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Clinical Trials/NCT05860101
NCT05860101
Recruiting
Not Applicable

An Investigation Into the Safety, Acceptability and Feasibility of a Brief Compassion-Focused Intervention for People Who Experience Distressing Mood Swings: A Case Series.

Institute of Psychiatry, London1 site in 1 country6 target enrollmentNovember 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bipolar Affective Disorder
Sponsor
Institute of Psychiatry, London
Enrollment
6
Locations
1
Primary Endpoint
the Credibility and Expectancy Questionnaire (CEQ)(Devilly & Borkovec, 2000)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2022
End Date
June 9, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institute of Psychiatry, London
Responsible Party
Principal Investigator
Principal Investigator

Tom Marsay

Trainee Clinical Psychologist

Institute of Psychiatry, London

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.

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • The Social Comparison Scale (Allan & Gilbert, 1995)(Assessment (Baseline) and Follow-Up (2 weeks post intervention))
  • internal states scale (ISS) (Bauer, 1991)(Assessment (Baseline) and Follow-Up (2 weeks post intervention))
  • The Self Compassion Scale Short Form(SCS-SF) (Raes, Pommier, Neff & Van Gucht, 2011)(Assessment (Baseline) and Follow-Up (2 weeks post intervention))
  • The Short Revised Almost Perfect Scale (SAPS) (Rice, Richardson & Tueller, 2014)(Assessment (Baseline) and Follow-Up (2 weeks post intervention))
  • The Social Safeness and Pleasure Scale (Gilbert et al, 2009)(Assessment (Baseline) and Follow-Up (2 weeks post intervention))

Study Sites (1)

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