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

May 5, 2023 updated by: Tom Marsay, Institute of Psychiatry, London

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

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom
        • Recruiting
        • Institute of Psychiatry, Psychology & Neuroscience
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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
Assessment/Baseline Only
Client Satisfaction Questionnaire (CSQ-8) (Larsen, Attkison, Hargreaves & Nguyen, 1979).
Time Frame: Follow-up (2 weeks post-intervention)
Follow-up (2 weeks post-intervention)

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)
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)
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)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2022

Primary Completion (Anticipated)

June 9, 2023

Study Completion (Anticipated)

June 9, 2023

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • R&D2022/059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual data with researchers outside of research team at this time

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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