A Compassionate-focused Intervention for Older People with Bipolar Disorder

NCT06882590 | Not Yet Recruiting DMC

• 1 other identifier: 348011
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder I or II

Keywords

Compassion-Focused Therapy; Older Adults; Rumination; Bipolar Disorder; Guilt; Shame

Outcome Measures

Primary Outcomes (2)

• Number of therapy sessions attended

  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

  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 Outcomes (8)

• 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

• The Bipolar Recovery Questionnaire

  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

  Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up

• Other as Shamer Scale

  Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up

• Guilt and Shame Questionnaire

  Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up

Other Outcomes (4)

• The MINI International Neuropsychiatric Interview

  Eligibility portion of the baseline assessments, prior to the intervention.

• The Hamilton Depression Rating Scale

  Eligibility portion of the baseline assessments, prior to the intervention.

• Ruminative Response Scale

  Eligibility portion of the baseline assessments, prior to the intervention.

Study Arms (1)

Therapy participants

OTHER

Participants to receive the compassionate-focused therapy

Other: Compassionate-focused therapy

Interventions

Compassionate-focused therapy OTHER

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

Therapy participants

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead
• Greater Manchester Mental Health NHS Foundation Trust: collaborator

Study Sites (1)

Greater Manchester Mental Health NHS Foundation Trust

Greater Manchester, United Kingdom

Location

MeSH Terms

Conditions

Rumination Syndrome; Bipolar Disorder

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Central Study Contacts

Imogen J Young, DClinPsy / MSc / BSc

CONTACT

447982314026; Imogen.Young@postgrad.manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student (Trainee Clinical Psychologist)

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 18, 2025
• Study Start: July 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

GB (1)