Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual: study protocol for the STAR (Study of Trauma And Recovery) trial

Emmanuelle Peters; Amy Hardy; Robert Dudley; Filippo Varese; Kathryn Greenwood; Craig Steel; Richard Emsley; Nadine Keen; Samantha Bowe; Sarah Swan; Raphael Underwood; Eleanor Longden; Sarah Byford; Laura Potts; Margaret Heslin; Nick Grey; Doug Turkington; David Fowler; Elizabeth Kuipers; Anthony Morrison

doi:10.1186/s13063-022-06215-x

Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual: study protocol for the STAR (Study of Trauma And Recovery) trial

Emmanuelle Peters, Amy Hardy, Robert Dudley, Filippo Varese, Kathryn Greenwood, Craig Steel, Richard Emsley, Nadine Keen, Samantha Bowe, Sarah Swan, Raphael Underwood, Eleanor Longden, Sarah Byford, Laura Potts, Margaret Heslin, Nick Grey, Doug Turkington, David Fowler, Elizabeth Kuipers, Anthony Morrison

Research output: Contribution to journal › Article › peer-review

13 Citations (Scopus)

Abstract

BACKGROUND: People with psychosis have high rates of trauma, with a post-traumatic stress disorder (PTSD) prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pilot studies have shown that trauma-focused (TF) psychological therapies can be safe and effective in such individuals. This trial, the largest to date, will evaluate the clinical effectiveness of a TF therapy integrated with cognitive behaviour therapy for psychosis (TF-CBTp) on post-traumatic stress symptoms in people with psychosis. The secondary aims are to compare groups on cost-effectiveness; ascertain whether TF-CBTp impacts on a range of other meaningful outcomes; determine whether therapy effects endure; and determine acceptability of the therapy in participants and therapists.

METHODS: Rater-blind, parallel arm, pragmatic randomised controlled trial comparing TF-CBTp + treatment as usual (TAU) to TAU only. Adults (N = 300) with distressing post-traumatic stress and psychosis symptoms from five mental health Trusts (60 per site) will be randomised to the two groups. Therapy will be manualised, lasting 9 months (m) with trained therapists. We will assess PTSD symptom severity (primary outcome); percentage who show loss of PTSD diagnosis and clinically significant change; psychosis symptoms; emotional well-being; substance use; suicidal ideation; psychological recovery; social functioning; health-related quality of life; service use, a total of four times: before randomisation; 4 m (mid-therapy); 9 m (end of therapy; primary end point); 24 m (15 m after end of therapy) post-randomisation. Four 3-monthly phone calls will be made between 9 m and 24 m assessment points, to collect service use over the previous 3 months. Therapy acceptability will be assessed through qualitative interviews with participants (N = 35) and therapists (N = 5-10). An internal pilot will ensure integrity of trial recruitment and outcome data, as well as therapy protocol safety and adherence. Data will be analysed following intention-to-treat principles using generalised linear mixed models and reported according to Consolidated Standards of Reporting Trials-Social and Psychological Interventions Statement.

DISCUSSION: The proposed intervention has the potential to provide significant patient benefit in terms of reductions in distressing symptoms of post-traumatic stress, psychosis, and emotional problems; enable clinicians to implement trauma-focused therapy confidently in this population; and be cost-effective compared to TAU through reduced service use.

TRIAL REGISTRATION: ISRCTN93382525 (03/08/20).

Original language	English
Pages (from-to)	429
Journal	Trials
Volume	23
Issue number	1
DOIs	https://doi.org/10.1186/s13063-022-06215-x
Publication status	Published - 23 May 2022

Keywords

Adult
Cognitive Behavioral Therapy/methods
Comorbidity
Humans
Multicenter Studies as Topic
Pragmatic Clinical Trials as Topic
Psychotic Disorders/diagnosis
Quality of Life
Randomized Controlled Trials as Topic
Stress Disorders, Post-Traumatic/diagnosis

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Peters, E., Hardy, A., Dudley, R., Varese, F., Greenwood, K., Steel, C., Emsley, R., Keen, N., Bowe, S., Swan, S., Underwood, R., Longden, E., Byford, S., Potts, L., Heslin, M., Grey, N., Turkington, D., Fowler, D., Kuipers, E., & Morrison, A. (2022). Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual: study protocol for the STAR (Study of Trauma And Recovery) trial. Trials, 23(1), 429. https://doi.org/10.1186/s13063-022-06215-x

Peters, Emmanuelle ; Hardy, Amy ; Dudley, Robert et al. / Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual : study protocol for the STAR (Study of Trauma And Recovery) trial. In: Trials. 2022 ; Vol. 23, No. 1. pp. 429.

