Treatment Adherence and ComplianceCT_DoBetterNCT06442072
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.
A study testing guided online self-help program in people with Treatment Adherence and Compliance and Anxiety, run by Rethink Wellbeing at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Treatment Adherence and Compliance, Anxiety, Depression
- What is being tested?
- guided online self-help program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jun 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Treatment Adherence and Compliance, Anxiety, Depression, Mental Health Issue, Quality of Life, Well-Being, Psychological
- Being tested
- guided online self-help program
- Keywords
- Mental Health, CBT, Productivtiy, Controlled trial, Effectiveness, Prevention, guided self-help, IFS
- Medical subject headings
- Treatment Adherence and Compliance, Anxiety Disorders, Depression, Psychological Well-Being, Social Adjustment, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided online self-help programBehavioural
16 weeks of training and application of psychotherapeutic methods
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: guided online self-help program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 0, 8, 12, 16
Secondary outcomes (5)
Loneliness
UCLA-3
Measured: Week 0, 8, 12, 16
Self-esteem
Rosenberg Self-esteem Scale
Measured: Week 0, 8, 12, 16
Connection/will to do good
by IWAH
Measured: 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
Measured: 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.
Measured: Week 1, 2, 3, 4, 5, 6, 8, 12, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start10 Jun 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Adherence and ComplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rethink Wellbeing
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Sponsor
- Investigators
- Inga Grossmann, PhD., Study director, Rethink Wellbeing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442072
- Sponsor's protocol ID
- CT2024RW
- Acronym
- CT_DoBetter
- Status last verified
- May 2024
- First submitted
- 18 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06442072
- Acronym / sponsor ID
- CT_DoBetter / CT2024RW
- Conditions
- Treatment Adherence and Compliance, Anxiety, Depression, Mental Health Issue, Quality of Life, Well-Being, Psychological
- Keywords
- Mental Health, CBT, Productivtiy, Controlled trial, Effectiveness, Prevention, guided self-help, IFS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rethink WellbeingUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- 10 Jun 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CBT Group Standard Guidance | Active comparator | Behavioral: guided online self-help program* 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 |
| CBT Buddy Standard Guidance | Active comparator | Behavioral: guided online self-help program* 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 |
| CBT Group Minimum Guidance | Active comparator | Behavioral: guided online self-help program* 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 |
| IFS Group Standard Guidance | Active comparator | Behavioral: guided online self-help program* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| guided online self-help program16 weeks of training and application of psychotherapeutic methods | Behavioural | CBT Buddy Standard Guidance, CBT Group Minimum Guidance, CBT Group Standard Guidance, IFS Group Standard Guidance |
Primary outcome
Productivity
Time frame: Week 0, 8, 12, 16
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.
Mental health burden
Time frame: Week 0, 8, 12, 16
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.
Wellbeing
Time frame: Week 0, 8, 12, 16
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.
5 secondary outcomes
Loneliness
Time frame: Week 0, 8, 12, 16
Self-esteem
Time frame: Week 0, 8, 12, 16
Connection/will to do good
Time frame: Week 0, 8, 12, 16
Program dropout
Time frame: Week 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16
Weekly engagement
Time frame: Week 1, 2, 3, 4, 5, 6, 8, 12, 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inga Grossmann, PhD. study director
Rethink Wellbeing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided online self-help program in people with Treatment Adherence and Compliance and Anxiety, run by Rethink Wellbeing at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inga Grossmann, PhD. (+4915209828014, inga@rethinkwellbeing.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Productivity (time frame: Week 0, 8, 12, 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.