NCT02733575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

3.4 years

First QC Date

February 25, 2016

Last Update Submit

March 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Attrition rate measured by number dropping out of therapy

    6 months

Secondary Outcomes (4)

  • Psychotic symptoms measured by PSYRATS

    Over 6 months of therapy, and 6-8 weeks post-therapy

  • Depression and anxiety symptoms measured by DASS-21

    Over 6 months of therapy, and 6-8 weeks post-therapy

  • Subjective wellbeing, symptoms, functioning, and risk/harm measured by CORE

    Over 6 months of therapy, and 6-8 weeks post-therapy

  • Dissociative experiences measured by DES-II

    Over 6 months of therapy, and 6-8 weeks post-therapy

Study Arms (1)

Compassion Focused Therapy

OTHER

Intervention

Other: Compassion Focused Therapy

Interventions

Up to 26 sessions of Compassion Focused Therapy

Compassion Focused Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South London and Maudsley NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Charlie Heriot-Maitland, DClinPsych

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2016

First Posted

April 11, 2016

Study Start

September 1, 2015

Primary Completion

January 8, 2019

Study Completion

January 8, 2019

Last Updated

March 15, 2019

Record last verified: 2019-03

Locations