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

Bipolar Affective Disorder Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860101
• Other study ID #: R&D2022/059
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: June 9, 2023

Study information

• Verified date: May 2023
• Source: Institute of Psychiatry, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: June 9, 2023
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Affective Disorder
• Bipolar Disorder
• Mood Disorders

Intervention

Other:
• Compassion-Focused Therapy
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.

Locations

Country	Name	City	State
United Kingdom	Institute of Psychiatry, Psychology & Neuroscience	London

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Psychiatry, London	South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Credibility and Expectancy Questionnaire (CEQ)(Devilly & Borkovec, 2000)		Assessment/Baseline Only
Primary	Client Satisfaction Questionnaire (CSQ-8) (Larsen, Attkison, Hargreaves & Nguyen, 1979).		Follow-up (2 weeks post-intervention)
Secondary	internal states scale (ISS) (Bauer, 1991)		Assessment (Baseline) and Follow-Up (2 weeks post intervention)
Secondary	The Self Compassion Scale Short Form(SCS-SF) (Raes, Pommier, Neff & Van Gucht, 2011)		Assessment (Baseline) and Follow-Up (2 weeks post intervention)
Secondary	The Short Revised Almost Perfect Scale (SAPS) (Rice, Richardson & Tueller, 2014)		Assessment (Baseline) and Follow-Up (2 weeks post intervention)
Secondary	The Social Comparison Scale (Allan & Gilbert, 1995)		Assessment (Baseline) and Follow-Up (2 weeks post intervention)
Secondary	The Social Safeness and Pleasure Scale (Gilbert et al, 2009)		Assessment (Baseline) and Follow-Up (2 weeks post intervention)