Online transdiagnostic intervention for emotional, trauma- and stressor-related disorders in the Mexican population: A randomized pilot and feasibility trial.
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SUBMITTER: de la Rosa-Gomez A
PROVIDER: S-EPMC10482736 | biostudies-literature | 2023 Oct
REPOSITORIES: biostudies-literature
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Online transdiagnostic intervention for emotional, trauma- and stressor-related disorders in the Mexican population: A randomized pilot and feasibility trial.
de la Rosa-Gómez Anabel A Hernández Posadas Alejandrina A Valencia Pablo D PD Flores-Plata Lorena Alejandra LA Serrano Zárate Berenice B Flores Elvira Alicia Ivet AI Dominguez-Rodriguez Alejandro A Vázquez Sánchez Mario Fabián MF González Santiago Edith E
Contemporary clinical trials communications 20230825
•Mexican individuals received via telehealth the unified protocol for anxiety, depression, and trauma related disorders.•Online unified protocol reduced depression, anxiety, emotional issues, uncertainty intolerance, and psychological distress.•The transdiagnostic unified protocol is well-suited to train therapists for emotional, trauma, and stressor-related disorders. ...[more]
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Project description:BackgroundEmotional and stress-related disorders show high incidence, prevalence, morbidity, and comorbidity rates in Mexico. In recent decades, research findings indicate that cognitive behavioral interventions, from a disorder-specific perspective, are the effective front-line treatment for anxiety and depression care. However, these treatments are not often used. Reasons include limited access and low availability to effective interventions and comorbidity between mental disorders. Emotional deregulation of negative affectivity has been found to be a mediating factor in addressing emotional disorders from a transdiagnostic perspective, aimed at two or more specific disorders. In addition, technological advancement has created alternatives for psychological assistance, highlighting the possibilities offered by technologies since Internet-supported intervention programs have been empirically tested for effectiveness, efficiency and efficacy and can be key to ensuring access to those who are inaccessible. The aim of the study is to evaluate the efficacy, moderators of clinical change and acceptability of a transdiagnostic guided Internet-delivered intervention versus a transdiagnostic self-guided Internet-delivered intervention for emotional, trauma and stress-related disorders, and waiting list in community sample.MethodsA three-armed, parallel group, superiority randomized controlled clinical trial with repeated measurements at four times: pretest, posttest, follow-up at 3, 6 and 12 months. Outcomes assessor, participant, care provider and investigator will be blinded. Participants aged 18 to 70 years will be randomly allocated 1:1:1 to one of three study arms: a) Transdiagnostic guided internet-delivered intervention with synchronous assistance, b) Transdiagnostic self-guided internet-delivered intervention, c) Waiting list group. Based on sample size estimation, a minimum of 207 participants (69 in each intervention group) will be included.DiscussionThe study could contribute to improving the efficacy of transdiagnostic internet-delivered interventions to promote the dissemination of evidence-based treatments and eventually, to decrease the high prevalence of emotional and trauma-related disorders in the Mexican population.Trial registrationClinicalTrial.gov: NCT05225701 . Registered February 4, 2022.
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Project description:IntroductionEmotional disorders (anxiety and depressive disorders) are a relevant public health concern associated with high prevalence, high costs, and important disability. Therefore, research priorities include designing and testing cost-effective interventions to reach everyone in need. Internet-delivered interventions for emotional disorders are effective and can help to disseminate and implement evidence-based treatments. However, although these treatments are generally effective, not all patients benefit from this treatment format equally. Blended treatments are a new form of intervention that combines the strengths of face-to-face and Internet approaches. Nevertheless, research on blended interventions has focused primarily on individual therapy, and less attention has been paid to the potential of using this format in group psychotherapy. This study aims to analyze the feasibility of blended transdiagnostic group CBT for emotional disorders. The current article describes the study protocol for this trial.Method and analysisA one-armed pilot trial will be conducted. Participants will be 30 adults suffering from DSM-5 anxiety and/or depressive disorders. The treatment consists of a blended transdiagnostic group intervention delivered during a period of 24 weeks. Groups of 6 to 10 patients will attend a total of eight 2-hour, face-to-face sessions, alternated with the use of an online platform where they will find the contents of the treatment protocol. The intervention has four core components: present-focused awareness, cognitive flexibility, identification and modification of behavioral and cognitive patterns of emotional avoidance, and interoceptive and situational exposure. These components are delivered in 16 modules. Assessments will be performed at baseline, during the treatment, at post-treatment, and at 3-month follow-up. Clinical and treatment acceptability outcomes will be included. Quantitative and qualitative data (participants' views about blended group psychotherapy) will be analyzed.Ethics and disseminationThe trial has received ethical approval from the Ethics Committee of Universitat Jaume I (September 2019) and will be conducted in accordance with the study protocol, the Declaration of Helsinki, and good clinical practice. The results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal.Trial registrationClinicalTrials.gov Identifier: NCT04008576. Registered 05 July 2019, https://clinicaltrials.gov/ct2/show/NCT04008576.
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Project description:At present, there is no established cognitive behavioral therapy (CBT) for treating emotional disorders in Japanese children. Therefore, we introduced the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in Japan and adapted it to the Japanese context. We then examined its feasibility and preliminary efficacy using a single-arm pretest, posttest, follow-up design. Seventeen Japanese children aged between 8 and 12 years (female n = 11; male n = 6; M = 10.06 ± 0.97 years) with a principal diagnosis of anxiety, obsessive-compulsive, or depressive disorders, and their parents were enrolled in the study. The primary outcome was the overall severity of emotional disorders as assessed by psychiatrists using the Clinical Global Impression-Severity Scale. Secondary outcomes included child- and parent-reported anxiety symptoms, depressive symptoms, and functional status. No severe adverse events were observed. The feasibility was confirmed by the low dropout proportion (11.76%), high attendance proportion (children: 95.6%; parents: 94.6%), and sufficient participant satisfaction. Linear mixed models (LMMs) showed that the overall severity of emotional disorders and child- and parent-reported anxiety symptoms improved from pre-treatment to post-treatment, and that these treatment effects were maintained during the 3-month follow-up period. Additionally, child- and parent-reported functional status improved from pre-treatment to the 3-month follow-up. In contrast, child-reported depressive symptoms improved from pre-treatment to follow-up, but there was no significant change in parent-reported depressive symptoms between pre-treatment and other time points. These findings demonstrate the feasibility and preliminary efficacy of the Japanese version of the UP-C, suggesting that future randomized controlled trials (RCTs) are warranted (Clinical trial registration: UMIN000026911).
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Project description:Significant evidence does exist on the effectiveness of transdiagnostic interventions to improve emotional problems in clinical populations, and their application as universal and indicated prevention programs. However, no randomized controlled trials (RCT) studying selective transdiagnostic prevention intervention have been published. This is the first known RCT to evaluate the efficacy/effectiveness of an evidence-based selective prevention transdiagnostic program for emotional problems in adolescents. The impact of three different interventions was evaluated: (1) PROCARE (Preventive transdiagnostic intervention for Adolescents at Risk for Emotional disorders), which is a group-based, online-delivered, abbreviated version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A), along with adding a booster session, to reduce risk of onset of anxiety and depression, (2) PROCARE + , which includes the PROCARE protocol along with personalized add-on modules tailored to match adolescents' risk factors, and (3) an active control condition (ACC) based on emotional psychoeducation. In total, 286 adolescents (53.3% girls) evidencing high risk and low protective factors were randomized and allocated to PROCARE, PROCARE + or ACC. Self- and parent-reported measures were taken at baseline, as well as after the intervention, a 6-month follow-up was carried out, together with a 1-month follow-up after the booster session. Differences between conditions were significant on most of the outcome measures, with superior effect sizes for PROCARE +. Interventions were excellent in terms of acceptability, with good satisfaction rates. Tailored selective transdiagnostic interventions focused on mitigating risk factors and promoting protective factors in vulnerable adolescents are promising.
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Project description:Significant evidence does exist on the effectiveness of transdiagnostic interventions to improve emotional problems in clinical populations, and their application as universal and indicated prevention programs. However, no randomized controlled trials (RCT) studying selective transdiagnostic prevention intervention have been published. This is the first known RCT to evaluate the efficacy/effectiveness of an evidence-based selective prevention transdiagnostic program for emotional problems in adolescents. The impact of three different interventions was evaluated: (1) PROCARE (Preventive transdiagnostic intervention for Adolescents at Risk for Emotional disorders), which is a group-based, abbreviated version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A), along with adding a booster session to reduce risk of onset of anxiety and depression, (2) PROCARE + , which includes the PROCARE protocol along with personalized add-on modules tailored to match adolescents' risk factors, and (3) an active control condition (ACC) based on emotional psychoeducation. In total, 208 adolescents (48.5% girls) evidencing high risk and low protective factors were randomized and allocated to PROCARE, PROCARE + or ACC. Data from 153 adolescents who completed all assessments in the different phases of the study were analyzed. Self- and parent-reported measures were taken at baseline, as well as after the intervention, a 6 month follow-up was carried out, together with a 1 month follow-up after the booster session. Differences between conditions were significant on most of the outcome measures, with superior effect sizes for PROCARE + in the short and long term. Interventions were acceptable in terms of acceptability, with good satisfaction rates. Tailored targeted selective transdiagnostic interventions focused on mitigating risk factors and promoting protective factors in vulnerable adolescents are promising.
