Compassion Focused Therapy for Distressing Experiences

Study Overview
=================
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.

Official Title
-----------------
A Case Series Study of Compassion Focused Therapy for Distressing Experiences

Conditions
-----------------
Psychosis

Intervention / Treatment
-----------------
* Other: Compassion Focused Therapy


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Compassion Focused Therapy<br>Intervention | Other: Compassion Focused Therapy<br>* Up to 26 sessions of Compassion Focused Therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attrition rate measured by number dropping out of therapy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychotic symptoms measured by PSYRATS | 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 | 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 | Measured by CORE (Clinical Outcomes in Routine Evaluation) | Over 6 months of therapy, and 6-8 weeks post-therapy | 
| Dissociative experiences measured by DES-II | Measured by DES-II (Dissociative Experiences Scale) | Over 6 months of therapy, and 6-8 weeks post-therapy |