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
Protocol serial number	15409
Sponsor	Manchester Mental Health & Social Care Trust (UK)
Funder	National Institute for Health Research

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Ms Sarah Jones
Scientific

Manchester Mental Health & Social Care Trust
Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment
Secondary study design	Randomised controlled trial
Study type	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 objectives	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;
Health condition(s) or problem(s) studied	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(s)	The Suicidal Behaviours Questionnaire – revised (SBQ-R); Timepoint(s): Baseline, 6 week follow up, 6 month follow up
Key secondary outcome measure(s)	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
Completion date	31/12/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	60
Total final enrolment	51
Key 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
Key exclusion criteria	Planned discharge within next 7 days.
Date of first enrolment	01/05/2014
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Manchester Mental Health & Social Care Trust

Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/01/2019	17/05/2023	Yes	No
Protocol article	protocol	11/02/2016		Yes	No
HRA research summary			28/06/2023	No	No
Other publications	qualitative results	16/10/2018		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/05/2023: Publication reference and total final enrolment added.
18/10/2018: Publication reference added.
15/02/2016: Publication reference added.