Post-Traumatic Stress DisorderNCT06435052
Efficacy of EMDR Versus CBT for Post-Traumatic Stress Disorder in Pakistan
A study testing Eye Movement Desensitization and Reprocessing (EMDR) Therapy and Cognitive Behavioral Therapy (CBT) in people with Post-Traumatic Stress Disorder and Depression, run by Khushal Khan Khattak Univeristy, Karak, Pakistan at 3 sites in Pakistan.
Trial summary
This randomized controlled trial compares Eye Movement Desensitization and Reprocessing (EMDR) therapy with Cognitive Behavioral Therapy (CBT) for the treatment of post-traumatic stress disorder (PTSD) in Pakistan. The study examines whether EMDR is at least as effective as CBT in reducing PTSD symptoms over time. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Post-Traumatic Stress Disorder, Depression, Anxiety
- What is being tested?
- Eye Movement Desensitization and Reprocessing (EMDR) Therapy and Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesPakistan
- Study dates
- 10 May 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 15 to 60 years.
- Confirmed diagnosis of post-traumatic stress disorder (PTSD), with PTSD identified as the primary clinical condition.
- Associated symptoms of depression and anxiety at screening.
- Able to participate in face-to-face psychotherapy and perform the basic eye and hand movements required for the treatment procedures.
- Able to provide informed consent and communicate sufficiently to participate meaningfully in assessment and psychotherapy.
Who cannot join
- Younger than 15 years or older than 60 years.
- Significant limitations in eye or hand movement, or inability to perform the basic movements required for participation in the treatment procedures.
- Prolonged unconsciousness or otherwise unable to maintain sufficient consciousness to participate meaningfully in assessment or psychotherapy.
- Does not meet the screening criteria for PTSD, or PTSD is not the primary clinical condition.
- Severe intellectual impairment that substantially limits the ability to understand, communicate, or participate in the assessment and psychotherapy procedures.
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Dr Farzana Bashir Clinic, Gulberg Green Office# G-67, Opal Sqaure, Islamabad (Wellness Clinic )
Islamabad, 4400
Paraplegic Center Peshawar
Peshawar, 25000
Psychiatry Unit & Rehabilitation Center, Lady Reading Hospital
Peshawar, 25000
About this study
Official title: Efficacy of Eye Movement Desensitization and Reprocessing Versus Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder and Comorbid Disorders in Pakistan: A Full-Fledged Randomized Controlled Trial
This randomized controlled trial compares Eye Movement Desensitization and Reprocessing (EMDR) therapy with Cognitive Behavioral Therapy (CBT) for the treatment of post-traumatic stress disorder (PTSD) in Pakistan. The study examines whether EMDR is at least as effective as CBT in reducing PTSD symptoms over time. It also assesses changes in symptoms of depression and anxiety that commonly occur alongside PTSD. Participants are randomly assigned to receive either EMDR or CBT, and their symptoms are assessed at different stages of treatment and follow-up.
Read the detailed description
This study is a multi-center, single-blind, two-group randomized controlled trial designed to compare Eye Movement Desensitization and Reprocessing (EMDR) therapy with Cognitive Behavioral Therapy (CBT) for the treatment of post-traumatic stress disorder (PTSD) and associated symptoms of depression and anxiety.
The study is conducted in sequential phases. During the initial phase, the psychometric properties of the assessment measures are examined and treatment fidelity is evaluated to determine whether EMDR and CBT are delivered consistently and in accordance with their respective treatment protocols. The subsequent phase focuses on the comparative clinical effectiveness of EMDR and CBT.
Eligible participants with PTSD are randomly allocated to either the EMDR or CBT treatment condition using a covariate-adaptive stratified randomization procedure with a 1:1 allocation ratio. Treatment is delivered face-to-face by clinical psychologists trained in the respective psychotherapeutic approaches. The number of treatment sessions varies according to participants' clinical needs and symptom severity.
The primary objective is to examine whether EMDR is non-inferior to CBT in reducing PTSD symptoms. Additional objectives are to examine changes in PTSD symptoms over the course of treatment and follow-up, assess changes in associated depressive and anxiety symptoms, and explore the relationship between changes in PTSD symptoms and changes in these comorbid symptoms.
PTSD symptoms are assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Depressive symptoms are assessed using the Hamilton Depression Rating Scale (HDRS), and anxiety symptoms are assessed using the State-Trait Anxiety Inventory (STAI). Assessments are conducted at baseline, during treatment, at the end of treatment, and at follow-up.
Treatment fidelity is also evaluated by assessing therapists' adherence to the EMDR and CBT protocols and their competence in delivering the interventions.
- Conditions
- Post-Traumatic Stress Disorder, Depression, Anxiety
- Being tested
- Eye Movement Desensitization and Reprocessing (EMDR) Therapy, Cognitive Behavioral Therapy (CBT)
- Keywords
- Post-Traumatic Stress Disorder, Eye Movement Desensitization and Reprocessing, Trauma-Focused Cognitive Behavioral Therapy, Depressive Symptoms, Anxiety Symptoms, Comorbidity, Randomized Controlled Trial, Pakistan
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and Reprocessing (EMDR) TherapyBehavioural
Eye Movement Desensitization and Reprocessing (EMDR) therapy was delivered face-to-face by clinical psychologists trained and certified in EMDR. Treatment followed an eight-stage EMDR protocol for post-traumatic stress disorder (PTSD), incorporating culturally adapted procedures where appropriate for the Pakistani clinical context. Treatment included history-taking and treatment planning, preparation, assessment, desensitization using bilateral stimulation, installation of adaptive cognitions, body scan, closure, and reevaluation. The number of sessions was determined according to participants' symptom severity and clinical needs and generally ranged from 6 to 14 sessions, typically delivered once per week.
Cognitive Behavioral Therapy (CBT)Behavioural
Cognitive Behavioral Therapy (CBT) was delivered face-to-face by clinical psychologists trained and certified in CBT. Treatment followed a structured trauma-focused CBT protocol for post-traumatic stress disorder (PTSD), with culturally adapted procedures used where appropriate for the Pakistani clinical context. Treatment included assessment and engagement, psychoeducation, relaxation, affective modulation, cognitive coping and restructuring, trauma narrative work, exposure-based procedures, caregiver involvement where appropriate, and enhancement of safety. The number of sessions was determined according to participants' symptom severity and clinical needs and generally ranged from 6 to 14 sessions, typically delivered once per week.
| Study group | Role | What they receive |
|---|---|---|
| Eye Movement Desensitization and Reprocessing (EMDR) Therapy | Experimental | Participants assigned to this arm received face-to-face Eye Movement Desensitization and Reprocessing (EMDR) therapy delivered by clinical psychologists trained in EMDR. Treatment followed an eight-stage EMDR protocol for PTSD, with culturally adapted procedures used where appropriate. The number of sessions varied according to symptom severity and clinical need, generally ranging from 6 to 14 sessions, typically delivered once per week. PTSD, depressive, and anxiety symptoms were assessed at baseline, during treatment, at the end of treatment, and at follow-up Receives: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR) Therapy |
| Cognitive Behavioral Therapy (CBT) | Active comparator | Participants assigned to this arm received face-to-face Cognitive Behavioral Therapy (CBT) delivered by clinical psychologists trained in CBT. Treatment followed a structured trauma-focused CBT protocol, with culturally adapted procedures used where appropriate. The number of sessions varied according to symptom severity and clinical need, generally ranging from 6 to 14 sessions, typically delivered once per week. PTSD, depressive, and anxiety symptoms were assessed at baseline, during treatment, at the end of treatment, and at follow-up. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic stress disorder symptoms
PTSD symptom severity was assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). CAPS-5 scores were collected at baseline, during treatment, at the end of treatment, and at follow-up to evaluate changes in PTSD symptoms over time and to compare the EMDR and CBT treatment groups.
Measured: Baseline (before treatment), mid-treatment (approximately halfway through the treatment course), end of treatment (following completion of treatment), and follow-up (approximately 1 to 3 months after treatment completion)
Secondary outcomes (2)
Depressive symptoms
Depressive symptoms were assessed using the Hamilton Depression Rating Scale (HDRS). Scores were collected at baseline, during treatment, at the end of treatment, and at follow-up to evaluate changes in depressive symptoms over time in the EMDR and CBT treatment groups.
Measured: Baseline (before treatment), mid-treatment (approximately halfway through the treatment course), end of treatment (following completion of treatment), and follow-up (approximately 1 to 3 months after treatment completion)
Anxiety symptoms
Anxiety symptoms were assessed using the State-Trait Anxiety Inventory (STAI). Scores were collected at baseline, during treatment, at the end of treatment, and at follow-up to evaluate changes in anxiety symptoms over time in the EMDR and CBT treatment groups.
