessment Short Test (Rosa et al. 2007). Qualitative interviews Qualitative interviews will be conducted at baseline exploring the participants’ experiences of BD and treatment, and their perceptions on what they need to recover. The primary analysis will compare scores generated at baseline (from the 6 months prior to baseline) and those generated 6 months post baseline (from the 6 months after baseline) using paired T-tests. Other comparisons will also be by simple paired t-tests in order to generate effect size differences.
Interventions
Social rhythm therapy is an adaptation of Interpersonal and Social Rhythm Therapy. It is 12-session face-to-face and online course of Social Rhythm Therapy over 12-14 weeks. In most cases this will be completed over 12 weeks but in order to maintain a patient-centred approach we have built in the flexibility for an extension of two weeks if patients are unable to attend some sessions.
The goals of SRT are to improve sleep quality, monitor and assess social rhythmicity, regularise social rhythms
Social rhythm therapy is an adaptation of Interpersonal and Social Rhythm Therapy. It is 12-session face-to-face and online course of Social Rhythm Therapy over 12-14 weeks. In most cases this will be completed over 12 weeks but in order to maintain a patient-centred approach we have built in the flexibility for an extension of two weeks if patients are unable to attend some sessions. The goals of SRT are to improve sleep quality, monitor and assess social rhythmicity, regularise social rhythms in the context of promoting self-awareness of how BD is impacting on each person’s life. It is a structured therapy and incorporates two generic psychotherapy components (promotion of self-awareness and articulation of the experience of BD symptoms) and one specific component (promotion of social rhythm regularity). It will be delivered by psychotherapists with at least 6 years experience in the Psychological Medicine Clinical Research Unit, University of Otago, Christchurch. The intervention will be delivered as 1 x one hour session per week for 12 sessions. The intervention is manualised and sessions will be audio-recorded and reviewed by a psychotherapy supervisor. Fidelity will be assessed using an adaptation of the fidelity scale developed by Frank et al 2005.
Sponsors
University of Otago, Christchurch
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
aged 18 years +; currently under community mental health service care; diagnosis of Bipolar I or Bipolar II; treatment resistant BD (have been in treatment with mental health services for two years during which time they have spent at least 4 months in each year in an episode of depression, mania, hypomania or mixed mood); must have been trialled on three mood stabilisers including a trial of Lithium; able to access internet.
Exclusion criteria
BD not primary diagnosis; unable to provide informed consent; unable to participate in a 12-week psychotherapy.
Outcome results
None listed