Psychological therapy for ongoing symptoms of bipolar disorder

Behavioural therapy for inter-episode bipolar symptoms: a multiple baseline case series evaluation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19416314

Enrollment

Registered

2023-02-01

Start date

2023-02-13

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Bipolar disorder Mental and Behavioural Disorders Bipolar affective disorder

Interventions

The study will involve participants being recruited in two waves or cohorts (6 in each) to allow iteration of the therapy protocol. In a multiple baseline case series, individuals in the study are ra

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

Inclusion criteria: Adults in the catchment areas of the study sites who: 1. Meet research diagnostic criteria for Bipolar I or II Disorder, Other Specified Bipolar Disorder or Cyclothymic Disorder 2. Do not meet 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. Have sufficient English to complete research questionnaires without translation 6. Have completed the intake measures

Exclusion criteria

Exclusion criteria: 1. Current substance dependence according to ICD-11 criteria 2. Frequent and serious self-harm that cannot be safely managed in a community outpatient setting 3. Currently engaged in another psychological therapy for bipolar disorder

Design outcomes

Primary

Measure	Time frame
1. Safety will be measured by rates of therapy-related adverse events across the study period, and rates of reliable deterioration on the Patient Health Questionnaire (PHQ), Altman Scale for Rating Mania (ASRM), Affective Lability Scale (ALS), Generalised Anxiety Disorder questionnaire (GAD), Quality of Life in Bipolar Disorder scale (QoL.BD) and Bipolar Recovery Questionnaire (BRQ) at 7 months (30 weeks) follow-up 2. Acceptability will be measured by therapy uptake and completion rates across the study period, and quantitative and qualitative feedback from participants and therapists at the post-therapy point 3. Potential of the intervention to deliver benefit will be measured by rates of reliable, and reliable and clinically significant, change in the Patient Health Questionnaire and the bipolar-depression scale of the Affective Lability Scale, from the baseline period (mean score) to the post-therapy period (mean score)	—

Measure

Time frame

1. Safety will be measured by rates of therapy-related adverse events across the study period, and rates of reliable deterioration on the Patient Health Questionnaire (PHQ), Altman Scale for Rating Mania (ASRM), Affective Lability Scale (ALS), Generalised Anxiety Disorder questionnaire (GAD), Quality of Life in Bipolar Disorder scale (QoL.BD) and Bipolar Recovery Questionnaire (BRQ) at 7 months (30 weeks) follow-up 2. Acceptability will be measured by therapy uptake and completion rates across the study period, and quantitative and qualitative feedback from participants and therapists at the post-therapy point 3. Potential of the intervention to deliver benefit will be measured by rates of reliable, and reliable and clinically significant, change in the Patient Health Questionnaire and the bipolar-depression scale of the Affective Lability Scale, from the baseline period (mean score) to the post-therapy period (mean score)

—

Secondary

Measure	Time frame
1. Rates of reliable and reliable and clinically significant change on the following measures: Bipolar Disorder Recovery Questionnaire, Quality of Life in Bipolar Disorder Scale and Generalised Anxiety Disorder assessment scale from pre-therapy to 7-month follow-up 2. Rates of reliable and reliable and clinically significant change on the Altman Scale for Rating Mania from the baseline period to the post-therapy period 3. Group-level change in PHQ, ALS, ASRM, BRQ, QoL.BD, GAD from baseline to 6-month follow-up and pre-therapy to 7-month follow-up 4. Mood instability will be measured (in addition to the ALS) by a visual analogue scale of mood at five timepoints per day for 14 days on two occasions (pre and post therapy) for each participant. This allows for the calculation of mood instability before and after therapy	—

Measure

Time frame

1. Rates of reliable and reliable and clinically significant change on the following measures: Bipolar Disorder Recovery Questionnaire, Quality of Life in Bipolar Disorder Scale and Generalised Anxiety Disorder assessment scale from pre-therapy to 7-month follow-up 2. Rates of reliable and reliable and clinically significant change on the Altman Scale for Rating Mania from the baseline period to the post-therapy period 3. Group-level change in PHQ, ALS, ASRM, BRQ, QoL.BD, GAD from baseline to 6-month follow-up and pre-therapy to 7-month follow-up 4. Mood instability will be measured (in addition to the ALS) by a visual analogue scale of mood at five timepoints per day for 14 days on two occasions (pre and post therapy) for each participant. This allows for the calculation of mood instability before and after therapy

—

Countries

England, United Kingdom

Outcome results

None listed

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