Dataset Information

Web-based Self-help Program for Adjustment Problems After an Accident (SelFIT): Protocol for a Randomized Controlled Trial.

ABSTRACT:

Background

Accidents and the resulting injuries are among the world's biggest health care issues, often causing long-term effects on psychological and physical health. With regard to psychological consequences, accidents can cause a wide range of burdens including adjustment problems. Although adjustment problems are among the most frequent mental health problems, there are few specific interventions available. The newly developed program SelFIT (German acronym: Selber wieder fit nach einem Unfall; "fit again after an accident") aims to remedy this situation by offering a low-threshold, web-based self-help intervention for psychological distress after an accident.

Objective

The overall aim is to evaluate the efficacy and cost-effectiveness of the SelFIT program plus care as usual (CAU) compared to only CAU. Furthermore, the program's user-friendliness, acceptance, and adherence are assessed. We expect that the use of SelFIT will be associated with a greater reduction in psychological distress, greater improvement in mental and physical well-being, and greater cost-effectiveness compared to CAU.

Methods

Adults (n=240) experiencing adjustment problems due to an accident they had between 2 weeks and 2 years before entering the study will be randomized into either the intervention or control group. Participants in the intervention group receive direct access to SelFIT. The control group receives access to the program after 12 weeks. There are 6 measurement points for both groups (baseline as well as after 4, 8, 12, 24, and 36 weeks). The main outcome is a reduction in anxiety, depression, and stress symptoms that indicate adjustment problems. Secondary outcomes include well-being, optimism, embitterment, self-esteem, self-efficacy, emotion regulation, pain, costs of health care consumption, and productivity loss, as well as the program's adherence, acceptance, and user-friendliness.

Results

Recruitment began in December 2019 and will continue at least until January 2021, with the option to extend this for another 6 months until July 2021. As of July 2020, 324 people have shown interest in participating, and 48 people have given their informed consent.

Conclusions

To the best of our knowledge, this is the first study examining a web-based self-help program designed to treat adjustment problems resulting from an accident. If effective, the program could complement the still limited offerings for secondary and tertiary prevention of psychological distress after an accident.

Trial registration

ClinicalTrials.gov NCT03785912; https://clinicaltrials.gov/ct2/show/NCT03785912.

International registered report identifier (irrid)

DERR1-10.2196/21200.

SUBMITTER: Hegy JK

PROVIDER: S-EPMC7775196 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Web-based Self-help Program for Adjustment Problems After an Accident (SelFIT): Protocol for a Randomized Controlled Trial.

Hegy Julia Katharina JK Brog Noemi Anja NA Berger Thomas T Znoj Hansjoerg H

JMIR research protocols 20201217 12

<h4>Background</h4>Accidents and the resulting injuries are among the world's biggest health care issues, often causing long-term effects on psychological and physical health. With regard to psychological consequences, accidents can cause a wide range of burdens including adjustment problems. Although adjustment problems are among the most frequent mental health problems, there are few specific interventions available. The newly developed program SelFIT (German acronym: Selber wieder fit nach ei ...[more]

PMID: 33331830

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Project description:BackgroundWe present the results of a feasibility, randomized waitlist control group (CG) parallel design study with a 1:1 allocation ratio. Participants were randomized into an intervention group (IG) or a waitlist CG. The intervention was a 6-week digital self-management program, Help to Overcome Problems Effectively (HOPE), for people with cancer.ObjectiveThis study aims to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive randomized controlled trial. In addition, a preliminary assessment of the impact of the HOPE program via secondary outcomes will be used to assess signals of efficacy in a trial context.MethodsParticipants were drawn from an opportunity sample, referred by Macmillan Cancer Support, and were invited via email to participate in the study (N=61). Primary outcomes were rates of recruitment, retention, follow-up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial. Secondary outcomes were self-report measures of participants' positive mental well-being, depression, anxiety, and patient activation (ie, confidence in managing their cancer). The intervention and data collection took place on the web.ResultsThe recruitment rate was 77% (47/61). A total of 41 participants completed the baseline questionnaires and were randomized to either the IG (n=21) or the waitlist CG (n=20). The retention rate (attending all program sessions) was greater than 50% (all: 21/41, 51%, IG: 10/21, 48%; and CG: 11/20, 55%). The follow-up rate (completing all questionnaires) was greater than 80% (all: 33/41, 80%; IG: 16/21, 76%; and CG: 17/20, 85%). The completion rate (attending ≥3 sessions and completing all questionnaires) was greater than 60% (all: 25/41, 61%; IG: 13/21, 62%; and CG: 12/20, 60%). Engagement data showed that participants viewed between half (5.1/10, 51%) and three-quarters (12.2/16, 76%) of the pages in each session.ConclusionsAll progression criteria for a definitive trial were met, as supported by the primary outcome data. The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation. A full-scale trial of the digital HOPE program for people with cancer will allow us to fully evaluate the efficacy of the intervention relative to a CG.Trial registrationISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250.International registered report identifier (irrid)RR2-10.2196/24264.

Project description:BACKGROUND:Medically unexplained symptoms (MUS) constitute a major health problem because of their high prevalence, the suffering and disability they cause, and the associated medical costs. Web-based interventions may provide an accessible and convenient tool for managing MUS. We developed a personalized, Web-based, guided self-help intervention for MUS in primary care (Grip self-help) and would compare its effectiveness with that of usual care. OBJECTIVE:This paper aims to describe the rationale, objectives, and design of a pragmatic randomized controlled trial (RCT) assessing the effectiveness of Grip self-help. METHODS:For a pragmatic multicenter RCT, 165 adult patients with mild to moderate MUS will be recruited through general practices in the Netherlands. Randomization will be performed at general practice level. Over the course of several months, patients in the intervention group will receive a personalized set of Web-based self-help exercises, targeting the unhelpful cognitions, emotions, behaviors, and social factors that are relevant to them. The intervention is guided by a general practice mental health worker. The control group will receive care-as-usual. Primary outcome is physical health-related quality of life (RAND-36 or 36-item general health survey, physical component score). Secondary outcomes include severity of physical and psychological symptoms, mental health-related quality of life, cost-effectiveness, and acceptability. Assessments will take place at baseline, end of treatment, and at 16-, 26-, and 52-week follow-ups. RESULTS:Recruitment started in December 2018, and enrolment is ongoing. The first results are expected to be submitted for publication in December 2021. CONCLUSIONS:To our knowledge, this is the first study to combine the concepts of electronic health, self-help, and personalized medicine in the treatment of MUS. By improving the quality of life and reducing symptoms of patients with MUS, Grip self-help has the potential to reduce costs and conserve scarce health care resources. TRIAL REGISTRATION:Dutch Trial Register NTR7390; https://www.trialregister.nl/trial/7390. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/13738.

