Bipolar disorder Mental and Behavioural Disorders Bipolar affective disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. DSM-V diagnosis of bipolar disorder (I, II or other specified) assessed using the Structured Clinical Interview for DSM-V (SCID) 2. Aged 16 or above; Updated 31/01/2019: Aged 18 or above 3. Score 5 or above on the Generalised Anxiety Disorder Assessment (GAD7) 4. Sufficient understanding of English in order to be able to engage in the study
Exclusion criteria
Exclusion criteria: 1. Currently within an episode of depression or mania 2. Unable to provide informed consent 3. Acute suicide risk 4. DSM-V diagnosis of substance use disorder, moderate or severe assessed using SCID 5. A change in medication within 3 months prior to randomisation 6. Currently engaged in a psychological intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment measured by number of referrals and number consenting and randomised; Timepoint: Baseline 2. Retention measured by percentage follow-up and questionnaire response rates; Timepoint(s): 4 and 8 months assessment points Progression to a full trial will be based on the following criteria: 1. No serious negative consequences are associated with trial participation (criterion 1) 2. Any concerns over the feasibility and acceptability of a full trial can be rectified (criterion 2) 3. Overall recruitment at 80% or above within the 12-month recruitment period (criterion 3) 4. 8-month follow up data is obtained from at least 80% of participants (criterion 4) 5. At least 80% of participants allocated to the intervention group do not drop out (i.e. attend at least 50% of the possible sessions) (criterion 5) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Attendance at intervention sessions; Timepoint: 4 months 2. Qualitative interview exploring the personal experiences of involvement in the trial (including both arms); Timepoint: 4 months | — |
Countries
United Kingdom