Behavioral Activation in Depressed Online Workers

NCT06181825 | Completed

• 1 other identifier: 19958
• Study Type: interventional
• Target: 804
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Keywords

emotion regulation

Outcome Measures

Primary Outcomes (3)

• 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.

  8 weeks

• 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.

  8 weeks

• 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.

  8 weeks

Secondary Outcomes (2)

• Emotion Regulation Scale (ERQ)

  8 weeks

• Behavioral Activation for Depression Scale Activation Subscale (BADS-AC)

  8 weeks

Study Arms (2)

COMET-BA

EXPERIMENTAL

COMET-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.

Behavioral: COMET-BA (Common Elements Toolbox- Behavioral Activation)

Waitlist Control

NO INTERVENTION

Thoss 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.

Interventions

COMET-BA (Common Elements Toolbox- Behavioral Activation) BEHAVIORAL

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

COMET-BA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Bloomington, Indiana, 47405, United States

Location

Related Publications (1)

• 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.

  PMID: 41182705 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Self-Control; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: January 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

US (1)