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.
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
15409
Study information
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
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;
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
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
Reason abandoned (if study stopped)
Eligibility
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 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 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 Mental Health & Social Care Trust
Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
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
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |