NCT02410265

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

March 30, 2015

Last Update Submit

March 16, 2020

Conditions

Anxiety Disorders

Keywords

guided self-helpstudent mental healthtask shiftingprevention

Outcome Measures

Primary Outcomes (1)

  • Change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)

    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 Outcomes (15)

  • Sustained change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)

    Baseline to 3-month post-intervention, and 6-month follow-up

  • Change in panic disorder symptoms measured by The Panic Disorder Self-Report (PDSR)

    Baseline to 3-month post-intervention, and 6-month follow-up

  • Change in social phobia symptoms measured by the Social Phobia Diagnostic Questionnaire (SPDQ)

    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)

    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])

    Baseline to 3-month post-intervention, and 6-month follow-up

  • +10 more secondary outcomes

Study Arms (3)

Lantern: Guided self-help program

EXPERIMENTAL

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

Mental Health Online: Self-help program

EXPERIMENTAL

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

Delayed Program

NO INTERVENTION

Subject assigned to this arm will receive one of the online programs in 9 months.

Interventions

Lantern: Guided self-help programBEHAVIORAL

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.

Lantern: Guided self-help program
Mental Health Online: Self-help programBEHAVIORAL

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.

Mental Health Online: Self-help program

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Newman MG, Kanuri N, Rackoff GN, Jacobson NC, Bell MJ, Taylor CB. A randomized controlled feasibility trial of internet-delivered guided self-help for generalized anxiety disorder (GAD) among university students in India. Psychotherapy (Chic). 2021 Dec;58(4):591-601. doi: 10.1037/pst0000383.

    PMID: 34881930DERIVED

  • Kanuri N, Newman MG, Ruzek JI, Kuhn E, Manjula M, Jones M, Thomas N, Abbott JA, Sharma S, Taylor CB. The Feasibility, Acceptability, and Efficacy of Delivering Internet-Based Self-Help and Guided Self-Help Interventions for Generalized Anxiety Disorder to Indian University Students: Design of a Randomized Controlled Trial. JMIR Res Protoc. 2015 Dec 11;4(4):e136. doi: 10.2196/resprot.4783.

    PMID: 26679295DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 7, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 18, 2020

Record last verified: 2020-03