Topic: Mental Health
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meet DSM-IV criteria for bipolar I or II disorder, or bipolar disorder not otherwise specified, characterised by a past major depressive episode and DSM-IV hypomania of two days or more (Akiskal et al., 2006). 2. Complete baseline assessment sessions in an outpatient setting 3. A baseline score of at least 15 on the Beck Depression Inventory that is maintained over two consecutive weeks prior to the study (to ensure presence of significant current distress as targeted in the trial) 4. Aged 16 and above
Exclusion criteria
Exclusion criteria: 1. A diagnosis of a non-affective psychotic disorder according to DSM-IV 2. Current mania or mixed episode according to DSM-IV 3. A primary substance use disorder according to DSM-IV 4. Moderate to severe learning disability 5. Organic impairment that accounts for mental health problem 6. Non-English speaking (owing to the standardised assessment measures)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Beck Depression Inventory (Beck et al., 1961); Timepoint(s): self-report scale administered at baseline, and 3, 6, 12, and 18 months post randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anxiety (GAD-7; Spitzer et al., 2006); Timepoint(s): 0, 3, 6, 12, 18 months 2. Composite internal state scale score (ISS; Bauer et al., 1991); Timepoint(s): 0, 3, 6, 12, 18 months 3. Hamilton (1960) Depression; Timepoint(s): 0, 3, 6, 9, 12, 18 months 4. Health status (EQ-5D/Euroqol, Kind et al 1996).; Timepoint(s): 0, 3, 6, 12, 18 months 5. Hypomanic Attitudes and Positive Predictions Inventory; Dodd et al., 2009; Mansell, 2006; Timepoint(s): 0, 3, 6, 12, 18 months 6. Measure of manic symptoms (Bech-Rafaelson; Bech et al., 1978); Timepoint(s): 0, 3, 6, 12, 18 7. Recovery measure (Pitt et al., in press); Timepoint(s): 0, 3, 6, 12, 18 months 8. SCID-LIFE interview for episodes of mania or depression (Paykel et al., 2006); Timepoint(s): 0, 3, 6, 12, 18 months | — |
Countries
United Kingdom