Bipolar Affective DisorderNCT05860101
Compassion-Focused Therapy for Distressing Mood Swings: A Case Series
A study testing Compassion-Focused Therapy in people with Bipolar Affective Disorder, run by Institute of Psychiatry, London at 1 site in United Kingdom.
Trial summary
The goal of this case series is to investigate whether a brief compassion-focused intervention is a safe, acceptable and feasible therapy for clients with bipolar affective disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Affective Disorder
- What is being tested?
- Compassion-Focused Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Nov 2022to 9 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 years and older)
- Diagnosis of Bipolar Affective Disorder
Who cannot join
- Client considered to be actively at acute risk - judgement made by responsible clinical team and also by risk assessment at our first assessment session. High risk clients are excluded as due to time constraints it will be difficult to address risk issues and complete the intervention in the short time frame we have outlined.
- Client already receiving some form of CFT intervention, as this be a potential confounder.
- Level of English not strong enough to complete assessment and intervention sessions without use of interpreter. Again, due to time constraints it would be difficult to complete the intervention with clients in the timeframe outline whilst using an interpreter or navigating the language barrier.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Institute of Psychiatry, Psychology & Neuroscience
London
Tom Marsay, BSc, 07596892500, tom.marsay@kcl.ac.uk
About this study
Official title: An Investigation Into the Safety, Acceptability and Feasibility of a Brief Compassion-Focused Intervention for People Who Experience Distressing Mood Swings: A Case Series.
The goal of this case series is to investigate whether a brief compassion-focused intervention is a safe, acceptable and feasible therapy for clients with bipolar affective disorder. The secondary questions are whether a brief compassion focused intervention for BPD clients is associated with changes in bipolar mood symptoms and/ or with changes in psychological processes linked to mood symptoms in bipolar, including: Self-compassion, perfectionism, social comparison and social safeness. Four visual analogue scales will also be completed daily by each participant throughout the project. These scales will measure domains relevant to BPAD symptomology and self-compassion.
Participants will complete a 4 session Compassion-Focused Therapy Intervention. The first session will involve completion of the psychoeducation and formulation work which was started during the initial assessment session. Each intervention session will also involve the introduction and practice of CFT techniques or exercises. The trial therapist will introduce the exercise and practice it together with the participant during the session. Participants will then be asked to continue practicing the exercises for homework. Their experience of the practice and any difficulties can then be discussed at the start of the next session.
- Conditions
- Bipolar Affective Disorder
- Being tested
- Compassion-Focused Therapy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion-Focused TherapyOther
Compassion Focused Therapy (CFT) is based on the premise that we have three emotion regulation systems, the threat, drive and soothing systems. It has been suggested that our psychological wellbeing is dependent on maintaining a balance between these three systems, and if we lose this balance, e.g. the threat or drive systems become more dominant, then we start to experience emotional difficulties (Gilbert, 2009). In this study, participants are given various exercises to develop their soothing system, and help them to balance overactive threat.
| Study group | Role | What they receive |
|---|---|---|
| 1 week waitlist | Other | Not described Receives: Other: Compassion-Focused Therapy |
| 2 week waitlist | Other | Not described Receives: Other: Compassion-Focused Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Credibility and Expectancy Questionnaire (CEQ)(Devilly & Borkovec, 2000)
Measured: Assessment/Baseline Only
Client Satisfaction Questionnaire (CSQ-8) (Larsen, Attkison, Hargreaves & Nguyen, 1979).
Measured: Follow-up (2 weeks post-intervention)
Secondary outcomes (5)
internal states scale (ISS) (Bauer, 1991)
Measured: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
The Self Compassion Scale Short Form(SCS-SF) (Raes, Pommier, Neff & Van Gucht, 2011)
Measured: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
The Short Revised Almost Perfect Scale (SAPS) (Rice, Richardson & Tueller, 2014)
Measured: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
The Social Comparison Scale (Allan & Gilbert, 1995)
Measured: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
The Social Safeness and Pleasure Scale (Gilbert et al, 2009)
Measured: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 Nov 2022
- Primary completion9 Jun 2023 (estimated)
- Study completion9 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Affective DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Psychiatry, London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Principal investigator, Tom Marsay, Institute of Psychiatry, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860101
- Sponsor's protocol ID
- R&D2022/059
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual data with researchers outside of research team at this time
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Safety, Acceptability and Feasibility of a Brief Compassion-Focused Intervention for People Who Experience Distressing Mood Swings: A Case Series.
