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Completed

NCT Number: NCT02733575

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South London and Maudsley NHS Foundation Trust

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Compassion Focused Therapy

Other

Up to 26 sessions of Compassion Focused Therapy

Primary outcomes

  1. Attrition rate measured by number dropping out of therapy

    Time frame: 6 months

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

A Case Series Study of Compassion Focused Therapy for Distressing Experiences

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2016
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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