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
About this trial
This is an interventional treatment trial for Psychosis
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)
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
NCT ID
NCT02733575
First Posted
February 25, 2016
Last Updated
March 13, 2019
Sponsor
King's College London
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
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Compassion Focused Therapy for Distressing Experiences
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