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.

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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.

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Project description:BACKGROUND:Mental disorders have become a major health issue, and a substantial number of afflicted individuals do not get appropriate treatment. Web-based interventions are promising supplementary tools for improving health care for patients with mental disorders, as they can be delivered at low costs and used independently of time and location. Although psychodynamic treatments are used frequently in the face-to-face setting, there has been a paucity of studies on psychodynamic Web-based self-help interventions. OBJECTIVE:The objective of this study was to determine the feasibility and preliminary efficacy of a transdiagnostic affect-focused psychodynamic Web-based self-help intervention designed to increase emotional competence of patients with mental disorders. METHODS:A total of 82 psychotherapy inpatients with mixed diagnoses were randomized into two groups. Following discharge, the intervention group (IG) got access to a guided version of the intervention for 10 weeks. After a waiting period of 10 weeks, the wait-list control group (WLCG) got access to an unguided version of the intervention. We reported the assessments at the beginning (T0) and at the end of the intervention, resp. the waiting period (T1). The primary outcome was satisfaction with the treatment at T1. Secondary outcome measures included emotional competence, depression, anxiety, and quality of life. Statistical analyses were performed with descriptive statistics (primary outcome) and analysis of covariance; a repeated measurement analysis of variance was used for the secondary outcomes. Effect sizes were calculated using Cohen d and data were analyzed as per protocol, as well as intention-to-treat (ITT). RESULTS:Patients were chronically ill, diagnosed with multiple diagnoses, most frequently with depression (84%, 58/69), anxiety (68%, 47/69), personality disorder (38%, 26/69), and depersonalization-derealization disorder (22%, 15/69). A majority of the patients (86%, 36/42) logged into the program, of which 86% (31/36) completed the first unit. Satisfaction with the units mastered was rated as good (52%, 16/31) and very good (26%, 9/31). However, there was a steady decline of participation over the course of the program; only 36% of the participants (13/36) participated throughout the trial completing at least 50% of the sessions. According to the ITT analysis, participants improved statistically significantly and with moderate effect sizes (Cohen d) compared with the WLCG regarding depression (d=0.60), quality of life (d=0.53), and emotional competence (d=0.49). Effects were considerably stronger for the completers with respect to depression (d=1.33), quality of life (d=0.83), emotional competence (d=0.68), and general anxiety (d=0.62). CONCLUSIONS:Although overall program satisfaction and benefit of the program were favorable with respect to the indicators of emotional disorders, the rate of completion was low. Our findings point to the need to target the intervention more specifically to the needs and capabilities of participants and to the context of the intervention. TRIAL REGISTRATION:Clinicaltrials.gov NCT02671929; https://clinicaltrials.gov/ct2/show/NCT02671929 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb).

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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