- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02733575
Compassion Focused Therapy for Distressing Experiences
A Case Series Study of Compassion Focused Therapy for Distressing Experiences
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- South London and Maudsley NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Compassion Focused Therapy
Intervention
|
Up to 26 sessions of Compassion Focused Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Attrition rate measured by number dropping out of therapy
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychotic symptoms measured by PSYRATS
Time Frame: Over 6 months of therapy, and 6-8 weeks post-therapy
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Measured by PSYRATS (Psychotic Symptom Rating Scales)
|
Over 6 months of therapy, and 6-8 weeks post-therapy
|
|
Depression and anxiety symptoms measured by DASS-21
Time Frame: Over 6 months of therapy, and 6-8 weeks post-therapy
|
Measured by DASS-21 (Depression, Anxiety and Stress Scale)
|
Over 6 months of therapy, and 6-8 weeks post-therapy
|
|
Subjective wellbeing, symptoms, functioning, and risk/harm measured by CORE
Time Frame: Over 6 months of therapy, and 6-8 weeks post-therapy
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Measured by CORE (Clinical Outcomes in Routine Evaluation)
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Over 6 months of therapy, and 6-8 weeks post-therapy
|
|
Dissociative experiences measured by DES-II
Time Frame: Over 6 months of therapy, and 6-8 weeks post-therapy
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Measured by DES-II (Dissociative Experiences Scale)
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Over 6 months of therapy, and 6-8 weeks post-therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charlie Heriot-Maitland, DClinPsych, King's College London
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R&D2018/024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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