An interventional study of Third-Wave CBT via Teletherapy and Third-Wave CBT In-Person in Generalized Anxiety Disorder, sponsored by Government College University Faisalabad. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Government College University Faisalabad · Not applicable, Interventional, and Treatment
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.
517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.
This study's planned enrollment of 25 is below the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →Government College University Faisalabad is the lead sponsor of 23 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Third-Wave CBT via Teletherapy
Behavioral: Third-Wave CBT In-Person
Twelve weekly 40-minute remote sessions via video conferencing, including mindfulness, behavioral activation, and exposure therapy.
Twelve weekly 40-minute face-to-face sessions with identical third-wave CBT content.
Hamilton Anxiety Rating Scale (HAM-A)
A clinician-rated scale assessing anxiety severity. Range: 0-56 (higher scores indicate worse outcomes).
Time frame: 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).
Time frame: 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).
Time frame: 3 Months
Perceived Stress Scale (PSS)
A 10-item self-report measure evaluating perceived stress. Range: 0-40 (higher scores indicate worse outcomes).
Time frame: 3 Months
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).
Time frame: 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).
Time frame: 3 Months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
Data sharing details ↗ · osf.io
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Generalized Anxiety Disorder →
Government College University Faisalabad