Effects of SlowMo, a Blended Digital Therapy Targeting Reasoning, on Paranoia Among People With Psychosis: A Randomized Clinical Trial

Philippa Garety; Thomas Ward; Richard Emsley; Kathryn Greenwood; Daniel Freeman; David Fowler; Elizabeth Kuipers; Paul Bebbington; Mar Rus-Calafell; Alison McGourty; Catarina Sacadura; Nicola Collett; Kirsty James; Amy Hardy

doi:10.1001/jamapsychiatry.2021.0326

Effects of SlowMo, a Blended Digital Therapy Targeting Reasoning, on Paranoia Among People With Psychosis: A Randomized Clinical Trial

Philippa Garety, Thomas Ward, Richard Emsley, Kathryn Greenwood, Daniel Freeman, David Fowler, Elizabeth Kuipers, Paul Bebbington, Mar Rus-Calafell, Alison McGourty, Catarina Sacadura, Nicola Collett, Kirsty James, Amy Hardy

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Abstract

Importance: Persistent paranoia is common among patients with psychosis. Cognitive-behavioral therapy for psychosis can be effective. However, challenges in engagement and effectiveness remain.

Objective: To investigate the effects on paranoia and mechanisms of action of SlowMo, a digitally supported reasoning intervention, plus usual care compared with usual care only.

Design, Setting, and Participants: This parallel-arm, assessor-blinded, randomized clinical trial recruited participants at UK community health services from May 1, 2017, to May 14, 2019. Eligible participants consisted of a referral sample with schizophrenia-spectrum psychosis and distressing, persistent (≥3 months) paranoia.

Interventions: Individuals were randomized 1:1 to SlowMo, consisting of 8 digitally supported face-to-face sessions and a mobile app, plus usual care (n = 181) and usual care only (n = 181).

Main Outcomes and Measures: The primary outcome was paranoia, measured by the Green et al Paranoid Thoughts Scale (GPTS) total score at 24 weeks. Secondary outcomes included GPTS total score at 12 weeks and GPTS Part A (reference) and Part B (persecutory) scores, the Psychotic Symptom Rating Scales (PSYRATS Delusion subscale), reasoning (belief flexibility, possibility of being mistaken [Maudsley Assessment of Delusions, rated 0%-100%]), and jumping to conclusions (Beads Task).

Results: A total of 361 participants were included in intention-to-treat analysis, of whom 252 (69.8%) were male and 249 (69.0%) were White; the mean (SD) age was 42.6 (11.6) years. At 24 weeks, 332 participants (92.0%) provided primary outcome data. Of 181 participants in the SlowMo group, 145 (80.1%) completed therapy. SlowMo plus usual care was not associated with greater reductions than usual care in GPTS total score at 24 weeks (Cohen d, 0.20; 95% CI, -0.02 to 0.40; P = .06). There were significant effects on secondary paranoia outcomes at 12 weeks, including GPTS total score (Cohen d, 0.30; 95% CI, 0.09-0.51; P = .005), Part A score (Cohen d, 0.22; 95% CI, 0.06-0.39; P = .009), and Part B score (Cohen d, 0.32; 95% CI, 0.08-0.56; P = .009), and at 24 weeks, including Part B score (Cohen d, 0.25; 95% CI, 0.01-0.49; P = .04) but not Part A score (Cohen d, 0.12; 95% CI, -0.05 to 0.28; P = .18). Improvements were observed in an observer-rated measure of persecutory delusions (PSYRATS delusion) at 12 weeks (Cohen d, 0.47; 95% CI, 0.17-0.78; P = .002) and 24 weeks (Cohen d, 0.50; 95% CI, 0.20-0.80; P = .001) and belief flexibility at 12 weeks (Cohen d, 0.29; 95% CI, 0.09-0.49; P = .004) and 24 weeks (Cohen d, 0.28; 95% CI, 0.08-0.49; P = .005). There were no significant effects on jumping to conclusions. Improved belief flexibility and worry mediated paranoia change (range mediated, 36%-56%).