Project description:BackgroundThe death of a partner is a critical life event in later life, which requires grief work as well as the development of a new perspective for the future. Cognitive behavioral web-based self-help interventions for coping with prolonged grief have established their efficacy in decreasing symptoms of grief, depression, and loneliness. However, no study has tested the efficacy for reducing grief after losses occurring less than 6 months ago and the role of self-tailoring of the content.ObjectiveThis study aims to evaluate the clinical efficacy and acceptance of a web-based self-help intervention to support the grief process of older adults who have lost their partner. It will compare the outcomes, adherence, and working alliance in a standardized format with those in a self-tailored delivery format and investigate the effects of age, time since loss, and severity of grief at baseline as predictors. Focus groups to understand user experience and a cost-effectiveness analysis will complement the study.MethodsThe study includes 3 different randomized control trials. The trial in Switzerland comprises a waitlist control group and 2 active arms consisting of 2 delivery formats, standardized and self-tailored. In the Netherlands and in Portugal, the trials follow a 2-arm design that will be, respectively, complemented with focus groups on technology acceptance and cost-effectiveness analysis. The main target group will consist of adults aged >60 years from the general population in Switzerland (n≥85), the Netherlands (n≥40), and Portugal (n≥80) who lost their partner and seek help for coping with grief symptoms, psychological distress, and adaptation problems in daily life. The trials will test the intervention's clinical efficacy for reducing grief (primary outcome) and depression symptoms and loneliness (secondary outcomes) after the intervention. Measurements will take place at baseline (week 0), after the intervention (week 10), and at follow-up (week 20).ResultsThe trials started in March 2022 and are expected to end in December 2022 or when the needed sample size is achieved. The first results are expected by January 2023.ConclusionsThe trials will provide insights into the efficacy and acceptance of a web-based self-help intervention among older adults who have recently lost a partner. Results will extend the knowledge on the role of self-tailoring, working alliance, and satisfaction in the effects of the intervention. Finally, the study will suggest adaptations to improve the acceptance of web-based self-help interventions for older mourners and explore the cost-effectiveness of this intervention. Limitations include a self-selective sample and the lack of cross-cultural comparisons.Trial registrationSwitzerland: ClinicalTrials.gov NCT05280041; https://clinicaltrials.gov/ct2/show/NCT05280041; Portugal: ClinicalTrials.gov NCT05156346; https://clinicaltrials.gov/ct2/show/NCT05156346.International registered report identifier (irrid)PRR1-10.2196/37827.

Project description:BackgroundAviophobia (the fear of flying) can greatly impact the daily life functioning of people with the condition. Traditional exposure-based treatment is hampered by the limited availability of airplane practice situations, which is a result of economical and practical concerns. Easily accessible and low-cost virtual reality exposure therapy may address these challenges.ObjectiveThe purpose of our study is to investigate the effectiveness of ZeroPhobia: Aviophobia (a self-help mobile app-based treatment) in reducing flight anxiety symptoms and depressive and anxiety symptoms. We will also investigate the effects of usage intensity, the sense of immersion, inherent absorption ability, and perceived user-friendliness on the treatment effect.MethodsParticipants (N=114) who are aged 18-64 years and experience at least mild symptoms of aviophobia will be recruited from the general Dutch population and randomized into a treatment group or waitlist control group. By using their own phones and rudimentary mobile virtual reality headsets, participants will receive six modules of psychoeducation and cognitive behavioral therapy, which will include six levels of virtual reality exposure therapy over a period of 6 weeks. Assessments will be conducted at baseline, posttest (ie, after 6 weeks), and 3- and 12-month follow-ups. The primary outcome measure of our study is the Flight Anxiety Situations Questionnaire. The secondary outcome measures include anxiety and depression measures and additional covariates (including usage intensity, the degree of immersion, etc). We will test treatment effectiveness by conducting an intention-to-treat analysis and estimating average treatment effects on the treated. The mechanisms of treatment effect will also be explored.ResultsThe study was funded on September 25, 2018. Ethical approval was received on October 11, 2019. Recruitment closed on May 7, 2020.ConclusionsOur study will further the scientific understanding and clinical implications of technology's current ability to aid in providing effective, accessible treatment for the fear of flying.Trial registrationNetherlands Trial Registry NL70238.029.19; https://www.trialregister.nl/trial/8257.International registered report identifier (irrid)DERR1-10.2196/22008.

