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| Name | Class |
|---|---|
| Allied Hospital Faisalabad | OTHER |
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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:
Participants will:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teletherapy | Experimental |
| |
| In-Person therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Third-Wave CBT via Teletherapy | Behavioral | Twelve weekly 40-minute remote sessions via video conferencing, including mindfulness, behavioral activation, and exposure therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale (PSS) | A 10-item self-report measure evaluating perceived stress. Range: 0-40 (higher scores indicate worse outcomes). | 3 Months |
| Work and Social Adjustment Scale (WSAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| imaan Sabeeh, MS Scholar | Contact | +92-309-7000728 | imaansabeeh@gmail.com | |
| Asma Riaz, PHD | Contact | +92-334-5154091 | asmariaz@gcuf.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| Imaan Sabeeh, MS Scholar | Government College University Faisalabad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allied Hospital II | Recruiting | Faisalabad | Punjab Province | 38000 | Pakistan |
De-identified individual participant data (IPD) will be made available upon reasonable request to qualified researchers. Data will include baseline characteristics, outcome measures, treatment adherence metrics, and supporting documents such as the study protocol and statistical analysis plan.
Data will be available six months post-publication
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.
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Third-Wave CBT In-Person | Behavioral | Twelve weekly 40-minute face-to-face sessions with identical third-wave CBT content. |
|
A 5-item self-report measure assessing functional impairment in work and social domains. Range: 0-40 (higher scores indicate worse outcomes).
| 3 Months |
| Working Alliance Inventory (WAI) | A 12-item scale measuring therapeutic alliance between client and therapist. Range: 12-84 (higher scores indicate better outcomes). | 3 Months |