Sustainable Upscaling of Depression Prevention

NCT05633186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2024-05-09

No results posted yet for this study

Summary

Research shows that online unguided self-help interventions focused on psycho-education, skills training and lifestyle can prevent mild mood complaints from turning into a full-blown depression. These encouraging results are found even though the adherence to these types of interventions is generally low.

With this project, the investigators examine whether effectiveness and adherence to online unguided self-help interventions can be increased by additional motivational guidance elements. This is examined by adding three additional components to the intervention: 1) A coach who provides online feedback once a week to provide support. 2) Mobile application to monitor mood and related factors and to receive automated personalized messages, 3) Content based on the principles of motivational interviewing. A secondary aim is to compare the additional effects of the individual components against the additional costs.

Conditions

Interventions

BEHAVIORAL

Moodbuster Life

All participants get access to the Moodbuster Life intervention. Moodbuster Life is an online self-help intervention that contains 5 web-based modules focusing on lifestyle and coping: psycho-education, behavioral activation, physical activity, problem-solving, and worrying. All participants start with module 1, psycho-education. Next, participants can choose what module they wish to continue with. All modules take about 45 minutes to complete and contain text, exercises, video clips and preparing the home-work assignments. Executing the home-work assignments may take 20 minutes each week.

BEHAVIORAL

Mobile application

The participants randomized to receive this component will receive access to a mobile application. The aim of this app is two-folded, (1) used for diary ratings, (2) sending out personalized automated messages. First, the participants will rate their mood, sleep and related factors on a daily basis. The participants are prompted to rate the diary ratings three times a day (morning, afternoon, evening). Moreover, the application graphically pictures progression over time. Second, the application will send personalized automated messages. The content of the messages is informative, affirmative or encouraging. The investigators will use reinforcement learning (RL) to find so-called policies that show best long-term engagement and most sustained improvement of participants' mood. To drive choices, the investigators will use the data mentioned in the advising for the modules as well as behavioral data (mood ratings), data across all users is exploited.

BEHAVIORAL

Guidance by a coach

A coach will provide support once per week at a scheduled time to participants who are allocated to receive support. The coaches are psychologists who are not part of the research team. The support will be provided via the Moodbuster Life messaging system and is focused on helping the participant work through the modules, showing empathy and motivating the participants to continue with the modules. The coaching is not aimed at developing a patient-therapist relationship.

BEHAVIORAL

Motivational Content

Participants who are randomized to this component, receive access to extra content that is based on the principles of motivational interviewing. This includes an extended first module that contains psychoeducation on the importance of motivations and on how persons can motivate themselves to engage with the interventions. Participants are asked about their life goals (long term) and intervention goals (short time) and are guided in how they should formulate these goals to increase the chance of success. Moreover, in each of the 4 modules a short exercise aimed at increasing motivation is included.

Sponsors & Collaborators

  • VU University of Amsterdam

    lead OTHER

Principal Investigators

  • Heleen Riper, Prof.dr. · Department of Clinical, Neuro and Developmental Psychology, Vrije Universiteit, 1081BT Amsterdam, The Netherlands

  • Annet Kleiboer, dr. · Department of Clinical, Neuro and Developmental Psychology, Vrije Universiteit, 1081BT Amsterdam, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05633186 on ClinicalTrials.gov