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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17751649
Enrollment
150
Registered
2024-08-21
Start date
2025-10-08
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Current interventions as of 05/02/2025: This study encompasses two primary components. Firstly, it involves administering a 15-week enhanced Cognitive Behavioral Therapy (CBT) intervention along wit

Sponsors

University College Cork
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria: Current exclusion criteria as of 09/02/2026: 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, schizophrenia, bipolar affective disorders, personality disorders 6. Significant cognitive impairment 7. Requiring intensive in-patient care due to their medical illness Previous 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

Design outcomes

Primary

MeasureTime frame
Current primary outcomes as of 09/02/2026 Suicidal ideation measured using the Beck scale for suicidal ideation (BSSI) measured at baseline, post-intervention, and 3- month follow-up _____ Previous primary outcome measure as of 21/01/2025: 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) 2. Suicidal behaviours (thoughts and acts) measured using the Suicide Cognition Scale-revised (SCS-R), Beck scale for suicidal ideation (BSSI) 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) _____ Previous primary outcome measure: 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) 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)

Secondary

MeasureTime frame
Current secondary outcomes as of 09/02/2026: 1. Severity of depression and anxiety measured using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) 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) 2. Coping measured using Brief-COPE 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) 3. Hopelessness measured using the Beck hopelessness scale 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) 4. Self-harm behaviours measured by Deliberate Self-harm Inventory (DSHI) at baseline, post-intervention, and 3- month follow-up 5. Quality of life and mental wellbeing measured using WHO-5 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) 6. Biological markers such as hypothalamic pituitary adrenal (HPA)-axis functioning (cortisol), inflammation (C-reactive protein, IL-6, TNF-alpha), tryptophan-kynurenine pathway (tryptophan, kynurenine, kynurenic acid), neuroplasticity (Brain-Derived Neurotrophic Factor [BDNF]) measured using blood and salivary samples 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). Previous secondary outcomes: 1. Severity of depression and anxiety measured using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) 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) 2. Coping measured using Brief-COPE 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) 3.

Countries

Ireland

Contacts

Public ContactAlmas Khan
almaskhan@ucc.ie+353 (0)892048357

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 30, 2026