A Compassionate-focused Intervention for Older People with Bipolar Disorder

ConditionBipolar Disorder I or II

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60-90

SponsorUniversity of Manchester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

6 Participants

are divided into 1 treatment group

Group A: Therapy participantsOther 1 intervention

Trial outcomes

Primary outcomes

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.

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

The primary outcome of the study is the feasibility of the compassionate-focused intervention, which will be measured using the above metric.

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 outcomes

The Altman Self-Rating Mania Scale

Any preliminary potential clinical benefits will be determined using the following outcome measures.

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

Any preliminary potential clinical benefits will be determined using the following outcome measures.

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

Any preliminary potential clinical benefits will be determined using the following outcome measures.

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

Any preliminary potential clinical benefits will be determined using the following outcome measures.

Time frame

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

Other outcomes

The MINI International Neuropsychiatric Interview

Diagnostic interview for Bipolar I or II.

Time frame

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

The Hamilton Depression Rating Scale

Assess depression severity.

Time frame

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

Ruminative Response Scale

Assess levels of rumination.

Time frame

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

The Montreal Cognitive Assessment (MOCA)

Assessment of cognitive impairment.

Time frame

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

Locations

Map coordinates are unavailable for these locations. Locations are shown below instead.

Greater Manchester Mental Health NHS Foundation Trust Status unavailable Greater Manchester

United Kingdom

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Manchester

Lead sponsor

Greater Manchester Mental Health NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: