Compassion Focused Therapy for Distressing Experiences

Psychosis Clinical Trial

Official title:

A Case Series Study of Compassion Focused Therapy for Distressing Experiences

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733575
• Other study ID #: R&D2018/024
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: January 8, 2019

Study information

• Verified date: March 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 8, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Psychosis

Intervention

Other:
• Compassion Focused Therapy
Up to 26 sessions of Compassion Focused Therapy

Locations

Country	Name	City	State
United Kingdom	South London and Maudsley NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attrition rate measured by number dropping out of therapy		6 months
Secondary	Psychotic symptoms measured by PSYRATS	Measured by PSYRATS (Psychotic Symptom Rating Scales)	Over 6 months of therapy, and 6-8 weeks post-therapy
Secondary	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
Secondary	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
Secondary	Dissociative experiences measured by DES-II	Measured by DES-II (Dissociative Experiences Scale)	Over 6 months of therapy, and 6-8 weeks post-therapy

External Links

•   UK Clinical Research Network Study Portfolio