Self HarmNCT03853382
Cognitive Analytic Therapy-informed Containment for Self-Harm (CATCH)
A study testing Cognitive analytic informed brief therapy in people with Self Harm, run by University of Manchester at 2 sites in United Kingdom.
Trial summary
Non-suicidal self-injury (NSSI) is when somebody engages in self-harm, such as cutting, without meaning to end his or her life. A large number of people engage in NSSI for lots of reasons, for example to cope with emotions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self Harm
- What is being tested?
- Cognitive analytic informed brief therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Apr 2019to 1 Sep 2020
- 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
- Be aged over 16 years (parental consent is not needed; The British Psychological Society, 2008)
- Be comfortable with and have access to email and the internet for completing study measures
- Be currently under or receiving support form clinical/health service including NHS, 3rd sector, or University health services
- Following DSM-V (American Psychiatric Association, 2013), have had five or more instances of NSSI in the past year:
- NSSI methods are operationalised to include cutting, burning, biting, or scratching oneself, as well as head-banging or self-poisoning.
- Have an adequate English language ability to understand study materials
- Be deemed capable of providing informed consent by their clinical team.
Who cannot join
- Be currently receiving any other psychological therapy (e.g. including but not limited to CBT and/or DBT), and will not have received psychological therapies in the last one month.
- Have previously received any CAT
- Have been diagnosed with Learning Disability or Autistic Spectrum Disorder as judged by clinical team - since the intervention has not been developed for this population
- Be currently judged at high risk of suicidal behaviour (although if participants were keen to be involved, they could be considered when their mental health has improved).
- Have been hospitalised as a result of self-harm in the past month
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Mersery Care NHS Foundation Trust
Liverpool
Greater Manchester Mental Health NHS Foundation Trust
Manchester
About this study
Official title: Cognitive Analytic Therapy-informed Containment for Self-Harm (CATCH): A Feasibility Trial
Non-suicidal self-injury (NSSI) is when somebody engages in self-harm, such as cutting, without meaning to end his or her life. A large number of people engage in NSSI for lots of reasons, for example to cope with emotions. However, currently there are large waiting lists to access psychological therapy through the NHS. Therefore, it is important to research brief therapies so that individuals who engage in NSSI can receive treatment quicker. One potentially helpful therapy suggested is Cognitive Analytic Therapy (CAT), which focuses on patterns in relationships. NSSI can be understood as a way in which people relate to themselves, which suggests that CAT would fit well in terms of understanding and working with these difficulties.
This study aims to evaluate a brief two-session CAT therapy for people who engage in NSSI. The project aims to evaluate the feasibility and acceptability of the therapy, using interviews and questionnaires. This means looking at whether participants stick with the therapy, and how they find taking part in the therapy.
All participants will meet with a researcher for an initial session to complete baseline questionnaires about their current difficulties, thoughts and feelings. Participants will then be randomly allocated to a condition: either the therapy condition or the treatment-as-usual (TAU) condition. Participants in the therapy condition will receive two therapy sessions, whilst participants in the TAU condition will not receive any therapy sessions. All participants will attend a final session to complete more questionnaires. Participants will be asked to complete online surveys weekly. Some participants will be invited to take part in interviews about their experience of the therapy. All participants will receive a shopping voucher as compensation for their time. Using the data collected from this study, future work can be done to provide better treatment for people who engage in NSSI.
- Conditions
- Self Harm
- Being tested
- Cognitive analytic informed brief therapy
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive analytic informed brief therapyBehavioural
The brief CAT-informed therapy will take place over two sessions. Session one will last around 90 minutes. In session one, we will discuss with the participant their experience of self-harm and begin to support them to make sense of patterns in their self-harming behaviour. This will be done by thinking about the events that come before or follow self-harm, as well as thoughts and emotions associated with self-harm; it will also be done by thinking about ways that the participant relates to him/herself and other people. By the end of the first session, the researcher and the participant will have collaboratively developed a written diagram which shows patterns in the participant's self-harm.
Session two will involve revisiting the mapping of patterns. The researcher and participant will the collaboratively develop 'exits' or ways to break patterns and cycles of thinking, feeling and behaviour. Both sessions will have structured endings.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Analytic Informed Brief Therapy | Experimental | Not described Receives: Behavioral: Cognitive analytic informed brief therapy |
| Treatment As Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability- attendance rates
We will judge the intervention feasible based on whether > 70% of those randomised to receive the intervention complete both sessions.
