Compassion Focused Therapy for Distressing Experiences

March 13, 2019 updated by: King's College London

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom
        • South London and Maudsley NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
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
Time Frame: Over 6 months of therapy, and 6-8 weeks post-therapy
Measured by DES-II (Dissociative Experiences Scale)
Over 6 months of therapy, and 6-8 weeks post-therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Charlie Heriot-Maitland, DClinPsych, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

January 8, 2019

Study Completion (ACTUAL)

January 8, 2019

Study Registration Dates

First Submitted

February 25, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (ESTIMATE)

April 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

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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