scholarly journals Hands-off: Study protocol of a two-armed randomized controlled trial of a web-based self-help tool to reduce problematic pornography use

2020 ◽  
Vol 9 (2) ◽  
pp. 433-445
Author(s):  
Beáta Bőthe ◽  
Christian Baumgartner ◽  
Michael P. Schaub ◽  
Zsolt Demetrovics ◽  
Gábor Orosz

AbstractBackground and AimsThe past-year prevalence of problematic pornography use (PPU) was 1–6% in adult populations. As a result of treatment obstacles and barriers, such as unaffordable treatments, only a minority of problematic pornography users may seek treatment. Having a free, online, self-help program may overcome treatment barriers and may help those individuals who cannot receive traditional or offline treatment for PPU. Although the effectiveness of such online programs reducing substance use and problematic gambling have been reported, no prior study has examined the efficacy of an online self-help intervention aiming to reduce PPU.MethodsThis two-armed randomized controlled trial (RCT) will examine the effectiveness of an online self-help program (Hands-off) to reduce PPU, while also considering psychopathological comorbidities. The six-week intervention condition includes six core modules developed to reduce PPU based on motivational interviewing, cognitive behavioral therapy, mindfulness, and wise social-psychological intervention techniques. The target sample size is 242 participants. Self-report questionnaires will be administered at baseline, right after the end of the intervention, at one-month, and three-month follow-ups after the end of the intervention. The primary outcome will be the level of PPU. Secondary outcomes will include pornography use frequency, pornography craving, pornography use-avoidance self-efficacy, sex mindset, sexual satisfaction, negative and positive emotions, and life satisfaction. Data will be analyzed on an intention-to-treat basis using linear mixed models.ResultsResults will be reported at conferences and published in a scientific peer-reviewed journal. The participants will be sent a lay-person-friendly summary of the results via e-mail.

Author(s):  
Beáta Bőthe ◽  
Christian Baumgartner ◽  
Michael P. Schaub ◽  
Zsolt Demetrovics ◽  
Gábor Orosz

Abstract Background and Aims Despite problematic pornography use (PPU) being prevalent, no previous study has examined the effectiveness of evidence-based interventions for PPU, using rigorous methods. Using a two-armed randomized controlled trial study design, we examined the feasibility and initial effectiveness of a six-week online PPU intervention. Methods We recruited 264 participants (3.8% women, M age = 33.2, SD = 10.6) who were randomized and assigned to either the self-help intervention (n = 123) or waitlist control condition (n = 141), and completed self-report questionnaires at baseline and after the end of the intervention (six-week follow-up). Multivariable linear regression models were generated and tested on a complete case basis to investigate possible treatment effects. Participants provided quantitative and qualitative feedback regarding the intervention’s content and appearance. Results Participants evaluated all modules positively in the intervention in general. There were differential dropout rates (89.4% in intervention vs. 44.7% in control group) with an overall follow-up rate of 34.5%. The intervention group reported significantly lower levels of PPU (P < 0.001, d = 1.32) at the six-week follow-up. Moreover, they reported lower pornography use frequency (P < 0.001, d = 1.65), self-perceived pornography addiction (P = 0.01, d = 0.85), pornography craving (P = 0.02, d = 0.40), and higher pornography avoidance self-efficacy (P = 0.001, d = 0.87) at the six-week follow-up. Discussion and Conclusions The present study was only a first step in rigorous treatment studies for PPU, but the findings are promising and suggest that online interventions for PPU might help reduce PPU in some cases, even without the guidance of therapists, by reducing treatment barriers.


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 8 (11) ◽  
Author(s):  
Marianna Riello ◽  
Marianna Purgato ◽  
Chiara Bove ◽  
Federico Tedeschi ◽  
David MacTaggart ◽  
...  

