Pub Date : 2025-03-18DOI: 10.1016/s2215-0366(25)00070-7
No Abstract
{"title":"The value of many","authors":"","doi":"10.1016/s2215-0366(25)00070-7","DOIUrl":"https://doi.org/10.1016/s2215-0366(25)00070-7","url":null,"abstract":"No Abstract","PeriodicalId":48784,"journal":{"name":"Lancet Psychiatry","volume":"56 1","pages":""},"PeriodicalIF":64.3,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143653660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-18DOI: 10.1016/s2215-0366(25)00025-2
Nobuyuki Nomura, Spyridon Siafis, Johannes Schneider-Thoma, Lasse Brandt, Jinyoung Park, Orestis Efthimiou, Josef Priller, John M Davis, Hiroyoshi Takeuchi, Stefan Leucht
Background
Sedative adverse events are common in patients with schizophrenia undergoing antipsychotic treatment, which affects treatment adherence and the patients’ quality of life. Although tolerance to sedation is believed to develop, robust evidence documenting the timing of sedation onset and resolution remains elusive. To address this gap, we aimed to assess the dynamics of onset and resolution of sedation across various antipsychotics in patients with schizophrenia.
Methods
In this meta-analysis, we included placebo-controlled, randomised controlled trials (RCTs) of antipsychotic monotherapy for the acute phase of schizophrenia and schizoaffective disorder. We searched PubMed for RCTs from inception until May 6, 2021 and obtained individual participant data of included trials through the Yale University Open Data Access project. We created Kaplan–Meier curves to assess the probability of onset of sedation and resolution from the incidence of sedation across time after treatment initiation. People with lived experience were not involved in this study. This study is registered with PROSPERO, CRD42022351647.
Findings
We included a total of 6791 participants (4549 [67·0%] men and 2242 [33·0%] women, with a mean age of 38·0 years [SD 12·4, range 13–81], 1172 [17·3%] were Asian, 1626 [23·9%] were Black, 3654 [53·8%] were White, and 339 [5·0%] were other ethnicities) from 19 RCTs. Sedative adverse events were observed in 582 (8·6%) of 6791 participants and typically occurred shortly after treatment initiation. Among participants receiving antipsychotics, 418 (83%) of 505 sedation events occurred within the first 2 weeks of treatment. Following the onset of sedation, 50% of symptoms were resolved within 1 week. After 4 weeks of treatment, 24% (95% CI 19·7–29·3) continued to have sedation with oral agents and 22·3% (15·3–32·3) with long-acting injectables.
Interpretation
The high incidence of sedation within the first 2 weeks of treatment with antipsychotics emphasises the importance of early monitoring. Half of the sedation resolved within 1 week and 75% within 1 month, suggesting that tolerance to sedation is acquired quickly. If sedation is sustained, contributing factors should be evaluated.
Funding
German Federal Ministry of Education and Research.
{"title":"The trajectory of sedative adverse events caused by antipsychotics: a meta-analysis of individual participant data from randomised, placebo-controlled, clinical trials in acute phase schizophrenia","authors":"Nobuyuki Nomura, Spyridon Siafis, Johannes Schneider-Thoma, Lasse Brandt, Jinyoung Park, Orestis Efthimiou, Josef Priller, John M Davis, Hiroyoshi Takeuchi, Stefan Leucht","doi":"10.1016/s2215-0366(25)00025-2","DOIUrl":"https://doi.org/10.1016/s2215-0366(25)00025-2","url":null,"abstract":"<h3>Background</h3>Sedative adverse events are common in patients with schizophrenia undergoing antipsychotic treatment, which affects treatment adherence and the patients’ quality of life. Although tolerance to sedation is believed to develop, robust evidence documenting the timing of sedation onset and resolution remains elusive. To address this gap, we aimed to assess the dynamics of onset and resolution of sedation across various antipsychotics in patients with schizophrenia.<h3>Methods</h3>In this meta-analysis, we included placebo-controlled, randomised controlled trials (RCTs) of antipsychotic monotherapy for the acute phase of schizophrenia and schizoaffective disorder. We searched PubMed for RCTs from inception until May 6, 2021 and obtained individual participant data of included trials through the Yale University Open Data Access project. We created Kaplan–Meier curves to assess the probability of onset of sedation and resolution from the incidence of sedation across time after treatment initiation. People with lived experience were not involved in this study. This study is registered with PROSPERO, CRD42022351647.<h3>Findings</h3>We included a total of 6791 participants (4549 [67·0%] men and 2242 [33·0%] women, with a mean age of 38·0 years [SD 12·4, range 13–81], 1172 [17·3%] were Asian, 1626 [23·9%] were Black, 3654 [53·8%] were White, and 339 [5·0%] were other ethnicities) from 19 RCTs. Sedative adverse events were observed in 582 (8·6%) of 6791 participants and typically occurred shortly after treatment initiation. Among participants receiving antipsychotics, 418 (83%) of 505 sedation events occurred within the first 2 weeks of treatment. Following the onset of sedation, 50% of symptoms were resolved within 1 week. After 4 weeks of treatment, 24% (95% CI 19·7–29·3) continued to have sedation with oral agents and 22·3% (15·3–32·3) with long-acting injectables.<h3>Interpretation</h3>The high incidence of sedation within the first 2 weeks of treatment with antipsychotics emphasises the importance of early monitoring. Half of the sedation resolved within 1 week and 75% within 1 month, suggesting that tolerance to sedation is acquired quickly. If sedation is sustained, contributing factors should be evaluated.<h3>Funding</h3>German Federal Ministry of Education and Research.","PeriodicalId":48784,"journal":{"name":"Lancet Psychiatry","volume":"6 1","pages":""},"PeriodicalIF":64.3,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143653664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-18DOI: 10.1016/s2215-0366(25)00028-8
Anthony J Cleare, Jess Kerr-Gaffney, Kimberley Goldsmith, Zohra Zenasni, Nahel Yaziji, Huajie Jin, Alessandro Colasanti, John R Geddes, David Kessler, R Hamish McAllister-Williams, Allan H Young, Alvaro Barrera, Lindsey Marwood, Rachael W Taylor, Helena Tee
<h3>Background</h3>Lithium and quetiapine are first-line augmentation options for treatment-resistant depression; however, few studies have compared them directly, and none for longer than 8 weeks. We aimed to assess whether quetiapine augmentation therapy is more clinically effective and cost-effective than lithium for patients with treatment-resistant depression over 12 months.<h3>Methods</h3>We did this pragmatic, open-label, parallel-group, randomised controlled superiority trial at six National Health Service trusts in England. Eligible participants were adults (aged ≥18 years) with a current episode of major depressive disorder meeting DSM-5 criteria, with a score of 14 or higher on the 17-item Hamilton Depression Rating Scale at screening who had responded inadequately to two or more therapeutic antidepressant trials. Exclusion criteria included having a diagnosis of bipolar disorder or current psychosis. Participants were randomly assigned (1:1) to the decision to prescribe lithium or quetiapine, stratified by site, depression severity, and treatment resistance, using block randomisation with randomly varying block sizes. After randomisation, pre-prescribing safety checks were undertaken as per standard care before proceeding to trial medication initiation. The coprimary outcomes were depressive symptom severity over 12 months, measured weekly using the Quick Inventory of Depressive Symptomatology, and time to all-cause treatment discontinuation. Economic analyses compared the cost-effectiveness of the two treatments from both an NHS and personal social services perspective, and a societal perspective. Primary analyses were done in the intention-to-treat population, which included all randomly assigned participants. People with lived experience were involved in the trial. The trial is completed and registered with the International Standard Randomised Controlled Trial registry, ISRCTN16387615.<h3>Findings</h3>Between Dec 5, 2016, and July 26, 2021, 212 participants (97 [46%] male gender and 115 [54%] female gender) were randomly assigned to the decision to prescribe quetiapine (n=107) or lithium (n=105). The mean age of participants was 42·4 years (SD 14·0 years) and 188 (89%) of 212 participants were White, seven (3%) were of mixed ethnicity, nine (4%) participants were Asian, four (2%) were Black, three (1%) were of Other ethnicity, and ethnicity was not recorded for one (1%) participant. Participants in the quetiapine group had a significantly lower overall burden of depressive symptom severity than participants in the lithium group (area under the between-group differences curve –68·36 [95% CI –129·95 to –6·76; p=0·0296). Time to discontinuation did not significantly differ between the two groups. Quetiapine was more cost-effective than lithium. 32 serious adverse events were recorded in 18 participants, one of which was deemed possibly related to the trial medication in a female participant in the lithium group. The most common serio
{"title":"Clinical and cost-effectiveness of lithium versus quetiapine augmentation for treatment-resistant depression: a pragmatic, open-label, parallel-group, randomised controlled superiority trial in the UK","authors":"Anthony J Cleare, Jess Kerr-Gaffney, Kimberley Goldsmith, Zohra Zenasni, Nahel Yaziji, Huajie Jin, Alessandro Colasanti, John R Geddes, David Kessler, R Hamish McAllister-Williams, Allan H Young, Alvaro Barrera, Lindsey Marwood, Rachael W Taylor, Helena Tee","doi":"10.1016/s2215-0366(25)00028-8","DOIUrl":"https://doi.org/10.1016/s2215-0366(25)00028-8","url":null,"abstract":"<h3>Background</h3>Lithium and quetiapine are first-line augmentation options for treatment-resistant depression; however, few studies have compared them directly, and none for longer than 8 weeks. We aimed to assess whether quetiapine augmentation therapy is more clinically effective and cost-effective than lithium for patients with treatment-resistant depression over 12 months.<h3>Methods</h3>We did this pragmatic, open-label, parallel-group, randomised controlled superiority trial at six National Health Service trusts in England. Eligible participants were adults (aged ≥18 years) with a current episode of major depressive disorder meeting DSM-5 criteria, with a score of 14 or higher on the 17-item Hamilton Depression Rating Scale at screening who had responded inadequately to two or more therapeutic antidepressant trials. Exclusion criteria included having a diagnosis of bipolar disorder or current psychosis. Participants were randomly assigned (1:1) to the decision to prescribe lithium or quetiapine, stratified by site, depression severity, and treatment resistance, using block randomisation with randomly varying block sizes. After randomisation, pre-prescribing safety checks were undertaken as per standard care before proceeding to trial medication initiation. The coprimary outcomes were depressive symptom severity over 12 months, measured weekly using the Quick Inventory of Depressive Symptomatology, and time to all-cause treatment discontinuation. Economic analyses compared the cost-effectiveness of the two treatments from both an NHS and personal social services perspective, and a societal perspective. Primary analyses were done in the intention-to-treat population, which included all randomly assigned participants. People with lived experience were involved in the trial. The trial is completed and registered with the International Standard Randomised Controlled Trial registry, ISRCTN16387615.<h3>Findings</h3>Between Dec 5, 2016, and July 26, 2021, 212 participants (97 [46%] male gender and 115 [54%] female gender) were randomly assigned to the decision to prescribe quetiapine (n=107) or lithium (n=105). The mean age of participants was 42·4 years (SD 14·0 years) and 188 (89%) of 212 participants were White, seven (3%) were of mixed ethnicity, nine (4%) participants were Asian, four (2%) were Black, three (1%) were of Other ethnicity, and ethnicity was not recorded for one (1%) participant. Participants in the quetiapine group had a significantly lower overall burden of depressive symptom severity than participants in the lithium group (area under the between-group differences curve –68·36 [95% CI –129·95 to –6·76; p=0·0296). Time to discontinuation did not significantly differ between the two groups. Quetiapine was more cost-effective than lithium. 32 serious adverse events were recorded in 18 participants, one of which was deemed possibly related to the trial medication in a female participant in the lithium group. The most common serio","PeriodicalId":48784,"journal":{"name":"Lancet Psychiatry","volume":"91 1","pages":""},"PeriodicalIF":64.3,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143653665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-18DOI: 10.1016/s2215-0366(25)00058-6
Hannah K Betcher, Megan N Kummerlowe
No Abstract
{"title":"Quetiapine augmentation for treatment-resistant depression","authors":"Hannah K Betcher, Megan N Kummerlowe","doi":"10.1016/s2215-0366(25)00058-6","DOIUrl":"https://doi.org/10.1016/s2215-0366(25)00058-6","url":null,"abstract":"No Abstract","PeriodicalId":48784,"journal":{"name":"Lancet Psychiatry","volume":"183 1","pages":""},"PeriodicalIF":64.3,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143653662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-18DOI: 10.1016/s2215-0366(25)00065-3
Subho Chakrabarti
No Abstract
{"title":"Antipsychotics and sedation: from clinical to shared decision making","authors":"Subho Chakrabarti","doi":"10.1016/s2215-0366(25)00065-3","DOIUrl":"https://doi.org/10.1016/s2215-0366(25)00065-3","url":null,"abstract":"No Abstract","PeriodicalId":48784,"journal":{"name":"Lancet Psychiatry","volume":"17 1","pages":""},"PeriodicalIF":64.3,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143653661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-17DOI: 10.1016/s2215-0366(25)00039-2
Akbar Ullah, Farah Lunat, Traolach Brugha, Matthias Pierce, Richard Morriss, Deepali Sharma, Atif Rahman, Kamaldeep Bhui, Peter Bower, Nusrat Husain
<h3>Background</h3>Minority ethnic groups often face ethnocultural barriers in accessing mental health treatments. The ROSHNI-2 trial compared culturally adapted cognitive behavioural therapy (Positive Health Programme [PHP]) with treatment as usual for postnatal depression in British south Asian women. We aimed to assess the cost-effectiveness of the PHP intervention.<h3>Methods</h3>The ROSHNI-2 trial was a multicentre, two-arm, assessor-blinded, randomised controlled trial; we conducted an economic evaluation over a 12-month period to assess the cost-effectiveness of PHP plus treatment as usual versus treatment as usual alone from the perspective of the English National Health Service and personal social services. In the trial, British south Asian women aged 16 years or older with a child aged up to 12 months, and meeting DSM-5 criteria for depression, were recruited from northwest England, Yorkshire, the East Midlands, and London. The PHP intervention involved 12 group sessions delivered by two trained bilingual facilitators, held once per week for 2 months and once per fortnight thereafter, each lasting 60–90 min. Questionnaires on depression symptoms, quality of life, and resource use were completed at baseline, 4 months (end of intervention), and 12 months after random assignment. Quality-adjusted life-years (QALYs) were used for the cost-utility analysis, and recovery from depression at 4 months (the primary clinical outcome), assessed using the Hamilton Rating Scale for Depression, informed the cost-effectiveness analysis. After the onset of the COVID-19 pandemic, the intervention was adapted for online delivery for the remaining participants. A stratified analysis compared the cost-effectiveness of online versus in-person delivery. The trial involved researchers with lived experience, and all methods, including health economic measures, were developed in consultation with service users, community members, and faith leaders. This is a preplanned analysis of the ROSHNI-2 trial, registered with ISRCTN (ISRCTN10697380).<h3>Findings</h3>From Feb 8, 2017, to March 29, 2020, 732 eligible women were enrolled: 368 participants were randomly assigned to the PHP arm and 364 to the treatment as usual arm. The base-case intention-to-treat analysis showed that PHP significantly increased costs (£712, 95% CI 311 to 1113) and QALYs (0·036, 95% CI 0·006 to 0·067), with an incremental cost-effectiveness ratio of £19 601 (7622 to 83 772). Based on the UK National Institute for Health and Care Excellence (NICE) maximum willingness-to-pay threshold of £30 000 per QALY, the likelihood of PHP being cost-effective was 77% from a health and social care perspective. Cost per remission from depression at the 4-month follow-up was £5509 (2916 to 17 860). In a stratified analysis of 34 participants attending online sessions during the pandemic, incremental QALY effects were 0·125 (0·048 to 0·203), resulting in costs of £202 (–3906 to 10 918) per additional QALY gain
{"title":"Cost-effectiveness of a group psychological intervention for postnatal depression in British south Asian women: an economic evaluation from the ROSHNI-2 trial","authors":"Akbar Ullah, Farah Lunat, Traolach Brugha, Matthias Pierce, Richard Morriss, Deepali Sharma, Atif Rahman, Kamaldeep Bhui, Peter Bower, Nusrat Husain","doi":"10.1016/s2215-0366(25)00039-2","DOIUrl":"https://doi.org/10.1016/s2215-0366(25)00039-2","url":null,"abstract":"<h3>Background</h3>Minority ethnic groups often face ethnocultural barriers in accessing mental health treatments. The ROSHNI-2 trial compared culturally adapted cognitive behavioural therapy (Positive Health Programme [PHP]) with treatment as usual for postnatal depression in British south Asian women. We aimed to assess the cost-effectiveness of the PHP intervention.<h3>Methods</h3>The ROSHNI-2 trial was a multicentre, two-arm, assessor-blinded, randomised controlled trial; we conducted an economic evaluation over a 12-month period to assess the cost-effectiveness of PHP plus treatment as usual versus treatment as usual alone from the perspective of the English National Health Service and personal social services. In the trial, British south Asian women aged 16 years or older with a child aged up to 12 months, and meeting DSM-5 criteria for depression, were recruited from northwest England, Yorkshire, the East Midlands, and London. The PHP intervention involved 12 group sessions delivered by two trained bilingual facilitators, held once per week for 2 months and once per fortnight thereafter, each lasting 60–90 min. Questionnaires on depression symptoms, quality of life, and resource use were completed at baseline, 4 months (end of intervention), and 12 months after random assignment. Quality-adjusted life-years (QALYs) were used for the cost-utility analysis, and recovery from depression at 4 months (the primary clinical outcome), assessed using the Hamilton Rating Scale for Depression, informed the cost-effectiveness analysis. After the onset of the COVID-19 pandemic, the intervention was adapted for online delivery for the remaining participants. A stratified analysis compared the cost-effectiveness of online versus in-person delivery. The trial involved researchers with lived experience, and all methods, including health economic measures, were developed in consultation with service users, community members, and faith leaders. This is a preplanned analysis of the ROSHNI-2 trial, registered with ISRCTN (ISRCTN10697380).