Project description:BACKGROUND:Alcohol misuse and emotional problems (ie, depression and anxiety) are highly comorbid among Canadian young adults. However, there is a lack of integrated, accessible, and evidence-based treatment options for these young adults. OBJECTIVE:The main goal of this study is to develop and test the efficacy of an integrated, online self-help program designed to target both alcohol misuse and emotional problems. METHODS:A two-arm randomized controlled trial design will be used to compare the efficacy of the online integrated treatment to a psychoeducational control group. A target sample of 214 participants will be recruited and randomly assigned to either condition. The integrated treatment will last 8 weeks, and participants will work through 12 modules. Modules will incorporate content based on principles of cognitive behavioral therapy and motivational interviewing. Participants in the control group will receive links to psychoeducational resources and will have access to the full treatment after follow-up. The primary outcome will be the number of Canadian standard drinks consumed in the week leading up the assessment. Secondary outcomes of interest include symptoms of depression, anxiety, alcohol-related problems, quality of life, and use of other drugs. Assessments will be completed at 3 time-points: at baseline, at the end of treatment (ie, 8 weeks), and at follow-up (ie, 24 weeks). Upon completion, data will be analyzed using generalized linear mixed models. RESULTS:Data collection began in June 2018 and will continue until January 2020. Final study results will be submitted for publication by July 2020. CONCLUSIONS:Currently, there are no integrated treatments designed to target alcohol misuse and the range of emotional problems experienced by young adults. This research stands to provide an effective, accessible (ie, Web-based), and feasible option to treat the many struggling young adults in this country. TRIAL REGISTRATION:ClinicalTrials.gov ID NCT03406039; https://clinicaltrials.gov/ct2/show/NCT03406039 (Archived by WebCite at http://www.webcitation.org/72fDefnrh). REGISTERED REPORT IDENTIFIER:PRR1-10.2196/11298.

Project description:BackgroundPrevention of depression is important due to the substantial burden of disease associated with it. To this end, we developed a novel, brief, and low-threshold Web-based self-help approach for depressive complaints called complaint-directed mini-interventions (CDMIs). These CDMIs focus on highly prevalent complaints that are demonstrably associated with depression and have a substantial economic impact: stress, sleep problems, and worry.ObjectiveThe aim was to evaluate the effectiveness of the Web-based self-help CDMIs in a sample of adults with mild-to-moderate depressive symptoms compared to a wait-list control group.MethodsA two-armed randomized controlled trial was conducted. An open recruitment strategy was used. Participants were randomized to either the Web-based CDMIs or the no-intervention wait-list control group. The CDMIs are online, unguided, self-help interventions, largely based on cognitive behavioral techniques, which consist of 3 to 4 modules with up to 6 exercises per module. Participants are free to choose between the modules and exercises. Assessments, using self-report questionnaires, took place at baseline and at 3 and 6 months after baseline. The control group was given access to the intervention following the 3-month assessment. The primary goal of the CDMIs is to reduce depressive complaints. The primary outcome of the study was a reduction in depressive complaints as measured by the Inventory of Depressive Symptomatology Self-Report (IDS-SR). Secondary outcomes included reductions in stress, worry, sleep problems, and anxiety complaints, and improvements in well-being. Data were analyzed using linear mixed models.ResultsIn total, 329 participants enrolled in the trial, of which 165 were randomized to the intervention group and 164 to the control group. Approximately three-quarters of the intervention group actually created an account. Of these participants, 91.3% (116/127) logged into their chosen CDMI at least once during the 3-month intervention period (median 3, range 0-166). After 3 months, there was a significant reduction in depressive symptomatology for participants in the intervention group compared to participants in the wait-list control group (reduction in depression: mean -4.47, 95% CI -6.54 to -2.40; Cohen d=-0.70). Furthermore, significant effects were observed for sleep problems, worry, anxiety, and well-being, with effect sizes ranging from -0.29 to -0.40. The intervention did not significantly reduce stress. At 6-month follow-up, the improvements in the intervention group were generally sustained.ConclusionsThis study shows that the online self-help CDMIs have a positive impact on various mental health outcomes. Future research should focus on which specific strategies may boost adherence, and increase the reach of the CDMIs among people with low socioeconomic status.ClinicaltrialNetherlands Trial Register (NTR): NTR4612; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4612 (Archived by WebCite at http://www.webcitation.org/6n4PVYddM).

