Generalized Anxiety DisorderTIPCBT-GADNCT07119515
Teletherapy vs. In-Person Cognitive Behavioral Therapy for Generalized Anxiety Disorder
A study testing Third-Wave CBT via Teletherapy and Third-Wave CBT In-Person in people with Generalized Anxiety Disorder, run by Government College University Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Third-Wave CBT via Teletherapy and Third-Wave CBT In-Person
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2025to 26 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Allied Hospital II
Faisalabad, Punjab Province, 38000
Head Psychologist, +92-321-7605488
Imaan Sabeeh, MS Scholar
About this study
Official title: A Randomized Controlled Trial Comparing Teletherapy and In-Person Third-Wave CBT for Generalized Anxiety Disorders
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.
Read more
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.
Read the 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
- Being tested
- Third-Wave CBT via Teletherapy, Third-Wave CBT In-Person
- 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
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third-Wave CBT via TeletherapyBehavioural
Twelve weekly 40-minute remote sessions via video conferencing, including mindfulness, behavioral activation, and exposure therapy.
Third-Wave CBT In-PersonBehavioural
Twelve weekly 40-minute face-to-face sessions with identical third-wave CBT content.
| Study group | Role | What they receive |
|---|---|---|
| Teletherapy | Experimental | Not described Receives: Behavioral: Third-Wave CBT via Teletherapy |
| In-Person therapy | Active comparator | Not described Receives: Behavioral: Third-Wave CBT In-Person |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale (HAM-A)
A clinician-rated scale assessing anxiety severity. Range: 0-56 (higher scores indicate worse outcomes).
Measured: 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).
Measured: 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).
Measured: 3 Months
Secondary outcomes (3)
Perceived Stress Scale (PSS)
A 10-item self-report measure evaluating perceived stress. Range: 0-40 (higher scores indicate worse outcomes).
Measured: 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).
Measured: 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).
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start10 Mar 2025
- Primary completion26 Aug 2025 (estimated)
- Study completion26 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Government College University Faisalabad
- Sponsor type
- University, hospital or other
- Collaborators
- Allied Hospital Faisalabad
- Responsible party
- Principal investigator, Imaan Sabeeh, Government College University Faisalabad
- Investigators
- Imaan Sabeeh, MS Scholar, Principal investigator, Government College University Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119515
- Sponsor's protocol ID
- GCUF-IRB-585-2025
- Acronym
- TIPCBT-GAD
- Status last verified
- Aug 2025
- First submitted
- 30 Apr 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Teletherapy and In-Person Third-Wave CBT for Generalized Anxiety Disorders
- ClinicalTrials.gov ID
- NCT07119515
- Acronym / sponsor ID
- TIPCBT-GAD / GCUF-IRB-585-2025
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Government College University FaisalabadUniversity, hospital or other
- Collaborators
- Allied Hospital Faisalabad
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 26 Aug 2025 (estimated)
- Study completion
- 26 Aug 2025 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teletherapy | Experimental | Behavioral: Third-Wave CBT via Teletherapy |
| In-Person therapy | Active comparator | Behavioral: Third-Wave CBT In-Person |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Third-Wave CBT via TeletherapyTwelve weekly 40-minute remote sessions via video conferencing, including mindfulness, behavioral activation, and exposure therapy. | Behavioural | Teletherapy |
| Third-Wave CBT In-PersonTwelve weekly 40-minute face-to-face sessions with identical third-wave CBT content. | Behavioural | In-Person therapy |
Primary outcome
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 3 Months
A clinician-rated scale assessing anxiety severity. Range: 0-56 (higher scores indicate worse outcomes).
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 3 Months
A 7-item self-report questionnaire measuring anxiety severity. Range: 0-21 (higher scores indicate worse outcomes).
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 3 Months
A 9-item self-report tool for assessing depressive symptoms. Range: 0-27 (higher scores indicate worse outcomes).
3 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: 3 Months
Work and Social Adjustment Scale (WSAS)
Time frame: 3 Months
Working Alliance Inventory (WAI)
Time frame: 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Imaan Sabeeh, MS Scholar principal investigator
Government College University Faisalabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Third-Wave CBT via Teletherapy and Third-Wave CBT In-Person in people with Generalized Anxiety Disorder, run by Government College University Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact imaan Sabeeh, MS Scholar (+92-309-7000728, imaansabeeh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (HAM-A) (time frame: 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.