Protocol for a sequential, multiple assignment, randomised trial to test the effectiveness of message-based psychotherapy for depression compared with telepsychotherapy
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ABSTRACT: Introduction
Digital mental health tools have become popular alternatives to traditional psychotherapy. One emerging form of digital mental health is message-based care, the use of text messages or asynchronous voice or video messaging to provide psychotherapy. There has been no research into whether this is an effective method of psychotherapy as a stand-alone treatment or in combination with traditional psychotherapy. Methods and analysis
This is a sequential, multiple assignment randomised trial to compare message-based care, videoconference-psychotherapy and a combination of the two treatments in 1000 depressed adults. Participants will be recruited through Talkspace, a digital mental health company, and randomised to receive 6 weeks of either message-based care only or videoconference-psychotherapy only. At 6 weeks, participants will be evaluated for their response to treatment. Those with a 50% or more response to treatment will continue with their assigned condition. Those who do not respond will be randomised to either monthly videoconference-psychotherapy or weekly videoconference-psychotherapy plus message-based care. Primary outcomes will be depression and social functioning. We will also explore moderators of treatment outcome. Ethics and dissemination
The study received ethics approval from the University of Washington Institutional Review Board. Results of this study will be presented in peer-reviewed journals and at professional conferences. Trial registration number
NCT04513080; Pre-results.
SUBMITTER: Arean P
PROVIDER: S-EPMC8565526 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:Although psychotherapy is one of the most efficacious and effective treatments for depression, limited accessibility to trained providers markedly limits access to care. In an attempt to overcome this obstacle, several platforms seeking to provide these services using digital modalities (eg, video, text, and chat) have been developed. However, the use of these modalities individually poses barriers to intervention access and acceptability. Multimodal platforms, comprising those that allow users to select from a number of available modalities, may be able to provide a solution to these concerns. OBJECTIVE:We aimed to investigate the preliminary effectiveness of providing psychotherapy through a multimodal digital psychotherapy platform. In addition, we aimed to examine differential responses to intervention by gender, self-reported physical health status, and self-reported financial status, as well as how prior exposure to traditional face-to-face psychotherapy affected the effectiveness of a multimodal digital psychotherapy intervention. Finally, we aimed to examine the dose-response effect. METHODS:Data were collected from a total of 318 active users of BetterHelp, a multimodal digital psychotherapy platform. Data on physical health status, financial status, and prior exposure to psychotherapy were obtained using self-report measures. Effectiveness was determined by the extent of symptom severity change, which was measured using the Patient Health Questionnaire at Time 1 (time of enrollment) and Time 2 (3 months after enrollment). Intervention dosage was measured as the sum of individual therapist-user interactions across modalities. RESULTS:Depression symptom severity was significantly reduced after the use of the multimodal digital psychotherapy intervention (P<.001). Individuals without prior traditional psychotherapy experience revealed increased improvement after intervention (P=.006). We found no significant dose-response effect of therapy, nor significant differences in outcomes across gender, self-reported financial status, and self-reported physical health status. CONCLUSIONS:Users of BetterHelp experienced significantly reduced depression symptom severity after engaging with the platform. Study findings suggest that this intervention is equally effective across gender, self-reported financial status, and self-reported physical health status and particularly effective for individuals without a history of psychotherapy. Overall, study results suggest that multimodal digital psychotherapy is a potentially effective treatment for adult depression; nevertheless, experimental trials are needed. We discuss directions for future research.
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Project description:The purpose of this study is to assess the relative effectiveness of Interpersonal Psychotherapy (IPT), Psychoeducative Group Therapy (PeGT), and treatment as usual (TAU) for patients with Major Depressive Disorder (MDD) in municipal psychiatric secondary care in one Finnish region.All adult patients (N?=?1515) with MDD symptoms referred to secondary care in 2004-2006 were screened. Eligible, consenting patients were assigned randomly to 10-week IPT (N?=?46), PeGT (N?=?42), or TAU (N?=?46) treatment arms. Antidepressant pharmacotherapy among study participants was evaluated. The Hamilton Depression Rating scale (HAM-D) was the primary outcome measure. Assessment occurred at 1, 5, 3, 6, and 12 months. Actual amount of therapists' labor was also evaluated. All statistical analyses were performed with R software.All three treatment cells showed marked improvement at 12-month follow-up. At 3 months, 42 % in IPT, 61 % in PeGT, and 42 % in TAU showed a mean ?50 % in HAM-D improvement; after 12 months, these values were 61 %, 76 %, and 68 %. Concomitant medication and limited sample size minimized between-treatment differences. Statistically significant differences emerged only between PeGT and TAU favoring PeGT. Secondary outcome measures (CGI-s and SOFAS) showed parallel results.All three treatments notably benefited highly comorbid MDD patients in a public sector secondary care unit.ClinicalTrials.gov NCT02314767 (09.12.2014).
