scholarly journals Guided Self-Help Works: Randomized Waitlist Controlled Trial of Pacifica, a Mobile App Integrating Cognitive Behavioral Therapy and Mindfulness for Stress, Anxiety, and Depression

10.2196/12556 ◽  
2019 ◽  
Vol 21 (6) ◽  
pp. e12556 ◽  
Author(s):  
Christine Moberg ◽  
Andrea Niles ◽  
Dale Beermann
Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Victoria Ka-Ying Hui ◽  
Christy Yim-Fan Wong ◽  
Eric Ka-Yiu Ma ◽  
Fiona Yan-Yee Ho ◽  
Christian S. Chan

Abstract Background Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This paper reports a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, using a waitlist group as control, for people with major depression and insomnia. Methods A two-arm parallel randomized controlled trial is conducted in a target sample of 285 non-suicidal Hong Kong Chinese older than 17 years of age with major depression and insomnia. Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application proACT-S. This smartphone app has been pilot tested and revamped to improve user experience. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity, and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow-up. The recruitment is completed. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the efficacy of the CBT-I intervention. Discussion It is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, thereby reducing the burden of the public healthcare system in Hong Kong. Trial registration ClinicalTrials.gov NCT04228146. Retrospectively registered on 14 January 2020.


2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Najme Abedishargh ◽  
Abbas Ramezani Farani ◽  
Banafsheh Gharraee ◽  
Hojjatollah Farahani

Background: The obesity crisis is one of the major public health issues in the 21st century, and depression, anxiety, and stress are the psychological factors that mediate obesity. Objectives: This research was conducted to evaluate the effectiveness of Internet-based cognitive-behavioral therapy (ICBT) in reducing body mass index (BMI), stress, anxiety, and depression in overweight women via a virtual group. Methods: This randomized controlled trial study was conducted on three groups of the experiment, the waiting list, and the routine treatment. It was done as single-phase, single-center, and double-blinded. The statistical population included all women with BMI ≥ 25 in Neyshabur city in 2019 - 2020. The research sample included 90 subjects randomly assigned to the groups. The therapeutic intervention was applied in the form of 42 ICBT sessions using a virtual WhatsApp group. The participants completed the Depression Anxiety Stress Scale (DASS), and their BMI was also calculated before and after the sessions. Results: The analysis of covariance indicated the significant effect of ICBT on the reduction of BMI compared to the usual treatment group and waiting list group [F (72, 2) = 15.54, P < 0.0005; Partialη2 = 0.30]. However, it was not significant on the reduction of stress [F (72, 2) = 0.47, P = 0.63; Partialη2 = 0.01], anxiety [F (72, 2) = 0.49, P = 0.61; Partialη2 = 0.01], and depression [F (72, 2) = 0.06, P = 0.93; Partialη2 = 0.002]. Conclusions: The present study showed the direct effect of ICBT on the reduction of BMI. However, these sessions could not reduce the participants’ stress, anxiety, and depression.


2021 ◽  
Author(s):  
Christian Shaunlyn Chan ◽  
Christy Wong ◽  
Branda Y. M. Yu ◽  
Victoria Ka-Ying Hui ◽  
Fiona Y. Y. Ho ◽  
...  

Background: Despite its efficacy in treating comorbid insomnia and depression, cognitive behavioral therapy for insomnia (CBT-I) is limited in its accessibility and, in many regions, cultural compatibility. Smartphone-based treatments is a low-cost, convenient alternative modality. This study evaluated a self-help smartphone-based CBT-I in alleviating major depression and insomnia.Methods: A parallel-group randomized, waitlist-controlled trial was conducted with 322 adults with major depression and insomnia. Participants were randomized to receive either a 6-week CBT-I via a smartphone application, proACT-S, or waitlist condition. The primary outcomes included depression severity, insomnia severity, and sleep quality. The secondary outcomes included anxiety severity, subjective health, and acceptability of treatment. Assessments were administered at baseline, post-intervention follow up (Week 6), and Week 12 follow-up. The waitlist group received treatment after the first follow-up.Results: Intention to treat analysis was conducted with multilevel modeling. In all but one models, the interaction between treatment condition and the time point at Week 6 follow-up was significant. Compared with the waitlist group, the treatment group had lower levels of depression (CES-D: treatment difference = 0.83, 95% CI [0.58, 1.09]), insomnia (ISI: treatment difference = 0.89, 95% CI [0.64, 1.16]), and anxiety (HADS-A: treatment difference = 0.80, 95% CI [0.55, 1.06]). They also had better sleep quality (PSQI: treatment difference = 0.84, 95% CI [0.58, 1.10]). No differences across any measures were found at Week 12, after the waitlist control group received the treatment. Conclusion: proACT-S is an efficacious sleep-focused self-help treatment for major depression and insomnia.


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