Clinical trial NCT02410265: Online, Guided Interventions to Reduce Generalized Anxiety Disorder Among Indian University Students
Official title: Using Technology to Address Anxiety and Stress in Indian University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: guided self-help
student mental health
task shifting
prevention
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health and Neuro Sciences, India
First posted: 2015-04-07
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)
timeFrame: Baseline to 3-month post-intervention
Secondary outcomes:
measure: Sustained change in GAD symptoms measured by the 4th edition of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
measure: Change in panic disorder symptoms measured by The Panic Disorder Self-Report (PDSR)
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
measure: Change in social phobia symptoms measured by the Social Phobia Diagnostic Questionnaire (SPDQ)
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
measure: Change in post-traumatic stress disorder symptoms measured by the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL5)
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
measure: 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])
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
measure: Change in specific phobia symptoms measured by questions of distress severity for specific fears
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
measure: Change in depression symptoms measured by the Depression Anxiety Stress Scales (DASS)
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
measure: Change in worry symptoms measured by the Penn State Worry Questionnaire (PSWQ)
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
measure: Change in insomnia symptoms measured by the Insomnia Severity Index (ISI)
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
measure: Change in subject self-efficacy measured by the General Self-efficacy Scale
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
measure: Change in emotional distress from anxiety measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress from Anxiety measure
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
measure: Change in self-report difficulties with emotions, concentration, and relationships measured by the Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
measure: Change in relationship satisfaction measured by the PROMIS Satisfaction with Social Roles and Activities measure
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
measure: 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.
timeFrame: Baseline to 3-month post-intervention
measure: Change in non-specific distress measured by the Kessler Distress Measure (K10)
timeFrame: Baseline to 3-month post-intervention, and 6-month follow-up
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.