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Not yet recruiting NCT06882590

A Compassionate-focused Intervention for Older People with Bipolar Disorder

No phase Interventional Bipolar Disorder I or II

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Compassionate-focused therapy.
Who it may be relevant to
Registry conditions: Bipolar Disorder I or II. Basic parameters: 60 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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.]
  • 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.]
Secondary outcome measures (8)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United Kingdom · 1 center
  • Greater Manchester Mental Health NHS Foundation Trust — Greater Manchester

Identifiers

NCT: NCT06882590 · 348011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