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Compassion Focused Therapy for Distressing Experiences

Primary Purpose

Psychosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Compassion Focused Therapy
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over 18 years old
  • Psychosis related diagnosis (F20-39)
  • Distressing positive symptoms of psychosis. Each participant will have been routinely screened with PSYRATS at their service entry assessment. On PSYRATS, at least one positive symptom (i.e. hallucination or delusion) will be present, and distress will be evidenced by an associated intensity score of 2 or above
  • Willing to engage in psychological therapy
  • Sufficient command of English language
  • Able to provide informed consent

Exclusion Criteria:

  • Currently engaged in CBT, or have completed a 12+ session course of CBT within the last 3 years. If recruitment is under target, this will be relaxed to 12+ session course of CBT (Cognitive Behavioural Therapy) within the last 6 months
  • Currently engaged with another treatment study (e.g. medicine or therapy)

Sites / Locations

  • South London and Maudsley NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Compassion Focused Therapy

Arm Description

Intervention

Outcomes

Primary Outcome Measures

Attrition rate measured by number dropping out of therapy

Secondary Outcome Measures

Psychotic symptoms measured by PSYRATS
Measured by PSYRATS (Psychotic Symptom Rating Scales)
Depression and anxiety symptoms measured by DASS-21
Measured by DASS-21 (Depression, Anxiety and Stress Scale)
Subjective wellbeing, symptoms, functioning, and risk/harm measured by CORE
Measured by CORE (Clinical Outcomes in Routine Evaluation)
Dissociative experiences measured by DES-II
Measured by DES-II (Dissociative Experiences Scale)

Full Information

First Posted
February 25, 2016
Last Updated
March 13, 2019
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT02733575
Brief Title
Compassion Focused Therapy for Distressing Experiences
Official Title
A Case Series Study of Compassion Focused Therapy for Distressing Experiences
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
January 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to develop and test the feasibility of a new therapy called Compassion Focused Therapy (CFT) for psychosis. This therapy helps people with psychosis manage distressing experiences by building internal feelings of safeness and affiliation, and by providing contexts, practices and insights that facilitate the development of compassion to self and others. The focus is on helping people feel safe in relation to their experiences and their social worlds. CFT is a promising new approach that has been successfully provided for people with a range of mental health difficulties. It is also firmly based in the most up-to-date knowledge and science about how the mind works (both normally and under stress). 9 participants will be recruited from NHS psychological therapies services for people with psychosis in South London and Maudsley (SLAM) NHS Foundation Trust. Following a short baseline period they will receive up to 26 weekly sessions (about 6 months) of CFT with a clinical psychologist, and will provide interview and questionnaire research data at five different points during the study. At these assessment points, data will be gathered on participants' experiences, mood, perceptions of their position in the social world, and heart rate variability. The initial therapy protocol has been developed by psychologists with expertise in CFT, alongside people with lived experience of hearing voices and having distressing beliefs. However, it will continue to be developed and evolve as the study progresses, and as more is learnt (e.g. from the service-user participants) about applying the model in this population. At the end of this study, the aim is to have all the information needed to run a randomised controlled trial of this therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compassion Focused Therapy
Arm Type
Other
Arm Description
Intervention
Intervention Type
Other
Intervention Name(s)
Compassion Focused Therapy
Intervention Description
Up to 26 sessions of Compassion Focused Therapy
Primary Outcome Measure Information:
Title
Attrition rate measured by number dropping out of therapy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Psychotic symptoms measured by PSYRATS
Description
Measured by PSYRATS (Psychotic Symptom Rating Scales)
Time Frame
Over 6 months of therapy, and 6-8 weeks post-therapy
Title
Depression and anxiety symptoms measured by DASS-21
Description
Measured by DASS-21 (Depression, Anxiety and Stress Scale)
Time Frame
Over 6 months of therapy, and 6-8 weeks post-therapy
Title
Subjective wellbeing, symptoms, functioning, and risk/harm measured by CORE
Description
Measured by CORE (Clinical Outcomes in Routine Evaluation)
Time Frame
Over 6 months of therapy, and 6-8 weeks post-therapy
Title
Dissociative experiences measured by DES-II
Description
Measured by DES-II (Dissociative Experiences Scale)
Time Frame
Over 6 months of therapy, and 6-8 weeks post-therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 years old Psychosis related diagnosis (F20-39) Distressing positive symptoms of psychosis. Each participant will have been routinely screened with PSYRATS at their service entry assessment. On PSYRATS, at least one positive symptom (i.e. hallucination or delusion) will be present, and distress will be evidenced by an associated intensity score of 2 or above Willing to engage in psychological therapy Sufficient command of English language Able to provide informed consent Exclusion Criteria: Currently engaged in CBT, or have completed a 12+ session course of CBT within the last 3 years. If recruitment is under target, this will be relaxed to 12+ session course of CBT (Cognitive Behavioural Therapy) within the last 6 months Currently engaged with another treatment study (e.g. medicine or therapy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlie Heriot-Maitland, DClinPsych
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
South London and Maudsley NHS Foundation Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Compassion Focused Therapy for Distressing Experiences

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