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DepressionBA-ProlNCT06181825

Behavioral Activation in Depressed Online Workers

A study testing COMET-BA (Common Elements Toolbox- Behavioral Activation) in people with Depression and Anxiety, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, the investigators will test the effectiveness of a digital, low intensity mental health intervention in depressed individuals. There will be two conditions: the Common Elements Toolbox- Behavioral Activation (COMET-BA) intervention and a waiting list control group. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Anxiety
What is being tested?
COMET-BA (Common Elements Toolbox- Behavioral Activation)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
804 participants
Where
1 siteUnited States
Study dates
1 Jan 2024to 1 May 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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PHQ9 > 9 at baseline, indicate "yes" that they are interested in learning coping skills for their mental health

Who cannot join

  • PHQ9 < or = 9 at baseline, indicate they are not interested in learning coping skills for mental health

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Indiana University

    Bloomington, Indiana, 47405

Other trials in United States

About this study

Official title: Investigating the Efficacy of a Behavioral Activation Low Intensity Intervention in Online Research Participants

In this study, the investigators will test the effectiveness of a digital, low intensity mental health intervention in depressed individuals. There will be two conditions: the Common Elements Toolbox- Behavioral Activation (COMET-BA) intervention and a waiting list control group. COMET-BA will include 4 weekly modules which will focus on elements of behavioral activation, including positive activity scheduling, avoidance, values, and change plans. A similar intervention, was previously tested in an online worker sample and participant feedback was integrated into the current version of the intervention.

Read the detailed description

Participants who follow the study link in Prolific will immediately be taken to the Informed Consent Statement (ICS), which will include a description of the study, risks and benefits, payment, eligibility and confidentiality. After reading the ICS, participants will confirm their consent by clicking "I consent to participate in this study." They will then be taken to the welcome page for the study and confirm that they will provide their best answers (see Attachments, "Screener"). Once participants have confirmed their consent, they will be asked screener and demographic questions (i.e., age, sex assigned at birth, gender, race/ethnicity, sexual orientation, relationship status, education level, annual income, employment status, if they have ever taken psychiatric medication/engagement in mental health services, how many people they can rely on for social support, physical health, how often they drink alcohol, and how old they were when they first struggled with depression, anxiety, or stress). In order to participate in the study, they must indicate "yes" that they are interested in learning coping skills for their mental health at this time. This is meant to address potential bias for online workers to participate in order to receive compensation without interest in adhering to the intervention if randomized to the treatment arm. Additionally, they will be administered the Patient Health Questionnaire 9-item (PHQ-9) and must reach the threshold for elevated depression symptoms (total score > 9). Information about the screener (e.g., types of questions) is provided to participants in the Informed Consent Form. Total time to complete the screener is about 3 minutes.

Participants who are ineligible will be automatically sent to a page that notifies them they do not qualify for the study. At this point their participation will be terminated.

Participants who are eligible for the study will then be prompted to complete the Week 1 Questionnaire (see Attachments, "Week 1") via the Prolific platform. Study team will send out a Bulk Message to eligible participants to complete the weekly modules on a week-by-week basis. The message to participants can be found in the Attachments, "Message". In this questionnaire they will fill out a series of measures including: the Generalized Anxiety Disorder 7-item (GAD-7), WHO-5 Well-being Index (WHO-5), 3 questions from the Insomnia Severity Index (ISI), Emotion Regulation Questionnaire (ERQ), Ten-Item Personality Inventory (TIPI), Adverse Childhood Experiences Scale (ACES), Work and Social Adjustment Scale (WSAS), and the Behavioral Activation for Depression Scale Activation Subscale (BADS-AC). After completing these questionnaires participants will be randomized to either the COMET-BA intervention condition or the control condition (which will receive access to the intervention after 8 weeks ). This randomization will be completed via the Qualtrics randomizer function - which randomly and evenly assigns participants to the two conditions.

Participants who are assigned to the COMET-BA condition will then be taken to the first intervention module (see Attachments, "Week 1"). They will then receive the first module, Positive Activity Scheduling, where participants will learn about the theory underlying behavioral activation and impact of scheduling positive activities. They will be asked to brainstorm and plan a positive activity they can do in the next week. In total, the time estimate for week 1 is about 10 minutes. Participants in the control condition will be notified of the condition assignment and reminded about upcoming weekly questionnaires but will not receive the module for week 1 until the study is over. The time to complete Week 1 for the control condition is about 5 minutes.

