A multicentred two-arm parallel single-blind superiority randomised controlled trial comparing psychological and emotional stabilisation with eye movement desensitisation and reprocessing and treatment-as-usual to treatment-as-usual with adults with intellectual disabilities who have post-traumatic stress disorder (the Trauma-AID trial): protocol

Willner, Paul; Anderson, Pippa; Bisson, Jonathan I; Clifford, Clair; Cooper, Vivien; Farrell, Derek; Harris, Shaun; Hiles, Steve; Holland, Gail; Hutchings, Hayley; Murphy, Glynis H; Rose, John; Stenfert-Kroese, Biza; Unwin, Gemma L; Watkins, Alan; Willott, Sara; Langdon, Peter E

doi:10.1136/bmjopen-2025-108818

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A multicentred two-arm parallel single-blind superiority randomised controlled trial comparing psychological and emotional stabilisation with eye movement desensitisation and reprocessing and treatment-as-usual to treatment-as-usu...

Paul Willner, Pippa Anderson

, Jonathan I Bisson, Clair Clifford, Vivien Cooper, Derek Farrell, Shaun Harris

, Steve Hiles, Gail Holland

, Hayley Hutchings

, Glynis H Murphy, John Rose, Biza Stenfert-Kroese, Gemma L Unwin, Alan Watkins

, Sara Willott, Peter E Langdon

BMJ Open, Volume: 15, Issue: 12, Start page: e108818

Swansea University Authors: Paul Willner, Pippa Anderson , Shaun Harris , Steve Hiles, Gail Holland , Hayley Hutchings , Alan Watkins

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DOI (Published version): 10.1136/bmjopen-2025-108818

Abstract

Introduction: The primary objective of this clinical trial is to determine the clinical and cost-effectiveness of psychoeducation and emotional stabilisation (PES), together with eye movement desensitisation and reprocessing (EMDR) plus treatment-as-usual (TAU) in reducing symptoms of post-traumatic...

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Published in:	BMJ Open
ISSN:	2044-6055 2044-6055
Published:	BMJ Publishing Group Ltd 2025
Online Access:	Check full text
URI:	https://cronfa.swan.ac.uk/Record/cronfa71154

