scholarly journals Effectiveness of a Transdiagnostic Guided Internet-Delivered Protocol for Emotional Disorders Versus Treatment as Usual in Specialized Care: Randomized Controlled Trial

10.2196/18220 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e18220 ◽  
Author(s):  
Alberto González-Robles ◽  
Amanda Díaz-García ◽  
Azucena García-Palacios ◽  
Pablo Roca ◽  
Josep Antoni Ramos-Quiroga ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Emotional Disorders ◽  
Controlled Trial ◽  
Treatment As Usual ◽  
Health Care Settings ◽  
Randomized Controlled ◽  
To Receive ◽  
Specialized Mental Health

Background Anxiety disorders and depression (emotional disorders) are highly prevalent mental disorders. Extensive empirical evidence supports the efficacy of cognitive behavioral therapy (CBT) for the treatment of these disorders. However, there are still some barriers related to their dissemination and implementation, which make it difficult for patients to receive these treatments, especially in public health care settings where resources are limited. Recent advances in improving CBT dissemination encompass different perspectives. One is the transdiagnostic approach, which offers treatment protocols that can be used for a range of emotional disorders. Another approach is the use of the internet to reach a larger number of people who could benefit from CBT. Objective This study aimed to analyze the effectiveness and acceptability of a transdiagnostic internet-delivered protocol (EmotionRegulation) with human and automated guidance in patients from public specialized mental health care settings. Methods A 2-armed randomized controlled trial (RCT) was conducted to compare the effectiveness of EmotionRegulation with treatment as usual (TAU) in specialized mental health care. In all, 214 participants were randomly assigned to receive either EmotionRegulation (n=106) or TAU (n=108). Measurement assessments were conducted at pre- and postintervention and at a 3-month follow-up. Results The results revealed the superiority of EmotionRegulation over TAU on measures of depression (d=0.41), anxiety (d=0.35), and health-related quality of life (d=−0.45) at posttreatment, and these gains were maintained at the 3-month follow-up. Furthermore, the results for expectations and opinions showed that EmotionRegulation was well accepted by participants. Conclusions EmotionRegulation was more effective than TAU for the treatment of emotional disorders in the Spanish public mental health system. The implications of this RCT, limitations, and suggestions for future research are discussed. Trial Registration ClinicalTrials.gov NCT02345668; https://clinicaltrials.gov/ct2/show/NCT02345668

scholarly journals Effectiveness of a Transdiagnostic Guided Internet-Delivered Protocol for Emotional Disorders Versus Treatment as Usual in Specialized Care: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Alberto González-Robles ◽  
Amanda Díaz-García ◽  
Azucena García-Palacios ◽  
Pablo Roca ◽  
Josep Antoni Ramos-Quiroga ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Emotional Disorders ◽  
Controlled Trial ◽  
Treatment As Usual ◽  
Health Care Settings ◽  
Randomized Controlled ◽  
To Receive ◽  
Specialized Mental Health

BACKGROUND Anxiety disorders and depression (emotional disorders) are highly prevalent mental disorders. Extensive empirical evidence supports the efficacy of cognitive behavioral therapy (CBT) for the treatment of these disorders. However, there are still some barriers related to their dissemination and implementation, which make it difficult for patients to receive these treatments, especially in public health care settings where resources are limited. Recent advances in improving CBT dissemination encompass different perspectives. One is the transdiagnostic approach, which offers treatment protocols that can be used for a range of emotional disorders. Another approach is the use of the internet to reach a larger number of people who could benefit from CBT. OBJECTIVE This study aimed to analyze the effectiveness and acceptability of a transdiagnostic internet-delivered protocol (EmotionRegulation) with human and automated guidance in patients from public specialized mental health care settings. METHODS A 2-armed randomized controlled trial (RCT) was conducted to compare the effectiveness of EmotionRegulation with treatment as usual (TAU) in specialized mental health care. In all, 214 participants were randomly assigned to receive either EmotionRegulation (n=106) or TAU (n=108). Measurement assessments were conducted at pre- and postintervention and at a 3-month follow-up. RESULTS The results revealed the superiority of EmotionRegulation over TAU on measures of depression (<i>d</i>=0.41), anxiety (<i>d</i>=0.35), and health-related quality of life (<i>d</i>=−0.45) at posttreatment, and these gains were maintained at the 3-month follow-up. Furthermore, the results for expectations and opinions showed that EmotionRegulation was well accepted by participants. CONCLUSIONS EmotionRegulation was more effective than TAU for the treatment of emotional disorders in the Spanish public mental health system. The implications of this RCT, limitations, and suggestions for future research are discussed. CLINICALTRIAL ClinicalTrials.gov NCT02345668; https://clinicaltrials.gov/ct2/show/NCT02345668