<h3>Findings</h3>From Feb 8, 2017, to March 29, 2020, 732 eligible women were enrolled: 368 participants were randomly assigned to the PHP arm and 364 to the treatment as usual arm. The base-case intention-to-treat analysis showed that PHP significantly increased costs (£712, 95% CI 311 to 1113) and QALYs (0·036, 95% CI 0·006 to 0·067), with an incremental cost-effectiveness ratio of £19 601 (7622 to 83 772). Based on the UK National Institute for Health and Care Excellence (NICE) maximum willingness-to-pay threshold of £30 000 per QALY, the likelihood of PHP being cost-effective was 77% from a health and social care perspective. Cost per remission from depression at the 4-month follow-up was £5509 (2916 to 17 860). In a stratified analysis of 34 participants attending online sessions during the pandemic, incremental QALY effects were 0·125 (0·048 to 0·203), resulting in costs of £202 (–3906 to 10 918) per additional QALY gain","PeriodicalId":48784,"journal":{"name":"Lancet Psychiatry","volume":"49 1","pages":""},"PeriodicalIF":64.3,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143640870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-11DOI: 10.1016/s2215-0366(25)00064-1
William D R Smitha, Rebecca Defina, Caitlin Hitchcock
No Abstract
{"title":"Cultural practices within Indigenous Australian communities enhance mental health","authors":"William D R Smitha, Rebecca Defina, Caitlin Hitchcock","doi":"10.1016/s2215-0366(25)00064-1","DOIUrl":"https://doi.org/10.1016/s2215-0366(25)00064-1","url":null,"abstract":"No Abstract","PeriodicalId":48784,"journal":{"name":"Lancet Psychiatry","volume":"92 1","pages":""},"PeriodicalIF":64.3,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143599649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-11DOI: 10.1016/s2215-0366(25)00036-7
Kathy Leadbitter, Sophie Langhorne, Richard Smallman, Petrina Chu, Ceri Ellis, Louisa Harrison, Tessa Hutton, Charlotte Butter, Caitlin Goldie, Kirsty James, Latha Hackett, Alison Dunkerley, Penny Bee, Gemma Shields, Linda Davies, Richard Emsley, Jonathan Green
<h3>Background</h3>Caregivers of autistic children experience particularly poor levels of mental health and increased caregiving complexities. Proactive post-diagnostic family support is recommended but is inconsistently implemented, largely not evidence based, and does not directly address caregiver mental health. This study aimed to test the clinical effectiveness of the Empower-Autism programme plus treatment as usual versus the usual local post-diagnostic psychoeducation offer plus treatment as usual on caregiver mental health at the 52-week follow-up.<h3>Methods</h3>We did a prospective, multicentre, two-parallel-group, randomised controlled superiority trial of the Empower-Autism programme. Empower-Autism is a group-based, manualised, post-diagnostic programme designed to improve the mental health of caregivers of newly diagnosed autistic children. The programme combines autism psychoeducation and psychotherapeutic components based on Acceptance and Commitment Therapy and was delivered online via videoconferencing. Participants were recruited from 11 North-West England autism diagnostic or intervention centres and were parents or primary caregivers of children aged 2–15 years given an autism diagnosis within the past 12 months. Exclusion criteria were insufficient English language skills, significant learning disability, hearing or visual impairment, or psychiatric condition in caregiver and significant current family safeguarding concerns. Participants were randomly assigned to the intervention or treatment as usual (2:1), stratified by centre. Assessors were masked to group assignment but participants were not. The primary outcome was caregiver mental health assessed by the General Health Questionnaire-30 at 52 weeks. All outcomes were analysed following an intention-to-treat approach using linear mixed models on available cases in the first instance, which resulted in a modified intention-to-treat set due to missing data. Sensitivity analyses on multiply imputed data reflected the full intention-to-treat set. People with lived experience were involved in the trial across all stages. The trial was prospectively registered (ISRCTN 45412843) on Sept 11, 2019, and is complete.