NCT03853382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

February 20, 2019

Last Update Submit

January 5, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Acceptability- attendance rates

    We will judge the intervention feasible based on whether \> 70% of those randomised to receive the intervention complete both sessions.

    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.

    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).

    Five weeks

Secondary Outcomes (5)

  • Non-Suicidal Self-Injury

    Five weeks

  • Self-Compassion Scale (SCS; Neff, 2003).

    Five weeks

  • Depressive symptoms

    Five weeks

  • Self-concept instability

    Five weeks

  • Self-injury urges

    Five weeks

Study Arms (2)

Cognitive Analytic Informed Brief Therapy

EXPERIMENTAL
Behavioral: Cognitive analytic informed brief therapy

Treatment As Usual

NO INTERVENTION

Interventions

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.

Cognitive Analytic Informed Brief Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mersery Care NHS Foundation Trust

Liverpool, United Kingdom

Location

Greater Manchester Mental Health NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical lecturer

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 25, 2019

Study Start

April 1, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Due to the small scale nature of the trial there is no plan to share Individual Patient Data

Locations