Conclusions and Relevance: SlowMo did not demonstrate significant improvements in the primary measure of paranoia at 24 weeks; however, a beneficial effect of SlowMo on paranoia was indicated by the results on the primary measure at an earlier point and on observer-rated paranoia and self-reported persecution at 12 and 24 weeks. Further work to optimize SlowMo's effects is warranted.

Trial Registration: isrctn.org Identifier: ISRCTN 32448671.

Original language	English
Article number	20210326
Pages (from-to)	714-725
Number of pages	12
Journal	JAMA Psychiatry
Volume	78
Issue number	7
Early online date	7 Apr 2021
DOIs	https://doi.org/10.1001/jamapsychiatry.2021.0326
Publication status	Published - Jul 2021

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Effects of SlowMo, a_GARETY_Epub7Aor2021_GREEN AAMAccepted author manuscript, 347 KB

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Garety, P., Ward, T., Emsley, R., Greenwood, K., Freeman, D., Fowler, D., Kuipers, E., Bebbington, P., Rus-Calafell, M., McGourty, A., Sacadura, C., Collett, N., James, K., & Hardy, A. (2021). Effects of SlowMo, a Blended Digital Therapy Targeting Reasoning, on Paranoia Among People With Psychosis: A Randomized Clinical Trial. JAMA Psychiatry, 78(7), 714-725. Article 20210326. https://doi.org/10.1001/jamapsychiatry.2021.0326

@article{69e54e6a916c480ea4b2be54615639c8,

title = "Effects of SlowMo, a Blended Digital Therapy Targeting Reasoning, on Paranoia Among People With Psychosis: A Randomized Clinical Trial",

abstract = "Importance: Persistent paranoia is common among patients with psychosis. Cognitive-behavioral therapy for psychosis can be effective. However, challenges in engagement and effectiveness remain.Objective: To investigate the effects on paranoia and mechanisms of action of SlowMo, a digitally supported reasoning intervention, plus usual care compared with usual care only.Design, Setting, and Participants: This parallel-arm, assessor-blinded, randomized clinical trial recruited participants at UK community health services from May 1, 2017, to May 14, 2019. Eligible participants consisted of a referral sample with schizophrenia-spectrum psychosis and distressing, persistent (≥3 months) paranoia.Interventions: Individuals were randomized 1:1 to SlowMo, consisting of 8 digitally supported face-to-face sessions and a mobile app, plus usual care (n = 181) and usual care only (n = 181).Main Outcomes and Measures: The primary outcome was paranoia, measured by the Green et al Paranoid Thoughts Scale (GPTS) total score at 24 weeks. Secondary outcomes included GPTS total score at 12 weeks and GPTS Part A (reference) and Part B (persecutory) scores, the Psychotic Symptom Rating Scales (PSYRATS Delusion subscale), reasoning (belief flexibility, possibility of being mistaken [Maudsley Assessment of Delusions, rated 0%-100%]), and jumping to conclusions (Beads Task).Results: A total of 361 participants were included in intention-to-treat analysis, of whom 252 (69.8%) were male and 249 (69.0%) were White; the mean (SD) age was 42.6 (11.6) years. At 24 weeks, 332 participants (92.0%) provided primary outcome data. Of 181 participants in the SlowMo group, 145 (80.1%) completed therapy. SlowMo plus usual care was not associated with greater reductions than usual care in GPTS total score at 24 weeks (Cohen d, 0.20; 95% CI, -0.02 to 0.40; P = .06). There were significant effects on secondary paranoia outcomes at 12 weeks, including GPTS total score (Cohen d, 0.30; 95% CI, 0.09-0.51; P = .005), Part A score (Cohen d, 0.22; 95% CI, 0.06-0.39; P = .009), and Part B score (Cohen d, 0.32; 95% CI, 0.08-0.56; P = .009), and at 24 weeks, including Part B score (Cohen d, 0.25; 95% CI, 0.01-0.49; P = .04) but not Part A score (Cohen d, 0.12; 95% CI, -0.05 to 0.28; P = .18). Improvements were observed in an observer-rated measure of persecutory delusions (PSYRATS delusion) at 12 weeks (Cohen d, 0.47; 95% CI, 0.17-0.78; P = .002) and 24 weeks (Cohen d, 0.50; 95% CI, 0.20-0.80; P = .001) and belief flexibility at 12 weeks (Cohen d, 0.29; 95% CI, 0.09-0.49; P = .004) and 24 weeks (Cohen d, 0.28; 95% CI, 0.08-0.49; P = .005). There were no significant effects on jumping to conclusions. Improved belief flexibility and worry mediated paranoia change (range mediated, 36%-56%).Conclusions and Relevance: SlowMo did not demonstrate significant improvements in the primary measure of paranoia at 24 weeks; however, a beneficial effect of SlowMo on paranoia was indicated by the results on the primary measure at an earlier point and on observer-rated paranoia and self-reported persecution at 12 and 24 weeks. Further work to optimize SlowMo's effects is warranted.Trial Registration: isrctn.org Identifier: ISRCTN 32448671.",

