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The acceptance of digital mental mental health interventions for binge eating

The acceptance of digital mental health interventions for recurrent binge eating. A randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001054808
Enrollment
230
Registered
2021-08-10
Start date
2021-08-02
Completion date
2021-08-27
Last updated
2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The present study will evaluate whether a brief acceptance-facilitated intervention can improve participants acceptance of digital mental health interventions for recurrent binge eating. We will also assess whether this AFI can boost motivation, positive attitudes, intervention uptake and engagement, study retention, and symptom improvement. While AFIs have been shown to lead to these outcomes in other clinical conditions (e.g., depression, chronic pain etc.), it is as yet unclear whether this pattern of results generalize to people with recurrent binge eating. If demonstrated, improvements in receptiveness to cheap and scalable mental health interventions may be realized. The following hypothesis was derived. Participants randomized to the AFI will experience significantly greater improvements in all primary and secondary outcomes than participants randomized to an assessment only condition.

Interventions

The intervention administered in this study is called an acceptance-facilitated intervention (AFI).The AFI consists of a 5-8 min video in which the Investigator's provide information about digital mental health interventions for binge eating, with the intention of positively influencing clients' acceptance of these intervention modalities. The AFI content is based on the assumptions of the Unified Theory of Acceptance of Technology and the evidence on barriers of acceptance. The information pres

The intervention administered in this study is called an acceptance-facilitated intervention (AFI).The AFI consists of a 5-8 min video in which the Investigator's provide information about digital mental health interventions for binge eating, with the intention of positively influencing clients' acceptance of these intervention modalities. The AFI content is based on the assumptions of the Unified Theory of Acceptance of Technology and the evidence on barriers of acceptance. The information presented consists of evidence for the effectiveness of digital interventions for binge eating, data security and anonymity concerning digital interventions, the broad range of advantages (e.g., flexibility, cost-effective etc.), and the potential to receive technical support. The intervention will also address many barriers towards digital health uptake, including data safety, internet anxiety, and skepticism regarding their use. In this AFI video, participants will be provided with instructions on how best to use and access digital interventions, including how to login and set a secure password. The video will be embedded within the Qualtrics platform. In particular, after participants are randomized to this AFI, the video will be presented on the subsequent webpage. Participants merely click on it to watch it. To know whether participants watched the video as instructed, participants will be told prior to the video that 3 multiple choice questions will be asked of them about the video. These "attention check" questions will be very simple and each one will be asked in relation to distinct aspects of the video (e.g., mins 1-2, mins 3-4, then mins 5-6). No other measures of adherence will be applied. After participants complete the AFI video and the measures, they will be prescribed one of two digital interventions (per the pre-registered trial - ACTRN12621000914864). The first will be a internet-based intervention designed to primarily target extreme dietary restraint as the mechanism to reduce binge eating. The internet intervention is composed of 4 sessions. 1. Psycho-education: information on what dieting means, when it can become harmful, and why it can promote binge eating. 2. Self-monitoring: the importance of monitoring behaviors, thoughts, and emotions related to food, eating, and dieting 3. Regular eating: participants taught how to adopt a pattern of regular, flexible eating approach. 4. Food exposure: participants are taught how to overcome fear and anxiety around "forbidden" foods. The second digital intervention will be delivered only via a smartphone app. The app is based on transdiagnostic cognitive-behavioral therapy (Fairburn, 2008) in that it is designed to target a range of factors implicated in the maintenance of binge eating (e.g., overvaluation with weight/shape, extreme dietary restraint & mood intolerance). There are also 4 modules to this app: 1. Psychoeducation about binge eating and its cycle 2. Implementing self-monitoring and regular eating 3. Learning healthy coping strategies through acceptance, mindfulness, and problem solving 4. Building a better body image Each session/module of the two interventions will take around 30-60 minutes to complete, and participants will be encouraged to practice the strategies taught in each session on a daily basis. Therefore, total time commitment will vary from person to person. Participants will be encouraged to stay on each session for around 7 days prior to moving to the next session, although they will be instructed that they can go at a pace that suits themselves. The total duration of the interventions will be 4 weeks, though participants have the opportunity to continue using the interventions after this period. Each session/module will include: written text, quizzes/ interactive video or audio recordings discussing the content of the session and how to implement the prescribed strategies; downloadable handouts to complete the prescribed activities (created for the purpose of this study); and quizzes designed to consolidate learning. Adherence will be monitored by assessing whether participants complete each of the sessions/modules, including how much of the session/module will be completed. This will be extracted from the platforms used to host the two digital interventions.

Sponsors

Deakin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Educational / counselling / training

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants must: 1) Be aged 18 years or over 2) Have access to the internet or smartphone 3) Experience the presence of recurrent binge eating, defined as binge eating at least once per fortnight, on average, over the past 3 months via self-report.

Exclusion criteria

No other exclusion criteria will be employed.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026