NCT05633186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

November 16, 2022

Last Update Submit

May 7, 2024

Conditions

Depression

Keywords

UpscalingDepression preventionInternet interventionscostsimplementation

Outcome Measures

Primary Outcomes (1)

  • Mood improvement

    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.

    6 weeks

Secondary Outcomes (10)

  • Adherence to the online self-help intervention

    5 weeks

  • Anxiety Symptoms

    6 weeks

  • Problem Solving Skills

    6 weeks

  • Behavioral activation

    6 weeks

  • Worrying

    6 weeks

  • +5 more secondary outcomes

Other Outcomes (2)

  • Costs for each component

    5 weeks

  • Time investment

    6 weeks

Study Arms (8)

Condition 1

EXPERIMENTAL

Moodbuster Life + Mobile Application + Guidance by a coach + Motivational Content

Behavioral: Moodbuster LifeBehavioral: Mobile applicationBehavioral: Guidance by a coachBehavioral: Motivational Content

Condition 2

EXPERIMENTAL

Moodbuster Life + Mobile Application + Guidance by a coach

Behavioral: Moodbuster LifeBehavioral: Mobile applicationBehavioral: Guidance by a coach

Condition 3

EXPERIMENTAL

Moodbuster Life + Mobile Application + Motivational Content

Behavioral: Moodbuster LifeBehavioral: Mobile applicationBehavioral: Motivational Content

Condition 4

EXPERIMENTAL

Moodbuster Life + Mobile Application

Behavioral: Moodbuster LifeBehavioral: Mobile application

Condition 5

EXPERIMENTAL

Moodbuster Life + Guidance by a coach + Motivational Content

Behavioral: Moodbuster LifeBehavioral: Guidance by a coachBehavioral: Motivational Content

Condition 6

EXPERIMENTAL

Moodbuster Life + Guidance by a coach

Behavioral: Moodbuster LifeBehavioral: Guidance by a coach

Condition 7

EXPERIMENTAL

Moodbuster Life + Motivational Content

Behavioral: Moodbuster LifeBehavioral: Motivational Content

Condition 8

EXPERIMENTAL

Moodbuster Life

Behavioral: Moodbuster Life

Interventions

Moodbuster LifeBEHAVIORAL

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.

Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8
Mobile applicationBEHAVIORAL

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.

Condition 1Condition 2Condition 3Condition 4
Guidance by a coachBEHAVIORAL

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.

Condition 1Condition 2Condition 5Condition 6
Motivational ContentBEHAVIORAL

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.

Condition 1Condition 3Condition 5Condition 7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit

Amsterdam, Netherlands

Location

Related Publications (13)

  • Buntrock C, Ebert DD, Lehr D, Smit F, Riper H, Berking M, Cuijpers P. Effect of a Web-Based Guided Self-help Intervention for Prevention of Major Depression in Adults With Subthreshold Depression: A Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1854-63. doi: 10.1001/jama.2016.4326.

    PMID: 27139058BACKGROUND

  • Simon GE, VonKorff M, Rutter C, Wagner E. Randomised trial of monitoring, feedback, and management of care by telephone to improve treatment of depression in primary care. BMJ. 2000 Feb 26;320(7234):550-4. doi: 10.1136/bmj.320.7234.550.

    PMID: 10688563BACKGROUND

  • Batterham PJ, Calear AL. Preferences for Internet-Based Mental Health Interventions in an Adult Online Sample: Findings From an Online Community Survey. JMIR Ment Health. 2017 Jun 30;4(2):e26. doi: 10.2196/mental.7722.

    PMID: 28666976RESULT

  • Buntrock C, Ebert D, Lehr D, Riper H, Smit F, Cuijpers P, Berking M. Effectiveness of a web-based cognitive behavioural intervention for subthreshold depression: pragmatic randomised controlled trial. Psychother Psychosom. 2015;84(6):348-58. doi: 10.1159/000438673. Epub 2015 Sep 24.

    PMID: 26398885RESULT

  • Hassouni, A. E., Hoogendoorn, M., van Otterlo, M., Eiben, A. E., Muhonen, V., & Barbaro, E. (2018). A clustering-based reinforcement learning approach for tailored personalization of e-Health interventions. arXiv preprint arXiv:1804.03592.

    RESULT

  • Karyotaki E, Kleiboer A, Smit F, Turner DT, Pastor AM, Andersson G, Berger T, Botella C, Breton JM, Carlbring P, Christensen H, de Graaf E, Griffiths K, Donker T, Farrer L, Huibers MJ, Lenndin J, Mackinnon A, Meyer B, Moritz S, Riper H, Spek V, Vernmark K, Cuijpers P. Predictors of treatment dropout in self-guided web-based interventions for depression: an 'individual patient data' meta-analysis. Psychol Med. 2015 Oct;45(13):2717-26. doi: 10.1017/S0033291715000665. Epub 2015 Apr 17.

    PMID: 25881626RESULT

  • Karyotaki E, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, Mackinnon A, Meyer B, Botella C, Littlewood E, Andersson G, Christensen H, Klein JP, Schroder J, Breton-Lopez J, Scheider J, Griffiths K, Farrer L, Huibers MJ, Phillips R, Gilbody S, Moritz S, Berger T, Pop V, Spek V, Cuijpers P. Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data. JAMA Psychiatry. 2017 Apr 1;74(4):351-359. doi: 10.1001/jamapsychiatry.2017.0044.

    PMID: 28241179RESULT

  • Kelders, S. M. (2015, June). Involvement as a working mechanism for persuasive technology. In International Conference on Persuasive Technology (pp. 3-14). Springer, Cham.

    RESULT

  • Kranzler HR, McKay JR. Personalized treatment of alcohol dependence. Curr Psychiatry Rep. 2012 Oct;14(5):486-93. doi: 10.1007/s11920-012-0296-5.

    PMID: 22810115RESULT

  • Mohr DC, Cuijpers P, Lehman K. Supportive accountability: a model for providing human support to enhance adherence to eHealth interventions. J Med Internet Res. 2011 Mar 10;13(1):e30. doi: 10.2196/jmir.1602.

    PMID: 21393123RESULT

  • Riper H, Andersson G, Christensen H, Cuijpers P, Lange A, Eysenbach G. Theme issue on e-mental health: a growing field in internet research. J Med Internet Res. 2010 Dec 19;12(5):e74. doi: 10.2196/jmir.1713.

    PMID: 21169177RESULT

  • van Zoonen K, Buntrock C, Ebert DD, Smit F, Reynolds CF 3rd, Beekman AT, Cuijpers P. Preventing the onset of major depressive disorder: a meta-analytic review of psychological interventions. Int J Epidemiol. 2014 Apr;43(2):318-29. doi: 10.1093/ije/dyt175.

    PMID: 24760873RESULT

  • Warmerdam L, Riper H, Klein M, van den Ven P, Rocha A, Ricardo Henriques M, Tousset E, Silva H, Andersson G, Cuijpers P. Innovative ICT solutions to improve treatment outcomes for depression: the ICT4Depression project. Stud Health Technol Inform. 2012;181:339-43.

    PMID: 22954884RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Heleen Riper, Prof.dr.

    Department of Clinical, Neuro and Developmental Psychology, Vrije Universiteit, 1081BT Amsterdam, The Netherlands

    PRINCIPAL INVESTIGATOR

  • Annet Kleiboer, dr.

    Department of Clinical, Neuro and Developmental Psychology, Vrije Universiteit, 1081BT Amsterdam, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Study participants cannot be blinded to the allocation scheme as the participants will know what components are added to their intervention.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: All participants receive access to the Moodbuster Life intervention with no or a maximum of 3 additional components. The investigators will use a full-factorial design to study the additional effect of each component either alone or in interaction. Participants are randomized to one of all possible combinations of the 3 components. In our study, with 3 additional components, this means that there are 8 conditions (2x2x2).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 16, 2022

First Posted

December 1, 2022

Study Start

August 31, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Individual participant data (anonymised and encrypted) will be available on request following a standardized data accession form.

Shared Documents
STUDY PROTOCOL
Time Frame
Immediately following publication of the main results, no end date.
Access Criteria
Accession will be granted through a standardized accession form following review by the project's PI.

Locations

NL(1)