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NCT Number: NCT06882590

A 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.

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Key information

Conditions

Bipolar Disorder I or II Bipolar Disorder Bipolar and Related Disorders Digestive System Diseases Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorders Mood Disorders Rumination Syndrome

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Greater Manchester Mental Health NHS Foundation Trust

Greater Manchester, United Kingdom

Location contact

Joanna Bryant

CONTACT

[email protected]

0161 271 0084

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Compassionate-focused therapy

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Other outcomes

  1. The MINI International Neuropsychiatric Interview

    Time frame: Eligibility portion of the baseline assessments, prior to the intervention.

    Diagnostic interview for Bipolar I or II.

  2. The Hamilton Depression Rating Scale

    Time frame: Eligibility portion of the baseline assessments, prior to the intervention.

    Assess depression severity.

  3. Ruminative Response Scale

    Time frame: Eligibility portion of the baseline assessments, prior to the intervention.

    Assess levels of rumination.

  4. The Montreal Cognitive Assessment (MOCA)

    Time frame: Eligibility portion of the baseline assessments, prior to the intervention.

    Assessment of cognitive impairment.

Study contacts

Contact information is provided by the study sponsor or research team.

Imogen J Young, DClinPsy / MSc / BSc

CONTACT

[email protected]

447982314026

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

  • Greater Manchester Mental Health NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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