Project description:BackgroundOwing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to specialized treatment. Guided self-help cognitive behavioral therapy-enhanced (CBT-E) may have great advantages for patients if its efficacy can be established.ObjectiveThe aim of this study was to examine the efficacy of guided self-help CBT-E compared with that of a delayed-treatment control condition.MethodsA single-blind 2-arm randomized controlled trial was designed to evaluate guided self-help CBT-E according to an intention-to-treat analysis. A total of 180 patients were randomly assigned to guided self-help CBT-E (n=90, 50%) or the delayed-treatment control condition (n=90, 50%) for which guided self-help CBT-E was provided after the initial 12-week delay. The primary outcome was reduction in binges. The secondary outcome was full recovery at the end of treatment, as measured using the Eating Disorder Examination during the last 4 weeks of treatment. A linear mixed model analysis was performed to compare treatment outcomes at the end of treatment. A second linear mixed model analysis was performed to measure between- and within-group effects for up to 24 weeks of follow-up. The Eating Disorder Examination-Questionnaire and clinical impairment assessment were conducted before and after treatment and during follow-up. In addition, dropout rates were assessed in both conditions.ResultsDuring the last 4 weeks of treatment, objective binges reduced from an average of 19 (SD 16) to 3 (SD 5) binges, and 40% (36/90) showed full recovery in the guided self-help CBT-E group. Between-group effect size (Cohen d) was 1.0 for objective binges. At follow-up, after both groups received treatment, there was no longer a difference between the groups. Of the 180 participants, 142 (78.9%) completed treatment. The overall treatment dropout appeared to be associated with gender, level of education, and number of objective binges at baseline but not with treatment condition.ConclusionsThis is the first study to investigate the efficacy of guided self-help CBT-E. Guided self-help CBT-E appeared to be an efficacious treatment. This study's findings underscore the international guidelines recommending this type of treatment for binge eating disorder.Trial registrationNetherlands Trial Registry (NTR) NL7994; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7994.International registered report identifier (irrid)RR2-10.1186/s12888-020-02604-1.

Project description:BackgroundSuicidal thoughts are common, causing distress for millions of people all over the world. However, people with suicidal thoughts might not access support due to financial restraints, stigma or a lack of available treatment offers. Self-help programs provided online could overcome these barriers, and previous efforts show promising results in terms of reducing suicidal thoughts. This study aims to examine the effectiveness of an online self-help intervention in reducing suicidal thoughts among people at risk of suicide. The Danish Self-help Online against Suicidal thoughts (SOS) trial is a partial replication of a previously conducted Dutch trial.Methods and designA randomized, waiting-list controlled trial with 1:1 allocation ratio will be carried out. A total of 438 people with suicidal thoughts will be recruited from the Danish suicide hotline, The Lifeline's, website and allocated to the intervention condition (N = 219) or the control condition (N = 219). The intervention condition consists of a 6-week, Internet-based self-help therapy intervention. The format of the intervention is self-help, but the participants can be guided by the trial manager. The control condition consists of a waiting-list assignment for 32 weeks. The primary outcomes are frequency and intensity of suicidal thoughts. Secondary outcome measures include depressive symptoms, hopelessness, worrying, quality of life, costs related to health care utilization and production loss. Number of deliberate self-harm episodes, suicides and deaths will, as well as the participant's evaluation of the intervention and the experience of negative effects, be investigated. Assessments will be conducted over the intervention website through self-report questionnaires at baseline, 2 weeks, 4 weeks, 6 weeks and 32 weeks (6 months post intervention).DiscussionIf we find the intervention to be linked to reductions in suicidal thoughts, this will strengthen the evidence that online self-help interventions are relevant tools for people with suicidal thoughts.Trial registrationClinicalTrials.gov, NCT02872610 . Registered on 9 August 2016.

Dataset Information

Web-based Self-help Program for Adjustment Problems After an Accident (SelFIT): Protocol for a Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

Web-based Self-help Program for Adjustment Problems After an Accident (SelFIT): Protocol for a Randomized Controlled Trial.

Similar Datasets

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