Topic: Mental Health Research Network
Conditions
Interventions
A new therapeutic intervention for use in bipolar disorder, known as Integrated Mood Management (IMM), has been developed by the research team. This is composed of five sessions which aim to educate
versus
b) True Colours monitoring plus FIMM (face-to-face support from a trained facilitator and several telephone contact ?boosters-sessions?)
Both control and intervention arms are selected from p
Study Entry : Single Randomisation only
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant in OXTEXT-1, and has opted into considering participation in further research studies 2. Participant is willing and able to give informed consent for participation in the study. 3. Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) bipolar I or II 4. Aged 16 or over 5. Reliable participation in True Colours mood monitoring for >=4 weeks (at least 3 out of 4 responses received for both Quick Inventory of Depressive Symptoms (QIDS) and Altman Self-Rating Mania (ASRM) over the last 4 weeks prior to invitation to participate). 6. Understanding of verbal and written English that is sufficient to participate in trial procedures, including integrated mood management (IMM).; Target Gender: Male & Female ; Lower Age Limit 16 years
Exclusion criteria
Exclusion criteria: 1. Current participant in OXTEXT- 2(because delivery of an additional intervention would confound the results of this pre- vs post-monitoring cost comparison study) 2. Treating psychiatrist or research team judge prospective participant to be acutely unwell to the extent that they cannot participate in IMM 3. Treating psychiatrist considers IMM to be inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quick Inventory of Depressive Symptomatology; Timepoint(s): 3 and 12 months after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Altman Self-Rating Mania Scale; Timepoint(s): 3 and 12 months after randomisation 2. EuroQol EQ-5D; Timepoint(s): Monthly post randomisation 3. ICECAP-A questionnaire; Timepoint(s): Baseline and 3, 6,9 and 12 months 4. Medicines and health resource use questionnnaire; Timepoint(s): Baseline then 3,6,9 and 12 months 5. OxCAP-MH; Timepoint(s): Baseline and 12 months post randomisation 6. Self-management knowledge, understanding and action; Timepoint(s): Baseline and 3,6,9 and 12 months post randomisation 7. Time to recurrence; Timepoint(s): 3,6,9 and 12 months post randomisation | — |
Countries
United Kingdom
Outcome results
None listed