Effectiveness of Prompt Mental Health Care: Preliminary results from a randomized controlled trial

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Knapstad ◽  
L V Lervik ◽  
S M M Saether ◽  
L E Aaroe ◽  
O R F Smith
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Mental Health Care ◽  
Controlled Trial ◽  
Sensitivity Analyses ◽  
Depression And Anxiety ◽  
Symptoms Of Depression ◽  
Randomized Controlled

Abstract Background Prompt Mental Health Care (PMHC) service is a Norwegian initiative, adapted from the English ‘Improved Access to Psychological Therapy’ (IAPT), aimed at improving access to primary care treatment for anxiety and depression. Thus far, both PMHC and IAPT have been evaluated by cohort studies only. Albeit yielding promising results, the extent to which these are attributable to the treatment thus remains unsettled. This study investigates the effectiveness of PMHC compared to treatment as usual (TAU) at six months follow-up. Methods Randomized controlled trial with parallel assignment in two PMHC sites from November 2015 to March 2018. Participants were 681 adults (aged ≥18 years) considered for admission to PMHC due to anxiety and/or mild to moderate depression. These were randomly assigned on a 70:30 ratio. Main outcomes were recovery rates and changes in symptoms of depression and anxiety between baseline and follow-up. Primary outcome data were available for 73%/67% in the PMHC/TAU group. Sensitivity analyses based on observed patterns of missingness were conducted. Results A reliable recovery rate of 58.5% was observed in the PMHC group and 31.9% in the TAU group, yielding a between-group effect size (ES) of 0.61 [95% CI 0.37-0.85, p&lt;.001]. The differences in degree of improvement between PMHC and TAU yielded an ES of -0.88 [95% CI -1.23-0.43, p &lt; 0.001] for symptoms of depression and -0.60 [95% CI -0.90-0.30, p &lt; 0.001] for symptoms of anxiety in favour of PMHC. All sensitivity analyses pointed in the same direction with small variations in point estimates. Findings were slightly more robust for depressive than anxiety symptoms. Conclusions The PMHC treatment was substantially more effective than TAU in alleviating symptoms of anxiety and depression. This adaptation of IAPT is considered a viable supplement to existing health services to increase access of effective treatment for adults who suffer from anxiety and mild to moderate depression. Key messages This study is the first to evaluate the effectiveness of an IAPT-like treatment model in terms of a randomized controlled trial. Prompt Mental Health Care was substantially more effective than TAU in alleviating symptoms of depression and anxiety at 6-months follow-up.

scholarly journals Feasibility and Acceptability of a Digital Intervention to Support Shared Decision-making in Children’s and Young People’s Mental Health: Mixed Methods Pilot Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Shaun Liverpool ◽  
Julian Edbrooke-Childs
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Decision Making ◽  
Randomized Controlled Trial ◽  
Shared Decision Making ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Shared Decision ◽  
Randomized Controlled

BACKGROUND Interventions to involve parents in decisions regarding children’s and young people’s mental health are associated with positive outcomes. However, appropriately planning effectiveness studies is critical to ensure that meaningful evidence is collected. It is important to conduct pilot studies to evaluate the feasibility and acceptability of the intervention itself and the feasibility of the protocol to test effectiveness. OBJECTIVE This paper reports the findings from a feasibility and acceptability study of Power Up for Parents, an intervention to promote shared decision-making (SDM) and support parents and caregivers making decisions regarding children’s and young people’s mental health. METHODS A mixed method study design was adopted. In stage 1, health care professionals and parents provided feedback on acceptability, usefulness, and suggestions for further development. Stage 2 was a multicenter, 3-arm, individual, and cluster randomized controlled pilot feasibility trial with parents accessing services related to children’s and young people’s mental health. Outcome measures collected data on demographics, participation rates, SDM, satisfaction, and parents’ anxiety. Qualitative data were analyzed using thematic analysis. Google Analytics estimates were used to report engagement with the prototype. Outcomes from both stages were tested against a published set of criteria for proceeding to a randomized controlled trial. RESULTS Despite evidence suggesting the acceptability of Power Up for Parents, the findings suggest that recruitment modifications are needed to enhance the feasibility of collecting follow-up data before scaling up to a fully powered randomized controlled trial. On the basis of the Go or No-Go criteria, only 50% (6/12) of the sites successfully recruited participants, and only 38% (16/42) of parents completed follow-up measures. Nonetheless, health care practitioners and parents generally accessed and used the intervention. Themes describing <i>appearance and functionality, perceived need and general helpfulness, accessibility and appropriateness,</i> and <i>a wish list for improvement</i> emerged, providing valuable information to inform future development and refinement of the intervention. CONCLUSIONS Owing to the high attrition observed in the trial, proceeding directly to a full randomized controlled trial may not be feasible with this recruitment strategy. Nonetheless, with some minor adjustments and upgrades to the intervention, this pilot study provides a platform for future evaluations of Power Up for Parents. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 39238984; http://www.isrctn.com/ISRCTN39238984. INTERNATIONAL REGISTERED REPORT RR2-10.2196/14571

scholarly journals A Web-Based Mental Health Platform for Individuals Seeking Specialized Mental Health Care Services: Multicenter Pragmatic Randomized Controlled Trial

10.2196/10838 ◽  
2019 ◽  
Vol 21 (6) ◽  
pp. e10838 ◽  
Author(s):  
Jennifer M Hensel ◽  
James Shaw ◽  
Noah M Ivers ◽  
Laura Desveaux ◽  
Simone N Vigod ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Web Based ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Health Application ◽  
Specialized Mental Health

Background Web-based self-directed mental health applications are rapidly emerging to address health service gaps and unmet needs for information and support. Objective The aim of this study was to determine if a multicomponent, moderated Web-based mental health application could benefit individuals with mental health symptoms severe enough to warrant specialized mental health care. Methods A multicenter, pragmatic randomized controlled trial was conducted across several outpatient mental health programs affiliated with 3 hospital programs in Ontario, Canada. Individuals referred to or receiving treatment, aged 16 years or older, with access to the internet and an email address, and having the ability to navigate a Web-based mental health application were eligible. A total of 812 participants were randomized 2:1 to receive immediate (immediate treatment group, ITG) or delayed (delayed treatment group, DTG) access for 3 months to the Big White Wall (BWW), a multicomponent Web-based mental health intervention based in the United Kingdom and New Zealand. The primary outcome was the total score on the Recovery Assessment Scale, revised (RAS-r) which measures mental health recovery. Secondary outcomes were total scores on the Patient Health Questionnaire-9 item (PHQ-9), the Generalized Anxiety Disorder Questionnaire-7 item (GAD-7), the EuroQOL 5-dimension quality of life questionnaire (EQ-5D-5L), and the Community Integration Questionnaire. An exploratory analysis examined the association between actual BWW use (categorized into quartiles) and outcomes among study completers. Results Intervention participants achieved small, statistically significant increases in adjusted RAS-r score (4.97 points, 95% CI 2.90 to 7.05), and decreases in PHQ-9 score (−1.83 points, 95% CI −2.85 to −0.82) and GAD-7 score (−1.55 points, 95% CI −2.42 to −0.70). Follow-up was achieved for 55% (446/812) at 3 months, 48% (260/542) of ITG participants and 69% (186/270) of DTG participants. Only 58% (312/542) of ITG participants logged on more than once. Some higher BWW user groups had significantly greater improvements in PHQ-9 and GAD-7 relative to the lowest use group. Conclusions The Web-based application may be beneficial; however, many participants did not engage in an ongoing way. This has implications for patient selection and engagement as well as delivery and funding structures for similar Web-based interventions. Trial Registration ClinicalTrials.gov NCT02896894; https://clinicaltrials.gov/ct2/show/NCT02896894 (Archived by WebCite at http://www.webcitation.org/78LIpnuRO)

scholarly journals A web-based mental health platform in individuals seeking specialized mental health care services: multi-centre pragmatic randomized controlled trial (Preprint)

2018 ◽  
Author(s):  
Jennifer Hensel ◽  
James Shaw ◽  
Noah Ivers ◽  
Laura Desveaux ◽  
Simone Vigod ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Mental Health Care ◽  
Controlled Trial ◽  
Web Based ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Health Application ◽  
Specialized Mental Health

BACKGROUND Web-based self-directed mental health applications are rapidly emerging as a solution to health service gaps and unmet needs for information and support. OBJECTIVE The aim of this study was to determine if a multi-component web-based moderated mental health application could benefit individuals with mental health symptoms severe enough to warrant specialized mental health care. METHODS A multi-centre, pragmatic randomized controlled trial was conducted across several outpatient mental health programs affiliated with 3 hospital programs in Ontario, Canada. Individuals referred to or receiving treatment, 16 years of age or older, with access to the internet and an email address, and having the ability to navigate a web-based mental health application were eligible. 812 participants were randomized 2:1 to receive immediate (ITG) or delayed (DTG) access for 3 months to the Big White WallTM, a web-based multi-component mental health intervention based in the United Kingdom and New Zealand. The primary outcome was total score on the Recovery Assessment Scale, revised (RAS-r) measuring mental health recovery. Secondary outcomes were total scores on the Patient Health Questionnaire-9 item (PHQ-9), the Generalized Anxiety Disorder Questionnaire-7 item (GAD-7), the EQ-5D-5L, and the Community Integration Questionnaire (CIQ). An exploratory analysis examined the association between actual BWW use (categorized into quartiles) and outcomes among study completers. RESULTS Intervention participants achieved small, statistically significant increases in adjusted RAS-r score (4.97 points, 95% CI 2.90 to 7.05), and decreases in PHQ-9 score (-1.83 points, 95% CI -2.85 to -0.82) and GAD-7 score (-1.55 points, 95% CI -2.42 to -0.70). Follow-up was achieved for 446 (55%) at 3 months; 48% of ITG participants, and 69% of DTG participants. Only 58% of ITG participants logged on more than once. Some higher BWW user groups had significantly greater improvements in PHQ-9 and GAD-7 relative to the lowest use group. CONCLUSIONS The web-based application may be beneficial, however, many participants did not engage in an ongoing way. This has implications for patient selection and engagement as well as delivery and funding structures for similar web-based interventions. CLINICALTRIAL Clinicaltrials.gov NCT02896894. Registered on 31 August 2016 (retrospectively registered). https://clinicaltrials.gov/ct2/show/NCT02896894

scholarly journals The efficacy of Narrative Exposure Therapy for Children (KIDNET) as a Treatment for Traumatized Young Refugees versus Treatment as Usual: Study Protocol for a Multi-Center Randomized Controlled Trial (YOURTREAT)