author = "Philippa Garety and Thomas Ward and Richard Emsley and Kathryn Greenwood and Daniel Freeman and David Fowler and Elizabeth Kuipers and Paul Bebbington and Mar Rus-Calafell and Alison McGourty and Catarina Sacadura and Nicola Collett and Kirsty James and Amy Hardy",

note = "Funding Information: Funding/Support: This project was funded by Funding Information: grant 15/48/21 from the Efficacy and Mechanism Evaluation (EME) Programme, an Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership (Dr Emsley, Dr Greenwood, Dr Freeman, Mr Fowler, Dr Kuipers, Dr Bebbington, and Dr Hardy); in part by the NIHR Biomedical Research Centre at South London and Maudsley NHS (National Health Service) Foundation Trust and King{\textquoteright}s College London (Drs Garety and Emsley); by research professorship NIHR300051 from the NIHR (Dr Emsley); by research professorship NIHR-RP-2014-05-003 from the NIHR (Dr Freeman); grant BRC-1215-20005 from the NIHR Oxford Health Biomedical Research Centre (Dr Freeman); and by the NIHR Kent, Surrey and Sussex NIHR Applied Research Collaboration (Mr Fowler). Publisher Copyright: {\textcopyright} 2021 American Medical Association. All rights reserved. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

year = "2021",

month = jul,

doi = "10.1001/jamapsychiatry.2021.0326",

language = "English",

volume = "78",

pages = "714--725",

journal = "JAMA Psychiatry",

issn = "2168-622X",

publisher = "American Medical Association",

number = "7",

}

Garety, P , Ward, T , Emsley, R, Greenwood, K, Freeman, D, Fowler, D, Kuipers, E, Bebbington, P, Rus-Calafell, M, McGourty, A, Sacadura, C, Collett, N, James, K & Hardy, A 2021, 'Effects of SlowMo, a Blended Digital Therapy Targeting Reasoning, on Paranoia Among People With Psychosis: A Randomized Clinical Trial', JAMA Psychiatry, vol. 78, no. 7, 20210326, pp. 714-725. https://doi.org/10.1001/jamapsychiatry.2021.0326

TY - JOUR

T1 - Effects of SlowMo, a Blended Digital Therapy Targeting Reasoning, on Paranoia Among People With Psychosis