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Project description:IntroductionThe postdischarge suicide risk among psychiatric patients is significantly higher than it is among patients with other diseases and general population. The brief contact interventions (BCIs) are recommended to decrease suicide risk in areas with limited mental health service resources like China. This study aims to develop a postdischarge suicide intervention strategy based on BCIs and evaluate its implementability under the implementation outcome framework.Methods and analysisThis study will invite psychiatric patients and family members, clinical and community mental health service providers as the community team to develop a postdischarge suicide intervention strategy. The study will recruit 312 patients with psychotic symptoms and 312 patients with major depressive disorder discharged from Shenzhen Kangning Hospital (SKH) in a Sequential Multiple Assignment Randomised Trial. Participants will be initially randomised into two intervention groups to receive BCIs monthly and weekly, and they will be rerandomised into three intervention groups to receive BCIs monthly, biweekly and weekly at 3 months after discharge according to the change of their suicide risk. Follow-ups are scheduled at 1, 3, 6 and 12 months after discharge. With the intention-to-treat approach, generalised estimating equation and survival analysis will be applied. This study will also collect qualitative and quantitative information on implementation and service outcomes from the community team.Ethics/disseminationThis study has received ethical approval from the Ethics Committee Review Board of SKH. All participants will provide written informed consent prior to enrolment. The findings of the study will be disseminated through peer-reviewed scientific journals, conference presentations. A project report will be submitted to the National Natural Science Foundation of China as the concluding report of this funded project, and to the mental health authorities in the Shenzhen to refine and apply evidence-based and pragmatic interventions into health systems for postdischarge suicide prevention.Trial registration numberNCT04907669.
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Project description:BACKGROUND:Due to limited resources, waiting periods for psychotherapy are often long and burdening for those in need of treatment and the health care system. In order to bridge the gap between initial contact and the beginning of psychotherapy, web-based interventions can be applied. The implementation of a web-based depression intervention during waiting periods has the potential to reduce depressive symptoms and enhance well-being in depressive individuals waiting for psychotherapy. METHODS:In a two-arm randomized controlled trial, effectiveness and acceptance of a guided web-based intervention for depressive individuals on a waitlist for psychotherapy are evaluated. Participants are recruited in several German outpatient clinics. All those contacting the outpatient clinics with the wish to enter psychotherapy receive study information and a depression screening. Those adults (age???18) with depressive symptoms above cut-off (CES-D scale >?22) and internet access are randomized to either intervention condition (treatment as usual and immediate access to the web-based intervention) or waiting control condition (treatment as usual and delayed access to the web-based intervention). At three points of assessment (baseline, post-treatment, 3-months-follow-up) depressive symptoms and secondary outcomes, such as quality of life, attitudes towards psychotherapy and web-based interventions and adverse events are assessed. Additionally, participants' acceptance of the web-based intervention is evaluated, using measures of intervention adherence and satisfaction. DISCUSSION:This study investigates a relevant setting for the implementation of web-based interventions, potentially improving the provision of psychological health care. The results of this study contribute to the evaluation of innovative and resource-preserving health care models for outpatient psychological treatment. TRIAL REGISTRATION:This trial has been registered on 13 February 2017 in the German clinical trials register (DRKS); registration number DRKS00010282 .
