Bipolar disorder Mental and Behavioural Disorders
Conditions
Interventions
This is a feasibility study with two arms: usual care + the new therapy, and usual care only. 60 participants will be randomised to these two arms, with half receiving each.
As this is a feasibility
Sponsors
University of Exeter
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Participants will be adults who: 1. Meet research diagnostic criteria for Bipolar I or II Disorder, Other Specified Bipolar Disorder or Cyclothymic Disorder 2. Do not meet the criteria for a manic or severe depressive episode 3. Have IEBS, defined as at least mild depressive symptoms (Patient Health Questionnaire [PHQ9] >=5) or above-average bipolar mood instability defined as >=1.3 on the brief Affective Lability Scale (ALS) depression-elation scale 4. Are willing to engage in psychological work addressing IEBS or its impact on functioning 5. Sufficient English to complete questionnaires without translation 6. Have completed the intake measures 7. Are registered with a General Practice within the study site catchment area
Exclusion criteria
Exclusion criteria: 1. Current substance dependence according to ICD-11 criteria (as this may interfere with the ability to engage in and use therapy; current substance abuse is not an exclusion criterion). 2. Risk of harm to self or others that cannot be safely managed in a community outpatient setting. 3. Currently engaged in another psychological therapy for bipolar disorder. 4. Participant anticipates they will be unable to regularly attend therapy sessions within the site area (e.g. planning to move out of the study area, work commitments prevent regular attendance, lengthy period of travel not mitigated by access to online therapy sessions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Average recruitment rate recorded as the number of eligible participants recruited per site over 15 months to assess the feasibility of a future trial 2. Completion of the 30-week follow-up point | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcome measures (completed at baseline, 14, 30 and 52-week follow-up) 1. Depression symptom severity measured using the Patient Health Questionnaire – 9 (PHQ-9) 2. The extent to which mood tends to fluctuate measured using the Affective Lability Scales (ALS) 3. Level of current mania symptoms measured using the Bech-Rafaelsen Mania Scale 4. Disorder-specific quality of life measured using Brief Quality of Life in Bipolar Disorder (QoLBD) 5. Anxiety symptoms measured using the General Anxiety Disorder Assessment – 7 (GAD-7) 6. Sense of personal recovery measured using the Bipolar Recovery Questionnaire (BRQ) 7. Life chart self-report – self-report of number and duration of depressive and manic episodes in the period since the last assessment (completed at 14, 30 and 52-week follow-up points only) 8. Health economic variables (employment, health service use, ability to perform activities of daily living) measured using the Health Economics Questionnaire (HEQ) over the past 6 months / since last contact 9. Health-related quality of life measured using EQ-5D-5L | — |
Countries
England, United Kingdom
Contacts
Public ContactStudy Team
Outcome results
None listed