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Clinical Trials/NCT06181825
NCT06181825CompletedNot Applicable

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

Indiana University2 sites in 1 country804 target enrollmentStarted: January 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
804
Locations
2
Primary Endpoint
World Health Organization Well-Being Index-5 (WHO-5)

Study Overview

Brief 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. 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 8 weeks

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.

Patient Health Questionnaire 9 (PHQ-9)

Time Frame: 8 weeks

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.

Generalized Anxiety Disorder Scale-7 (GAD-7)

Time Frame: 8 weeks

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.

Secondary Outcomes

  • Behavioral Activation for Depression Scale Activation Subscale (BADS-AC)(8 weeks)
  • Emotion Regulation Scale (ERQ)(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lorenzo Lorenzo-Luaces

Associate Professor

Indiana University

Study Sites (2)

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