Assessing the feasibility and acceptability of developing and implementing a problem-solving training to improve symptoms of depression, anxiety and suicidal ideation
| ISRCTN | ISRCTN18110929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18110929 |
| IRAS number | 302570 |
| Secondary identifying numbers | IRAS 302570 |
- Submission date
- 03/02/2022
- Registration date
- 18/03/2022
- Last edited
- 23/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Problem-solving skills are important in helping people work out what to do when faced with a problem. A problem might be anything that is on your mind a lot, or something that you worry about. Lots of people have problems in life and sometimes these can be more difficult to address when in hospital We know that ignoring problems can have an impact on how people feel and behave and if left, you may find that they affect your physical and mental health. The aim of this study is to find out whether a brief problem-solving intervention can help to support people to feel better, act differently and take an active part in addressing problems whilst living in hospital.
Who can participate?
Patients aged over 18 years who are expected to be in hospital for the next 6 months with English as a first language, unless they are already involved in another study.
What does the study involve?
Participants will be asked to complete some questionnaires at the start and end of the study. These will measure whether the problem-solving skills have any impact on mental health, feelings of hopelessness and thoughts about suicide. Participants will be randomly allocated to receive either the problem-solving skills therapy plus usual care or just to receive usual care. Participants assigned to take part in the problem-solving skills therapy will be expected to attend 5 2-hour workshops in a group of up to ten other patients over the course of 1 week.
What are the possible benefits and risks of participating?
Participants will be given the opportunity to learn some new problem-solving skills which may help them cope better when faced with problems as an inpatient. It is unlikely that participants might feel upset or anxious during the study, but if they do feel upset they are free to leave at any time. Participants can also talk to a member of ward staff or the research team who will support them.
Where is the study run from?
University of York (UK)
When is the study starting and how long is it expected to run for?
April 2021 to December 2022
Who is funding the study?
Tees Esk and Wear Valleys NHS Foundation Trust (UK)
Who is the main contact?
Dr Amanda E Perry
amanda.perry@york.ac.uk
Contact information
Principal Investigator
Health Sciences Department
University of York
Heslington
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0002-0279-1884 |
|---|---|
| Phone | +44 (0)1904 321929 |
| amanda.perry@york.ac.uk |
Study information
| Study design | Single-site interventional feasibility randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request participant information sheet |
| Scientific title | 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]) |
| Study acronym | IS-DASH |
| Study objectives | Problem-solving skills reduces symptoms of depression, hopelessness and suicidal intent in comparison to care as usual. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Prevention of depression, hopelessness and suicidal intent in patients in a secure in-patient hospital setting |
| 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. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/04/2021 |
| Completion date | 01/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2022 |
| Date of final enrolment | 31/07/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of York
York
YO10 5DD
United Kingdom
Sponsor information
University/education
ARRC Buildings
Health Sciences Department
Heslington
York
YO10 5DD
England
United Kingdom
| Phone | +44 (0)7795315045 |
|---|---|
| michael.barber@york.ac.uk | |
| Website | https://www.york.ac.uk/healthsciences/research/mental-health/projects/problem-solving-secure-environments/ |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | A dissemination event will be led with service users to show the findings of the study. The study will throughout explore how the information can be made accessible to staff and patients, for example, via the ward computers and reception television services. Reporting of the study progress to the Forensic Research Group, Quarterly Forensic Newsletter and through the staff Research Champion’s (whose role it is to disseminate research information on each ward). The structure and will lead to the write up and a peer reviewed academic publication. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 15/03/2022 | 16/03/2022 | No | No |
| Protocol file | version 1 | 15/03/2022 | 23/03/2022 | No | No |
Additional files
Editorial Notes
23/03/2022: The protocol (not peer reviewed) has been uploaded as an additional file.
15/03/2022: Trial's existence confirmed by Tees Esk and Wear Valleys NHS Foundation Trust.