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Project description:IntroductionMisophonia is a recently defined disorder characterized by distressing responses to everyday sounds, such as chewing or sniffling. Individuals with misophonia experience significant functional impairment but have limited options for evidenced-based behavioral treatment. To address this gap in the literature, the current pilot trial explored the acceptability and efficacy of a transdiagnostic cognitive-behavioral approach to treating symptoms of misophonia.MethodsThis trial was conducted in two studies: In Study 1, the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) was delivered to eight patients in order to receive feedback to guide revisions to the treatment to suit this population. In Study 2, ten patients received the revised UP treatment to explore its acceptability and preliminary efficacy. This study used a single-case experimental design with multiple baselines, randomizing patients to either a 2-week baseline or 4-week baseline prior to the 16 weeks of treatment, followed by four weeks of follow-up.ResultsThe findings from these studies suggested that patients found both the original and adapted versions of the UP to be acceptable and taught them skills for how to manage their misophonia symptoms. Importantly, the findings also suggested that the UP can help remediate symptoms of misophonia, particularly the emotional and behavioral responses.DiscussionThese findings provide preliminary evidence that this transdiagnostic treatment for emotional disorders can improve symptoms of misophonia in adults.
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Project description:Considering PTSD Treatment is an online program adapted from the National Center for PTSD's AboutFace website. Developed to help veterans overcome barriers to seeking treatment for posttraumatic stress disorder (PTSD), the program features videos of veterans describing PTSD and what treatment was like. Peer specialists are available at the beginning and end to chat with participants. We describe initial pilot feasibility data in 50 veterans recruited through online ads who screened positive for PTSD and were not currently in treatment. Eighty percent of participants who consented enrolled in the program and 64.0 % completed all modules. On average, participants rated the program at least "moderately" helpful and over 90 % reported feeling more knowledgeable about PTSD and PTSD treatment. Of the 21 participants who completed the one month follow-up, 52.4 % said they had talked to or were assessed by a provider and 61.9 % said they started treatment. There was not a significant change in stigma scores from baseline to follow-up. Results provide initial support for the feasibility, acceptability, and effectiveness of Considering PTSD Treatment for increasing treatment seeking readiness and support the need for a larger randomized controlled trial.
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Project description:BackgroundOnline self-help interventions have proven to be effective in treating various specific mental disorders, mainly depression and anxiety. Knowledge regarding their acceptance, efficacy, and usefulness in addition to inpatient or outpatient psychotherapy is limited. Therefore, we plan to evaluate an affect-focused, transdiagnostic, psychodynamic online self-help intervention following inpatient psychotherapy for mixed diagnoses in a feasibility study to determine acceptance, satisfaction, and preliminary estimates of efficacy.MethodsThe intervention is based on the book "Living Like You Mean It" by Ronald J. Frederick (2009) and the Swedish adaption by Johansson and colleagues (2013). The book was translated into German and thoroughly revised using parts of the Swedish adaption and additional tasks from their intervention. In a pilot phase, corrections concerning comprehensibility of the content and exercises were made based on patient's feedback. In the second step, we developed a website presenting the German adaption in eight units. In the third step, at least N = 66 patients from the Department of Psychosomatic Medicine and Psychotherapy will be recruited for a feasibility study. Patients are randomized into two groups. The intervention group (IG) will receive ten weeks of access to the online self-help intervention together with weekly therapeutic feedback on their progress. The wait-list control group (WLC) will receive access to the intervention for ten weeks as well, but without therapeutic feedback and with a ten-week delay. We will conduct assessments at the beginning of the intervention of the IG (T0), the end of the intervention of the IG (T1), two months later (only IG, T2), and at the end of the intervention of the WLC (T3). The primary outcome is satisfaction with the treatment as measured by the ZUF-8 at T1 and T3 respectively. Secondary outcome measures include emotional competence, depression, anxiety, and quality of life.ConclusionWe expect insight into the usefulness and acceptance of an online self-help intervention used to maintain inpatient treatment effects. Furthermore, we await both groups to benefit from the participation in the intervention. Pre- post and between subject differences will be used as estimate effect sizes to calculate the necessary sample size for a larger efficacy trial.
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