A Compassionate-focused Intervention for Older People with Bipolar Disorder

March 16, 2025 updated by: Imogen Young, University of Manchester

A Brief Compassionate-focused Intervention for Older People with Bipolar Disorder

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Therapy participants
Participants to receive the compassionate-focused therapy
Other: Compassionate-focused therapy
A 9-session therapy intervention targeting negative thinking, feelings of guilt and shame, and cultivating compassion for self and others.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of therapy sessions attended
Time Frame: 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.
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.
Number of participants who drop-out and at which stage of the intervention
Time Frame: 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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Altman Self-Rating Mania Scale
Time Frame: 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.
Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
The Bipolar Recovery Questionnaire
Time Frame: 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.
Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
The Quality of Life in Bipolar Disorder Questionnaire
Time Frame: 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.
Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
Other as Shamer Scale
Time Frame: 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.
Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
Guilt and Shame Questionnaire
Time Frame: 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.
Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
The Compassionate Engagement and Action Scale
Time Frame: 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.
Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
Generalised Anxiety Disorder Questionnaire (GAD-7)
Time Frame: 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.
Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: 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.
Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The MINI International Neuropsychiatric Interview
Time Frame: Eligibility portion of the baseline assessments, prior to the intervention.
Diagnostic interview for Bipolar I or II.
Eligibility portion of the baseline assessments, prior to the intervention.
The Hamilton Depression Rating Scale
Time Frame: Eligibility portion of the baseline assessments, prior to the intervention.
Assess depression severity.
Eligibility portion of the baseline assessments, prior to the intervention.
Ruminative Response Scale
Time Frame: Eligibility portion of the baseline assessments, prior to the intervention.
Assess levels of rumination.
Eligibility portion of the baseline assessments, prior to the intervention.
The Montreal Cognitive Assessment (MOCA)
Time Frame: Eligibility portion of the baseline assessments, prior to the intervention.
Assessment of cognitive impairment.
Eligibility portion of the baseline assessments, prior to the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Collaborators

Greater Manchester Mental Health NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 16, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 348011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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