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Compassion Focused Therapy for Distressing Experiences

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02733575
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
King's College London

Study Description
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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.


Condition or disease Intervention/treatment Phase
Psychosis Other: Compassion Focused Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Case Series Study of Compassion Focused Therapy for Distressing Experiences
Study Start Date : September 2015
Actual Primary Completion Date : January 8, 2019
Actual Study Completion Date : January 8, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Compassion Focused Therapy
Intervention
 Other: Compassion Focused Therapy
Up to 26 sessions of Compassion Focused Therapy


Outcome Measures
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Primary Outcome Measures :
  1. Attrition rate measured by number dropping out of therapy [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733575


Locations
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United Kingdom
South London and Maudsley NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
King's College London
Investigators
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Principal Investigator: Charlie Heriot-Maitland, DClinPsych King's College London
More Information
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02733575    
Other Study ID Numbers: R&D2018/024
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders