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

NCT07119515 | Recruiting DMC

• 1 other identifier: GCUF-IRB-585-2025
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Keywords

Teletherapy; In-person therapy; Cognitive behavioral therapy (CBT); Generalized anxiety disorder (GAD); Randomized controlled trial (RCT); Mental health accessibility; Anxiety disorders; Pakistan; Therapeutic alliance; Third-wave CBT; Remote mental health services

Outcome Measures

Primary Outcomes (3)

• Hamilton Anxiety Rating Scale (HAM-A)

  A clinician-rated scale assessing anxiety severity. Range: 0-56 (higher scores indicate worse outcomes).

  3 Months

• Generalized Anxiety Disorder-7 (GAD-7)

  A 7-item self-report questionnaire measuring anxiety severity. Range: 0-21 (higher scores indicate worse outcomes).

  3 Months

• Patient Health Questionnaire-9 (PHQ-9)

  A 9-item self-report tool for assessing depressive symptoms. Range: 0-27 (higher scores indicate worse outcomes).

  3 Months

Secondary Outcomes (3)

• Perceived Stress Scale (PSS)

  3 Months

• Work and Social Adjustment Scale (WSAS)

  3 Months

• Working Alliance Inventory (WAI)

  3 Months

Study Arms (2)

Teletherapy

EXPERIMENTAL

Behavioral: Third-Wave CBT via Teletherapy

In-Person therapy

ACTIVE COMPARATOR

Behavioral: Third-Wave CBT In-Person

Interventions

Third-Wave CBT via Teletherapy BEHAVIORAL

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

Teletherapy

Third-Wave CBT In-Person BEHAVIORAL

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

In-Person therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Government College University Faisalabad: lead
• Allied Hospital Faisalabad: collaborator

Study Sites (1)

Allied Hospital II

Faisalabad, Punjab Province, 38000, Pakistan

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Imaan Sabeeh, MS Scholar

  Government College University Faisalabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imaan Sabeeh, MS Scholar

CONTACT

+92-309-7000728; imaansabeeh@gmail.com

Asma Riaz, PHD

CONTACT

+92-334-5154091; asmariaz@gcuf.edu.pk

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: MS Scholar , Department of Applied Psychology, GCUF

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: August 13, 2025
• Study Start: March 10, 2025
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available six months post-publication
• Access Criteria: Access will be granted to researchers affiliated with academic institutions, non-profit organizations, or governmental agencies for non-commercial research purposes. De-identified IPD (demographics, clinical outcomes, treatment data) and supporting documents (protocol, statistical analysis plan, informed consent template) can be assessed. Data will be accessible after publication of the primary study results.

Locations

PA (1)