Evaluating an Online Wellness Intervention for Indian College Students

NCT ID: NCT04592588

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

513 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2021-12-30

Brief Summary

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We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with Indian college students. Students will be randomized to the COMET condition or to a wait-list control condition.

Primary outcome measures (depressive symptoms, anxiety symptoms, and subjective well-being) will be measures at two weeks post-intervention, four weeks post-intervention, and twelve weeks post-intervention.

We will evaluate COMET as a universal intervention (using the full sample) and as a targeted intervention (analyzing those who reported elevated depressive symptoms or anxiety symptoms at baseline).

Detailed Description

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Conditions

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Depressive Symptoms Anxiety Happiness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Common Elements Toolbox (COMET)

The Common Elements Toolbox is an online intervention consisting of modules from empirically supported treatments for common mental health problems.

Group Type EXPERIMENTAL

Common Elements Toolbox

Intervention Type BEHAVIORAL

COMET is an online unguided self-help intervention that lasts approximately 45-60 minutes.

Wait-list control condition

Group Type SHAM_COMPARATOR

Wait-list control

Intervention Type BEHAVIORAL

Participants in the control condition will receive access to the intervention after data collection for the study has been completed.

Interventions

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Common Elements Toolbox

COMET is an online unguided self-help intervention that lasts approximately 45-60 minutes.

Intervention Type BEHAVIORAL

Wait-list control

Participants in the control condition will receive access to the intervention after data collection for the study has been completed.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: At least 18 years old and a student at a participating university in India.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ashoka University

UNKNOWN

Sponsor Role collaborator

Jindal Global University

UNKNOWN

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ashoka University

New Delhi, , India

Site Status

Jindal Global University

Sonīpat, , India

Site Status

Countries

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India

Other Identifiers

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843879

Identifier Type: -

Identifier Source: org_study_id

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