Patrick Smith, Anke Ehlers, Ewan Carr, David M Clark, Tim Dalgleish, Gordon Forbes, Kimberley Goldsmith, Helena Griffiths, Monica Gupta, Dorothy King, Sarah Miles, Dominic T Plant, Anne Smith, Jess Steward, William Yule, Richard Meiser-Stedman
{"title":"治疗师支持的在线认知疗法治疗年轻人创伤后应激障碍的早期随机对照试验。","authors":"Patrick Smith, Anke Ehlers, Ewan Carr, David M Clark, Tim Dalgleish, Gordon Forbes, Kimberley Goldsmith, Helena Griffiths, Monica Gupta, Dorothy King, Sarah Miles, Dominic T Plant, Anne Smith, Jess Steward, William Yule, Richard Meiser-Stedman","doi":"10.1111/jcpp.14124","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Effective face-to-face treatments for Post-Traumatic Stress Disorder (PTSD) are available, but most young people with PTSD do not receive effective treatment. Therapist-supported online Cognitive Therapy has the potential to improve accessibility of effective treatment. This early-stage trial gathered data on the feasibility, acceptability, and initial signal of clinical efficacy of a novel online Cognitive Therapy program for young people with PTSD.</p><p><strong>Methods: </strong>A two-arm, parallel-groups, single-blind, early-stage feasibility RCT compared online Cognitive Therapy to a waitlList condition. Participants were N = 31 adolescents (12-17 years-old) with a diagnosis of PTSD, randomised in a 1:1 ratio using minimisation. Thresholds for progression to a larger trial were set a priori for recruitment rate, data completeness, and the initial signal of clinical efficacy. The primary clinical outcome was PTSD diagnosis at 16 weeks post-randomisation. Secondary clinical outcomes were continuous measures of PTSD, depression, and anxiety at 16 weeks; and at 38 weeks in the online Cognitive Therapy arm.</p><p><strong>Results: </strong>All pre-determined feasibility thresholds for progression to a larger trial were met. We recruited to target at a rate of 1-2 participants/month. No patient dropped out of therapy; 94% of all participants were retained at 16 weeks. At 16-weeks, the intention-to-treat (ITT) effect adjusted odds ratio was 0.20 (95% CI, 0.02, 1.42), indicating that the odds of meeting PTSD caseness after online therapy were 80% lower than after the waitlist (10/16 participants met PTSD caseness after therapy compared to 11/13 after WL). Effect-size estimates for all secondary clinical outcomes were large-moderate; improvements were sustained 38 weeks after online Cognitive Therapy.</p><p><strong>Conclusions: </strong>Therapist-supported online Cognitive Therapy for PTSD is acceptable to young people and has potential for meaningful and sustained clinical effects. A larger trial appears feasible to deliver. Further work is needed to refine the intervention and its delivery and to evaluate it in a larger confirmatory trial.</p>","PeriodicalId":187,"journal":{"name":"Journal of Child Psychology and Psychiatry","volume":" ","pages":""},"PeriodicalIF":6.5000,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Early-stage randomised controlled trial of therapist-supported online cognitive therapy for post-traumatic stress disorder in young people.\",\"authors\":\"Patrick Smith, Anke Ehlers, Ewan Carr, David M Clark, Tim Dalgleish, Gordon Forbes, Kimberley Goldsmith, Helena Griffiths, Monica Gupta, Dorothy King, Sarah Miles, Dominic T Plant, Anne Smith, Jess Steward, William Yule, Richard Meiser-Stedman\",\"doi\":\"10.1111/jcpp.14124\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Effective face-to-face treatments for Post-Traumatic Stress Disorder (PTSD) are available, but most young people with PTSD do not receive effective treatment. Therapist-supported online Cognitive Therapy has the potential to improve accessibility of effective treatment. This early-stage trial gathered data on the feasibility, acceptability, and initial signal of clinical efficacy of a novel online Cognitive Therapy program for young people with PTSD.</p><p><strong>Methods: </strong>A two-arm, parallel-groups, single-blind, early-stage feasibility RCT compared online Cognitive Therapy to a waitlList condition. Participants were N = 31 adolescents (12-17 years-old) with a diagnosis of PTSD, randomised in a 1:1 ratio using minimisation. Thresholds for progression to a larger trial were set a priori for recruitment rate, data completeness, and the initial signal of clinical efficacy. The primary clinical outcome was PTSD diagnosis at 16 weeks post-randomisation. Secondary clinical outcomes were continuous measures of PTSD, depression, and anxiety at 16 weeks; and at 38 weeks in the online Cognitive Therapy arm.</p><p><strong>Results: </strong>All pre-determined feasibility thresholds for progression to a larger trial were met. We recruited to target at a rate of 1-2 participants/month. No patient dropped out of therapy; 94% of all participants were retained at 16 weeks. At 16-weeks, the intention-to-treat (ITT) effect adjusted odds ratio was 0.20 (95% CI, 0.02, 1.42), indicating that the odds of meeting PTSD caseness after online therapy were 80% lower than after the waitlist (10/16 participants met PTSD caseness after therapy compared to 11/13 after WL). Effect-size estimates for all secondary clinical outcomes were large-moderate; improvements were sustained 38 weeks after online Cognitive Therapy.