Measured: Five weeks
Safety- adverse experiences
Safety will be assessed via an Adverse Effects in Psychotherapy (AEP) self-report measure (Hutton, Byrne \& Morrison, 2017; unpublished). Items rated as greater than "a little" will be classified as notable adverse experiences. Adverse events occurring during the course of the trial (identified through discussion with the participant or clinical team) will also be monitored and recorded. These will include hospitalisation (related to mental health), medically serious self-harm (i.e. requiring medical intervention), and suicidal ideation where a plan and intent are present.
Measured: Five weeks
Feasibility - completion rate of assessments
Feasibility will be based upon (i) > 70% of participants attending the post-therapy follow-up point and (ii) a rate of missing data per outcome measure of < 25% (this rate of missing data has been used to indicate high risk of bias within systematic reviews; Hutton et al., 2015).
Measured: Five weeks
Secondary outcomes (5)
Non-Suicidal Self-Injury
Self-Injurious Thoughts and Behaviours Inventory Short-Form structured interview (SITBI-SF; Nock et al., 2007).
Measured: Five weeks
Self-Compassion Scale (SCS; Neff, 2003).
The Self-Compassion Scale (SCS; Neff, 2003), assesses levels of self-compassion. The SCS includes 26 items rated on a scale of 1 (almost never) to 5 (almost always) as to how often participants engage in a range of thoughts or behaviours. The SCS includes six subscales including self-criticism (scores range from 5 to 25), self-kindness (scores range from 5 to 25), isolation (scores range from 4 to 20), common humanity (scores range from 4 to 20), over-identification (scores range from 4 to 20) and mindfulness (scores range from 4 to 20). Higher scores indicate greater self-compassion.
Measured: Five weeks
Depressive symptoms
Patient Health Questionnaire (PHQ9; Kroenke et al., 2001).The PHQ9, used to assess depression, includes nine items and determines the extent to which participants have been bothered by difficulties over the last two weeks by rating on a scale of 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27, with higher scores indicating greater symptom severity.
Measured: Five weeks
Self-concept instability
The Personality Structure Questionnaire (PSQ; Pollock et al., 2001) will be used to assess self-concept stability. The PSQ includes 8 items rated on a five-point scale with opposite ends representing agreement with an unstable or stable sense of self. Scores range from 0 to 40 with greater scores indicating greater instability
Measured: Five weeks
Self-injury urges
Alexian Brothers Urges to Self-injure scale (ABUSI; Washburn et al., 2010). The ABUSI asks participants to rate their urges to self-injure over the last week on frequency, strength, time thinking of self-injuring, and ability to resist. Score range from 0 to 30 with higher scores indicating more severe urges to self-injure
Measured: Five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Apr 2019
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self HarmStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Taylor, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853382
- Sponsor's protocol ID
- 257582
- Status last verified
- Jan 2021
- First submitted
- 20 Feb 2019
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small scale nature of the trial there is no plan to share Individual Patient Data
Publications
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Analytic Therapy-informed Containment for Self-Harm (CATCH): A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03853382
- Acronym / sponsor ID
- 257582
- Conditions
- Self Harm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 25 Feb 2019 (actual)
- 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.
Non-suicidal self-injury (NSSI) is when somebody engages in self-harm, such as cutting, without meaning to end his or her life. A large number of people engage in NSSI for lots of reasons, for example to cope with emotions. However, currently there are large waiting lists to access psychological therapy through the NHS. Therefore, it is important to research brief therapies so that individuals who engage in NSSI can receive treatment quicker. One potentially helpful therapy suggested is Cognitive Analytic Therapy (CAT), which focuses on patterns in relationships. NSSI can be understood as a way in which people relate to themselves, which suggests that CAT would fit well in terms of understanding and working with these difficulties.
This study aims to evaluate a brief two-session CAT therapy for people who engage in NSSI. The project aims to evaluate the feasibility and acceptability of the therapy, using interviews and questionnaires. This means looking at whether participants stick with the therapy, and how they find taking part in the therapy.
