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.

Depression Clinical Trial

— CT_DoBetter  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06442072
• Other study ID #: CT2024RW
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Rethink Wellbeing
• Contact: Inga Grossmann, PhD.
• Phone: +4915209828014
• Email: inga[@]rethinkwellbeing.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Cognitive Dysfunction
• Depression
• Interpersonal Relations
• Loneliness
• Mental Health Issue
• Quality of Life
• Self Esteem
• Social Functioning
• Treatment Adherence and Compliance

Intervention

Behavioral:
• guided online self-help program
16 weeks of training and application of psychotherapeutic methods

Locations

Country	Name	City	State
Netherlands	Rethink Wellbeing	Wapenveld

Sponsors (2)

Lead Sponsor	Collaborator
Rethink Wellbeing	Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Loneliness	UCLA-3	Week 0, 8, 12, 16
Secondary	Self-esteem	Rosenberg Self-esteem Scale	Week 0, 8, 12, 16
Secondary	Connection/will to do good	by IWAH	Week 0, 8, 12, 16
Secondary	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
Secondary	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