</p><p><strong>Conclusions: </strong>Therapist-supported online Cognitive Therapy for PTSD is acceptable to young people and has potential for meaningful and sustained clinical effects. A larger trial appears feasible to deliver. Further work is needed to refine the intervention and its delivery and to evaluate it in a larger confirmatory trial.</p>\",\"PeriodicalId\":187,\"journal\":{\"name\":\"Journal of Child Psychology and Psychiatry\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":6.5000,\"publicationDate\":\"2025-02-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Child Psychology and Psychiatry\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/jcpp.14124\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PSYCHIATRY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Child Psychology and Psychiatry","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/jcpp.14124","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PSYCHIATRY","Score":null,"Total":0}
Early-stage randomised controlled trial of therapist-supported online cognitive therapy for post-traumatic stress disorder in young people.
Background: Effective face-to-face treatments for Post-Traumatic Stress Disorder (PTSD) are available, but most young people with PTSD do not receive effective treatment. Therapist-supported online Cognitive Therapy has the potential to improve accessibility of effective treatment. This early-stage trial gathered data on the feasibility, acceptability, and initial signal of clinical efficacy of a novel online Cognitive Therapy program for young people with PTSD.
Methods: A two-arm, parallel-groups, single-blind, early-stage feasibility RCT compared online Cognitive Therapy to a waitlList condition. Participants were N = 31 adolescents (12-17 years-old) with a diagnosis of PTSD, randomised in a 1:1 ratio using minimisation. Thresholds for progression to a larger trial were set a priori for recruitment rate, data completeness, and the initial signal of clinical efficacy. The primary clinical outcome was PTSD diagnosis at 16 weeks post-randomisation. Secondary clinical outcomes were continuous measures of PTSD, depression, and anxiety at 16 weeks; and at 38 weeks in the online Cognitive Therapy arm.
Results: All pre-determined feasibility thresholds for progression to a larger trial were met. We recruited to target at a rate of 1-2 participants/month. No patient dropped out of therapy; 94% of all participants were retained at 16 weeks. At 16-weeks, the intention-to-treat (ITT) effect adjusted odds ratio was 0.20 (95% CI, 0.02, 1.42), indicating that the odds of meeting PTSD caseness after online therapy were 80% lower than after the waitlist (10/16 participants met PTSD caseness after therapy compared to 11/13 after WL). Effect-size estimates for all secondary clinical outcomes were large-moderate; improvements were sustained 38 weeks after online Cognitive Therapy.
Conclusions: Therapist-supported online Cognitive Therapy for PTSD is acceptable to young people and has potential for meaningful and sustained clinical effects. A larger trial appears feasible to deliver. Further work is needed to refine the intervention and its delivery and to evaluate it in a larger confirmatory trial.
期刊介绍：
The Journal of Child Psychology and Psychiatry (JCPP) is a highly regarded international publication that focuses on the fields of child and adolescent psychology and psychiatry. It is recognized for publishing top-tier, clinically relevant research across various disciplines related to these areas. JCPP has a broad global readership and covers a diverse range of topics, including:
Epidemiology: Studies on the prevalence and distribution of mental health issues in children and adolescents.
Diagnosis: Research on the identification and classification of childhood disorders.
Treatments: Psychotherapeutic and psychopharmacological interventions for child and adolescent mental health.
Behavior and Cognition: Studies on the behavioral and cognitive aspects of childhood disorders.
Neuroscience and Neurobiology: Research on the neural and biological underpinnings of child mental health.
Genetics: Genetic factors contributing to the development of childhood disorders.
JCPP serves as a platform for integrating empirical research, clinical studies, and high-quality reviews from diverse perspectives, theoretical viewpoints, and disciplines. This interdisciplinary approach is a key feature of the journal, as it fosters a comprehensive understanding of child and adolescent mental health.
The Journal of Child Psychology and Psychiatry is published 12 times a year and is affiliated with the Association for Child and Adolescent Mental Health (ACAMH), which supports the journal's mission to advance knowledge and practice in the field of child and adolescent mental health.
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