In the next week, participants will have access to the Week 2 modules through the Prolific platform and sent a message through the Prolific platform (see attachments "Message"). All participants will complete the weekly outcome measures, including the GAD-7, PHQ-9, WHO-5, ERQ, WSAS, and BADS-AC. For those in the COMET-BA condition, they will receive the Avoidance module (see Attachments, "Week 2"). First, participants will complete the weekly outcome measures, including the GAD-7, PHQ-9, WHO-5, ERQ, WSAS, and BADS-AC. Participants in the COMET-BA condition will then be asked about their adherence to last week's plan, receive psychoeducation around the nature of avoidance in depression, and complete an exercise to practice identifying avoidance strategies before they complete the another positive activity scheduling exercise for the upcoming week. In total, the time estimate for week 2 is about 10 minutes. Participants in the control condition will be administered the questionnaires alone and not the COMET-BA module. The time to complete the questionnaires for Week 2 is about 5 minutes.

In the third week, participants will have access to the Week 3 modules through the Prolific platform and sent a message through the Prolific platform (see attachments "Message"). Participants will complete the weekly outcome measures, including the GAD-7, PHQ-9, WHO-5, ERQ, WSAS, and BADS-AC, and then have access to the Week 3 modules through the Prolific platform. For those in the COMET-BA condition, they will receive the Values module (see Attachments, "Week 3"). First, participants will complete the weekly outcome measures, including the GAD-7, PHQ-9, WHO-5, ERQ, WSAS, and BADS-AC. Participants in this module will again be asked about their adherence to last week's plan, receive psychoeducation around the nature of and benefit to acting on one's values, and complete an exercise to practice identifying their values and a plan to act on them in the upcoming week. In total, the time estimate for Week 3 is about 10 minutes. Participants in the control condition will be administered the questionnaires alone and not the COMET-BA module. The time to complete the questionnaires for Week 3 is about 5 minutes.

In the fourth week, participants will have access to the Week 4 modules through the Prolific platform and sent a message through the Prolific platform (see attachments "Message"). Participants will complete the weekly outcome measures, including the GAD-7, PHQ-9, WHO-5, ERQ, WSAS, and BADS-AC, and then have access to have access to the Week 4 modules through the Prolific platform. For those in the COMET-BA condition, they will receive the Change Plan module (see Attachments, "Week 4"). First, participants will complete the weekly outcome measures, including the GAD-7, PHQ-9, WHO-5, ERQ, WSAS, and BADS-AC. Participants in this module will again be asked about their adherence to last week's plan, then receive psychoeducation around the nature of change plans and complete a change plan exercise for the future. In total, the time estimate for Week 4 is about 10 minutes. Participants in the control condition will be administered the questionnaires alone and not the COMET-BA module. The time to complete the questionnaires for Week 4 is about 5 minutes.

Participants who are assigned to the control condition will receive weekly links through Prolific similar to the COMET-BA condition, but rather than receiving a module they will be directed to a series of questionnaires identical to the weekly questionnaires outlined in the COMET-BA condition (GAD-7, PHQ-9, WHO-5, ERQ, WSAS, and BADS-AC). This is all the control condition will be completing. Provided the intervention condition will entail completing an online, survey-style intervention, the control condition will similarly be completing weekly surveys as a "waitlist" condition until the end of the study, when the intervention materials will be made available freely for all participants. All surveys and intervention materials will end with a mental wellbeing resource list (see Attachments, "Resource List") for both the Control and COMET-BA groups.

After completing the COMET-BA intervention, all participants from both conditions will receive a 1-week follow-up after the completion of the Week 4 module (see Attachments, "Follow-Up 1"). This will include the PHQ-9, GAD-7, WHO-5, ERQ, ISI, WSAS, and the BADS-AC. The same questionnaire will be sent out 3 weeks later to establish a 4-week follow-up (see Attachments, "Follow-Up 2"). Thus, the total time for the study from start to end is about 8 weeks. In the informed consent statement, participants will be informed that there are follow-up assessments that they can receive additional compensation for. The study team will also put a message at the end of each module reminding them to watch for the follow ups. They will not be notified of these follow-up assessments, but will be able to see the follow-up assessments posted on Prolific. Participants who do not complete the follow up assessments within 1 day will be sent a reminder within Prolific's system (see Attachments, "COMET-BA Prolific Follow Up Reminder"). During these follow-ups all participants (e.g., those in both the intervention and control conditions) will complete the following questionnaires: GAD-7, PHQ-9, WHO-5, ISI, ERQ, WSAS, and BADS-AC.

After completing the follow-up measure at 8 weeks, enrollment in the study will end. At this point, participants in the control condition will receive the intervention modules via a link through the Prolific platform (see "Final Message Prolific"). Whether they complete the intervention or not is entirely up to them and it will not be tracked by the research team. Their use of the COMET intervention is entirely optional and will not be recorded by the research team. They will not fill out any follow up measures after completing or not completing the COMET intervention. The materials are made available so they may also access the materials available to those in the intervention condition as they may desire.

Conditions
Depression, Anxiety
Being tested
COMET-BA (Common Elements Toolbox- Behavioral Activation)
Keywords
emotion regulation
Medical subject headings
Depression, Anxiety Disorders, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COMET-BA (Common Elements Toolbox- Behavioral Activation)Behavioural

    COMET-BA includes 4 online weekly modules which focus on elements of behavioral activation, including positive activity scheduling, avoidance reduction, values, and change plans.

Study groups in NCT06181825
Study groupRoleWhat they receive
COMET-BAExperimentalCOMET-BA (Common Elements Toolbox- Behavioral Activation) includes 4 online weekly modules which focus on elements of behavioral activation, including positive activity scheduling, avoidance reduction, values, and change plans.
Receives: Behavioral: COMET-BA (Common Elements Toolbox- Behavioral Activation)
Waitlist ControlNo interventionThoss assigned to the waitlist control condition will complete weekly surveys but will not have access to the COMET-BA materials until the data collection period is over.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Health Questionnaire 9 (PHQ-9)

    Depression symptoms will be assessed with the PHQ-9. The PHQ-9 is a 9-item self-report measure that assesses the frequency of symptoms of major depressive disorder as outlined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Response options range from 0 ("not at all") to 3 (nearly every day). Total scores on the PHQ-9 range from 0-27 with greater scores indicating greater frequency of depressive symptoms. A score greater than or equal to 10 on the PHQ-9 has been identified as a positive screen for major depression (Kroenke \& Spitzer, 2002). PHQ-9 will be assessed at baseline, each week of the intervention, and 1-week and 4-weeks post-intervention follow-up.

    Measured: 8 weeks

  2. Generalized Anxiety Disorder Scale-7 (GAD-7)

    Anxiety symptoms will be assessed with the GAD-7, a 7-item self-report measure that assesses the frequency of anxiety symptoms. Responses range from 0 ("not at all") to 3 ("nearly every day"), yielding total scores that range from 0-21 with greater scores indicating greater frequency of anxiety symptoms. A score greater than or equal to 10 on the GAD-7 has been identified as a positive screen for anxiety in primary care settings (Spitzer et al., 2006). GAD-7 will be assessed at baseline, each week of the intervention, and 1-week and 4-weeks post-intervention follow-up.

    Measured: 8 weeks

  3. World Health Organization Well-Being Index-5 (WHO-5)

    Well-being will be assessed with the WHO-5, a 5-item self-report measure of subjective well-being. Items are rated on a 6-point Likert scale ranging from 0 ("at no time") to 5 ("all of the time"), yielding total raw scores that range from 0-25. Raw scores are multiplied by four to generate a score from 0-100 with greater scores indicating higher levels of subjective well-being. A score of 50 is considered the cutoff to screen for major depression (Topp et al., 2015). WHO-5 will be assessed at baseline, each week of the intervention, and 1-week and 4-weeks post-intervention follow-up.

    Measured: 8 weeks

Secondary outcomes (2)
  1. Emotion Regulation Scale (ERQ)

    The ERQ (Gross \& John, 2003) is a ten-item self-report measure of individual differences in the use of two emotion regulation strategies: cognitive reappraisal (ERQ-reappraisal; items 1, 3, 5, 6, 8, and 10) and expressive suppression (ERQ-suppression; items 2, 4, 6, and 9). The ERQ items are rated on a seven-point Likert scale with responses ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The research team will average item scores to produce final scores on the same metric of the original items (i.e., 1 to 7) in order to make the ERQ-reappraisal and ERQ-suppression subscales (with differing numbers of items) comparable. The ERQ will be assessed at baseline, each week of the intervention, and 1-week and 4-weeks post-intervention follow-up.

    Measured: 8 weeks

  2. Behavioral Activation for Depression Scale Activation Subscale (BADS-AC)

    The BADS is a self-report questionaire of behavioral activation that consists of 25 questions, each rated on a seven-point scale ranging from 0 ("not at all") to 6 ("completely"). The Activation subscale consists of 10 of the questions in the BADS. Items from the Activation subscale are summed to yield a total score of 0-60, with greater scores indicating greater activation. The BADS-AC will be assessed at baseline, each week of the intervention, and 1-week and 4-weeks post-intervention follow-up.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2023
  2. Study start1 Jan 2024
  3. Primary completion1 May 2024
  4. Study completion1 May 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
804 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06181825
Sponsor's protocol ID
19958
Acronym
BA-Prol
Status last verified
May 2024
First submitted
13 Dec 2023
Last updated
17 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Peipert A, Lorenzo-Luaces L. Is there a treatment for the Turker blues? A fully remote nationwide randomized controlled trial of a digital intervention for depression in adult online workers. J Consult Clin Psychol. 2025 Nov;93(11):719-734. doi: 10.1037/ccp0000982.

    PubMed 41182705

Questions about this trial

What is this clinical trial studying?

A study testing COMET-BA (Common Elements Toolbox- Behavioral Activation) in people with Depression and Anxiety, run by Indiana University at 1 site in United States.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 May 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire 9 (PHQ-9) (time frame: 8 weeks). 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?

On the ClinicalTrials.gov record for NCT06181825, which also lists 1 linked publication.

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 17 May 2024.

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