Clinical trial NCT06882590: A Compassionate-focused Intervention for Older People with Bipolar Disorder
Official title: A Brief Compassionate-focused Intervention for Older People with Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bipolar Disorder I or II
Keywords: Compassion-Focused Therapy
Older Adults
Rumination
Bipolar Disorder
Guilt
Shame
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Greater Manchester Mental Health NHS Foundation Trust
First posted: 2025-03-18
Enrollment: 6
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

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.

Primary outcomes:
measure: Number of therapy sessions attended
timeFrame: 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.
measure: Number of participants who drop-out and at which stage of the intervention
timeFrame: 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:
measure: The Altman Self-Rating Mania Scale
timeFrame: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
measure: The Bipolar Recovery Questionnaire
timeFrame: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
measure: The Quality of Life in Bipolar Disorder Questionnaire
timeFrame: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
measure: Other as Shamer Scale
timeFrame: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
measure: Guilt and Shame Questionnaire
timeFrame: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
measure: The Compassionate Engagement and Action Scale
timeFrame: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
measure: Generalised Anxiety Disorder Questionnaire (GAD-7)
timeFrame: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
Other outcomes:
measure: The MINI International Neuropsychiatric Interview
timeFrame: Eligibility portion of the baseline assessments, prior to the intervention.
measure: The Hamilton Depression Rating Scale
timeFrame: Eligibility portion of the baseline assessments, prior to the intervention.
measure: Ruminative Response Scale
timeFrame: Eligibility portion of the baseline assessments, prior to the intervention.
measure: The Montreal Cognitive Assessment (MOCA)
timeFrame: Eligibility portion of the baseline assessments, prior to the intervention.
Locations:
city: Greater Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHS Foundation Trust
Study officials:
References: