Can a new talking therapy for people with bipolar disorders lead to improvements that are better than their usual treatment?

Not Applicable

Completed

• Conditions: Topic: Mental Health; Subtopic: Bipolar affective disorder; Disease: Bipolar affective disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN83928726
• Lead Sponsor: niversity of Manchester (UK)

Brief Summary

1. 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25344393 2. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/27654637

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-01-13
• Study Start: 2014-07-25
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>3. Hamilton (1960) Depression; Timepoint(s): 0, 3, 6, 9, 12, 18 months<br>4. Health status (EQ-5D/Euroqol, Kind et al 1996).; Timepoint(s): 0, 3, 6, 12, 18 months<br>5. Hypomanic Attitudes and Positive Predictions Inventory; Dodd et al., 2009; Mansell, 2006; Timepoint(s): 0, 3, 6, 12, 18 months<br>6. Measure of manic symptoms (Bech-Rafaelson; Bech et al., 1978); Timepoint(s): 0, 3, 6, 12, 18<br>7. Recovery measure (Pitt et al., in press); Timepoint(s): 0, 3, 6, 12, 18 months<br>8. SCID-LIFE interview for episodes of mania or depression (Paykel et al., 2006); Timepoint(s): 0, 3, 6, 12, 18 months