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

Stanford University

Status: Completed

Conditions: Anxiety Disorders

Treatments: Behavioral: Mental Health Online: Self-help program; Behavioral: Lantern: Guided self-help program

Study type: Interventional

Funder types: Other

Identifiers

NCT02410265

31629

Details and patient eligibility

About

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.

Full 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.

Enrollment: 193 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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193 participants in 3 patient groups

Lantern: Guided self-help program

Experimental group

Description:

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.

Treatment:

Behavioral: Lantern: Guided self-help program

Mental Health Online: Self-help program

Experimental group

Description:

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.

Treatment:

Behavioral: Mental Health Online: Self-help program

Delayed Program

No Intervention group

Description:

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