A Compassionate-focused Intervention for Older People with Bipolar Disorder

Not Applicable

Not yet recruiting

• Conditions: Bipolar Disorder I or II

• Registration Number: NCT06882590
• Lead Sponsor: University of Manchester

Brief Summary

The aim of this study is to determine whether it is feasible to deliver a 9-session compassionate-focused therapy for older people with bipolar disorder. Participants will be asked to complete baseline measures and at post-intervention follow-up (12 weeks and 24 weeks) to understand any potential clinical benefits of the therapy.

Detailed Description

The present study will evaluate the feasibility of a compassionate-focused intervention targeting rumination that is specifically tailored for older people with bipolar disorder. In addition to evaluating its feasibility, the study will also investigate whether there are any clinical benefits associated with the intervention, namely, any potential reductions in negative rumination and feelings of guilt and shame. To date, there has been no research evaluating the feasibility of this type of intervention.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-16
• Last Update Submitted: 2025-03-16
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Study Start: 2025-07-01
• Primary Completion: 2026-02-01
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Adults aged 60 years and above.
• Have a nominated healthcare professional (i.e. GP/Care Coordinator)
• Meet the criteria for a diagnosis of bipolar disorder I or II according to the MINI.
• Score of >57 on Ruminative Response Scale (RRS)
• Be able to provide written informed consent.
• Be able to speak sufficient English to engage in the assessments and intervention.

Exclusion Criteria

• Currently in an episode of mania or hypomania according to the MINI.
• Experiencing 'severe depression' according to the Hamilton Depression Rating Scale, which equates to a score of over 24.
• MoCA score of <22 to exclude for moderate and severe cognitive impairment.
• Currently receiving psychological therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of therapy sessions attended	The timeframe for number of therapy sessions attended will span the length of intervention; from the first assessment session to final therapy session. The estimated period of time over which the event is assessed is up to 9 weeks.	The primary outcome of the study is the feasibility of the compassionate-focused intervention, which will be measured using the above metric.
Number of participants who drop-out and at which stage of the intervention	The time frame covers first therapy session to final therapy session. The estimated period of time over which the event is assessed is up to 9 weeks.	The primary outcome of the study is the feasibility of the compassionate-focused intervention, which will be measured using the above metric.

Secondary Outcome Measures

Name	Time	Method
The Altman Self-Rating Mania Scale	Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up	Any preliminary potential clinical benefits will be determined using the following outcome measures.
The Bipolar Recovery Questionnaire	Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up	Any preliminary potential clinical benefits will be determined using the following outcome measures.
The Quality of Life in Bipolar Disorder Questionnaire	Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up	Any preliminary potential clinical benefits will be determined using the following outcome measures.
Other as Shamer Scale	Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up	Any preliminary potential clinical benefits will be determined using the following outcome measures.
Guilt and Shame Questionnaire	Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up	Any preliminary potential clinical benefits will be determined using the following outcome measures.
The Compassionate Engagement and Action Scale	Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up	Any preliminary potential clinical benefits will be determined using the following outcome measures.
Generalised Anxiety Disorder Questionnaire (GAD-7)	Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up	Any preliminary potential clinical benefits will be determined using the following outcome measures.
Center for Epidemiologic Studies Depression Scale (CES-D)	Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up	Any preliminary potential clinical benefits will be determined using the following outcome measures.

Trial Locations

Locations (1)

Greater Manchester Mental Health NHS Foundation Trust; 🇬🇧 Greater Manchester, United Kingdom