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title = "Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual: study protocol for the STAR (Study of Trauma And Recovery) trial",

abstract = "BACKGROUND: People with psychosis have high rates of trauma, with a post-traumatic stress disorder (PTSD) prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pilot studies have shown that trauma-focused (TF) psychological therapies can be safe and effective in such individuals. This trial, the largest to date, will evaluate the clinical effectiveness of a TF therapy integrated with cognitive behaviour therapy for psychosis (TF-CBTp) on post-traumatic stress symptoms in people with psychosis. The secondary aims are to compare groups on cost-effectiveness; ascertain whether TF-CBTp impacts on a range of other meaningful outcomes; determine whether therapy effects endure; and determine acceptability of the therapy in participants and therapists.METHODS: Rater-blind, parallel arm, pragmatic randomised controlled trial comparing TF-CBTp + treatment as usual (TAU) to TAU only. Adults (N = 300) with distressing post-traumatic stress and psychosis symptoms from five mental health Trusts (60 per site) will be randomised to the two groups. Therapy will be manualised, lasting 9 months (m) with trained therapists. We will assess PTSD symptom severity (primary outcome); percentage who show loss of PTSD diagnosis and clinically significant change; psychosis symptoms; emotional well-being; substance use; suicidal ideation; psychological recovery; social functioning; health-related quality of life; service use, a total of four times: before randomisation; 4 m (mid-therapy); 9 m (end of therapy; primary end point); 24 m (15 m after end of therapy) post-randomisation. Four 3-monthly phone calls will be made between 9 m and 24 m assessment points, to collect service use over the previous 3 months. Therapy acceptability will be assessed through qualitative interviews with participants (N = 35) and therapists (N = 5-10). An internal pilot will ensure integrity of trial recruitment and outcome data, as well as therapy protocol safety and adherence. Data will be analysed following intention-to-treat principles using generalised linear mixed models and reported according to Consolidated Standards of Reporting Trials-Social and Psychological Interventions Statement.DISCUSSION: The proposed intervention has the potential to provide significant patient benefit in terms of reductions in distressing symptoms of post-traumatic stress, psychosis, and emotional problems; enable clinicians to implement trauma-focused therapy confidently in this population; and be cost-effective compared to TAU through reduced service use.TRIAL REGISTRATION: ISRCTN93382525 (03/08/20).",

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Peters, E , Hardy, A, Dudley, R, Varese, F, Greenwood, K, Steel, C, Emsley, R, Keen, N, Bowe, S, Swan, S , Underwood, R, Longden, E, Byford, S , Potts, L , Heslin, M, Grey, N, Turkington, D, Fowler, D, Kuipers, E & Morrison, A 2022, 'Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual: study protocol for the STAR (Study of Trauma And Recovery) trial', Trials, vol. 23, no. 1, pp. 429. https://doi.org/10.1186/s13063-022-06215-x

Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual: study protocol for the STAR (Study of Trauma And Recovery) trial. / Peters, Emmanuelle ; Hardy, Amy; Dudley, Robert et al.
In: Trials, Vol. 23, No. 1, 23.05.2022, p. 429.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual

T2 - study protocol for the STAR (Study of Trauma And Recovery) trial

AU - Peters, Emmanuelle

AU - Hardy, Amy

AU - Dudley, Robert

AU - Varese, Filippo

AU - Greenwood, Kathryn

AU - Steel, Craig

AU - Emsley, Richard

AU - Keen, Nadine

AU - Bowe, Samantha

AU - Swan, Sarah

AU - Underwood, Raphael

AU - Longden, Eleanor

AU - Byford, Sarah

AU - Potts, Laura

AU - Heslin, Margaret

AU - Grey, Nick

AU - Turkington, Doug

AU - Fowler, David

AU - Kuipers, Elizabeth

AU - Morrison, Anthony

PY - 2022/5/23

Y1 - 2022/5/23

N2 - BACKGROUND: People with psychosis have high rates of trauma, with a post-traumatic stress disorder (PTSD) prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pilot studies have shown that trauma-focused (TF) psychological therapies can be safe and effective in such individuals. This trial, the largest to date, will evaluate the clinical effectiveness of a TF therapy integrated with cognitive behaviour therapy for psychosis (TF-CBTp) on post-traumatic stress symptoms in people with psychosis. The secondary aims are to compare groups on cost-effectiveness; ascertain whether TF-CBTp impacts on a range of other meaningful outcomes; determine whether therapy effects endure; and determine acceptability of the therapy in participants and therapists.METHODS: Rater-blind, parallel arm, pragmatic randomised controlled trial comparing TF-CBTp + treatment as usual (TAU) to TAU only. Adults (N = 300) with distressing post-traumatic stress and psychosis symptoms from five mental health Trusts (60 per site) will be randomised to the two groups. Therapy will be manualised, lasting 9 months (m) with trained therapists. We will assess PTSD symptom severity (primary outcome); percentage who show loss of PTSD diagnosis and clinically significant change; psychosis symptoms; emotional well-being; substance use; suicidal ideation; psychological recovery; social functioning; health-related quality of life; service use, a total of four times: before randomisation; 4 m (mid-therapy); 9 m (end of therapy; primary end point); 24 m (15 m after end of therapy) post-randomisation. Four 3-monthly phone calls will be made between 9 m and 24 m assessment points, to collect service use over the previous 3 months. Therapy acceptability will be assessed through qualitative interviews with participants (N = 35) and therapists (N = 5-10). An internal pilot will ensure integrity of trial recruitment and outcome data, as well as therapy protocol safety and adherence. Data will be analysed following intention-to-treat principles using generalised linear mixed models and reported according to Consolidated Standards of Reporting Trials-Social and Psychological Interventions Statement.DISCUSSION: The proposed intervention has the potential to provide significant patient benefit in terms of reductions in distressing symptoms of post-traumatic stress, psychosis, and emotional problems; enable clinicians to implement trauma-focused therapy confidently in this population; and be cost-effective compared to TAU through reduced service use.TRIAL REGISTRATION: ISRCTN93382525 (03/08/20).

AB - BACKGROUND: People with psychosis have high rates of trauma, with a post-traumatic stress disorder (PTSD) prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pilot studies have shown that trauma-focused (TF) psychological therapies can be safe and effective in such individuals. This trial, the largest to date, will evaluate the clinical effectiveness of a TF therapy integrated with cognitive behaviour therapy for psychosis (TF-CBTp) on post-traumatic stress symptoms in people with psychosis. The secondary aims are to compare groups on cost-effectiveness; ascertain whether TF-CBTp impacts on a range of other meaningful outcomes; determine whether therapy effects endure; and determine acceptability of the therapy in participants and therapists.METHODS: Rater-blind, parallel arm, pragmatic randomised controlled trial comparing TF-CBTp + treatment as usual (TAU) to TAU only. Adults (N = 300) with distressing post-traumatic stress and psychosis symptoms from five mental health Trusts (60 per site) will be randomised to the two groups. Therapy will be manualised, lasting 9 months (m) with trained therapists. We will assess PTSD symptom severity (primary outcome); percentage who show loss of PTSD diagnosis and clinically significant change; psychosis symptoms; emotional well-being; substance use; suicidal ideation; psychological recovery; social functioning; health-related quality of life; service use, a total of four times: before randomisation; 4 m (mid-therapy); 9 m (end of therapy; primary end point); 24 m (15 m after end of therapy) post-randomisation. Four 3-monthly phone calls will be made between 9 m and 24 m assessment points, to collect service use over the previous 3 months. Therapy acceptability will be assessed through qualitative interviews with participants (N = 35) and therapists (N = 5-10). An internal pilot will ensure integrity of trial recruitment and outcome data, as well as therapy protocol safety and adherence. Data will be analysed following intention-to-treat principles using generalised linear mixed models and reported according to Consolidated Standards of Reporting Trials-Social and Psychological Interventions Statement.DISCUSSION: The proposed intervention has the potential to provide significant patient benefit in terms of reductions in distressing symptoms of post-traumatic stress, psychosis, and emotional problems; enable clinicians to implement trauma-focused therapy confidently in this population; and be cost-effective compared to TAU through reduced service use.TRIAL REGISTRATION: ISRCTN93382525 (03/08/20).

KW - Adult

KW - Cognitive Behavioral Therapy/methods

KW - Comorbidity

KW - Humans

KW - Multicenter Studies as Topic

KW - Pragmatic Clinical Trials as Topic

KW - Psychotic Disorders/diagnosis

KW - Quality of Life

KW - Randomized Controlled Trials as Topic

KW - Stress Disorders, Post-Traumatic/diagnosis

U2 - 10.1186/s13063-022-06215-x

DO - 10.1186/s13063-022-06215-x

M3 - Article

C2 - 35606886

SN - 1745-6215

VL - 23

SP - 429

JO - Trials

JF - Trials

IS - 1

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Peters E , Hardy A, Dudley R, Varese F, Greenwood K, Steel C et al. Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual: study protocol for the STAR (Study of Trauma And Recovery) trial. Trials. 2022 May 23;23(1):429. doi: 10.1186/s13063-022-06215-x