first_indexed	2025-12-17T14:53:03Z
last_indexed	2026-01-14T05:32:44Z
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Secondary objectives include: (1) determining whether PES/EMDR plus TAU is superior to TAU in improving mental health problems and quality of life (QoL) among adults with intellectual disabilities who had a diagnosis of PTSD and (2) completing a process evaluation to examine intervention implementation and acceptability. Methods: This is a two-arm parallel single-blind randomised controlled trial comparing PES-EMDR+TAU to TAU including an internal pilot phase. Outcome data will be captured prior to randomisation, and at 4 (after PES), 8 (after EMDR) and 14 months postrandomisation by masked assessors. 144 adults with intellectual disabilities with a diagnosis of PTSD will be allocated (1:1) randomly using minimisation from National Health Service (NHS) community and inpatients services for adults with intellectual disabilities in England. Participants are eligible to take part in this trial if: (1) they are aged 18 or older, but younger than 66, (2) have a Full Scale IQ<75, (3) meet diagnostic criteria for PTSD and (4) have suffered a major identified trauma at least a year earlier and (5) are able to communicate using English and have capacity to consent to take part in this clinical trial. Participants allocated to the active intervention will receive 10 sessions of PES, followed by up to 15 sessions of EMDR alongside TAU. The active intervention is being delivered by psychologists experienced in working with adults with intellectual disabilities who have received additional intervention training. TAU is likely to include medication, behaviour support plans designed to target challenging behaviour, or non-trauma-focused psychological interventions. The primary outcome is a measure of PTSD symptoms. Secondary outcomes are other mental health problems, including anxiety and depression, challenging behaviour, participant and carer QoL, and carer burden. We are also capturing cost data to allow for a cost–utility analysis. A process evaluation will be completed using data generated from semistructured interviews with a sample of participants, therapists and carers alongside the capture of fidelity and adherence data. Analysis: The primary outcome will be assessed using an intention-to-treat analysis. Baseline characteristics will be compared between arms to determine whether any potentially influential imbalance occurred. The primary outcome will be analysed by analysis of covariance, adjusting for baseline values of the outcome and any variables used in the randomisation process. Secondary outcomes will be analysed using linear or logistic regression models as appropriate reflecting the distribution of the outcome variable. The treatment effect will be estimated as an adjusted difference between sample means, presented with 95% CIs and p values. A complier average causal effect analysis will be considered should the data availability be sufficient to estimate the impact of non-compliance. A series of subgroup analyses on the primary outcomes will be considered considering differences in the Impact of Event Scale–Intellectual Disabilities scores at 14 months for (1) differing levels of general intellectual functioning and (2) PTSD versus complex PTSD. Ethics and dissemination: This clinical trial was designed to allow for conclusions about whether PES/EMDR+TAU is efficacious in reducing symptoms of PTSD, relative to TAU, for adults with intellectual disabilities. A favourable ethical opinion has been received from an NHS ethics committee in the UK. The findings from this trial will be published within peer-reviewed journals and shared at national and international conferences. We will also aim to record and distribute podcasts detailing our findings together with our partners. Trial registration number ISRCTN35167485.</abstract><type>Journal Article</type><journal>BMJ Open</journal><volume>15</volume><journalNumber>12</journalNumber><paginationStart>e108818</paginationStart><paginationEnd/><publisher>BMJ Publishing Group Ltd</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>2044-6055</issnPrint><issnElectronic>2044-6055</issnElectronic><keywords/><publishedDay>17</publishedDay><publishedMonth>12</publishedMonth><publishedYear>2025</publishedYear><publishedDate>2025-12-17</publishedDate><doi>10.1136/bmjopen-2025-108818</doi><url/><notes>Protocol</notes><college>COLLEGE NANME</college><department>Psychology School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>PSYS</DepartmentCode><institution>Swansea University</institution><apcterm>Another institution paid the OA fee</apcterm><funders>This research is funded by the UK National Institute for Health Research, project 17/125/04.