<h3>Findings</h3>Between Sept 16, 2020 and April 14, 2022, 835 potential participants were referred and screened, 384 provided consent, and 379 caregivers were recruited, 255 of whom were randomly assigned to the intervention group and 124 to the treatment as usual group. 333 (88%) participants were female and 46 (12%) were male, with a mean age of 40·6 years (SD 7·3; range 23–69). 294 (78%) of the 379 caregivers were White British, 18 (5%) were White Other, 12 (3%) were Mixed or of multiple ethnicity, 32 (8%) were Asian or Asian British, 16 (4%) were Black or Black British, six (2%) were from any other ethnic group, and one (<1%) had missing ethnicity data. 267 (70%) index children were male, 111 (29%) were female, and one (<1%) was non-binary or other, with a me
{"title":"Clinical effectiveness of an online psychoeducational and psychotherapeutic programme for caregivers of children newly diagnosed as autistic: a parallel, assessor-masked, randomised controlled trial in the UK (REACH-ASD)","authors":"Kathy Leadbitter, Sophie Langhorne, Richard Smallman, Petrina Chu, Ceri Ellis, Louisa Harrison, Tessa Hutton, Charlotte Butter, Caitlin Goldie, Kirsty James, Latha Hackett, Alison Dunkerley, Penny Bee, Gemma Shields, Linda Davies, Richard Emsley, Jonathan Green","doi":"10.1016/s2215-0366(25)00036-7","DOIUrl":"https://doi.org/10.1016/s2215-0366(25)00036-7","url":null,"abstract":"<h3>Background</h3>Caregivers of autistic children experience particularly poor levels of mental health and increased caregiving complexities. Proactive post-diagnostic family support is recommended but is inconsistently implemented, largely not evidence based, and does not directly address caregiver mental health. This study aimed to test the clinical effectiveness of the Empower-Autism programme plus treatment as usual versus the usual local post-diagnostic psychoeducation offer plus treatment as usual on caregiver mental health at the 52-week follow-up.<h3>Methods</h3>We did a prospective, multicentre, two-parallel-group, randomised controlled superiority trial of the Empower-Autism programme. Empower-Autism is a group-based, manualised, post-diagnostic programme designed to improve the mental health of caregivers of newly diagnosed autistic children. The programme combines autism psychoeducation and psychotherapeutic components based on Acceptance and Commitment Therapy and was delivered online via videoconferencing. Participants were recruited from 11 North-West England autism diagnostic or intervention centres and were parents or primary caregivers of children aged 2–15 years given an autism diagnosis within the past 12 months. Exclusion criteria were insufficient English language skills, significant learning disability, hearing or visual impairment, or psychiatric condition in caregiver and significant current family safeguarding concerns. Participants were randomly assigned to the intervention or treatment as usual (2:1), stratified by centre. Assessors were masked to group assignment but participants were not. The primary outcome was caregiver mental health assessed by the General Health Questionnaire-30 at 52 weeks. All outcomes were analysed following an intention-to-treat approach using linear mixed models on available cases in the first instance, which resulted in a modified intention-to-treat set due to missing data. Sensitivity analyses on multiply imputed data reflected the full intention-to-treat set. People with lived experience were involved in the trial across all stages. The trial was prospectively registered (ISRCTN 45412843) on Sept 11, 2019, and is complete.<h3>Findings</h3>Between Sept 16, 2020 and April 14, 2022, 835 potential participants were referred and screened, 384 provided consent, and 379 caregivers were recruited, 255 of whom were randomly assigned to the intervention group and 124 to the treatment as usual group. 333 (88%) participants were female and 46 (12%) were male, with a mean age of 40·6 years (SD 7·3; range 23–69). 294 (78%) of the 379 caregivers were White British, 18 (5%) were White Other, 12 (3%) were Mixed or of multiple ethnicity, 32 (8%) were Asian or Asian British, 16 (4%) were Black or Black British, six (2%) were from any other ethnic group, and one (<1%) had missing ethnicity data. 267 (70%) index children were male, 111 (29%) were female, and one (<1%) was non-binary or other, with a me","PeriodicalId":48784,"journal":{"name":"Lancet Psychiatry","volume":"16 1","pages":""},"PeriodicalIF":64.3,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143599502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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