This article describes a randomized controlled trial to evaluate the effectiveness of a supervised online delivery of self-help plus (SH+), during the second wave of COVID-19 contagions in Northern Italy. The SH+ is a psychological intervention developed by the World Health Organization to increase a person's ability to deal with stress. In this trial, it was tested primarily as a tool to reduce anxiety and post-traumatic symptomatology in workers of residential nursing and care homes. In order to partial out non-specific effects of the intervention, the SH+ was compared to an equally supervised and structured alternative activity. Secondarily, in view of future emergencies, the potential of SH+ as a tool to reduce perceived stress, increase subjective well-being and foster individual resilience was explored. At post-intervention, the preregistered analysis revealed no difference in self-reported anxiety and/or post-traumatic symptomatology between the group receiving the SH+ and the group engaged in an alternative activity. Some specific and positive effects of the SH+ intervention were only found on self-reported intervention effectiveness and engagement in exploratory analyses. These findings raise the question whether the previously documented effectiveness of the SH+ on self-reported symptomatology and on the prevention of psychiatric conditions could be attributed mostly to non-specific rather than specific factors connected with participant enrolment in a psychological intervention. Indeed, the effects of the SH+ had been previously compared only to the effects of not being engaged in any alternative activity (often described in the literature as ‘treatment as usual’—or ‘enhanced treatment as usual’, when some relevant information is given to the control group as a one-off). Given the negative findings of this study, before the SH+ is implemented in clinical practice, further studies should be conducted to examine its short- and long-term beneficial effects, by means of randomized studies that employ alternative but similarly structured interventions as control conditions, aiming to minimize the confounding effect of non-specific factors.


SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A145-A145
Author(s):  
Sumedha Verma ◽  
Nina Quin ◽  
Laura Astbury ◽  
Cornelia Wellecke ◽  
Joshua Wiley ◽  
...  

Abstract Introduction Symptoms of insomnia are common in the postpartum period and are associated with a range of negative outcomes. Despite this, interventions to improve maternal postpartum sleep remain scarce. Cognitive Behavioral Therapy (CBT) and Light Dark Therapy (LDT) target two different mechanisms to reduce sleep disturbance. This randomized controlled trial examined the efficacy of CBT and LDT against a treatment-as-usual (TAU) condition in reducing maternal postpartum insomnia symptoms. Methods Nulliparous women 4–12 months postpartum with self-reported symptoms of insomnia (Insomnia Severity Index scores [ISI] &gt;7) were included; excluded were those with: current severe health/psychiatric conditions, unsettled infant behaviors, sleep-affecting medication use and photosensitivity. Eligible women were randomized 1:1:1 to 6 weeks of CBT (CBT for insomnia and fatigue), LDT (morning bright light therapy, evening light hygiene), or TAU. Interventions were therapist-assisted and personalized through two telephone calls and included automated self-help intervention materials (i.e., emails) delivered over six weeks. Symptoms of insomnia (ISI; primary outcome), fatigue, sleepiness, depression, and anxiety were assessed at baseline, mid-intervention, post-intervention, and 1-month post-intervention. Analyses were intention-to-treat latent growth models. Results 114 women were randomized (mean age = 32.20 ± 4.62 years) and 108 women completed the intervention. Compared to TAU, symptoms of insomnia significantly reduced from baseline to post-intervention in both CBT and LDT groups (p-values &lt;.001), with very large effect sizes (d &gt; 1.5) at post-intervention; gains were maintained at follow-up. Fatigue symptoms significantly reduced in the CBT group (p&lt;.0001; d = 0.85) but not LDT (p = 0.11) compared to TAU at post-intervention; gains were maintained for CBT at follow-up. Group differences in sleepiness, depression, and anxiety were nonsignificant (all p &gt; 0.08). Conclusion Therapist-assisted self-help CBT and LDT with different therapeutic mechanisms are both efficacious for reducing maternal insomnia symptoms during the postpartum period. Findings were mixed for fatigue, sleepiness and mood. Future research on predictors of treatment responses is needed. Support (if any) Australian National Health and Medical Research Council, Department of Education RTP Scholarship. Lucimed SA supplied light therapy glasses. Funders had no role in design/implementation of the trial. ANZCTR: ACTRN12618000842268.


2020 ◽  
Author(s):  
Kostadin Kushlev ◽  
Samantha Heintzelman

Happier people are healthier, but does becoming happier lead to better health? In the current work, we deploy a comprehensive, three-month positive psychological intervention (PPI) as an experimental tool to examine the effects of increasing happiness on physical health in a nonclinical population. In a randomized controlled trial (RCT), we found treatment participants had an incidence rate of sick days half as large as control participants, experiencing ever fewer sick days over the course of the program. These effects on physical health persisted three months after treatment and were mediated through the treatment effects on higher positive affect and life satisfaction, and lower negative affect. Beyond self-report, the positive intervention also had modest effects on lowering blood pressure and preventing weight gain. Combining experimental and longitudinal methodologies, this work provides critical evidence for a causal effect of happiness on physical health.


2022 ◽  
Vol 21 (1) ◽  
pp. 88-95
Author(s):  
Ceren Acarturk ◽  
Ersin Uygun ◽  
Zeynep Ilkkursun ◽  
Kenneth Carswell ◽  
Federico Tedeschi ◽  
...  

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