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Completed

NCT Number: NCT04592588

Evaluating an Online Wellness Intervention for Indian College Students

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).

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ashoka University, New Delhi, India

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

At least 18 years old and a student at a participating university in India.

Treatment and study plan

Common Elements Toolbox

Behavioral

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

Wait-list control

Behavioral

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

Primary outcomes

  1. Change in Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Up to 12 weeks post-intervention

    Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.

  2. Change in Generalized Anxiety Disorder Screener-7 (GAD-7)

    Time frame: Up to 12 weeks post-intervention

    Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.

  3. Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)

    Time frame: Up to 12 weeks post-intervention

    Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.

Secondary outcomes

  1. Ratings on the Acceptability of Intervention Measure (AIM)

    Time frame: Immediately after the intervention

    Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate higher acceptability ratings.

  2. Ratings on the Intervention Appropriateness Measure (IAM)

    Time frame: Immediately after the intervention

    Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate higher appropriateness.

  3. Mechanisms of Change

    Time frame: Up to 12 weeks post-intervention

    Participants answered questions relating to each module's mechanism of change on a 7-point Likert Scale, from "strongly disagree" to "strongly agree".

    Specifically, we asked participants:

    How capable they feel about managing negative thoughts If they will intentionally spend time doing activities they enjoy If they will notice and appreciate good things

  4. Ability to Cope with COVID-19

    Time frame: Up to 12 weeks post-intervention

    2 questions related to their ability to cope with stressors over the upcoming weeks (including challenges relating to COVID-19). Participants answered these questions on a 7-point Likert Scale, from "strongly disagree" to "strongly agree". Specifically, we asked participants:

    if they will be able to handle lifestyle changes due to the coronavirus, if the pandemic will have an extremely negative impact on their life.

  5. Secondary Control

    Time frame: Up to 12 weeks post-intervention

    We asked participants three items to assess secondary control (Weisz et al., 2010). The items are scored on a 4-point Likert scale, ranging from 0 ("Very false") to 3 ("Very true").

    The three items are:

    When something bad happens, I can find a way to think about it that makes me feel better.

    After a really hard day, I can make myself feel better by remembering some good things that happened.

    When bad things happen to me that I can't control, there are lots of things I can do to feel better.

    Higher scores indicate greater secondary control.

  6. Perceived Utility

    Time frame: Immediately after the intervention

    Participants were asked to rate three items relating to the perceived utility of each module. Specifically, we asked participants:

    How helpful the module was How engaging the module was How much they will continue applying content from the module Higher scores indicate greater perceived utility.

  7. Positive and Negative Affect Schedule

    Time frame: Up to 12 weeks post-intervention

    Questionnaire measuring positive affect and negative affect. Scores on the positive affect subscale range from 10-50, with higher scores representing higher levels of positive affect. Scores on the negative affect subscale range from 10-50, with lower scores representing lower levels of negative affect

  8. Perceived Stress Scale-4

    Time frame: Up to 12 weeks post-intervention

    Questionnaire measuring perceived stress. Scores range from 0-16, with higher scores indicating greater stress.

  9. The Social Connectedness Scale

    Time frame: Up to 12 weeks post-intervention

    Questionnaire measuring social connectedness. Scores range from 8 to 48, with higher scores indicating greater social connectedness.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Ashoka University
  • Jindal Global University

Registry information

Official study title

Online Wellness Activities for Indian College Students

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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