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Assessing the feasibility and acceptability of developing and implementing a problem-solving training to improve symptoms of depression, anxiety and suicidal ideation

Assessing the feasibility and acceptability of developing and implementing a problem-solving training: a randomised controlled trial to improve symptoms of depression, hopelessness and suicidal intent (In-patient Secure - Depression, Anxiety and Self-Harm [IS-DASH])

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18110929
Enrollment
40
Registered
2022-03-18
Start date
2022-05-01
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Prevention of depression, hopelessness and suicidal intent in patients in a secure in-patient hospital setting Mental and Behavioural Disorders

Interventions

Participants are randomised to receive problem solving skills and care as usual vs care as usual only. Participants will be randomized by the York Trials Unit Randomization Service at the University o

Sponsors

University of York
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Inpatient on forensic ward 2. English ability sufficient for understanding study materials without the need for a translator 3. Adult males and females >18 years of age 4. Remaining within the hospital for 6 months or more

Exclusion criteria

Exclusion criteria: 1. Individuals currently experiencing a mental health crisis 2. Individuals unable or unwilling to provide consent 3. Individuals that pose a risk to the research team 4. Individuals not remaining on the ward for the duration of the study 5. Individuals that are currently participating in another research intervention study

Design outcomes

Primary

MeasureTime frame
The feasibility and acceptability of the trial to inform a future definitive trial, assessed using: 1. The recruitment rate of patients joining the trial 2. The retention of patients by estimating 3-month follow-up 3. The acceptability of the peer-led intervention in terms of adherence and attendance to the intervention and completion rates on questionnaires 4. Sample size calculated based on recruitment rates, outcomes and adherence 5. The acceptability determined by addressing barriers to implementation to develop an optimal plan for delivery of the complex intervention in the main trial Data will be collected using a bespoke feasibility and acceptability questionnaire to cover: data on the number of eligible patients; numbers of those who consent to take part and withdraw (with reasons); follow-up and attrition rates, assess whether outcome data can be reliably and feasibly collected (completion rates); record the number of sessions attended and proportion that successfully complete; timing of the sessions and collect information from practitioners about what constitutes treatment as usual and measurement of acceptability and barriers to implementation for the definitive trial: during and up to 3 months post randomization.

Secondary

MeasureTime frame
1. Demographic characteristics measured using a bespoke questionnaire (including measurement of usual care) at baseline 2. Depression measured using the Patient Health Questionnaire (PHQ-9) at baseline and up to 3 months post randomization 3. Anxiety measured using the Generalised Anxiety Disorder Assessment (GAD-7) at baseline and up to 3 months post-randomization 4. Suicidal ideation measured using the Beck Suicidal Ideation Scale (BSSI) at baseline and up to 3 months post-randomization

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026