</funders><projectreference/><lastEdited>2026-01-13T14:44:12.3260193</lastEdited><Created>2025-12-17T14:51:45.7034199</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Health Data Science</level></path><authors><author><firstname>Paul</firstname><surname>Willner</surname><order>1</order></author><author><firstname>Pippa</firstname><surname>Anderson</surname><orcid>0000-0003-2959-2671</orcid><order>2</order></author><author><firstname>Jonathan I</firstname><surname>Bisson</surname><order>3</order></author><author><firstname>Clair</firstname><surname>Clifford</surname><order>4</order></author><author><firstname>Vivien</firstname><surname>Cooper</surname><order>5</order></author><author><firstname>Derek</firstname><surname>Farrell</surname><order>6</order></author><author><firstname>Shaun</firstname><surname>Harris</surname><orcid>0000-0001-7724-6621</orcid><order>7</order></author><author><firstname>Steve</firstname><surname>Hiles</surname><order>8</order></author><author><firstname>Gail</firstname><surname>Holland</surname><orcid>0000-0002-6924-2521</orcid><order>9</order></author><author><firstname>Hayley</firstname><surname>Hutchings</surname><orcid>0000-0003-4155-1741</orcid><order>10</order></author><author><firstname>Glynis H</firstname><surname>Murphy</surname><order>11</order></author><author><firstname>John</firstname><surname>Rose</surname><order>12</order></author><author><firstname>Biza</firstname><surname>Stenfert-Kroese</surname><order>13</order></author><author><firstname>Gemma L</firstname><surname>Unwin</surname><order>14</order></author><author><firstname>Alan</firstname><surname>Watkins</surname><orcid>0000-0003-3804-1943</orcid><order>15</order></author><author><firstname>Sara</firstname><surname>Willott</surname><order>16</order></author><author><firstname>Peter E</firstname><surname>Langdon</surname><orcid>0000-0002-7745-1825</orcid><order>17</order></author></authors><documents><document><filename>71154__35982__5f1644ce0ec24aeea0217c607fda751d.pdf</filename><originalFilename>71154.VOR.pdf</originalFilename><uploaded>2026-01-13T14:41:47.0638116</uploaded><type>Output</type><contentLength>450972</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>© Author(s) (or their employer(s)) 2025. 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spelling	2026-01-13T14:44:12.3260193 v2 71154 2025-12-17 A multicentred two-arm parallel single-blind superiority randomised controlled trial comparing psychological and emotional stabilisation with eye movement desensitisation and reprocessing and treatment-as-usual to treatment-as-usual with adults with intellectual disabilities who have post-traumatic stress disorder (the Trauma-AID trial): protocol 4c278ffb6e4af6ab8816be40af66ecd3 Paul Willner Paul Willner true false 128cdedfba6e5e6374fdc85d5c78c428 0000-0003-2959-2671 Pippa Anderson Pippa Anderson true false 10b1bd08dbad1f2681ff1e527af9f9a3 0000-0001-7724-6621 Shaun Harris Shaun Harris true false 5ecd70f8c0f27219f84a7f297d99b22b Steve Hiles Steve Hiles true false b9f3a8bf7478db012c8856b7bbbc7597 0000-0002-6924-2521 Gail Holland Gail Holland true false bdf5d5f154d339dd92bb25884b7c3652 0000-0003-4155-1741 Hayley Hutchings Hayley Hutchings true false 81fc05c9333d9df41b041157437bcc2f 0000-0003-3804-1943 Alan Watkins Alan Watkins true false 2025-12-17 PSYS Introduction: The primary objective of this clinical trial is to determine the clinical and cost-effectiveness of psychoeducation and emotional stabilisation (PES), together with eye movement desensitisation and reprocessing (EMDR) plus treatment-as-usual (TAU) in reducing symptoms of post-traumatic stress disorder (PTSD) among adults with intellectual disabilities compared with TAU. Secondary objectives include: (1) determining whether PES/EMDR plus TAU is superior to TAU in improving mental health problems and quality of life (QoL) among adults with intellectual disabilities who had a diagnosis of PTSD and (2) completing a process evaluation to examine intervention implementation and acceptability. Methods: This is a two-arm parallel single-blind randomised controlled trial comparing PES-EMDR+TAU to TAU including an internal pilot phase. Outcome data will be captured prior to randomisation, and at 4 (after PES), 8 (after EMDR) and 14 months postrandomisation by masked assessors. 144 adults with intellectual disabilities with a diagnosis of PTSD will be allocated (1:1) randomly using minimisation from National Health Service (NHS) community and inpatients services for adults with intellectual disabilities in England. Participants are eligible to take part in this trial if: (1) they are aged 18 or older, but younger than 66, (2) have a Full Scale IQ<75, (3) meet diagnostic criteria for PTSD and (4) have suffered a major identified trauma at least a year earlier and (5) are able to communicate using English and have capacity to consent to take part in this clinical trial. Participants allocated to the active intervention will receive 10 sessions of PES, followed by up to 15 sessions of EMDR alongside TAU. The active intervention is being delivered by psychologists experienced in working with adults with intellectual disabilities who have received additional intervention training. TAU is likely to include medication, behaviour support plans designed to target challenging behaviour, or non-trauma-focused psychological interventions. The primary outcome is a measure of PTSD symptoms. Secondary outcomes are other mental health problems, including anxiety and depression, challenging behaviour, participant and carer QoL, and carer burden. We are also capturing cost data to allow for a cost–utility analysis. A process evaluation will be completed using data generated from semistructured interviews with a sample of participants, therapists and carers alongside the capture of fidelity and adherence data. Analysis: The primary outcome will be assessed using an intention-to-treat analysis. Baseline characteristics will be compared between arms to determine whether any potentially influential imbalance occurred. The primary outcome will be analysed by analysis of covariance, adjusting for baseline values of the outcome and any variables used in the randomisation process. Secondary outcomes will be analysed using linear or logistic regression models as appropriate reflecting the distribution of the outcome variable. The treatment effect will be