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Compassion-Focused Therapy for Distressing Mood Swings: A Case Series

Primary Purpose

Bipolar Affective Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Compassion-Focused Therapy
Sponsored by
Institute of Psychiatry, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Affective Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Psychiatry, Psychology & NeuroscienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1 week waitlist

2 week waitlist

Arm Description

Outcomes

Primary Outcome Measures

the Credibility and Expectancy Questionnaire (CEQ)(Devilly & Borkovec, 2000)
Client Satisfaction Questionnaire (CSQ-8) (Larsen, Attkison, Hargreaves & Nguyen, 1979).

Secondary Outcome Measures

internal states scale (ISS) (Bauer, 1991)
The Self Compassion Scale Short Form(SCS-SF) (Raes, Pommier, Neff & Van Gucht, 2011)
The Short Revised Almost Perfect Scale (SAPS) (Rice, Richardson & Tueller, 2014)
The Social Comparison Scale (Allan & Gilbert, 1995)
The Social Safeness and Pleasure Scale (Gilbert et al, 2009)

Full Information

First Posted
April 25, 2023
Last Updated
May 5, 2023
Sponsor
Institute of Psychiatry, London
Collaborators
South London and Maudsley NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05860101
Brief Title
Compassion-Focused Therapy for Distressing Mood Swings: A Case Series
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
June 9, 2023 (Anticipated)
Study Completion Date
June 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Psychiatry, London
Collaborators
South London and Maudsley NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Affective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 week waitlist
Arm Type
Other
Arm Title
2 week waitlist
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Compassion-Focused Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
the Credibility and Expectancy Questionnaire (CEQ)(Devilly & Borkovec, 2000)
Time Frame
Assessment/Baseline Only
Title
Client Satisfaction Questionnaire (CSQ-8) (Larsen, Attkison, Hargreaves & Nguyen, 1979).
Time Frame
Follow-up (2 weeks post-intervention)
Secondary Outcome Measure Information:
Title
internal states scale (ISS) (Bauer, 1991)
Time Frame
Assessment (Baseline) and Follow-Up (2 weeks post intervention)
Title
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)
Title
The Short Revised Almost Perfect Scale (SAPS) (Rice, Richardson & Tueller, 2014)
Time Frame
Assessment (Baseline) and Follow-Up (2 weeks post intervention)
Title
The Social Comparison Scale (Allan & Gilbert, 1995)
Time Frame
Assessment (Baseline) and Follow-Up (2 weeks post intervention)
Title
The Social Safeness and Pleasure Scale (Gilbert et al, 2009)
Time Frame
Assessment (Baseline) and Follow-Up (2 weeks post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Institute of Psychiatry, Psychology & Neuroscience
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Marsay, BSc
Phone
07596892500
Email
tom.marsay@kcl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual data with researchers outside of research team at this time

Learn more about this trial

Compassion-Focused Therapy for Distressing Mood Swings: A Case Series

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