Efficacy of COMET on Prolific Participants

NCT05379881 | Completed

• 1 other identifier: 12290
• Study Type: interventional
• Target: 829
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will test the effectiveness of a digital, single-session mental health intervention. There will be two conditions: the COMET intervention and the control group. The program, COMET (Common Elements Toolbox), will include a variety of modules which will focus on cognitive restructuring, gratitude, behavioral activation, and self-compassion. A similar intervention has previously been tested with Indian adolescents and adapted for US graduate students.

Conditions

Depression; Anxiety; Emotion Regulation

Outcome Measures

Primary Outcomes (4)

• 2-week change in the Patient Health Questionnaire

  Changes in PHQ8 from baseline to Week 2. The PHQ8 is a measure of depression and the measure is scored on a scale of 0 - 24 where higher scores indicate higher depression (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.

  2 weeks

• 2-week change in the Generalized Anxiety Disorder 7 scale (GAD7)

  Changes in GAD7 from baseline to Week 2. The GAD7 is a measure of anxiety and the measure is scored on a scale of 0 - 21 where higher scores indicate higher anxiety (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.

  2 weeks

• 8-week change in the Patient Health Questionnaire

  Changes in PHQ8 from baseline to Week 8. The PHQ8 is a measure of depression and the measure is scored on a scale of 0 - 24 where higher scores indicate higher depression (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.

  8 weeks

• 8-week change in the Generalized Anxiety Disorder 7 scale (GAD7) 8-week change in the Generalized Anxiety Disorder 7 scale (GAD7)

  Changes in GAD7 from baseline to Week 2. The GAD7 is a measure of anxiety and the measure is scored on a scale of 0 - 21 where higher scores indicate higher anxiety (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.

  8 weeks

Secondary Outcomes (4)

• 8-week change in the World Health Organization Well-being Index 5 (WHO5)

  8 weeks

• 8-week change in the Work and Social Adjustment Scale (WSAS)

  8 weeks

• 8-week change in Emotion Regulation Scale (ERQ) - Reappraisal subscale

  8 weeks

• 8-week change in the Emotion Regulation Scale (ERQ) - Suppression subscale

  8 weeks

Study Arms (2)

Waiting list control (WLC)

NO INTERVENTION

Participants who are assigned to the control condition will complete the baseline questionnaires and assessments at weeks 2, 4, and 8. After the last assessment, they will be given access to COMET.

Common Elements Toolbox (COMET)

EXPERIMENTAL

COMET consists of the following modules: cognitive restructuring (labeled "flexible thinking"), behavioral activation (labeled "positive activities"), gratitude, and self-compassion. Participants complete these COMET modules by themselves. The format is reading psychoeducational along with completing specific activities.

Behavioral: Common Elements Toolbox (COMET)

Interventions

Common Elements Toolbox (COMET) BEHAVIORAL

COMET is an unguided single-session intervention (SSI) combining elements of cognitive-behavioral therapy (CBT) and positive psychology.

Also known as: single session intervention, unguided self-help, internet-based CBT

Common Elements Toolbox (COMET)

Eligibility Criteria

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

You may qualify if:

• A positive response (i.e., "yes") to the question: "Do you have or have you had a diagnosed, ongoing mental health/illness/condition?"

You may not qualify if:

• None

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Bloomington, Indiana, 47408, United States

Location

Related Publications (1)

• Lorenzo-Luaces L, Howard J. Efficacy of an Unguided, Digital Single-Session Intervention for Internalizing Symptoms in Web-Based Workers: Randomized Controlled Trial. J Med Internet Res. 2023 Jul 7;25:e45411. doi: 10.2196/45411.

  PMID: 37418303 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: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Pyschological and Brain Sciences

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: July 5, 2022
• Primary Completion: September 3, 2022
• Study Completion: September 3, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)