All participants will meet with a researcher for an initial session to complete baseline questionnaires about their current difficulties, thoughts and feelings. Participants will then be randomly allocated to a condition: either the therapy condition or the treatment-as-usual (TAU) condition. Participants in the therapy condition will receive two therapy sessions, whilst participants in the TAU condition will not receive any therapy sessions. All participants will attend a final session to complete more questionnaires. Participants will be asked to complete online surveys weekly. Some participants will be invited to take part in interviews about their experience of the therapy. All participants will receive a shopping voucher as compensation for their time. Using the data collected from this study, future work can be done to provide better treatment for people who engage in NSSI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Analytic Informed Brief Therapy | Experimental | Behavioral: Cognitive analytic informed brief therapy |
| Treatment As Usual | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be aged over 16 years (parental consent is not needed; The British Psychological Society, 2008)
- Be comfortable with and have access to email and the internet for completing study measures
- Be currently under or receiving support form clinical/health service including NHS, 3rd sector, or University health services
- Following DSM-V (American Psychiatric Association, 2013), have had five or more instances of NSSI in the past year:
- Have an adequate English language ability to understand study materials
Key exclusion criteria (5 listed)
- Be currently receiving any other psychological therapy (e.g. including but not limited to CBT and/or DBT), and will not have received psychological therapies in the last one month.
- Have previously received any CAT
- Have been diagnosed with Learning Disability or Autistic Spectrum Disorder as judged by clinical team - since the intervention has not been developed for this population
- Be currently judged at high risk of suicidal behaviour (although if participants were keen to be involved, they could be considered when their mental health has improved).
- Have been hospitalised as a result of self-harm in the past month
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 |
|---|---|---|
| Cognitive analytic informed brief therapyThe brief CAT-informed therapy will take place over two sessions. Session one will last around 90 minutes. In session one, we will discuss with the participant their experience of self-harm and begin to support them to make sense of patterns in their self-harming behaviour. This will be done by thinking about the events that come before or follow self-harm, as well as thoughts and emotions associated with self-harm; it will also be done by thinking about ways that the participant relates to him/herself and other people. By the end of the first session, the researcher and the participant will have collaboratively developed a written diagram which shows patterns in the participant's self-harm. Session two will involve revisiting the mapping of patterns. The researcher and participant will the collaboratively develop 'exits' or ways to break patterns and cycles of thinking, feeling and behaviour. Both sessions will have structured endings. | Behavioural | Cognitive Analytic Informed Brief Therapy |
Primary outcome
Acceptability- attendance rates
Time frame: Five weeks
We will judge the intervention feasible based on whether > 70% of those randomised to receive the intervention complete both sessions.
Safety- adverse experiences
Time frame: Five weeks
Safety will be assessed via an Adverse Effects in Psychotherapy (AEP) self-report measure (Hutton, Byrne \& Morrison, 2017; unpublished). Items rated as greater than "a little" will be classified as notable adverse experiences. Adverse events occurring during the course of the trial (identified through discussion with the participant or clinical team) will also be monitored and recorded. These will include hospitalisation (related to mental health), medically serious self-harm (i.e. requiring medical intervention), and suicidal ideation where a plan and intent are present.
Feasibility - completion rate of assessments
Time frame: Five weeks
Feasibility will be based upon (i) > 70% of participants attending the post-therapy follow-up point and (ii) a rate of missing data per outcome measure of < 25% (this rate of missing data has been used to indicate high risk of bias within systematic reviews; Hutton et al., 2015).
5 secondary outcomes
Non-Suicidal Self-Injury
Time frame: Five weeks
Self-Compassion Scale (SCS; Neff, 2003).
Time frame: Five weeks
Depressive symptoms
Time frame: Five weeks
Self-concept instability
Time frame: Five weeks
Self-injury urges
Time frame: Five weeks
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 6 Jan 2021.
- Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- Individual participant dataSharing planned: No. Due to the small scale nature of the trial there is no plan to share Individual Patient Data
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive analytic informed brief therapy in people with Self Harm, run by University of Manchester at 2 sites 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 7 inclusion and 5 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 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Acceptability- attendance rates (time frame: Five weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03853382, which also lists 1 linked publication.
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 6 Jan 2021.