Clinical trial NCT05860101: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Affective Disorder
Lead sponsor: Institute of Psychiatry, London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2023-05-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: the Credibility and Expectancy Questionnaire (CEQ)(Devilly & Borkovec, 2000)
timeFrame: Assessment/Baseline Only
measure: Client Satisfaction Questionnaire (CSQ-8) (Larsen, Attkison, Hargreaves & Nguyen, 1979).
timeFrame: Follow-up (2 weeks post-intervention)
Secondary outcomes:
measure: internal states scale (ISS) (Bauer, 1991)
timeFrame: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
measure: The Self Compassion Scale Short Form(SCS-SF) (Raes, Pommier, Neff & Van Gucht, 2011)
timeFrame: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
measure: The Short Revised Almost Perfect Scale (SAPS) (Rice, Richardson & Tueller, 2014)
timeFrame: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
measure: The Social Comparison Scale (Allan & Gilbert, 1995)
timeFrame: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
measure: The Social Safeness and Pleasure Scale (Gilbert et al, 2009)
timeFrame: Assessment (Baseline) and Follow-Up (2 weeks post intervention)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Psychiatry, Psychology & Neuroscience
Study officials:
References: