About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Third-Wave CBT via Teletherapy
BehavioralTwelve weekly 40-minute remote sessions via video conferencing, including mindfulness, behavioral activation, and exposure therapy.
Third-Wave CBT In-Person
BehavioralTwelve weekly 40-minute face-to-face sessions with identical third-wave CBT content.
Treatment groups
Trial outcomes
Primary outcomes
Hamilton Anxiety Rating Scale (HAM-A)
A clinician-rated scale assessing anxiety severity. Range: 0-56 (higher scores indicate worse outcomes).
Generalized Anxiety Disorder-7 (GAD-7)
A 7-item self-report questionnaire measuring anxiety severity. Range: 0-21 (higher scores indicate worse outcomes).
Patient Health Questionnaire-9 (PHQ-9)
A 9-item self-report tool for assessing depressive symptoms. Range: 0-27 (higher scores indicate worse outcomes).
Secondary outcomes
Perceived Stress Scale (PSS)
A 10-item self-report measure evaluating perceived stress. Range: 0-40 (higher scores indicate worse outcomes).
Work and Social Adjustment Scale (WSAS)
A 5-item self-report measure assessing functional impairment in work and social domains. Range: 0-40 (higher scores indicate worse outcomes).
Working Alliance Inventory (WAI)
A 12-item scale measuring therapeutic alliance between client and therapist. Range: 12-84 (higher scores indicate better outcomes).
Sponsors and contacts
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Government College University Faisalabad
Lead sponsor
Allied Hospital Faisalabad
Collaborator