2020 ◽  
Author(s):  
Sarah Wilker ◽  
Claudia Catani ◽  
Jasmin Wittmann ◽  
Melissa Preusse ◽  
Telja Schmidt ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Effective Treatment ◽  
Controlled Trial ◽  
Treatment Options ◽  
Trial Registration ◽  
Treatment As Usual ◽  
Narrative Exposure Therapy ◽  
Randomized Controlled

Abstract Background: Germany hosts a large number of refugees from war-affected countries. The integration of refugees, in particular young refugees from the Middle East, is one of the major current social challenges in Germany. Mental disorders, first of all post-traumatic stress disorder (PTSD) that results from war experiences, are common among young refugees and interfere with quality of life as well as functional integration. Evidence regarding effective treatment options for this population is scarce. In this trial, we aim to evaluate the pragmatic, short-term psychotherapy Narrative Exposure Therapy for Children (KIDNET) for the treatment of young refugees in Germany. Methods: In a rater-blinded multi-center randomized-controlled trial, KIDNET is compared to treatment as usual (TAU) within the general health care system. A total number of 80 young refugees who fulfill the diagnostic criteria of PTSD will be randomized to either KIDNET or TAU. Diagnostic interviews will take place at baseline before treatment as well as six and 12 months thereafter. They will assess exposure to traumatic events, PTSD and comorbid symptoms, as well as parameters of integration. Discussion: The results of this study will provide evidence regarding effective treatment options for young refugees in Germany, a population that has been understudied and received only limited access to mental health care so far. Next to the effects of treatment on mental health outcomes, integration parameters will be investigated. Therefore, this study will provide broad insights into treatment options for young refugees and their potential implications on successful integration. Trial registration: German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS), registered on May 15 th , 2019. The trial registration number is DRKS00017222 (www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017222)

scholarly journals The efficacy of Narrative Exposure Therapy for Children (KIDNET) as a Treatment for Traumatized Young Refugees versus Treatment as Usual: Study Protocol for a Multi-Center Randomized Controlled Trial (YOURTREAT)

2019 ◽  
Author(s):  
Sarah Wilker ◽  
Claudia Catani ◽  
Jasmin Wittmann ◽  
Melissa Preusse ◽  
Telja Schmidt ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Effective Treatment ◽  
Controlled Trial ◽  
Treatment Options ◽  
Trial Registration ◽  
Treatment As Usual ◽  
Narrative Exposure Therapy ◽  
Randomized Controlled

Abstract Background: Germany hosts a large number of refugees from war-affected countries. The integration of refugees, in particular young refugees from the Middle East, is one of the major current social challenges in Germany. Mental disorders, first of all post-traumatic stress disorder (PTSD) that results from war experiences, are common among young refugees and interfere with quality of life as well as functional integration. Evidence regarding effective treatment options for this population is scarce. In this trial, we aim to evaluate the pragmatic, short-term psychotherapy Narrative Exposure Therapy for Children (KIDNET) for the treatment of young refugees in Germany. Methods: In a rater-blinded multi-center randomized-controlled trial, KIDNET is compared to treatment as usual (TAU) within the general health care system. A total number of 80 young refugees who fulfill the diagnostic criteria of PTSD will be randomized to either KIDNET or TAU. Diagnostic interviews will take place at baseline before treatment as well as six and 12 months thereafter. They will assess exposure to traumatic events, PTSD and comorbid symptoms, as well as parameters of integration. Discussion: The results of this study will provide evidence regarding effective treatment options for young refugees in Germany, a population that has been understudied and received only limited access to mental health care so far. Next to the effects of treatment on mental health outcomes, integration parameters will be investigated. Therefore, this study will provide broad insights into treatment options for young refugees and their potential implications on successful integration. Trial registration: German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS), registered on May 15 th , 2019. The trial registration number is DRKS00017222 (www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017222)

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