T2 - A Randomized Clinical Trial

AU - Garety, Philippa

AU - Ward, Thomas

AU - Emsley, Richard

AU - Greenwood, Kathryn

AU - Freeman, Daniel

AU - Fowler, David

AU - Kuipers, Elizabeth

AU - Bebbington, Paul

AU - Rus-Calafell, Mar

AU - McGourty, Alison

AU - Sacadura, Catarina

AU - Collett, Nicola

AU - James, Kirsty

AU - Hardy, Amy

N1 - Funding Information: Funding/Support: This project was funded by Funding Information: grant 15/48/21 from the Efficacy and Mechanism Evaluation (EME) Programme, an Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership (Dr Emsley, Dr Greenwood, Dr Freeman, Mr Fowler, Dr Kuipers, Dr Bebbington, and Dr Hardy); in part by the NIHR Biomedical Research Centre at South London and Maudsley NHS (National Health Service) Foundation Trust and King’s College London (Drs Garety and Emsley); by research professorship NIHR300051 from the NIHR (Dr Emsley); by research professorship NIHR-RP-2014-05-003 from the NIHR (Dr Freeman); grant BRC-1215-20005 from the NIHR Oxford Health Biomedical Research Centre (Dr Freeman); and by the NIHR Kent, Surrey and Sussex NIHR Applied Research Collaboration (Mr Fowler). Publisher Copyright: © 2021 American Medical Association. All rights reserved. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/7

Y1 - 2021/7

N2 - Importance: Persistent paranoia is common among patients with psychosis. Cognitive-behavioral therapy for psychosis can be effective. However, challenges in engagement and effectiveness remain.Objective: To investigate the effects on paranoia and mechanisms of action of SlowMo, a digitally supported reasoning intervention, plus usual care compared with usual care only.Design, Setting, and Participants: This parallel-arm, assessor-blinded, randomized clinical trial recruited participants at UK community health services from May 1, 2017, to May 14, 2019. Eligible participants consisted of a referral sample with schizophrenia-spectrum psychosis and distressing, persistent (≥3 months) paranoia.Interventions: Individuals were randomized 1:1 to SlowMo, consisting of 8 digitally supported face-to-face sessions and a mobile app, plus usual care (n = 181) and usual care only (n = 181).Main Outcomes and Measures: The primary outcome was paranoia, measured by the Green et al Paranoid Thoughts Scale (GPTS) total score at 24 weeks. Secondary outcomes included GPTS total score at 12 weeks and GPTS Part A (reference) and Part B (persecutory) scores, the Psychotic Symptom Rating Scales (PSYRATS Delusion subscale), reasoning (belief flexibility, possibility of being mistaken [Maudsley Assessment of Delusions, rated 0%-100%]), and jumping to conclusions (Beads Task).Results: A total of 361 participants were included in intention-to-treat analysis, of whom 252 (69.8%) were male and 249 (69.0%) were White; the mean (SD) age was 42.6 (11.6) years. At 24 weeks, 332 participants (92.0%) provided primary outcome data. Of 181 participants in the SlowMo group, 145 (80.1%) completed therapy. SlowMo plus usual care was not associated with greater reductions than usual care in GPTS total score at 24 weeks (Cohen d, 0.20; 95% CI, -0.02 to 0.40; P = .06). There were significant effects on secondary paranoia outcomes at 12 weeks, including GPTS total score (Cohen d, 0.30; 95% CI, 0.09-0.51; P = .005), Part A score (Cohen d, 0.22; 95% CI, 0.06-0.39; P = .009), and Part B score (Cohen d, 0.32; 95% CI, 0.08-0.56; P = .009), and at 24 weeks, including Part B score (Cohen d, 0.25; 95% CI, 0.01-0.49; P = .04) but not Part A score (Cohen d, 0.12; 95% CI, -0.05 to 0.28; P = .18). Improvements were observed in an observer-rated measure of persecutory delusions (PSYRATS delusion) at 12 weeks (Cohen d, 0.47; 95% CI, 0.17-0.78; P = .002) and 24 weeks (Cohen d, 0.50; 95% CI, 0.20-0.80; P = .001) and belief flexibility at 12 weeks (Cohen d, 0.29; 95% CI, 0.09-0.49; P = .004) and 24 weeks (Cohen d, 0.28; 95% CI, 0.08-0.49; P = .005). There were no significant effects on jumping to conclusions. Improved belief flexibility and worry mediated paranoia change (range mediated, 36%-56%).Conclusions and Relevance: SlowMo did not demonstrate significant improvements in the primary measure of paranoia at 24 weeks; however, a beneficial effect of SlowMo on paranoia was indicated by the results on the primary measure at an earlier point and on observer-rated paranoia and self-reported persecution at 12 and 24 weeks. Further work to optimize SlowMo's effects is warranted.Trial Registration: isrctn.org Identifier: ISRCTN 32448671.

