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Cognitive Analytic Therapy-informed Containment for Self-Harm (CATCH)

Primary Purpose

Self Harm

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive analytic informed brief therapy
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self Harm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be aged over 16 years (parental consent is not needed; The British Psychological Society, 2008)
  2. Be comfortable with and have access to email and the internet for completing study measures
  3. Be currently under or receiving support form clinical/health service including NHS, 3rd sector, or University health services
  4. 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.

  5. Have an adequate English language ability to understand study materials
  6. Be deemed capable of providing informed consent by their clinical team.

Exclusion Criteria:

  1. 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.
  2. Have previously received any CAT
  3. 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
  4. 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).
  5. Have been hospitalised as a result of self-harm in the past month

Sites / Locations

  • Mersery Care NHS Foundation Trust
  • Greater Manchester Mental Health NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Analytic Informed Brief Therapy

Treatment As Usual

Arm Description

Outcomes

Primary Outcome Measures

Acceptability- attendance rates
We will judge the intervention feasible based on whether > 70% of those randomised to receive the intervention complete both sessions.
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.
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).

Secondary Outcome Measures

Non-Suicidal Self-Injury
Self-Injurious Thoughts and Behaviours Inventory Short-Form structured interview (SITBI-SF; Nock et al., 2007).
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.
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.
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
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

Full Information

First Posted
February 20, 2019
Last Updated
January 5, 2021
Sponsor
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT03853382
Brief Title
Cognitive Analytic Therapy-informed Containment for Self-Harm (CATCH)
Official Title
Cognitive Analytic Therapy-informed Containment for Self-Harm (CATCH): A Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self Harm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Analytic Informed Brief Therapy
Arm Type
Experimental
Arm Title
Treatment As Usual
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive analytic informed brief therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability- attendance rates
Description
We will judge the intervention feasible based on whether > 70% of those randomised to receive the intervention complete both sessions.
Time Frame
Five weeks
Title
Safety- adverse experiences
Description
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.
Time Frame
Five weeks
Title
Feasibility - completion rate of assessments
Description
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).
Time Frame
Five weeks
Secondary Outcome Measure Information:
Title
Non-Suicidal Self-Injury
Description
Self-Injurious Thoughts and Behaviours Inventory Short-Form structured interview (SITBI-SF; Nock et al., 2007).
Time Frame
Five weeks
Title
Self-Compassion Scale (SCS; Neff, 2003).
Description
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.
Time Frame
Five weeks
Title
Depressive symptoms
Description
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.
Time Frame
Five weeks
Title
Self-concept instability
Description
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
Time Frame
Five weeks
Title
Self-injury urges
Description
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
Time Frame
Five weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Mersery Care NHS Foundation Trust
City
Liverpool
Country
United Kingdom
Facility Name
Greater Manchester Mental Health NHS Foundation Trust
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to the small scale nature of the trial there is no plan to share Individual Patient Data
Citations:
PubMed Identifier
33884617
Citation
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.
Results Reference
derived

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Cognitive Analytic Therapy-informed Containment for Self-Harm (CATCH)

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