A pilot study to investigate the feasibility and acceptability of a cognitive behavioural suicide prevention therapy for people in acute psychiatric wards.
| ISRCTN | ISRCTN17890126 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17890126 |
| Secondary identifying numbers | 15409 |
- Submission date
- 22/04/2015
- Registration date
- 22/04/2015
- Last edited
- 17/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Suicide is a major cause of preventable death with patients in acute psychiatric wards being oat particularly high risk. Many patients experience repeated episodes of suicidal behaviour causing great mental distress and heavy use of NHS services. However there is little research investigating treatments that work in helping patients address issues that lead to suicide. This study investigates issues concerning the introduction of cognitive behavioural therapy (CBT) for suicide prevention for patients in acute psychiatric wards who are a very high risk group in a setting where use of psychological therapies is uncommon and requires evaluation.
Who can participate?
Adult (aged between18-65) inpatients on an acute psychiatric ward.
What does the study involve?
Researchers first observe ward life and investigate “usual patient journeys” to identify best ways of introducing the new therapy. Participants are then randomly allocated into one of two groups. Those in group 1 receive their usual treatment. Those in group 2 receive their usual treatment and cognitive behavioural suicide prevention therapy (CBSP). Ward staff and patients are asked about their views before and after introduction of the new therapy. Participants also complete questionnaires to identify how they feel (mood, suicidal ideas, functioning and general wellbeing). These assessments are made before treatment begins, after 6 weeks and then after 6 months. Staff and patients are interviewed to give their views of the new therapy, how it fits into ward routines, whether they like the therapy and if they feel any benefits or otherwise. We also identify costs of NHS treatment for both groups and make comparisons.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Manchester Mental Health & Social Care Trust (UK)
When is the study starting and how long is it expected to run for?
May 2014 to December 2015
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms Sarah Jones.
Contact information
Scientific
Manchester Mental Health & Social Care Trust
Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A pilot study to investigate the feasibility and acceptability of a cognitive behavioural suicide prevention therapy for people in acute psychiatric wards: a randomised controlled trial |
| Study acronym | INSITE Phase 2 |
| Study hypothesis | This feasibility study investigates issues concerning the introduction of cognitive behavioural therapy (CBT) for suicide prevention for patients in acute psychiatric wards who are a very high risk group in a setting where use of psychological therapies is uncommon and requires evaluation. |
| Ethics approval(s) | First MREC approval date 21/08/2013, ref: 13/NW/0504MHRNB; |
| Condition | Topic: Mental Health; Subtopic: Suicide and self-harm; Disease: Suicide and self harm |
| Intervention | Pilot study to investigate the feasibility of cognitive behavioural suicide prevention therapy (CBSP). Participants will be randomly allocated to two treatment arms - treatment as usual or treatment as usual plus CBSP Intervention. Follow Up Length: 5 month(s); Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure | The Suicidal Behaviours Questionnaire – revised (SBQ-R); Timepoint(s): Baseline, 6 week follow up, 6 month follow up |
| Secondary outcome measures | 1. Basic Emotions Scale (BES; Power, 2006); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 2. Beck Scale for Suicidal Ideation (BSS; Beck & Steer, 1991); Timepoint(s): Baseline, 6 week follow up and 6 month follow up 3. Calgary Depression Scale (Addington et al, 1990); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 4. Coping in Stressful Situations (Endler & Parker, 1990); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 5. EG-5D (Euroqol Group, 1990); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 6. Personal and Social Performance Scale (Morosoni et al 2000); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 7. Positive and Negative Syndrome Scale (PANSS; Kay, Opler & Fiszbein, 1987); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 8. Psychotic Symptoms Rating Scale (Haddock et al, 1999); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 9. Sleep Condition Indicator (SCI; Espie et al, 2013); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 10. The Beck Hopelessness Scale (BHS; Beck, 1988); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 11. The Defeat Scale (Gilbert & Allan, 1998); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 12. The Difficulties in Emotional Regulation Scale (Gratz & Roemer, 2004); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 13. The Entrapment Scale (Gilbert & Allan, 1998); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 14. The Forms of Self Criticising/Attacking & Self Reassuring Scale; Timepoint(s): Baseline, 6 week follow up, 6 month follow up 15. The Implicit Beliefs About Emotions Scale ( IBES; Tamir et al 2004); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 16. The Self Concept Questionnaire (Robson, 1989); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 17. The Suicide Probability Scale (SPS; Cull & Gill 1988); Timepoint(s): Baseline, 6 week follow up, 6 month follow up 18. The World Health Organisation Quality of Life Assessment , brief version (WHOQOL-BREF; Skevington, L; Timepoint(s): Baseline, 6 week follow up, 6 month follow up 19. Views on Inpatient Care (VOICE; Evans et al, 2012); Timepoint(s): Baseline, 6 week/6 month follow up (dependent on hospital admission dates 20. Views on Therapeutic Environments (VOTE; Laker et al, 2012); Timepoint(s): Baseline, 6 week/6 month follow up (depending on hospital admission dates) 21. Working Alliance Inventory (Horvath, 1992); Timepoint(s): Taken at 2 time points during course of therapy |
| Overall study start date | 01/05/2014 |
| Overall study end date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60; Description: Study team advised new sample size is 60 - 30 in interventional group and 30 in treatment as usual group 19/11/13 |
| Total final enrolment | 51 |
| Participant inclusion criteria | 1. Inpatients on an acute psychiatric ward 2. Adults aged 18-65 years 3. Mental capacity to provide informed consent 4. Positive risk of suicide verified SBQ-R |
| Participant exclusion criteria | Planned discharge within next 7 days. |
| Recruitment start date | 01/05/2014 |
| Recruitment end date | 31/12/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Sponsor information
Hospital/treatment centre
Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
England
United Kingdom
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/02/2016 | Yes | No | |
| Other publications | qualitative results | 16/10/2018 | Yes | No | |
| Results article | 01/01/2019 | 17/05/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
17/05/2023: Publication reference and total final enrolment added.
18/10/2018: Publication reference added.
15/02/2016: Publication reference added.