estimated as an adjusted difference between sample means, presented with 95% CIs and p values. A complier average causal effect analysis will be considered should the data availability be sufficient to estimate the impact of non-compliance. A series of subgroup analyses on the primary outcomes will be considered considering differences in the Impact of Event Scale–Intellectual Disabilities scores at 14 months for (1) differing levels of general intellectual functioning and (2) PTSD versus complex PTSD. Ethics and dissemination: This clinical trial was designed to allow for conclusions about whether PES/EMDR+TAU is efficacious in reducing symptoms of PTSD, relative to TAU, for adults with intellectual disabilities. A favourable ethical opinion has been received from an NHS ethics committee in the UK. The findings from this trial will be published within peer-reviewed journals and shared at national and international conferences. We will also aim to record and distribute podcasts detailing our findings together with our partners. Trial registration number ISRCTN35167485. Journal Article BMJ Open 15 12 e108818 BMJ Publishing Group Ltd 2044-6055 2044-6055 17 12 2025 2025-12-17 10.1136/bmjopen-2025-108818 Protocol COLLEGE NANME Psychology School COLLEGE CODE PSYS Swansea University Another institution paid the OA fee This research is funded by the UK National Institute for Health Research, project 17/125/04. 2026-01-13T14:44:12.3260193 2025-12-17T14:51:45.7034199 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Health Data Science Paul Willner 1 Pippa Anderson 0000-0003-2959-2671 2 Jonathan I Bisson 3 Clair Clifford 4 Vivien Cooper 5 Derek Farrell 6 Shaun Harris 0000-0001-7724-6621 7 Steve Hiles 8 Gail Holland 0000-0002-6924-2521 9 Hayley Hutchings 0000-0003-4155-1741 10 Glynis H Murphy 11 John Rose 12 Biza Stenfert-Kroese 13 Gemma L Unwin 14 Alan Watkins 0000-0003-3804-1943 15 Sara Willott 16 Peter E Langdon 0000-0002-7745-1825 17 71154__35982__5f1644ce0ec24aeea0217c607fda751d.pdf 71154.VOR.pdf 2026-01-13T14:41:47.0638116 Output 450972 application/pdf Version of Record true © Author(s) (or their employer(s)) 2025. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license. true eng https://creativecommons.org/licenses/by/4.0/
title	A multicentred two-arm parallel single-blind superiority randomised controlled trial comparing psychological and emotional stabilisation with eye movement desensitisation and reprocessing and treatment-as-usual to treatment-as-usual with adults with intellectual disabilities who have post-traumatic stress disorder (the Trauma-AID trial): protocol
spellingShingle	A multicentred two-arm parallel single-blind superiority randomised controlled trial comparing psychological and emotional stabilisation with eye movement desensitisation and reprocessing and treatment-as-usual to treatment-as-usual with adults with intellectual disabilities who have post-traumatic stress disorder (the Trauma-AID trial): protocol Paul Willner Pippa Anderson Shaun Harris Steve Hiles Gail Holland Hayley Hutchings Alan Watkins
title_short	A multicentred two-arm parallel single-blind superiority randomised controlled trial comparing psychological and emotional stabilisation with eye movement desensitisation and reprocessing and treatment-as-usual to treatment-as-usual with adults with intellectual disabilities who have post-traumatic stress disorder (the Trauma-AID trial): protocol
title_full	A multicentred two-arm parallel single-blind superiority randomised controlled trial comparing psychological and emotional stabilisation with eye movement desensitisation and reprocessing and treatment-as-usual to treatment-as-usual with adults with intellectual disabilities who have post-traumatic stress disorder (the Trauma-AID trial): protocol
title_fullStr	A multicentred two-arm parallel single-blind superiority randomised controlled trial comparing psychological and emotional stabilisation with eye movement desensitisation and reprocessing and treatment-as-usual to treatment-as-usual with adults with intellectual disabilities who have post-traumatic stress disorder (the Trauma-AID trial): protocol
title_full_unstemmed	A multicentred two-arm parallel single-blind superiority randomised controlled trial comparing psychological and emotional stabilisation with eye movement desensitisation and reprocessing and treatment-as-usual to treatment-as-usual with adults with intellectual disabilities who have post-traumatic stress disorder (the Trauma-AID trial): protocol
title_sort	A multicentred two-arm parallel single-blind superiority randomised controlled trial comparing psychological and emotional stabilisation with eye movement desensitisation and reprocessing and treatment-as-usual to treatment-as-usual with adults with intellectual disabilities who have post-traumatic stress disorder (the Trauma-AID trial): protocol
author_id_str_mv	4c278ffb6e4af6ab8816be40af66ecd3 128cdedfba6e5e6374fdc85d5c78c428 10b1bd08dbad1f2681ff1e527af9f9a3 5ecd70f8c0f27219f84a7f297d99b22b b9f3a8bf7478db012c8856b7bbbc7597 bdf5d5f154d339dd92bb25884b7c3652 81fc05c9333d9df41b041157437bcc2f
author_id_fullname_str_mv	4c278ffb6e4af6ab8816be40af66ecd3_*_Paul Willner 128cdedfba6e5e6374fdc85d5c78c428__Pippa Anderson 10b1bd08dbad1f2681ff1e527af9f9a3__Shaun Harris 5ecd70f8c0f27219f84a7f297d99b22b__Steve Hiles b9f3a8bf7478db012c8856b7bbbc7597__Gail Holland bdf5d5f154d339dd92bb25884b7c3652__Hayley Hutchings 81fc05c9333d9df41b041157437bcc2f_**_Alan Watkins
author	Paul Willner Pippa Anderson Shaun Harris Steve Hiles Gail Holland Hayley Hutchings Alan Watkins
