scholarly journals Evaluating an e-mental health program (“deprexis”) as adjunctive treatment tool in psychotherapy for depression: design of a pragmatic randomized controlled trial

2014 ◽  
Vol 14 (1) ◽  
Author(s):  
Tobias Krieger ◽  
Björn Meyer ◽  
Kerstin Sude ◽  
Antoine Urech ◽  
Andreas Maercker ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Health Program ◽  
Controlled Trial ◽  
Mental Health Program ◽  
Adjunctive Treatment ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled

scholarly journals The Web-Based Uprise Program for Mental Health in Australian University Students: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Karra D Harrington ◽  
Robert Eres ◽  
Michelle H Lim
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Health Program ◽  
Controlled Trial ◽  
Mental Health Program ◽  
Web Based ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

BACKGROUND University students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support. OBJECTIVE The aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students. METHODS This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program. RESULTS The trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes. CONCLUSIONS The acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students. CLINICALTRIAL Australian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/21307

scholarly journals The Web-Based Uprise Program for Mental Health in Australian University Students: Protocol for a Pilot Randomized Controlled Trial

10.2196/21307 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e21307
Author(s):  
Karra D Harrington ◽  
Robert Eres ◽  
Michelle H Lim
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Health Program ◽  
Controlled Trial ◽  
Mental Health Program ◽  
Web Based ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Background University students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support. Objective The aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students. Methods This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program. Results The trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes. Conclusions The acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291 International Registered Report Identifier (IRRID) DERR1-10.2196/21307

scholarly journals Effects of a Digital Mental Health Program on Perceived Stress in Adolescents Aged 13-17 Years: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Eliane M Boucher ◽  
Haley E Ward ◽  
Julia L Stafford ◽  
Acacia C Parks
Keyword(s):  
Mental Health ◽  
Stress Management ◽  
Perceived Stress ◽  
Cognitive Processes ◽  
Health Program ◽  
Controlled Trial ◽  
Mental Health Program ◽  
Randomized Controlled ◽  
School Based ◽  
Management Techniques

BACKGROUND Stress is an important transdiagnostic risk factor in adolescence and predicts a host of physical and psychological problems in adolescence and adulthood. Adolescence is also a developmental stage in which people may be more sensitive or reactive to stress. Indeed, research has shown that adolescents report high levels of stress, particularly when enrolled in school. However, adolescents report engaging in few, if any, stress management techniques. Consequently, the development of effective programs to help address adolescent stress is particularly important. To date, most stress management programs for adolescents are delivered within schools, and the evidence for such programs is mixed. Furthermore, most of these programs rely on traditional stress management techniques rather than incorporating methods to address the underlying negative cognitive processes, such as rumination, that may contribute to or exacerbate the effects of perceived stress. OBJECTIVE The aim of this study is to test the short-term effects of a digital mental health program designed for adolescents aged 13-17 years on perceived stress and rumination. METHODS This is a randomized controlled trial in which adolescents between the ages of 13 and 17 years, with elevated levels of perceived stress and brooding, will be randomly assigned to complete 8 weeks of a digital mental health program (Happify for Teens) or to a corresponding wait-list control group. The study will take place over 3 months, including the 8-week intervention period and 1-month postintervention follow-up. The primary outcome, perceived stress, along with secondary and exploratory outcomes (ie, brooding, optimism, sleep disturbance, and loneliness) will be assessed via self-report at baseline, 4 weeks, 8 weeks, and 12 weeks to compare changes in these outcomes across conditions. RESULTS Recruitment is expected to begin in the second quarter of 2021, with a target sample size of 800 participants (400 per condition). Participants will begin the study as they are recruited and will finish in waves, with the first wave of data expected 8 weeks after recruitment begins and the final wave of data expected by the end of the third quarter of 2021. CONCLUSIONS Although school-based stress management programs for adolescents are common, research suggests that they may be limited in their reach and more effective for school-based stress than other types of stress. This trial will be one of the first attempts to examine the potential benefits of a digital mental health program on adolescents to address stress along with negative cognitive processes such as rumination. If successful, this would help introduce a more scalable alternative to school-based programs that offers adolescents greater privacy while also providing insight into novel ways to target adolescent mental health more generally. CLINICALTRIAL ClinicalTrials.gov NCT04567888; https://clinicaltrials.gov/ct2/show/NCT04567888 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/25545

scholarly journals Clinical and cost-effectiveness of personalized tele-based coaching for farmers, foresters and gardeners to prevent depression: Study protocol of an 18-month follow-up pragmatic randomized controlled trial (TEC-A)

2019 ◽  
Author(s):  
Janika Thielecke ◽  
Claudia Buntrock ◽  
Ingrid Titzler ◽  
Lina Braun ◽  
Johanna Freund ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Depressive Symptom ◽  
Cost Effectiveness ◽  
Symptom Severity ◽  
Controlled Trial ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Depressive Symptom Severity ◽  
The Cost

Background: Farmers show high levels of depressive symptoms and mental health problems in various studies. This study is part of a nationwide prevention project carried out by a German social insurance company for farmers, foresters and gardeners (SVLFG ) to implement internet- and tele-based services among others to improve mental health in this population. The aim of the present study is to evaluate the (cost-)effectiveness of personalized tele-based coaching for reducing depressive symptom severity and preventing the onset of clinical depression, compared to enhanced treatment as usual (TAU+ ).Methods: In a two-armed, pragmatic randomized controlled trial (N=312) with follow-ups at post-treatment (6 months), 12 months and 18 months, insured farmers, foresters and gardeners, collaborating family members and pensioners with elevated depressive symptoms (PHQ-9 ≥ 5) will be randomly allocated to personalized tele-based coaching or TAU+. The coaching is provided by psychologists and consists of up to 34 tele-based sessions for 25 to 50 minutes delivered over 6 months. Primary outcome is depressive symptom severity at post-treatment. Secondary outcomes include depression onset, anxiety, stress and quality of life. A health-economic evaluation will be conducted from a societal perspective. Discussion: This study is the first pragmatic randomized controlled trial evaluating the (cost-) effectiveness of a nationwide tele-based preventive service for farmers. If proven effective, the implementation of personalized tele-based coaching has the potential to reduce disease burden and health care costs both at an individual and societal level.

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