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Project description:PurposeThis article describes the protocol for a Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depressive disorder (MDD). The goal is to promote uptake of evidence-based treatments in criminal justice settings by conducting a randomized effectiveness study that collects implementation data, including a full cost-effectiveness analysis.BackgroundMore than 2.3 million people are incarcerated in the United States on any given day. MDD is the most common severe mental illness among incarcerated individuals. Despite the prevalence and consequences of MDD among incarcerated populations, this study will be the first fully-powered randomized trial of any treatment for MDD in an incarcerated population.DesignGiven the politically charged nature of the justice system, advantageous health outcomes are often not enough to get an intervention implemented in prisons. To increase the policy impact of this trial, we sought advice from prison providers and administrators about outcomes that would be persuasive to policy-makers and defensible to the public. In this trial, effectiveness questions will be answered using a randomized clinical trial design comparing IPT plus prison treatment as usual (TAU) to TAU alone, with outcomes including depressive symptoms (primary), suicidality, and in prison functioning (enrollment and completion of correctional programs; disciplinary and incident reports; aggression/victimization; social support). Implementation outcomes will include cost-effectiveness; feasibility and acceptability of IPT to clients, providers, and administrators; prison provider intervention fidelity, attitudes, and competencies; and barriers and facilitators of implementation assessed through surveys, interviews, and process notes.
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Project description:OBJECTIVE:This study tested the effectiveness and cost-effectiveness of interpersonal psychotherapy (IPT) for major depressive disorder (MDD) among prisoners. It is the first fully powered randomized trial of any treatment (pharmacological or psychosocial) targeting MDD among incarcerated individuals. METHOD:One hundred eighty-one male (n = 117) and female (n = 64) prisoners from prison facilities in 2 states were randomized to group IPT (delivered by master's-level and nonspecialist prison counselors) for MDD plus prison treatment as usual (TAU) or to TAU alone. Participants' average age was 39 (range = 20-61); 20% were African American and 19% were Hispanic. Outcomes assessed at posttreatment and 3-month follow-up included depressive symptoms (primary; assessed using the Hamilton Rating Scale for Depression), suicidality (assessed with the Beck Scale for Suicide Ideation and Beck Hopelessness Scale), in-prison functioning (i.e., enrollment in correctional programs; discipline reports; aggression/victimization; and social support), remission from MDD, and posttraumatic stress disorder symptoms. RESULTS:IPT reduced depressive symptoms, hopelessness, and posttraumatic stress disorder symptoms, and increased rates of MDD remission relative to prison TAU alone. Effects on hopelessness were particularly strong. Cost per patient was $2,054 including costs for IPT training and supervision or $575 without these costs. For providers running their second or subsequent IPT group, cost per additional week in remission from MDD (relative to TAU alone) was $524 ($148 excluding training and supervision costs, which would not be needed for established programs). CONCLUSIONS:IPT is effective and cost-effective and we recommend its use for MDD among prisoners. It is currently the only treatment for MDD evaluated among incarcerated individuals. (PsycINFO Database Record (c) 2019 APA, all rights reserved).
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Project description:BACKGROUND:Smoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message could be a cost-effective way to deliver SHS to pregnant women who smoke. SHS delivered by text message helps non-pregnant smokers to stop but the currently available message programmes are not appropriate for use in pregnancy. A randomised controlled trial (RCT) has demonstrated the feasibility and acceptability of using a programme called 'MiQuit' to text SHS support to pregnant women who smoke. Another pilot RCT has shown that it would be feasible to run a larger, multi-centre trial within the UK National Health Service (NHS). The aim of this third RCT is to complete MiQuit's evaluation, demonstrating whether or not this is efficacious for smoking cessation in pregnancy. METHODS/DESIGN:This is a multi-centre, parallel-group RCT. Pregnant women aged over 16?years, of less than 25?weeks' gestation who smoke one or more daily cigarettes but smoked at least five daily cigarettes before pregnancy and who understand written English and are being identified in 24 English antenatal care hospitals. Participants are randomised to control or intervention groups in a 1:1 ratio stratified by gestation (<?16?weeks versus ??16?weeks). All participants receive a leaflet on stopping smoking during pregnancy; they are also able to access standard NHS smoking cessation support. Intervention group women also receive the 12-week MiQuit programme of tailored, interactive text message, and self-help cessation support. Women are followed up by telephone at 4?weeks after randomisation and 36?weeks' gestation. The RCT will recruit 692 women (346 per group), enabling a 95% confidence interval for the difference in quit rates to be estimated within ±?3%. To determine whether or not MiQuit helps pregnant smokers to stop, intervention group quit rates from this trial will be combined with those from the two earlier trials in a Trial Sequential Analysis (TSA) meta-analysis to derive a pooled efficacy estimate. DISCUSSION:If effective, MiQuit will be a cheap, cost-effective method to help pregnant women to stop smoking. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03231553 . Registered on 20 July 2017.
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