A Compassionate-focused Intervention for Older People with Bipolar Disorder

NCT ID: NCT06882590

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder I or II

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Therapy participants

Participants to receive the compassionate-focused therapy

Group Type OTHER

Compassionate-focused therapy

Intervention Type OTHER

A 9-session therapy intervention targeting negative thinking, feelings of guilt and shame, and cultivating compassion for self and others.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Compassionate-focused therapy

A 9-session therapy intervention targeting negative thinking, feelings of guilt and shame, and cultivating compassion for self and others.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Greater Manchester Mental Health NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Imogen Young

Doctoral Student (Trainee Clinical Psychologist)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Greater Manchester Mental Health NHS Foundation Trust

Greater Manchester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Imogen J Young, DClinPsy / MSc / BSc

Role: CONTACT

447982314026

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Joanna Bryant

Role: primary

0161 271 0084

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

348011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.