NCT05860101

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

April 25, 2023

Last Update Submit

May 5, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • the Credibility and Expectancy Questionnaire (CEQ)(Devilly & Borkovec, 2000)

    Assessment/Baseline Only

  • Client Satisfaction Questionnaire (CSQ-8) (Larsen, Attkison, Hargreaves & Nguyen, 1979).

    Follow-up (2 weeks post-intervention)

Secondary Outcomes (5)

  • 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 Comparison Scale (Allan & Gilbert, 1995)

    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 Arms (2)

1 week waitlist

OTHER
Other: Compassion-Focused Therapy

2 week waitlist

OTHER
Other: Compassion-Focused Therapy

Interventions

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.

1 week waitlist2 week waitlist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18 years and older)
  • Diagnosis of Bipolar Affective Disorder

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Psychiatry, Psychology & Neuroscience

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trainee Clinical Psychologist

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 16, 2023

Study Start

November 15, 2022

Primary Completion

June 9, 2023

Study Completion

June 9, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

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

Locations