Group psychoeducation versus group support using expert patients and clinical staff in the management of bipolar disorder

Conditions

Bipolar disorder Mental and Behavioural Disorders Bipolar affective disorder

Steven Jones, Lisa Riste, Christine Barrowclough, Peter Βartlett, Caroline Clements et al. (16 authors)

Programme Grants for Applied Research2018-09-0120 citations

Clinical effectiveness and acceptability of structured group psychoeducation versus optimised unstructured peer support for patients with remitted bipolar disorder (PARADES): a pragmatic, multicentre, observer-blind, randomised controlled superiority trial.

Morriss R, Lobban F, Riste L, Davies L, Holland F, Long R, Lykomitrou G, Peters S, Roberts C, Robinson H, Jones S, NIHR PARADES Psychoeducation Study Group.

2016-09-2742 citations

10.1016/s2215-0366(16)30302-9

PARADES Trial Psycho-Education Statistical Analysis Plan

Holland Fiona, Roberts Chris

Figshare2016-01-01

10.6084/m9.figshare.3205738.v4

Interventions

1. Bipolar Group Psychoeducation Intervention: The group will be run by three facilitators, two health professionals (usually one experienced and one in training), specially trained for the purpose

and one expert patient, also specially trained. The group psychoeducation programme will have 21 sessions, running for 90 minutes: 1.1. Meeting the group and what is bipolar disorder 1.2. Causes of bi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (SCID-DSM-IV) verified diagnosis of primary bipolar disorder 2. Increased risk of relapse (at least one episode in the last 24 months) 3. Age over 18 years, either sex

Exclusion criteria

Exclusion criteria: 1. Presence of a current manic, hypomanic, mixed affective or major depressive episode currently or within the previous 8 weeks 2. Current suicide plans or high suicide intent 3. Inability or unwillingness to give written informed consent to the study 4. Participants would have to be able to communicate in written and verbal English to a sufficient level to allow them to complete the measures and take part in the groups

Design outcomes

Primary

Measure	Time frame
1. Time to next bipolar episode and average weekly symptom score, both established using four monthly SCID LIFE interviews to generate weekly scores of mania and depression on 1 - 6 scale of severity 2. Primary economic measure of incremental cost per quality adjusted life year gained Follow-up of each patient will be for 24 months from randomisation. Patients who had not relapsed at 24 months will be censored on the time to next episode outcome. The peak effect of psychoeducation on time to next bipolar episode have been observed at 24 months after randomisation. Baseline interview using the SCID will assess the presence of axis 1 and axis 2 comorbid psychopathology and the number of previous bipolar episodes.	—

Measure

Time frame

1. Time to next bipolar episode and average weekly symptom score, both established using four monthly SCID LIFE interviews to generate weekly scores of mania and depression on 1 - 6 scale of severity 2. Primary economic measure of incremental cost per quality adjusted life year gained Follow-up of each patient will be for 24 months from randomisation. Patients who had not relapsed at 24 months will be censored on the time to next episode outcome. The peak effect of psychoeducation on time to next bipolar episode have been observed at 24 months after randomisation. Baseline interview using the SCID will assess the presence of axis 1 and axis 2 comorbid psychopathology and the number of previous bipolar episodes.

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Secondary

Measure	Time frame
1. Assessment of weekly symptoms using the LIFE 2. Assessment of function using the Social Adjustment Scale, and Social and Occupational Functioning Assessment Scale (SOFAS) 3. Observer and self-rated measures of mood: 17-item Hamilton Depression Scale (HDRS), Bech-Raphaelson Mania Scale (MAS), Beck Depression Inventory (BDI) and PHQ-9 (Personal Health Questionnaire) 4. Medication adherence Schedule of assessment: At baseline, 12 and 24 months (face to face assessments): SAS, Economic Interview (CSRI), EuroQol At 4, 8, 16, and 20 months (telephone assessments): LIFE, HDRS, MAS, SOFAS, MedAd, BDI version 1(by post), PHQ-9 (by post)	—

Measure

Time frame

1. Assessment of weekly symptoms using the LIFE 2. Assessment of function using the Social Adjustment Scale, and Social and Occupational Functioning Assessment Scale (SOFAS) 3. Observer and self-rated measures of mood: 17-item Hamilton Depression Scale (HDRS), Bech-Raphaelson Mania Scale (MAS), Beck Depression Inventory (BDI) and PHQ-9 (Personal Health Questionnaire) 4. Medication adherence Schedule of assessment: At baseline, 12 and 24 months (face to face assessments): SAS, Economic Interview (CSRI), EuroQol At 4, 8, 16, and 20 months (telephone assessments): LIFE, HDRS, MAS, SOFAS, MedAd, BDI version 1(by post), PHQ-9 (by post)

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Countries

United Kingdom

Outcome results

None listed