Teletherapy vs. In-Person Cognitive Behavioral Therapy for Generalized Anxiety Disorder

Not Applicable

Recruiting

• Conditions: Generalized Anxiety Disorder

• Registration Number: NCT07119515
• Lead Sponsor: Government College University Faisalabad

Brief Summary

The goal of this randomized controlled trial is to compare the clinical efficacy of teletherapy versus in-person third-wave cognitive behavioral therapy (CBT) in treating generalized anxiety disorder (GAD) among young individuals aged 18-45 years in Pakistan. The main questions it aims to answer are:

* Is teletherapy as effective as in-person therapy in reducing anxiety symptoms and stress?

* Do therapeutic alliance, treatment adherence, and social support influence treatment outcomes differently across delivery methods? Researchers will compare the teletherapy group (remote sessions via digital platforms) and the in-person therapy group (face-to-face sessions) to evaluate differences in symptom reduction, general health improvement, and moderating factors like therapeutic alliance.

Participants will:

* Undergo a 8-week intervention with weekly structured third-wave CBT sessions.

* Complete assessments at baseline, post-intervention, and follow-up using validated scales (e.g., Generalized Anxiety Disorder-7 \[GAD-7\], Hamilton Anxiety Rating Scale \[HAM-A\]).

* Engage in modules including mindfulness, behavioral activation, and exposure therapy, adapted for their assigned delivery method.

This study aims to address gaps in mental health accessibility in Pakistan by evaluating whether teletherapy can serve as a viable alternative to traditional in-person care.

Detailed Description

This randomized controlled trial (RCT) compares the efficacy of teletherapy versus traditional in-person delivery of third-wave cognitive behavioral therapy (CBT) for treating generalized anxiety disorder (GAD) among adults (aged 18-45 years) in Pakistan. Conducted at Allied Hospital II, Faisalabad, the study will randomize eligible participants(diagnosed via Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision \[DSM-5-TR\] criteria) into two parallel arms: (1) a teletherapy group receiving 12 weekly sessions via secure video conferencing, and (2) an in-person group attending face-to-face sessions with identical content. Both interventions will follow a standardized third-wave CBT protocol integrating mindfulness, acceptance, and behavioral strategies. Primary outcomes include changes in anxiety severity (measured by Hamilton Anxiety Rating Scale \[HAM-A\] and Generalized Anxiety Disorder-7 \[GAD-7\]) and depressive symptoms (Patient Health Questionnaire-9 \[PHQ-9\]). Secondary outcomes assess perceived stress (Perceived Stress Scale \[PSS\]), work and social adjustment (Work and Social Adjustment Scale \[WSAS\]) and therapeutic alliance (Working Alliance Inventory \[WAI\]). Assessments will occur at baseline, post-intervention, and follow-up. The study aims to address critical gaps in mental healthcare accessibility in resource-limited settings by evaluating whether teletherapy can achieve comparable outcomes to in-person therapy. Ethical approval will be obtained from GCUF's Institutional Review Board (IRB), and the trial adheres to Consolidated Standards of Reporting Trials (CONSORT) guidelines. Results may inform policy decisions to expand remote mental health services in Pakistan.

Study Timeline

• Study Start: 2025-03-10
• Study First Submitted: 2025-04-30
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2025-08-26
• Study Completion: 2025-08-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• age ≥18-≤45 years -meeting the diagnostic criteria according to DSM-5 TR -ability to understand and read English -ability to use digital technology and having access to the Internet -signed an informed consent form

Exclusion Criteria

• the presence of risk of suicide and self-destructive behaviors -presence of another severe mental disorder (i.e., substance abuse, psychotic disorder, or bipolar disorder) -presence of severe personality disorder -presence of a medical condition whose severity or characteristics prevent participation in treatment -receiving another psychological treatment during the study
• an increase or change in medication during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Scale (HAM-A)	3 Months	A clinician-rated scale assessing anxiety severity. Range: 0-56 (higher scores indicate worse outcomes).
Generalized Anxiety Disorder-7 (GAD-7)	3 Months	A 7-item self-report questionnaire measuring anxiety severity. Range: 0-21 (higher scores indicate worse outcomes).
Patient Health Questionnaire-9 (PHQ-9)	3 Months	A 9-item self-report tool for assessing depressive symptoms. Range: 0-27 (higher scores indicate worse outcomes).

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale (PSS)	3 Months	A 10-item self-report measure evaluating perceived stress. Range: 0-40 (higher scores indicate worse outcomes).
Working Alliance Inventory (WAI)	3 Months	A 12-item scale measuring therapeutic alliance between client and therapist. Range: 12-84 (higher scores indicate better outcomes).
Work and Social Adjustment Scale (WSAS)	3 Months	A 5-item self-report measure assessing functional impairment in work and social domains. Range: 0-40 (higher scores indicate worse outcomes).

Trial Locations

Locations (1)

Allied Hospital II; 🇵🇰 Faisalabad, Punjab, Pakistan