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.

NCT ID: NCT06442072

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

guided online self-help program

Intervention Type BEHAVIORAL

16 weeks of training and application of psychotherapeutic methods

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

Group Type ACTIVE_COMPARATOR

guided online self-help program

Intervention Type BEHAVIORAL

16 weeks of training and application of psychotherapeutic methods

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

Group Type ACTIVE_COMPARATOR

guided online self-help program

Intervention Type BEHAVIORAL

16 weeks of training and application of psychotherapeutic methods

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

Group Type ACTIVE_COMPARATOR

guided online self-help program

Intervention Type BEHAVIORAL

16 weeks of training and application of psychotherapeutic methods

Interventions

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guided online self-help program

16 weeks of training and application of psychotherapeutic methods

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University

OTHER

Sponsor Role collaborator

Rethink Wellbeing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Inga Grossmann, PhD.

Role: STUDY_DIRECTOR

Rethink Wellbeing

Locations

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Rethink Wellbeing

Wapenveld, , Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Inga Grossmann, PhD.

Role: CONTACT

+4915209828014

Facility Contacts

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Inga Grossmann, PhD.

Role: primary

Other Identifiers

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CT2024RW

Identifier Type: -

Identifier Source: org_study_id

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