Efficacy of an online intervention for treatment of depressive disorders: a three-arm randomized controlled trial comparing guided and unguided self-help with waitlist control (Preprint)

2021 ◽  
Author(s):  
Krämer Rico
Keyword(s):  
Depressive Symptoms ◽  
Depressive Disorders ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Intervention Group ◽  
Online Intervention ◽  
Self Report ◽  
Secondary Outcome ◽  
Control Group

BACKGROUND Digital health applications are efficacious treatment options for mild-to-moderate depressive disorders. However, the extent to which psychological guidance increases the efficacy of these applications is controversial. OBJECTIVE We evaluated the efficacy of the online intervention “Selfapy” for unipolar depression. We also investigated differences between a psychotherapist-guided vs. unguided version compared with those from a control group. METHODS A cohort of 401 participants with mild-to-severe depressive disorders were assigned randomly to either participate in a guided version of Selfapy (involving weekly telephone calls of 25-min duration), an unguided version of Selfapy, or to the waiting list (control group). Selfapy is a cognitive behavioral therapy-based intervention for depressive disorders of duration 12 weeks. Symptom assessment was undertaken at T1 (before study entrance), T2 (after 6 weeks), T3 (post-treatment, after 12 weeks), and T4 (follow-up, after 6 months). The main outcome was reduction in depressive symptoms in the Beck Depression Inventory (BDI-II) from T1 to T3. Secondary-outcome parameters were the Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR 16) and Beck Anxiety Inventory (BAI). RESULTS A total of 297 out of 401 participants (74.06%) completed the post-measurement at T3. In the primary analysis, both intervention groups showed a significantly higher reduction in depressive symptoms (BDI-II) from T1 to T3 compared with that in the control group, with high within-effect sizes (guided: d = 1.46; unguided d = 1.36). No significant differences were found for guided vs. unguided treatment groups. The response rate (BDI-II) for intention-to-treat data in the guided version was 46.4%, 40.0% for the unguided version, and 2.0% in the control group. After 6 months (T4), treatment effects could been maintained for both intervention groups (BDI-II) without differences between either intervention group. CONCLUSIONS Conclusions: Selfapy can help to reduce depressive symptoms in guided or unguided version. Follow-up data suggest that these effects could be maintained. The guided version was not superior to the unguided version. CLINICALTRIAL Trial Registration: Current Controlled Trial DRKS00017191 Date of registration: 14 May 2019 INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.1186/s13063-021-05218-4

Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

2021 ◽  
Author(s):  
Angela Chu ◽  
Tyler M Rose ◽  
Danielle A Gundrum ◽  
Tressa E McMorris ◽  
Eytan A Klausner ◽  
...  
Keyword(s):  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Intervention Period ◽  
Entire Study ◽  
Positive Effects ◽  
Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

scholarly journals Long-Term Effectiveness of a Stress Management Intervention at Work: A 9-Year Follow-Up Study Based on a Randomized Wait-List Controlled Trial in Male Managers

2017 ◽  
Vol 2017 ◽  
pp. 1-11 ◽  
Author(s):  
Jian Li ◽  
Natalie Riedel ◽  
Amira Barrech ◽  
Raphael M. Herr ◽  
Birgit Aust ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Stress Management ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
External Control ◽  
Control Group ◽  
Wait List ◽  
Eri Model

Objective. Short- and medium-term effectiveness (up to 3 years) of individual level stress management interventions (SMI) at work were demonstrated, yet long-term effectiveness remains unexplored. We therefore aimed to address this research gap. Methods. 94 male middle managers participated in a randomized wait-list controlled trial between 2006 and 2008 and in a post-trial-follow-up survey in 2015. During the first two years, all received an 18-hour psychotherapeutic SMI intervention which was based on the Effort-Reward Imbalance (ERI) model: tackling stressor on mismatch between effort and reward and promoting recovery on overcommitment. Work stress (i.e., ERI indicators) was the primary outcome, and the secondary outcome was depressive symptoms. The long-term effectiveness of the SMI was examined by mixed modeling, using an external control group (n=94). Results. Effort and reward were substantially improved with significant intervention ⁎ time interaction effects (p<0.001) compared to the external control group; effects on overcommitment and depressive symptoms were also significant (p<0.05 and p<0.01, resp.), though their trajectories in the intervention group were less sustainable. Conclusions. The effectiveness of this psychotherapeutic SMI at work based on the ERI model was observed over a 9-year period, particularly on the effort-reward ratio.

