Bipolar Disorder I or IINCT06882590
A Compassionate-focused Intervention for Older People with Bipolar Disorder
A study testing Compassionate-focused therapy in people with Bipolar Disorder I or II, run by University of Manchester at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Bipolar Disorder I or II
- What is being tested?
- Compassionate-focused therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Greater Manchester Mental Health NHS Foundation Trust
Greater Manchester
Joanna Bryant, 0161 271 0084, researchoffice@gmmh.nhs.uk
About this study
Official title: A Brief 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.
Read the 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.
- Conditions
- Bipolar Disorder I or II
- Being tested
- Compassionate-focused therapy
- Keywords
- Compassion-Focused Therapy, Older Adults, Rumination, Bipolar Disorder, Guilt, Shame
- Medical subject headings
- Rumination Syndrome, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassionate-focused therapyOther
A 9-session therapy intervention targeting negative thinking, feelings of guilt and shame, and cultivating compassion for self and others.
| Study group | Role | What they receive |
|---|---|---|
| Therapy participants | Other | Participants to receive the compassionate-focused therapy Receives: Other: Compassionate-focused therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Any preliminary potential clinical benefits will be determined using the following outcome measures.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
Guilt and Shame Questionnaire
Any preliminary potential clinical benefits will be determined using the following outcome measures.
Measured: 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
Any preliminary potential clinical benefits will be determined using the following outcome measures.
Measured: 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)
Any preliminary potential clinical benefits will be determined using the following outcome measures.
Measured: 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)
Any preliminary potential clinical benefits will be determined using the following outcome measures.
Measured: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder I or IIStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Greater Manchester Mental Health NHS Foundation Trust
- Responsible party
- Principal investigator, Imogen Young, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882590
- Sponsor's protocol ID
- 348011
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Compassionate-focused Intervention for Older People with Bipolar Disorder
- ClinicalTrials.gov ID
- NCT06882590
- Acronym / sponsor ID
- 348011
- Conditions
- Bipolar Disorder I or II
- Keywords
- Compassion-Focused Therapy, Older Adults, Rumination, Bipolar Disorder, Guilt, Shame
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Greater Manchester Mental Health NHS Foundation Trust
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapy participants | Other | Other: Compassionate-focused therapyParticipants to receive the compassionate-focused therapy |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassionate-focused therapyA 9-session therapy intervention targeting negative thinking, feelings of guilt and shame, and cultivating compassion for self and others. | Other | Therapy participants |
Primary outcome
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.
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassionate-focused therapy in people with Bipolar Disorder I or II, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imogen J Young, DClinPsy / MSc / BSc (447982314026, Imogen.Young@postgrad.manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.