author2	Paul Willner Pippa Anderson Jonathan I Bisson Clair Clifford Vivien Cooper Derek Farrell Shaun Harris Steve Hiles Gail Holland Hayley Hutchings Glynis H Murphy John Rose Biza Stenfert-Kroese Gemma L Unwin Alan Watkins Sara Willott Peter E Langdon
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container_title	BMJ Open
container_volume	15
container_issue	12
container_start_page	e108818
publishDate	2025
institution	Swansea University
issn	2044-6055 2044-6055
doi_str_mv	10.1136/bmjopen-2025-108818
publisher	BMJ Publishing Group Ltd
college_str	Faculty of Medicine, Health and Life Sciences
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hierarchy_top_title	Faculty of Medicine, Health and Life Sciences
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hierarchy_parent_title	Faculty of Medicine, Health and Life Sciences
department_str	Swansea University Medical School - Health Data Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Health Data Science
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description	Introduction: The primary objective of this clinical trial is to determine the clinical and cost-effectiveness of psychoeducation and emotional stabilisation (PES), together with eye movement desensitisation and reprocessing (EMDR) plus treatment-as-usual (TAU) in reducing symptoms of post-traumatic stress disorder (PTSD) among adults with intellectual disabilities compared with TAU. Secondary objectives include: (1) determining whether PES/EMDR plus TAU is superior to TAU in improving mental health problems and quality of life (QoL) among adults with intellectual disabilities who had a diagnosis of PTSD and (2) completing a process evaluation to examine intervention implementation and acceptability. Methods: This is a two-arm parallel single-blind randomised controlled trial comparing PES-EMDR+TAU to TAU including an internal pilot phase. Outcome data will be captured prior to randomisation, and at 4 (after PES), 8 (after EMDR) and 14 months postrandomisation by masked assessors. 144 adults with intellectual disabilities with a diagnosis of PTSD will be allocated (1:1) randomly using minimisation from National Health Service (NHS) community and inpatients services for adults with intellectual disabilities in England. Participants are eligible to take part in this trial if: (1) they are aged 18 or older, but younger than 66, (2) have a Full Scale IQ<75, (3) meet diagnostic criteria for PTSD and (4) have suffered a major identified trauma at least a year earlier and (5) are able to communicate using English and have capacity to consent to take part in this clinical trial. Participants allocated to the active intervention will receive 10 sessions of PES, followed by up to 15 sessions of EMDR alongside TAU. The active intervention is being delivered by psychologists experienced in working with adults with intellectual disabilities who have received additional intervention training. TAU is likely to include medication, behaviour support plans designed to target challenging behaviour, or non-trauma-focused psychological interventions. The primary outcome is a measure of PTSD symptoms. Secondary outcomes are other mental health problems, including anxiety and depression, challenging behaviour, participant and carer QoL, and carer burden. We are also capturing cost data to allow for a cost–utility analysis. A process evaluation will be completed using data generated from semistructured interviews with a sample of participants, therapists and carers alongside the capture of fidelity and adherence data. Analysis: The primary outcome will be assessed using an intention-to-treat analysis. Baseline characteristics will be compared between arms to determine whether any potentially influential imbalance occurred. The primary outcome will be analysed by analysis of covariance, adjusting for baseline values of the outcome and any variables used in the randomisation process. Secondary outcomes will be analysed using linear or logistic regression models as appropriate reflecting the distribution of the outcome variable. The treatment effect will be estimated as an adjusted difference between sample means, presented with 95% CIs and p values. A complier average causal effect analysis will be considered should the data availability be sufficient to estimate the impact of non-compliance. A series of subgroup analyses on the primary outcomes will be considered considering differences in the Impact of Event Scale–Intellectual Disabilities scores at 14 months for (1) differing levels of general intellectual functioning and (2) PTSD versus complex PTSD. Ethics and dissemination: This clinical trial was designed to allow for conclusions about whether PES/EMDR+TAU is efficacious in reducing symptoms of PTSD, relative to TAU, for adults with intellectual disabilities. A favourable ethical opinion has been received from an NHS ethics committee in the UK. The findings from this trial will be published within peer-reviewed journals and shared at national and international conferences. We will also aim to record and distribute podcasts detailing our findings together with our partners. Trial registration number ISRCTN35167485.
published_date	2025-12-17T05:34:43Z
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A multicentred two-arm parallel single-blind superiority randomised controlled trial comparing psychological and emotional stabilisation with eye movement desensitisation and reprocessing and treatment-as-usual to treatment-as-usu...

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