Bipolar at risk trial

Cognitive behavioural therapy in comparison to treatment as usual in adults at high risk of developing bipolar disorder (Bipolar At Risk): a feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10773067

Enrollment

Registered

2015-08-26

Start date

2015-06-01

Completion date

Unknown

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Mental Health

Interventions

The Cognitive Behavioural Therapy (CBT) intervention will use a specific cognitive model of mood swings. The model proposes that people hold a range of extreme and contradictory beliefs concerning the

Study Entry : Single Randomisation only

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 16-25 years old 2. Meet criteria for one of the following Bipolar At Risk (BAR) criteria: 2.1. Group I: Subthreshold mania (Young Mania Rating Scale total score between 5 and 15 + elevated mood = 2 + irritability = 2 for at least 4 days) 2.2. Group II: Depression + Cyclothymia: mild depressive symptoms (BDI-II >20 for at least 1 week) + diagnosis of cyclothymic disorder or bipolar disorder NOS as assessed by SCID I 2.3. Group III: Depression + genetic risk: mild depressive symptoms (BDI-II >20 for at least 1 week) + genetic risk (first degree relative with bipolar disorder) 3. Help seeking 4. Competent and willing to provide written, informed consent

Exclusion criteria

Exclusion criteria: 1. Past history of a treated or untreated manic episode or psychosis of one week duration or longer 2. Past treatment with a mood stabiliser for longer than 6 weeks or antipsychotic for 3 weeks (equals 15 mg per week of haloperidol or equivalent) 3. Moderate to severe learning disability 4. Organic brain disorder 5. Non-english speaking (this would prevent the use of standardised assessment instruments) . 6. Inpatient/acute psychiatric care needed 7. Substance dependency

Design outcomes

Primary

Measure	Time frame
Conversion to mania (SCID); Timepoint(s): 6 months, 12 months	—

Secondary

Measure	Time frame
1. Beck Depression Inventory; Timepoint(s): 6 months,12 months 2. EPQ adapted; Timepoint(s): 6 months, 12 months 3. Global Assessment of Functioning scale; Timepoint(s): 6 months, 12 months 4. Health Status (EQ-5D); Timepoint(s): 6 months, 12 months 5. Hypomanic Attitudes and Positive Predictions Inventory; Timepoint(s): 6 months, 12 months 6. Internal States Scale; Timepoint(s): 6 months, 12 months 7. World Health Organisation Quality of Life; Timepoint(s): 6 months,12 months 8. Young Mania Rating Scale; Timepoint(s): 6 months,12 months	—

Measure

Time frame

1. Beck Depression Inventory; Timepoint(s): 6 months,12 months 2. EPQ adapted; Timepoint(s): 6 months, 12 months 3. Global Assessment of Functioning scale; Timepoint(s): 6 months, 12 months 4. Health Status (EQ-5D); Timepoint(s): 6 months, 12 months 5. Hypomanic Attitudes and Positive Predictions Inventory; Timepoint(s): 6 months, 12 months 6. Internal States Scale; Timepoint(s): 6 months, 12 months 7. World Health Organisation Quality of Life; Timepoint(s): 6 months,12 months 8. Young Mania Rating Scale; Timepoint(s): 6 months,12 months

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026