Effectiveness of the internet-based Unified Protocol transdiagnostic intervention for the treatment of depression, anxiety and related disorders in a primary care setting: a randomized controlled trial

Abstract Background Research has shown that internet-based cognitive behavioural therapy (iCBT) can be a very promising solution to increase access to and the dissemination of evidence-based treatments to all of the population in need. However, iCBT is still underutilized in clinical contexts, such...

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Main Authors: Ladislav Timulak, Derek Richards, Louise Bhandal-Griffin, Patrick Healy, Juliana Azevedo, Graham Connon, Elaine Martin, Aoife Kearney, Conor O’Kelly, Angel Enrique, Nora Eilert, Sorcha O’Brien, Siobhan Harty, Alberto González-Robles, Elizabeth H. Eustis, David H. Barlow, Todd J. Farchione
Format: Article
Language:English
Published: BMC 2022-08-01
Series:Trials
Online Access:https://doi.org/10.1186/s13063-022-06551-y
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author Ladislav Timulak
Derek Richards
Louise Bhandal-Griffin
Patrick Healy
Juliana Azevedo
Graham Connon
Elaine Martin
Aoife Kearney
Conor O’Kelly
Angel Enrique
Nora Eilert
Sorcha O’Brien
Siobhan Harty
Alberto González-Robles
Elizabeth H. Eustis
David H. Barlow
Todd J. Farchione
author_facet Ladislav Timulak
Derek Richards
Louise Bhandal-Griffin
Patrick Healy
Juliana Azevedo
Graham Connon
Elaine Martin
Aoife Kearney
Conor O’Kelly
Angel Enrique
Nora Eilert
Sorcha O’Brien
Siobhan Harty
Alberto González-Robles
Elizabeth H. Eustis
David H. Barlow
Todd J. Farchione
author_sort Ladislav Timulak
collection DOAJ
description Abstract Background Research has shown that internet-based cognitive behavioural therapy (iCBT) can be a very promising solution to increase access to and the dissemination of evidence-based treatments to all of the population in need. However, iCBT is still underutilized in clinical contexts, such as primary care. In order to achieve the effective implementation of these protocols, more studies in ecological settings are needed. The Unified Protocol (UP) is a transdiagnostic CBT protocol for the treatment of emotional disorders, which includes depression, anxiety and related disorders, that has shown its efficacy across different contexts and populations. An internet-based UP (iUP) programme has recently been developed as an emerging internet-based treatment for emotional disorders. However, the internet-delivered version of the UP (iUP) has not yet been examined empirically. The current project seeks to analyse the effectiveness of the iUP as a treatment for depression, anxiety and related emotional disorders in a primary care public health setting. Methods The current study will employ a parallel-group, randomized controlled trial design. Participants will be randomly assigned to (a) the internet-based Unified Protocol (iUP), or (b) enhanced waiting list control (eWLC). Randomization will follow a 2:1 allocation ratio, with sample size calculations suggesting a required sample of 120 (iUP=80; eWLC=40). The Mini-International Neuropsychiatric Interview (M.I.N.I.) will be used for assessing potential participants. The Overall Anxiety Severity and Impairment Scale (OASIS) and the Overall Depression Severity and Impairment Scale (ODSIS) as well as other standardized questionnaires will be used for assessments at baseline, 4 weeks, 8 weeks and 12 weeks from baseline and for the iUP condition during the follow-up. Discussion Combining the advantages of a transdiagnostic treatment with an online delivery format may have the potential to significantly lower the burden of emotional disorders in public health primary care setting. Anxiety and depression, often comorbid, are the most prevalent psychological disorders in primary care. Because the iUP allows for the treatment of different disorders and comorbidity, this treatment could represent an adequate choice for patients that demand mental health care in a primary care setting. Trial registration ISRCTN18056450 https://doi.org/10.1186/ISRCTN18056450 .
