Sustainable Upscaling of Depression Prevention

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT05633186
• Lead Sponsor: VU University of Amsterdam

Brief 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.

Detailed Description

Given the substantial prevalence rate of Major Depression and its extreme burden among the general population, depression prevention is a high priority on the Dutch public health agenda. The aim of the Depression Prevention Program of the Dutch Ministry of Health, Welfare and Sport (Meerjarenprogramma (MJP, VWS 2017) entails a decrease in major depression prevalence of 30% by the year 2030. One solution to the problem is to offer online self-help interventions focusing on psycho-education, skills-training and lifestyle with the aim to improve mood. These interventions have proven to be effective and can prevent mood problems to sustain and/or worsen (van Zoonen et al., 2014). Self-help interventions are easily accessible and acceptable, and they can reach a population at low costs and on a large scale (Riper et al. 2010).

Still, while online self-help interventions can be effective (Karyotaki et al., 2017), engagement barriers exist, adherence rates are generally low, and integration into daily life routines is difficult to achieve (Karyotaki et al., 2015), which may jeopardize the potential population health impact of these interventions. From this perspective there is a clear optimization need of evidence-based online self-help interventions to increase their impact on the general population. One way to increase adherence and engagement, and subsequently the effectiveness of such interventions, is to administer the intervention with the help of (motivational) guidance elements. Guided interventions are known to increase adherence, engagement and effectiveness of interventions and can be operationalized in various ways (Mohr, Cuijpers \& Lehman, 2011; Kelders, 2017). Examples for types of guidance are human coaches, computerized coaches, chat support functions, personalized messages, and many more. While those motivational guidance elements can help the self-help interventions effectiveness, they come with higher costs as they need, for example, an infrastructure of therapists or coaches. It is therefore of high value to find the optimal balance between the effectiveness of the intervention and the necessary support components to establish a product with the potential to be implemented at scale.

The first objective of this study is to examine whether the effectiveness of an online self-help intervention ("Moodbuster Life") for adults who want to improve their mood can be optimized by three different motivational guidance components. The motivational components are: 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.

Secondary aims are (1) to investigate whether adherence to the online self-help intervention can be improved by three different motivational components and (2) to compare the additional effects of one component against additional costs defined as extra time investment (in the platform and beyond) and financial costs (service costs, costs incurred by participants).

Study Timeline

• Study Start: 2022-08-31
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

Inclusion Criteria

• Aged 18 years or older
• Mild to moderate depression as defined by a score between 5 and 15 on the Patient Health Questionnaire - 9 (PHQ-9)
• Adequate written proficiency in the Dutch language
• Have a valid email address and computer with internet access
• In possession of a smartphone

Exclusion Criteria

• Current risk for suicide according to the PHQ-9 questionnaire (question 9, score of 1 or higher)
• Currently receiving psychological treatment for depression or another psychiatric disorder in primary or specialized mental health care
• Currently having a psychiatric disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Mood improvement	6 weeks	Mood is assessed with the Center for Epidemiological Studies Depression Scale (CES-D). The total score ranges from 0 to 60, with a lower score indicating better mood. The CES-D is assessed at baseline and then again after 6 weeks.

Secondary Outcome Measures

Name	Time	Method
Worrying	6 weeks	To assess worrying, the abbreviated Penn State Worry Questionnaire (PSWQ) is administered. This 11-item questionnaire has total scores of 11 to 55, with higher scores indicating more worrying.
Satisfaction with the self-help intervention	6 weeks	Satisfaction with the intervention will be assessed with the Client Satisfaction Questionnaire for internet-based interventions (CSQ-I). The total score of this 8-item questionnaire ranges from 8 to 32, with higher scores indicating higher levels of participant satisfaction.
Technical Alliance	6 weeks	Technical alliance will be assessed with the Technical Alliance Inventory (TAI) at past-intervention. The total score of this 7-item questionnaire ranges from 7 to 84, with higher scores indicating higher levels of technical alliance.
Adherence to the online self-help intervention	5 weeks	Adherence to the intervention is measured with "meta-data". That is, number of logins, duration on the platform, visiting pages, completion of homework assignments (yes/no). Participants are advised to use the intervention for 5 weeks.
Anxiety Symptoms	6 weeks	Anxiety symptoms are measured with the 7-item anxiety subscale of the Hospital Anxiety and Depression Scale (HADS; with a total score ranging from 0 to 21, where higher scores indicate higher anxiety levels).
Problem Solving Skills	6 weeks	Problem solving skills are measured with 6-items (total score ranging from 6 to 36, with higher scores representing better problem solving skills). These 6 items are the six highest loading items of the Approach Avoidance Style subscale of the Problem-Solving Inventory (PSI), which in turn represent the problem solving subscale of the Cognitive Behavioral Therapy Skills scale (CBT-Skills).
Behavioral activation	6 weeks	Levels of behavioral activation are measured with the 9-item Behavioral Activation for Depression Scale - Short Form (BADS-SF; with a total range ranging from 0 to 54, with high scores representing higher activation)
Physical Activity	6 weeks	Information about levels of physical activity is gathered with the 7-item International Physical Activity Questionnaire - Short Form (IPAQ - SF). The scoring of the IPAQ is based on a metric called MET (multiples of the resting metabolic rate) minutes. MET minutes represent the amount of energy expended carrying out a physical activity. With higher scores indicating more vigorous physical activity.
Motivation for following the self-help intervention	6 weeks	Motivation for following the self-help intervention is measured with the 8-item Short Motivation Feedback List (SMFL; with total scores ranging from 0 to 80, where higher scores reflect higher levels of motivation). There are two different versions, of which the pre-intervention version will be assessed at baseline (t0) and the post-intervention one after 6 weeks (t1).
Intervention engagement	6 weeks	Past intervention engagement will be measured with the Twente Engagement with eHealth Technologies Scale (TWEETS) at t1. The total score of this 9-item questionnaire ranges from 0 to 36, with higher scores indicating higher levels of engagement.

Trial Locations

Locations (1)

Vrije Universiteit; 🇳🇱 Amsterdam, Netherlands