scholarly journals Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lucie Waedel ◽  
Anne Daubmann ◽  
Antonia Zapf ◽  
Olaf Reis
Keyword(s):  
Substance Use ◽  
Randomised Controlled Trial ◽  
Intellectual Disabilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

scholarly journals Prevention of Depressive Symptoms and Promotion of Well-being in Adolescents: A Randomized Controlled Trial of the Smile Program

2019 ◽  
Vol 35 (2) ◽  
pp. 300-313
Author(s):  
Óscar Sánchez-Hernández ◽  
Francisco X. Méndez ◽  
Manuel Ato ◽  
Judy Garber
Keyword(s):  
Depressive Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Behavioral Approach ◽  
Control Group ◽  
Post Intervention ◽  
Post Test ◽  
Intervention Condition

This study addressed the development and evaluation of the Smile Program whose main objective was the prevention of depression and the promotion of well-being in adolescents. The program is based on interventions that have been shown to be efficacious (a cognitive-behavioral approach). Participants were 89 adolescents (mean age = 13.88 years; SD = 0.95) recruited from a sample of 1212 students from seven schools. Results showed a significant reduction in self-reported depressive symptoms in the intervention group (n= 51) as compared to youth in the control group (n= 38). Based on parents’ report (n=56), youth in the intervention group had significantly better self-esteem at post-test as compared to youth in the control group. At four months post intervention, youth in the intervention group had higher psychological well-being than those in the control group; at the 8-month follow-up, youth in the intervention condition reported better family self-concept.

scholarly journals Mamma Mia – A randomized controlled trial of an internet-based intervention for perinatal depression

2018 ◽  
Vol 49 (11) ◽  
pp. 1850-1858 ◽  
Author(s):  
Silje Marie Haga ◽  
Filip Drozd ◽  
Carina Lisøy ◽  
Tore Wentzel-Larsen ◽  
Kari Slinning
Keyword(s):  
Depressive Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Depression Scale ◽  
Control Group ◽  
Group Data ◽  
Perinatal Depressive Symptoms ◽  
Group 2 ◽  
And Control

AbstractBackgroundStudies suggest that 10–15% of perinatal women experience depressive symptoms. Due to the risks, problems with detection, and barriers to treatment, effective universal preventive interventions are needed. The aim of this study was to assess the effectiveness of an automated internet intervention (‘Mamma Mia’) on perinatal depressive symptoms. Mamma Mia is tailored specifically to the perinatal phase and targets risk and protective factors for perinatal depressive symptoms.MethodsA total of 1342 pregnant women were randomized to an intervention (‘Mamma Mia’) and control group. Data were collected at gestational week (gw) 21–25, gw37, 6 weeks after birth, and 3 and 6 months after birth. We investigated whether (1) the intervention group displayed lower levels of depressive symptoms compared with the control group, (2) the effect of Mamma Mia changed over time, (3) the effect on depressive symptoms was moderated by baseline depressive symptoms, previous depression, and parity, and (4) this moderation changed by time. Finally, we examined if the prevalence of mothers with possible depression [i.e. Edinburgh Postnatal Depression Scale (EPDS)-score ⩾10] differed between the intervention and control group.ResultsParticipants in the Mamma Mia group displayed less depressive symptoms than participants in the control group during follow-up [F(1) = 7.03, p = 0.008]. There were indications that the effect of Mamma Mia was moderated by EPDS score at baseline. The prevalence of women with EPDS-score ⩾10 was lower in the Mamma Mia group at all follow-up measurements.ConclusionsThe study demonstrated the effects of the automated web-based universal intervention Mamma Mia on perinatal depressive symptoms.

scholarly journals A Randomised Controlled Trial Evaluating the Effectiveness and Tolerability of Step-up and Step-down Varenicline Therapy for Smoking Cessation: A Study Protocol

2017 ◽  
Vol 13 (3) ◽  
pp. 179-185
Author(s):  
Aaron D. Drovandi ◽  
Peta-Ann Teague ◽  
Beverley D. Glass ◽  
Bunmi Malau-Aduli
Keyword(s):  
Smoking Cessation ◽  
Adverse Events ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Intervention Group ◽  
Withdrawal Symptoms ◽  
Secondary Outcome ◽  
Control Group ◽  
Step Down

Background: Varenicline remains the most effective medication for smoking cessation; however, discontinuation as a result of adverse events negatively impacts medication adherence, and the likelihood of a quit attempt being successful. Post-treatment cravings and withdrawal symptoms may also occur, increasing the likelihood of treatment failure, due to lapse and relapse after achieving initial abstinence. This protocol details a trial investigating changes in the effectiveness and tolerability of varenicline, when an extended step-up and step-down regimen are used.Methods: A phase four, randomised, double-blinded, placebo-controlled single-centre study with a treatment period of 16 weeks, and follow-up period of 12 weeks will be conducted. Up to 201 participants will be enrolled and allocated in a 1:1:1 ratio to a placebo-matching control group, step-up, or step-down intervention group, all receiving behavioural counselling and quitting advice. Participants will be contacted weekly during treatment and fortnightly during follow-up. Eligible participants are smokers over 18 years old, willing to quit smoking, are able to attend clinic visits, and have no uncontrolled or serious medical issues. Primary outcome measures are comparisons of biochemically confirmed continuous abstinence rates, 7-day point prevalence abstinence rates, and the frequency, severity and duration of adverse events, cravings and withdrawal symptoms. Secondary outcome measures are participant adherence to the study medication throughout treatment, and comparisons of changes in smoking satisfaction and reward. Effects of each regimen on smoking cessation will be assessed by logistic regression, with survival analyses used for a more precise estimate of when cessation occurs. Primary endpoints will then be compared using a general linear model. Australian New Zealand Clinical Trials Registry: ACTRN12616000802404p

scholarly journals ZIEL: Internet-Based Self-Help for Adjustment Problems: Results of a Randomized Controlled Trial

2019 ◽  
Vol 8 (10) ◽  
pp. 1655 ◽  
Author(s):  
Christian Moser ◽  
Rahel Bachem ◽  
Thomas Berger ◽  
Andreas Maercker
Keyword(s):  
Quality Of Life ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Treatment Options ◽  
Intervention Group ◽  
Online Intervention ◽  
Adjustment Disorder ◽  
Control Group ◽  
Adjustment Problems

Adjustment Disorder (AjD) represents a healthcare paradox. On the one hand, it is one of the most diagnosed mental disorders worldwide. On the other hand, AjD and its possible treatment options remain a severely neglected field of research. In this context, we developed a self-guided online intervention for adjustment problems, named ZIEL, and tested its efficacy. It is based on and extends a bibliotherapeutic treatment approach for symptoms of AjD. In our study, a total of 98 individuals who had experienced a life event in the last two years, were randomly assigned to care as usual (CAU) or an online intervention group (CAU + online intervention). The primary endpoint was AjD symptom severity measured by Adjustment Disorder–New Module 20 (ADNM-20). Secondary endpoints were depressive symptoms, quality of life and other variables such as satisfaction and usability. Both the intervention and the control group improved comparably well regarding the severity of adjustment disorder symptoms post-treatment. However, participants in the intervention group showed significantly fewer depressive symptoms and a significantly higher quality of life (Cohen’s d: 0.89 (BDI) and −0.49 (SF-12)). The intervention was well-received by users with an above average usability rating. Overall, the results suggest that the ZIEL intervention has the promise to contribute to the treatment of AjD and reduce symptom burden by means of a scalable low-barrier approach.

Preventing depression using a smartphone app: a randomized controlled trial

2020 ◽  
pp. 1-10 ◽  
Author(s):  
Mark Deady ◽  
Nicholas Glozier ◽  
Rafael Calvo ◽  
David Johnston ◽  
Andrew Mackinnon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Intervention Group ◽  
Smartphone App ◽  
Control Group ◽  
Depression Symptoms ◽  
Randomized Controlled ◽  
Small Effect Size

Abstract Background There is evidence that depression can be prevented; however, traditional approaches face significant scalability issues. Digital technologies provide a potential solution, although this has not been adequately tested. The aim of this study was to evaluate the effectiveness of a new smartphone app designed to reduce depression symptoms and subsequent incident depression amongst a large group of Australian workers. Methods A randomized controlled trial was conducted with follow-up assessments at 5 weeks and 3 and 12 months post-baseline. Participants were employed Australians reporting no clinically significant depression. The intervention group (N = 1128) was allocated to use HeadGear, a smartphone app which included a 30-day behavioural activation and mindfulness intervention. The attention-control group (N = 1143) used an app which included a 30-day mood monitoring component. The primary outcome was the level of depressive symptomatology (PHQ-9) at 3-month follow-up. Analyses were conducted within an intention-to-treat framework using mixed modelling. Results Those assigned to the HeadGear arm had fewer depressive symptoms over the course of the trial compared to those assigned to the control (F3,734.7 = 2.98, p = 0.031). Prevalence of depression over the 12-month period was 8.0% and 3.5% for controls and HeadGear recipients, respectively, with odds of depression caseness amongst the intervention group of 0.43 (p = 0.001, 95% CI 0.26–0.70). Conclusions This trial demonstrates that a smartphone app can reduce depression symptoms and potentially prevent incident depression caseness and such interventions may have a role in improving working population mental health. Some caution in interpretation is needed regarding the clinical significance due to small effect size and trial attrition. Trial Registration Australian and New Zealand Clinical Trials Registry (www.anzctr.org.au/) ACTRN12617000548336

scholarly journals Improving the Course of Depressive Symptoms After Inpatient Psychotherapy Using Adjunct Web-Based Self-Help: Follow-Up Results of a Randomized Controlled Trial

10.2196/13655 ◽  
2019 ◽  
Vol 21 (10) ◽  
pp. e13655 ◽  
Author(s):  
Rüdiger Zwerenz ◽  
Carlotta Baumgarten ◽  
Jan Becker ◽  
Ana Tibubos ◽  
Martin Siepmann ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Inpatient Psychotherapy ◽  
Web Based ◽  
Randomized Controlled ◽  
Self Help ◽  
The Web

Background We recently showed in a randomized controlled trial that Web-based self-help as an adjunct improved the effectiveness of multimodal inpatient psychotherapy for depression. Objective The aims of this study were (1) to determine whether a Web-based self-help adjunctive to multimodal inpatient psychotherapeutic treatment could also improve the course of depressive symptoms and (2) to identify predictors of residual depressive symptoms at follow-up. Methods Overall, 229 patients were randomized either to the Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy. Participants in both groups were able to access their respective Web-based programs for 12 weeks, which meant that they typically had access after discharge from the inpatient unit (mean hospitalization duration: 40 days, T1). Follow-up was performed 6 months after study intake (T3). Results At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (d=0.58) and anxiety (d=0.46) as well as a better quality of life (d=0.43) and self-esteem (d=0.31) than participants of the control group. Nearly 3 times as many participants of the intervention group compared with the control group achieved remission in accordance with less deterioration. The number needed to treat based on the Beck Depression Inventory-II (BDI-II) improved over time (T1: 7.84, T2: 7.09, and T3: 5.12). Significant outcome predictors were BDI at discharge and treatment group. Conclusions Web-based self-help as an add-on to multimodal inpatient psychotherapy improved the short-term course of depressive symptoms beyond termination. Residual symptoms at discharge from inpatient treatment and utilization of the Web-based self-help were the major predictors of depressive symptoms at follow-up. Challenges and barriers (eg, costs, therapists’ concerns, or technical barriers) of adding Web-based interventions to inpatient treatment have to be addressed. Trial Registration ClinicalTrials.gov NCT02196896; https://clinicaltrials.gov/ct2/show/NCT02196896.

scholarly journals Improving the Course of Depressive Symptoms After Inpatient Psychotherapy Using Adjunct Web-Based Self-Help: Follow-Up Results of a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Rüdiger Zwerenz ◽  
Carlotta Baumgarten ◽  
Jan Becker ◽  
Ana Tibubos ◽  
Martin Siepmann ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Inpatient Psychotherapy ◽  
Web Based ◽  
Randomized Controlled ◽  
Self Help ◽  
The Web

BACKGROUND We recently showed in a randomized controlled trial that Web-based self-help as an adjunct improved the effectiveness of multimodal inpatient psychotherapy for depression. OBJECTIVE The aims of this study were (1) to determine whether a Web-based self-help adjunctive to multimodal inpatient psychotherapeutic treatment could also improve the course of depressive symptoms and (2) to identify predictors of residual depressive symptoms at follow-up. METHODS Overall, 229 patients were randomized either to the Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy. Participants in both groups were able to access their respective Web-based programs for 12 weeks, which meant that they typically had access after discharge from the inpatient unit (mean hospitalization duration: 40 days, T1). Follow-up was performed 6 months after study intake (T3). RESULTS At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (<italic>d</italic>=0.58) and anxiety (<italic>d</italic>=0.46) as well as a better quality of life (<italic>d</italic>=0.43) and self-esteem (<italic>d</italic>=0.31) than participants of the control group. Nearly 3 times as many participants of the intervention group compared with the control group achieved remission in accordance with less deterioration. The number needed to treat based on the Beck Depression Inventory-II (BDI-II) improved over time (T1: 7.84, T2: 7.09, and T3: 5.12). Significant outcome predictors were BDI at discharge and treatment group. CONCLUSIONS Web-based self-help as an add-on to multimodal inpatient psychotherapy improved the short-term course of depressive symptoms beyond termination. Residual symptoms at discharge from inpatient treatment and utilization of the Web-based self-help were the major predictors of depressive symptoms at follow-up. Challenges and barriers (eg, costs, therapists’ concerns, or technical barriers) of adding Web-based interventions to inpatient treatment have to be addressed. CLINICALTRIAL ClinicalTrials.gov NCT02196896; https://clinicaltrials.gov/ct2/show/NCT02196896.

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