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spelling doaj.art-61bae3b7135948d2b89e8fe3f3e7c60c2022-12-22T04:05:06ZengBMCTrials1745-62152022-08-0123111110.1186/s13063-022-06551-yEffectiveness of the internet-based Unified Protocol transdiagnostic intervention for the treatment of depression, anxiety and related disorders in a primary care setting: a randomized controlled trialLadislav Timulak0Derek Richards1Louise Bhandal-Griffin2Patrick Healy3Juliana Azevedo4Graham Connon5Elaine Martin6Aoife Kearney7Conor O’Kelly8Angel Enrique9Nora Eilert10Sorcha O’Brien11Siobhan Harty12Alberto González-Robles13Elizabeth H. Eustis14David H. Barlow15Todd J. Farchione16Trinity College DublinTrinity College DublinTrinity College DublinTrinity College DublinHealth Service ExecutiveHealth Service ExecutiveHealth Service ExecutiveHealth Service ExecutiveHealth Service ExecutiveTrinity College DublinTrinity College DublinTrinity College DublinSilverCloud Science, SilverCloud HealthUniversity of ZaragozaBoston UniversityBoston UniversityBoston UniversityAbstract Background Research has shown that internet-based cognitive behavioural therapy (iCBT) can be a very promising solution to increase access to and the dissemination of evidence-based treatments to all of the population in need. However, iCBT is still underutilized in clinical contexts, such as primary care. In order to achieve the effective implementation of these protocols, more studies in ecological settings are needed. The Unified Protocol (UP) is a transdiagnostic CBT protocol for the treatment of emotional disorders, which includes depression, anxiety and related disorders, that has shown its efficacy across different contexts and populations. An internet-based UP (iUP) programme has recently been developed as an emerging internet-based treatment for emotional disorders. However, the internet-delivered version of the UP (iUP) has not yet been examined empirically. The current project seeks to analyse the effectiveness of the iUP as a treatment for depression, anxiety and related emotional disorders in a primary care public health setting. Methods The current study will employ a parallel-group, randomized controlled trial design. Participants will be randomly assigned to (a) the internet-based Unified Protocol (iUP), or (b) enhanced waiting list control (eWLC). Randomization will follow a 2:1 allocation ratio, with sample size calculations suggesting a required sample of 120 (iUP=80; eWLC=40). The Mini-International Neuropsychiatric Interview (M.I.N.I.) will be used for assessing potential participants. The Overall Anxiety Severity and Impairment Scale (OASIS) and the Overall Depression Severity and Impairment Scale (ODSIS) as well as other standardized questionnaires will be used for assessments at baseline, 4 weeks, 8 weeks and 12 weeks from baseline and for the iUP condition during the follow-up. Discussion Combining the advantages of a transdiagnostic treatment with an online delivery format may have the potential to significantly lower the burden of emotional disorders in public health primary care setting. Anxiety and depression, often comorbid, are the most prevalent psychological disorders in primary care. Because the iUP allows for the treatment of different disorders and comorbidity, this treatment could represent an adequate choice for patients that demand mental health care in a primary care setting. Trial registration ISRCTN18056450 https://doi.org/10.1186/ISRCTN18056450 .https://doi.org/10.1186/s13063-022-06551-y
spellingShingle Ladislav Timulak
Derek Richards
Louise Bhandal-Griffin
Patrick Healy
Juliana Azevedo
Graham Connon
Elaine Martin
Aoife Kearney
Conor O’Kelly
Angel Enrique
Nora Eilert
Sorcha O’Brien
Siobhan Harty
Alberto González-Robles
Elizabeth H. Eustis
David H. Barlow
Todd J. Farchione
Effectiveness of the internet-based Unified Protocol transdiagnostic intervention for the treatment of depression, anxiety and related disorders in a primary care setting: a randomized controlled trial
Trials
title Effectiveness of the internet-based Unified Protocol transdiagnostic intervention for the treatment of depression, anxiety and related disorders in a primary care setting: a randomized controlled trial
title_full Effectiveness of the internet-based Unified Protocol transdiagnostic intervention for the treatment of depression, anxiety and related disorders in a primary care setting: a randomized controlled trial
title_fullStr Effectiveness of the internet-based Unified Protocol transdiagnostic intervention for the treatment of depression, anxiety and related disorders in a primary care setting: a randomized controlled trial
title_full_unstemmed Effectiveness of the internet-based Unified Protocol transdiagnostic intervention for the treatment of depression, anxiety and related disorders in a primary care setting: a randomized controlled trial
title_short Effectiveness of the internet-based Unified Protocol transdiagnostic intervention for the treatment of depression, anxiety and related disorders in a primary care setting: a randomized controlled trial
title_sort effectiveness of the internet based unified protocol transdiagnostic intervention for the treatment of depression anxiety and related disorders in a primary care setting a randomized controlled trial
url https://doi.org/10.1186/s13063-022-06551-y
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