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.

NCT06442072 | Not Yet Recruiting DMC

• 1 other identifier: CT2024RW
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Loneliness

  Week 0, 8, 12, 16

• Self-esteem

  Week 0, 8, 12, 16

• Connection/will to do good

  Week 0, 8, 12, 16

• Program dropout

  Week 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16

• Weekly engagement

  Week 1, 2, 3, 4, 5, 6, 8, 12, 16

Study Arms (4)

CBT Group Standard Guidance

ACTIVE COMPARATOR

* 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

CBT Buddy Standard Guidance

ACTIVE COMPARATOR

* 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

CBT Group Minimum Guidance

ACTIVE COMPARATOR

* 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

IFS Group Standard Guidance

ACTIVE COMPARATOR

* 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

Interventions

guided online self-help program BEHAVIORAL

16 weeks of training and application of psychotherapeutic methods

CBT Buddy Standard Guidance; CBT Group Minimum Guidance; CBT Group Standard Guidance; IFS Group Standard Guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rethink Wellbeing: lead
• Maastricht University: collaborator

Study Sites (1)

Rethink Wellbeing

Wapenveld, 8191TM, Netherlands

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance; Anxiety Disorders; Depression; Psychological Well-Being; Social Adjustment; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Mental Disorders; Behavioral Symptoms; Personal Satisfaction; Social Behavior; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Inga Grossmann, PhD.

  Rethink Wellbeing

  STUDY DIRECTOR

Central Study Contacts

Inga Grossmann, PhD.

CONTACT

+4915209828014; inga@rethinkwellbeing.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: June 4, 2024
• Study Start: June 10, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)