Enhanced cognitive behavioural therapy for self-harm in comorbid physical and mental health conditions: a pragmatic randomised controlled trial

Not Applicable

• Conditions: Self-harm and suicidal behaviours (ideation and act) in comorbid physical and mental health conditions; Mental and Behavioural Disorders

• Registration Number: ISRCTN17751649
• Lead Sponsor: Health Research Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-21
• Last Update Posted: 2 September 2024
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Adults over 18 years
2. Presence of a chronic physical illness(es) requiring the services of secondary/ tertiary care, specifically, cancer or asthma or Chronic Obstructive Pulmonary Disease (COPD) or any type of chronic pain (including fibromyalgia, trauma, or osteoarthritis) persisting over 3 months or defined as per ICD-11
3. A recent history (within the past 3 months) or risk of self-harm or suicidal behaviors (ideation and act)
4. Presence of comorbid mental health symptom(s) such as anxiety, mild-moderate depressive symptoms, or distress

Exclusion Criteria

1. Below the age of 18 years
2. Not requiring or undergoing secondary treatment
3. Not living with a chronic physical illness including non-melanoma skin cancer
4. Exhibiting high/severe risk of suicidal or self-harm behaviours, where the treating consultant doesn’t recommend participation in the study
5. Diagnosed with severe or enduring mental disorders like severe depression or anxiety (score of 9 or more on PHQ-4 screening test), schizophrenia, bipolar affective disorders, personality disorders
6. Significant cognitive impairment
7. Requiring intensive in-patient care due to their medical illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Repetition and severity of self-harm (thoughts and acts) measured using Deliberate Self-harm Inventory (DSHI) at baseline, post-intervention (15-16 weeks after baseline as 1st follow-up) and 3 months after first follow-up (10-12 weeks post first follow-up)<br>2. Suicidal behaviours (thoughts and acts) measured using the Suicide Cognition Scale-revised (SCS-R), Beck scale for suicidal ideation (BSSI) or the modified scale for suicidal ideation (MSSI) at baseline, post-intervention (15-16 weeks after baseline as 1st follow-up) and 3 months after first follow-up (10-12 weeks post first follow-up)