Online, Guided Interventions to Reduce Generalized Anxiety Disorder Among Indian University Students

March 16, 2020 updated by: Craig Barr Taylor, Stanford University

Using Technology to Address Anxiety and Stress in Indian University Students

This controlled, three-arm, randomized (1:1:1), multi-site trial will evaluate the efficacy, feasibility and acceptability of cognitive-behavioral therapy (CBT)-based online guided and unguided self-help intervention to reduce Generalized Anxiety Disorder (GAD) in Indian university students. The investigators aim to assess if these novel electronic health (eHealth) interventions can be integrated into Indian university systems to increase access to efficacious, less stigmatized, and cost-effective mental healthcare.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Students from three Indian colleges will be invited to complete an online, self-report survey. Based on their answers, they are categorized into clinical, subclinical, and asymptomatic for Generalized Anxiety Disorder (GAD). Those who meet the diagnostic criteria for GAD as detailed in the Diagnostic and Statistical Manual of Mental Disorders (DSM), 4th Edition are classified as clinical. Those who score a 5.7 or above using dimensional scoring of the GAD-Q-IV but are not "clinical" are classified as subclinical. All others are asymptomatic. After ruling out those with a clinical PTSD diagnosis (scoring 38 or above on the PCL5) and those currently receiving mental healthcare treatment, those who are clinical and subclinical are offered the opportunity to use one of the online programs. Those who accept are randomized between a guided self-help program, a self-help program, and a waitlist control group. Each student who enrolls will be reassessed at post-intervention (3 months) and followup (6 months later, or 9 months after completing baseline). Additionally, those who are classified as asymptomatic are invited to complete additional followup surveys at 3 and 9 months to provide data on anxiety symptom change over time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
193

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current student of one of the 3 college sites
  • Subjects must have a clinical or subclinical diagnosis of Generalized Anxiety Disorder (GAD); clinical diagnosis is met by self-reporting DSM-IV criteria for GAD; subclinical diagnosis is met by scoring a 5.7 or above using diagnostic scoring of the GAD-Q-IV

Exclusion Criteria:

  • Unable to give informed consent.
  • Is currently receiving mental health treatment.
  • Has clinical PTSD (a score of 38 or above on the PCL5)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lantern: Guided self-help program
Subject assigned to the Lantern intervention will receive 3-month access to a web-based, CBT-based guided self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD along with access to an "e-coach" who can monitor their progress in the program and provide feedback and encouragement via messaging and one voice call.
Behavioral: Lantern: Guided self-help program
Subject assigned to the Lantern intervention will receive 3-month access to a web-based, CBT-based guided self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD along with access to an "e-coach" who can monitor their progress in the program and provide feedback and encouragement via messaging and one voice call.
Experimental: Mental Health Online: Self-help program
Subject assigned to the Mental Health Online (MHO) intervention will receive 3-month access to a web-based, CBT-based self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD.
Behavioral: Mental Health Online: Self-help program
Subject assigned to the Mental Health Online (MHO) intervention will receive 3-month access to a web-based, CBT-based self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD.
No Intervention: Delayed Program
Subject assigned to this arm will receive one of the online programs in 9 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)
Time Frame: Baseline to 3-month post-intervention
Compare GAD symptoms using the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sustained change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare GAD symptoms using the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up
Change in panic disorder symptoms measured by The Panic Disorder Self-Report (PDSR)
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare panic disorder symptoms using the The Panic Disorder Self-Report (PDSR) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up
Change in social phobia symptoms measured by the Social Phobia Diagnostic Questionnaire (SPDQ)
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare social anxiety disorder symptoms using the Social Phobia Diagnostic Questionnaire (SPDQ) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up
Change in post-traumatic stress disorder symptoms measured by the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL5)
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare post traumatic stress disorder (PTSD) symptoms using the Post Traumatic Stress Disorder Checklist for DSM-5 between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up
Change in obsessive compulsive disorder (OCD) symptoms measured by the LEVEL 2-Repetitive Thoughts and Behaviors-Adult (adapted from the Florida Obsessive-Compulsive Inventory [FOCI] Severity Scale [Part B])
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare OCD symptoms using the the LEVEL 2-Repetitive Thoughts and Behaviors-Adult (adapted from the Florida Obsessive-Compulsive Inventory [FOCI] Severity Scale [Part B]) measure between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up
Change in specific phobia symptoms measured by questions of distress severity for specific fears
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare specific phobia symptoms using questions of distress severity for specific fears (dogs, snakes, spiders/bugs/insects, heights, flying, small enclosed spaces, driving, traveling in cars/trains/buses, bridges, tunnels, water, blood, other) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up
Change in depression symptoms measured by the Depression Anxiety Stress Scales (DASS)
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare depression symptoms using the Depression Anxiety Stress Scales (DASS) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up
Change in worry symptoms measured by the Penn State Worry Questionnaire (PSWQ)
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare worry symptoms using the Penn State Worry Questionnaire (PSWQ) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up
Change in insomnia symptoms measured by the Insomnia Severity Index (ISI)
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare insomnia symptoms using the Insomnia Severity Index between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up
Change in subject self-efficacy measured by the General Self-efficacy Scale
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare subject self-efficacy using the General Self-efficacy Scale between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up
Change in emotional distress from anxiety measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress from Anxiety measure
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare subject emotional distress from anxiety using the Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress from Anxiety measure between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up
Change in self-report difficulties with emotions, concentration, and relationships measured by the Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare subject perception of difficulties with emotions, concentration, and relationships using the Strengths and Difficulties Questionnaire between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up
Change in relationship satisfaction measured by the PROMIS Satisfaction with Social Roles and Activities measure
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare subject satisfaction with social roles using the PROMIS Satisfaction with Social Roles and Activities measure between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up
Factors associated with poor program engagement and/or discontinuation measured by analysis of self-report assessments of motivation, belief in program efficacy, satisfaction, etc. as well as analysis of demographics, comorbid mental illness, etc.
Time Frame: Baseline to 3-month post-intervention
Determine factors associated with poor program engagement and/or discontinuation in study participants in the guided and self-help intervention arms. Factors associated with poor program engagement and/or discontinuation will include demographics, belief in program efficacy, motivation, comorbid mental illness, socioeconomic status, and English language competence.
Baseline to 3-month post-intervention
Change in non-specific distress measured by the Kessler Distress Measure (K10)
Time Frame: Baseline to 3-month post-intervention, and 6-month follow-up
Compare subject perception of non-specific distress using the Kessler Distress measure (K10) between subjects randomized to guided self-help online programs versus self-help online programs versus waitlist control, when used for the treatment of anxiety among Indian university students with clinical and subclinical GAD.
Baseline to 3-month post-intervention, and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health and Neuro Sciences, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 31629

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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