Condition category
Mental and Behavioural Disorders
Date applied
22/04/2015
Date assigned
22/04/2015
Last edited
15/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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.

Trial website

Contact information

Type

Scientific

Primary contact

Ms Sarah Jones

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Other

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/05/2014

Overall trial end date

31/12/2015

Reason abandoned

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

Patient

Age group

Adult

Gender

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

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

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Manchester Mental Health & Social Care Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26869076

Publication citations

Additional files

Editorial Notes

15/02/2016: Publication reference added.