Global Controlled Trial on Effects of an Online Self-Help Program for of Ambitious Altruists on Their Mental Health, Wellbeing, and Productivity: Comparing Versions With IFS vs. CBT, Buddy- vs. Group-, Standard- vs. Minimum-Guidance Intensity. (CT_DoBetter)

Global Controlled Trial on Effects of a Guided Online Self-Help Program for of Ambitious Altruists on Their Mental Health, Wellbeing, and Productivity

This study aims to compare different versions of a 16-week online self-help program in terms of their effect on self-assessed mental health, well-being, and productivity. The versions differ in their intensity (standard, low) and type (buddy, group) of guidance, the applied psychotherapeutic approaches taught (IFS, CBT). We expect to recruit a sample of ~150 ambitious altruists and have them self-select into the four program versions. Participants take part in surveys before, at weeks 8, 12, and 16 to self-assess their productivity, mental health burden, quality of life, and other risk and protection factors. Weekly screenings will provide data on objective and subjective success components such as participant engagement, working alliance, and treatment adherence, which will be correlated with primary and secondary outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Quality of Life; Cognitive Dysfunction; Anxiety; Loneliness; Treatment Adherence and Compliance; Mental Health Issue; Self Esteem; Interpersonal Relations; Functioning, Psychosocial; Social Functioning; Well-Being, Psychological; Functioning, Social
• Intervention / Treatment: Behavioral: guided online self-help program

Detailed Description

Aim:

This study aims to compare different versions of an online self-help program in terms of their effect on self-assessed mental health, well-being, and productivity. The goal is to find out if a version might be more effective or similarly effective but less costly than the original one.

Control groups:

The original program version is an 8-week course with weekly guided group sessions of 2 hours: Third Wave CBT methods are taught by a workbook and practised in between the sessions. The pre-post results, on 42 ambitious altruists, showed significant moderate effects on all scales after week 12. In this study, we aim to compare the effects of the original version with 1. one using a buddy instead of the group format, 2. one using less guidance (3 instead of 9 group sessions), and 3. one using Internal Family Systems instead of Third Wave CBT. Instead of 8 weeks, we spaced out the same amount of sessions for the program after week 6, so that the last follow-up session will take place for everyone at week 16 now.

Sample:

We expect to deliver the program to ~150 participants, and each version to at least 25 of those. Ambitious altruists will be recruited via posts on Facebook and Slack online groups and personal contact to organizations associated with Effective Altruism. People will self-select into the different program versions. We exclude those in acute crisis, those with very low self-assessed social competence, and those who report not being ambitiously altruistic. We match groups and buddies based on availability and on, who we believe will bond better, i.e., similar age and career stage.

Measurements. Participants take part in Google form surveys before, at weeks 8, 12, and 16. These measure productivity (WPAI:GH), mental health burden (symptoms of interpersonal sensitivity, and OCD by BSI, depressiveness and anxiety by GAD7 & PHQ8), quality of life (WHOQOL-BREF, MHC-SF, ONS-4 LS), and other relevant factors (loneliness by UCLA-3, self-esteem by Rosenberg Self-esteem Scale, connection/will to do good by IWAH). An independent researcher, likely from Maastricht University, will likely check our data, calculate the results, and publish a paper about it to reduce potential biases. Also, participants' engagement will be assessed, i.e., no-shows, and dropouts, and participants attend a weekly screening in weeks 1-8, 12, and 16 to rate different success components, e.g. session engagement, working alliance, and treatment adherence. Those measures will be correlated with the primary and secondary outcomes at one point to see what influences outcomes and how strongly.

We applied to get an official letter of exemption from an ethics review due to these reasons:

• The study is only part of the already existing programs, nothing is changed in the operations affecting the participants due to the evaluation/study run
• Measurements are part of routine progress tracking
• The data is being used for publication purposes but does not introduce new risks
• The interventions as well as the data collection are 100% non-invasive and include a signed participant consent.
• The sampling excludes potentially vulnerable individuals, i.e., those in a current crisis.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Inga Grossmann, PhD.; Phone Number: +4915209828014; Email: inga@rethinkwellbeing.org

Study Locations

• Netherlands
  • Wapenveld, Netherlands, 8191TM
    • Rethink Wellbeing
    • Contact: Inga Grossmann, PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Exclusion Criteria:

• average of self-assessed sociality negative
• people in acute crisis (they confirm and sign to not be in such a state)
• people who self-report not to be ambitiously altruistic, i.g., not involved in the effective altruism community, or working on or planning to work on something impactful that might help others.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CBT Group Standard Guidance; 9 group sessions, at week 0-6, 8, 12, 18; groups of 4-6 peers and a trained facilitator; participants work through the tailored Third Wave CBT workbook by Rethink Wellbeing, one chapter each week; in between sessions, people practice the new skills learned in the workbook and are supported in an online community, guided by a trained psychologist and psychotherapist	Behavioral: guided online self-help program; 16 weeks of training and application of psychotherapeutic methods
Active Comparator: CBT Buddy Standard Guidance; 9 1:1 sessions after buddies get training in supporting each other - at week 0-6, 8, 12, 18; groups of up to 30 peers and a trained facilitator; participants work through the tailored Third Wave CBT workbook by Rethink Wellbeing, one chapter each week; in between buddy-sessions, people practice the new skills learned in the workbook and are supported in an online community, guided by a trained psychologist and psychotherapist	Behavioral: guided online self-help program; 16 weeks of training and application of psychotherapeutic methods
Active Comparator: CBT Group Minimum Guidance; 3 instead of 9 sessions, in week 1, 8 and 16.; groups of up to 30 peers and a trained facilitator; participants work through the tailored Third Wave CBT workbook by Rethink Wellbeing, one chapter each week; in between, people practice the new skills learned in the workbook and are supported in an online community, guided by a trained psychologist and psychotherapist	Behavioral: guided online self-help program; 16 weeks of training and application of psychotherapeutic methods
Active Comparator: IFS Group Standard Guidance; 9 group sessions, at week 0-6, 8, 12, 18; groups of 4-6 peers and a trained facilitator; Internal Family Systems methods taught instead of CBT methods as in every other group; participants work through the book "Self-Therapy: A Step-By-Step Guide to Creating Wholeness and Healing Your Inner Child Using IFS, A New, Cutting-Edge Psychotherapy" by Jay Earley, a few chapters each week; in between, people practice the new skills learned in the workbook and are supported in an online community, guided by a trained psychologist and psychotherapist	Behavioral: guided online self-help program; 16 weeks of training and application of psychotherapeutic methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Productivity	by WPAI:GH: Work Productivity & Activity Impairment Questionnaire. The item values will be merged into one scale by turning each into a z-score while higher numbers will mean a higher productivity, and then calculating the average.	Week 0, 8, 12, 16
Mental health burden	symptoms of interpersonal sensitivity, and executive dysfunction by BSI, of depressiveness and anxiety by GAD7 & PHQ8. The scores will be merged into one by turning each of the 4 scales into a z-score while higher numbers will mean a larger burden, and then calculating the average.	Week 0, 8, 12, 16
Wellbeing	psychological, social and emotional functioning as well as quality of life by WHOQOL-BREF, MHC-SF ONS-4 LS. The scores will be merged into one by turning each of the scales into a z-score while higher numbers will mean a higher wellbeing, and then calculating the average.	Week 0, 8, 12, 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loneliness	UCLA-3	Week 0, 8, 12, 16
Self-esteem	Rosenberg Self-esteem Scale	Week 0, 8, 12, 16
Connection/will to do good	by IWAH	Week 0, 8, 12, 16
Program dropout	% of participants announcing their drop-out or not showing up to 2+ sessions, higher numbers mean higher dropout	Week 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16
Weekly engagement	Treatment adherence, session engagement, working alliance, session attendance rate. The scores will be merged into one by turning each of the values into a z-score while higher numbers will mean a higher engagement, and then calculating the average.	Week 1, 2, 3, 4, 5, 6, 8, 12, 16

Collaborators and Investigators

• Sponsor: Rethink Wellbeing
• Collaborators: Maastricht University
• Investigators: Study Director: Inga Grossmann, PhD., Rethink Wellbeing

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 18, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Estimated): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Mental Health; Prevention; guided self-help; CBT; Effectiveness; Controlled trial; IFS; Productivtiy
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: CT2024RW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No