- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05860101
Compassion-Focused Therapy for Distressing Mood Swings: A Case Series
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom
- Recruiting
- Institute of Psychiatry, Psychology & Neuroscience
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Contact:
- Tom Marsay, BSc
- Phone Number: 07596892500
- Email: tom.marsay@kcl.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (18 years and older)
- Diagnosis of Bipolar Affective Disorder
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1 week waitlist
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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.
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Other: 2 week waitlist
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the Credibility and Expectancy Questionnaire (CEQ)(Devilly & Borkovec, 2000)
Time Frame: Assessment/Baseline Only
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Assessment/Baseline Only
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Client Satisfaction Questionnaire (CSQ-8) (Larsen, Attkison, Hargreaves & Nguyen, 1979).
Time Frame: Follow-up (2 weeks post-intervention)
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Follow-up (2 weeks post-intervention)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
internal states scale (ISS) (Bauer, 1991)
Time Frame: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
|
Assessment (Baseline) and Follow-Up (2 weeks post intervention)
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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)
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Assessment (Baseline) and Follow-Up (2 weeks post intervention)
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The Short Revised Almost Perfect Scale (SAPS) (Rice, Richardson & Tueller, 2014)
Time Frame: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
|
Assessment (Baseline) and Follow-Up (2 weeks post intervention)
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The Social Comparison Scale (Allan & Gilbert, 1995)
Time Frame: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
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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)
|
Assessment (Baseline) and Follow-Up (2 weeks post intervention)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R&D2022/059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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