Clinical trial NCT06442072: 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.
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Treatment Adherence and Compliance
Anxiety
Depression
Mental Health Issue
Quality of Life
Well-Being, Psychological
Social Functioning
Cognitive Dysfunction
Interpersonal Relations
Self Esteem
Loneliness
Functioning, Psychosocial
Functioning, Social
Keywords: Mental Health
CBT
Productivtiy
Controlled trial
Effectiveness
Prevention
guided self-help
IFS
Lead sponsor: Rethink Wellbeing
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2024-06-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Productivity
timeFrame: Week 0, 8, 12, 16
measure: Mental health burden
timeFrame: Week 0, 8, 12, 16
measure: Wellbeing
timeFrame: Week 0, 8, 12, 16
Secondary outcomes:
measure: Loneliness
timeFrame: Week 0, 8, 12, 16
measure: Self-esteem
timeFrame: Week 0, 8, 12, 16
measure: Connection/will to do good
timeFrame: Week 0, 8, 12, 16
measure: Program dropout
timeFrame: Week 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16
measure: Weekly engagement
timeFrame: Week 1, 2, 3, 4, 5, 6, 8, 12, 16
Other outcomes:
Locations:
city: Wapenveld
country: Netherlands
facility: Rethink Wellbeing
Study officials:
affiliation: Rethink Wellbeing
name: Inga Grossmann, PhD.
role: STUDY_DIRECTOR
References: