NCT05138120

Brief Summary

We are evaluating an online single-session intervention for mental health promotion among Indian college students.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

November 20, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2022

Completed
Last Updated

July 12, 2023

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

November 16, 2021

Last Update Submit

July 10, 2023

Conditions

Depressive SymptomsAnxietyHappiness

Outcome Measures

Primary Outcomes (3)

  • Change in Patient Health Questionnaire-9 (PHQ-9)

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

    Up to 8 weeks post-intervention

  • Change in Generalized Anxiety Disorder Screener-7 (GAD-7)

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

    Up to 8 weeks post-intervention

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

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

    Up to 8 weeks post-intervention

Secondary Outcomes (6)

  • Ratings on the Acceptability of Intervention Measure (AIM)

    Immediately after the intervention

  • Ratings on the Intervention Appropriateness Measure (IAM)

    Immediately after the intervention

  • Mechanisms of Change

    Up to 8 weeks post-intervention

  • Secondary Control

    Up to 8 weeks post-intervention

  • Positive and Negative Affect Schedule

    Up to 8 weeks post-intervention

  • +1 more secondary outcomes

Study Arms (2)

Common Elements Toolbox

EXPERIMENTAL
Behavioral: Common Elements Toolbox

Wait-list control

NO INTERVENTION

Interventions

Common Elements ToolboxBEHAVIORAL

An unguided online single-session intervention with four modules: behavioral activation, cognitive restructuring, gratitude, and self-compassion.

Common Elements Toolbox

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • College Student
  • Access to internet
  • Proficient in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 30, 2021

Study Start

November 20, 2021

Primary Completion

November 20, 2022

Study Completion

November 20, 2022

Last Updated

July 12, 2023

Record last verified: 2021-11