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

NCT ID: NCT07119515

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2025-08-26

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.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Teletherapy

Group Type: EXPERIMENTAL

Third-Wave CBT via Teletherapy

Intervention Type: BEHAVIORAL

Twelve weekly 40-minute remote sessions via video conferencing, including mindfulness, behavioral activation, and exposure therapy.

In-Person therapy

Group Type: ACTIVE_COMPARATOR

Third-Wave CBT In-Person

Intervention Type: BEHAVIORAL

Twelve weekly 40-minute face-to-face sessions with identical third-wave CBT content.

Interventions

Third-Wave CBT via Teletherapy

Twelve weekly 40-minute remote sessions via video conferencing, including mindfulness, behavioral activation, and exposure therapy.

Intervention Type: BEHAVIORAL

Third-Wave CBT In-Person

Twelve weekly 40-minute face-to-face sessions with identical third-wave CBT content.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allied Hospital Faisalabad

OTHER

Sponsor Role: collaborator

Government College University Faisalabad

OTHER

Sponsor Role: lead

Responsible Party

Imaan Sabeeh

MS Scholar , Department of Applied Psychology, GCUF

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Imaan Sabeeh, MS Scholar

Role: PRINCIPAL_INVESTIGATOR

Government College University Faisalabad

Locations

Allied Hospital II

Faisalabad, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

imaan Sabeeh, MS Scholar

Role: CONTACT

imaansabeeh@gmail.com

+92-309-7000728

Asma Riaz, PHD

Role: CONTACT

asmariaz@gcuf.edu.pk

+92-334-5154091

Facility Contacts

Head Psychologist

Role: primary

+92-321-7605488

Other Identifiers

GCUF-IRB-585-2025

Identifier Type: -

Identifier Source: org_study_id