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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: 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 of York. This web‐based randomization process will randomize patients to one of the two arms of the trial based on a computer‐generated code. The information will be stored on a secure server and access to the sequence will be confined to the Trial Manager. Allocation to the trial arms will be in the ratio of 1:1. The Trial Manager will access the treatment allocation for each patient by remote internet‐based randomization. The group allocation will be disclosed to the Trial Manager after baseline data has been collected for each participant. The allocation outcome will be entered into the secure shared database so that all members of the research team can view the allocation. The brief problem‐solving intervention involves delivery of a well‐established social problem‐solving theory. The PI will deliver the intervention in groups of up to ten patients in a workshop lasting up to 2 hours, delivered over a 5‐day period. CONDITION: Prevention of depression, hopelessness and suicidal intent in patients in a secure in‐patient hospital setting ; Mental and Behavioural Disorders PRIMARY OUTCOME: ; 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 OUTCOME: ; 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; 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
Epistemonikos ID: d4d2bc8778f933e813c3cda0c31f48aa9c746976
First added on: Aug 25, 2024