PsychosisNCT02733575
Compassion Focused Therapy for Distressing Experiences
A study testing Compassion Focused Therapy in people with Psychosis, run by King's College London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis
- What is being tested?
- Compassion Focused Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to 8 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South London and Maudsley NHS Foundation Trust
London
About this study
Official title: 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.
- Conditions
- Psychosis
- Being tested
- Compassion Focused Therapy
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion Focused TherapyOther
Up to 26 sessions of Compassion Focused Therapy
| Study group | Role | What they receive |
|---|---|---|
| Compassion Focused Therapy | Other | Intervention Receives: Other: Compassion Focused Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition rate measured by number dropping out of therapy
Measured: 6 months
Secondary outcomes (4)
Psychotic symptoms measured by PSYRATS
Measured by PSYRATS (Psychotic Symptom Rating Scales)
Measured: Over 6 months of therapy, and 6-8 weeks post-therapy
Depression and anxiety symptoms measured by DASS-21
Measured by DASS-21 (Depression, Anxiety and Stress Scale)
Measured: Over 6 months of therapy, and 6-8 weeks post-therapy
Subjective wellbeing, symptoms, functioning, and risk/harm measured by CORE
Measured by CORE (Clinical Outcomes in Routine Evaluation)
Measured: Over 6 months of therapy, and 6-8 weeks post-therapy
Dissociative experiences measured by DES-II
Measured by DES-II (Dissociative Experiences Scale)
Measured: Over 6 months of therapy, and 6-8 weeks post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startSep 2015
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlie Heriot-Maitland, DClinPsych, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733575
- Sponsor's protocol ID
- R&D2018/024
- Status last verified
- Mar 2019
- First submitted
- 25 Feb 2016
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Series Study of Compassion Focused Therapy for Distressing Experiences
- ClinicalTrials.gov ID
- NCT02733575
- Acronym / sponsor ID
- R&D2018/024
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compassion Focused Therapy | Other | Other: Compassion Focused TherapyIntervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassion Focused TherapyUp to 26 sessions of Compassion Focused Therapy | Other | Compassion Focused Therapy |
Primary outcome
Attrition rate measured by number dropping out of therapy
Time frame: 6 months
4 secondary outcomes
Psychotic symptoms measured by PSYRATS
Time frame: 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
Subjective wellbeing, symptoms, functioning, and risk/harm measured by CORE
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlie Heriot-Maitland, DClinPsych principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion Focused Therapy in people with Psychosis, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attrition rate measured by number dropping out of therapy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.