AB - Importance: Persistent paranoia is common among patients with psychosis. Cognitive-behavioral therapy for psychosis can be effective. However, challenges in engagement and effectiveness remain.Objective: To investigate the effects on paranoia and mechanisms of action of SlowMo, a digitally supported reasoning intervention, plus usual care compared with usual care only.Design, Setting, and Participants: This parallel-arm, assessor-blinded, randomized clinical trial recruited participants at UK community health services from May 1, 2017, to May 14, 2019. Eligible participants consisted of a referral sample with schizophrenia-spectrum psychosis and distressing, persistent (≥3 months) paranoia.Interventions: Individuals were randomized 1:1 to SlowMo, consisting of 8 digitally supported face-to-face sessions and a mobile app, plus usual care (n = 181) and usual care only (n = 181).Main Outcomes and Measures: The primary outcome was paranoia, measured by the Green et al Paranoid Thoughts Scale (GPTS) total score at 24 weeks. Secondary outcomes included GPTS total score at 12 weeks and GPTS Part A (reference) and Part B (persecutory) scores, the Psychotic Symptom Rating Scales (PSYRATS Delusion subscale), reasoning (belief flexibility, possibility of being mistaken [Maudsley Assessment of Delusions, rated 0%-100%]), and jumping to conclusions (Beads Task).Results: A total of 361 participants were included in intention-to-treat analysis, of whom 252 (69.8%) were male and 249 (69.0%) were White; the mean (SD) age was 42.6 (11.6) years. At 24 weeks, 332 participants (92.0%) provided primary outcome data. Of 181 participants in the SlowMo group, 145 (80.1%) completed therapy. SlowMo plus usual care was not associated with greater reductions than usual care in GPTS total score at 24 weeks (Cohen d, 0.20; 95% CI, -0.02 to 0.40; P = .06). There were significant effects on secondary paranoia outcomes at 12 weeks, including GPTS total score (Cohen d, 0.30; 95% CI, 0.09-0.51; P = .005), Part A score (Cohen d, 0.22; 95% CI, 0.06-0.39; P = .009), and Part B score (Cohen d, 0.32; 95% CI, 0.08-0.56; P = .009), and at 24 weeks, including Part B score (Cohen d, 0.25; 95% CI, 0.01-0.49; P = .04) but not Part A score (Cohen d, 0.12; 95% CI, -0.05 to 0.28; P = .18). Improvements were observed in an observer-rated measure of persecutory delusions (PSYRATS delusion) at 12 weeks (Cohen d, 0.47; 95% CI, 0.17-0.78; P = .002) and 24 weeks (Cohen d, 0.50; 95% CI, 0.20-0.80; P = .001) and belief flexibility at 12 weeks (Cohen d, 0.29; 95% CI, 0.09-0.49; P = .004) and 24 weeks (Cohen d, 0.28; 95% CI, 0.08-0.49; P = .005). There were no significant effects on jumping to conclusions. Improved belief flexibility and worry mediated paranoia change (range mediated, 36%-56%).Conclusions and Relevance: SlowMo did not demonstrate significant improvements in the primary measure of paranoia at 24 weeks; however, a beneficial effect of SlowMo on paranoia was indicated by the results on the primary measure at an earlier point and on observer-rated paranoia and self-reported persecution at 12 and 24 weeks. Further work to optimize SlowMo's effects is warranted.Trial Registration: isrctn.org Identifier: ISRCTN 32448671.

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DO - 10.1001/jamapsychiatry.2021.0326

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C2 - 33825827

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Effects of SlowMo, a Blended Digital Therapy Targeting Reasoning, on Paranoia Among People With Psychosis: A Randomized Clinical Trial

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