- ClinicalTrials.gov ID
- NCT05860101
- Acronym / sponsor ID
- R&D2022/059
- Conditions
- Bipolar Affective Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Institute of Psychiatry, LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 9 Jun 2023 (estimated)
- Study completion
- 9 Jun 2023 (estimated)
- First posted
- 16 May 2023 (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 goal of this case series is to investigate whether a brief compassion-focused intervention is a safe, acceptable and feasible therapy for clients with bipolar affective disorder. The secondary questions are whether a brief compassion focused intervention for BPD clients is associated with changes in bipolar mood symptoms and/ or with changes in psychological processes linked to mood symptoms in bipolar, including: Self-compassion, perfectionism, social comparison and social safeness. Four visual analogue scales will also be completed daily by each participant throughout the project. These scales will measure domains relevant to BPAD symptomology and self-compassion.
Participants will complete a 4 session Compassion-Focused Therapy Intervention. The first session will involve completion of the psychoeducation and formulation work which was started during the initial assessment session. Each intervention session will also involve the introduction and practice of CFT techniques or exercises. The trial therapist will introduce the exercise and practice it together with the participant during the session. Participants will then be asked to continue practicing the exercises for homework. Their experience of the practice and any difficulties can then be discussed at the start of the next session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 week waitlist | Other | Other: Compassion-Focused Therapy |
| 2 week waitlist | Other | Other: Compassion-Focused Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (18 years and older)
- Diagnosis of Bipolar Affective Disorder
Key exclusion criteria (3 listed)
- Client considered to be actively at acute risk - judgement made by responsible clinical team and also by risk assessment at our first assessment session. High risk clients are excluded as due to time constraints it will be difficult to address risk issues and complete the intervention in the short time frame we have outlined.
- Client already receiving some form of CFT intervention, as this be a potential confounder.
- Level of English not strong enough to complete assessment and intervention sessions without use of interpreter. Again, due to time constraints it would be difficult to complete the intervention with clients in the timeframe outline whilst using an interpreter or navigating the language barrier.
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 |
|---|---|---|
| Compassion-Focused TherapyCompassion Focused Therapy (CFT) is based on the premise that we have three emotion regulation systems, the threat, drive and soothing systems. It has been suggested that our psychological wellbeing is dependent on maintaining a balance between these three systems, and if we lose this balance, e.g. the threat or drive systems become more dominant, then we start to experience emotional difficulties (Gilbert, 2009). In this study, participants are given various exercises to develop their soothing system, and help them to balance overactive threat. | Other | 1 week waitlist, 2 week waitlist |
Primary outcome
the Credibility and Expectancy Questionnaire (CEQ)(Devilly & Borkovec, 2000)
Time frame: Assessment/Baseline Only
Client Satisfaction Questionnaire (CSQ-8) (Larsen, Attkison, Hargreaves & Nguyen, 1979).
Time frame: Follow-up (2 weeks post-intervention)
5 secondary outcomes
internal states scale (ISS) (Bauer, 1991)
Time frame: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
The Self Compassion Scale Short Form(SCS-SF) (Raes, Pommier, Neff & Van Gucht, 2011)
Time frame: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
The Short Revised Almost Perfect Scale (SAPS) (Rice, Richardson & Tueller, 2014)
Time frame: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
The Social Comparison Scale (Allan & Gilbert, 1995)
Time frame: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
The Social Safeness and Pleasure Scale (Gilbert et al, 2009)
Time frame: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No. No plan to share individual data with researchers outside of research team at this time
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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. This study is not recruiting at the moment.
Institute of Psychiatry, Psychology & Neuroscience
London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion-Focused Therapy in people with Bipolar Affective Disorder, run by Institute of Psychiatry, London 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Credibility and Expectancy Questionnaire (CEQ)(Devilly & Borkovec, 2000) (time frame: Assessment/Baseline Only). 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 16 May 2023.