Measured: Baseline (before treatment), mid-treatment (approximately halfway through the treatment course), end of treatment (following completion of treatment), and follow-up (approximately 1 to 3 months after treatment completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start10 May 2022
- Primary completion28 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress 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
- Model description
- Participants are assigned in parallel to one of two treatment groups, Eye Movement Desensitization and Reprocessing (EMDR) therapy or Cognitive Behavioral Therapy (CBT), using a 1:1 randomized allocation. Participants remain in their assigned treatment group throughout the study; no crossover between interventions is planned.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khushal Khan Khattak Univeristy, Karak, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anwar Khan, Khushal Khan Khattak Univeristy, Karak, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435052
- Sponsor's protocol ID
- 111
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study involves sensitive mental health, trauma-related, and clinical information, and the consent and ethical framework for the study did not provide for public or external sharing of individual-level participant data. Aggregate study findings may be reported in publications and other research outputs.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Eye Movement Desensitization and Reprocessing Versus Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder and Comorbid Disorders in Pakistan: A Full-Fledged Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06435052
- Acronym / sponsor ID
- 111
- Conditions
- Post-Traumatic Stress Disorder, Depression, Anxiety
- Keywords
- Post-Traumatic Stress Disorder, Eye Movement Desensitization and Reprocessing, Trauma-Focused Cognitive Behavioral Therapy, Depressive Symptoms, Anxiety Symptoms, Comorbidity, Randomized Controlled Trial, Pakistan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Khushal Khan Khattak Univeristy, Karak, PakistanUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 30 May 2024 (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.
This randomized controlled trial compares Eye Movement Desensitization and Reprocessing (EMDR) therapy with Cognitive Behavioral Therapy (CBT) for the treatment of post-traumatic stress disorder (PTSD) in Pakistan. The study examines whether EMDR is at least as effective as CBT in reducing PTSD symptoms over time. It also assesses changes in symptoms of depression and anxiety that commonly occur alongside PTSD. Participants are randomly assigned to receive either EMDR or CBT, and their symptoms are assessed at different stages of treatment and follow-up.
Detailed description
This study is a multi-center, single-blind, two-group randomized controlled trial designed to compare Eye Movement Desensitization and Reprocessing (EMDR) therapy with Cognitive Behavioral Therapy (CBT) for the treatment of post-traumatic stress disorder (PTSD) and associated symptoms of depression and anxiety.
The study is conducted in sequential phases. During the initial phase, the psychometric properties of the assessment measures are examined and treatment fidelity is evaluated to determine whether EMDR and CBT are delivered consistently and in accordance with their respective treatment protocols. The subsequent phase focuses on the comparative clinical effectiveness of EMDR and CBT.
Eligible participants with PTSD are randomly allocated to either the EMDR or CBT treatment condition using a covariate-adaptive stratified randomization procedure with a 1:1 allocation ratio. Treatment is delivered face-to-face by clinical psychologists trained in the respective psychotherapeutic approaches. The number of treatment sessions varies according to participants' clinical needs and symptom severity.
The primary objective is to examine whether EMDR is non-inferior to CBT in reducing PTSD symptoms. Additional objectives are to examine changes in PTSD symptoms over the course of treatment and follow-up, assess changes in associated depressive and anxiety symptoms, and explore the relationship between changes in PTSD symptoms and changes in these comorbid symptoms.
PTSD symptoms are assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Depressive symptoms are assessed using the Hamilton Depression Rating Scale (HDRS), and anxiety symptoms are assessed using the State-Trait Anxiety Inventory (STAI). Assessments are conducted at baseline, during treatment, at the end of treatment, and at follow-up.
Treatment fidelity is also evaluated by assessing therapists' adherence to the EMDR and CBT protocols and their competence in delivering the interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned in parallel to one of two treatment groups, Eye Movement Desensitization and Reprocessing (EMDR) therapy or Cognitive Behavioral Therapy (CBT), using a 1:1 randomized allocation. Participants remain in their assigned treatment group throughout the study; no crossover between interventions is planned.
| Arm | Type | Receives |
|---|---|---|
| Eye Movement Desensitization and Reprocessing (EMDR) Therapy | Experimental | Behavioral: Eye Movement Desensitization and Reprocessing (EMDR) TherapyParticipants assigned to this arm received face-to-face Eye Movement Desensitization and Reprocessing (EMDR) therapy delivered by clinical psychologists trained in EMDR. Treatment followed an eight-stage EMDR protocol for PTSD, with culturally adapted procedures used where appropriate. The number of sessions varied according to symptom severity and clinical need, generally ranging from 6 to 14 sessions, typically delivered once per week. PTSD, depressive, and anxiety symptoms were assessed at baseline, during treatment, at the end of treatment, and at follow-up |
| Cognitive Behavioral Therapy (CBT) | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT)Participants assigned to this arm received face-to-face Cognitive Behavioral Therapy (CBT) delivered by clinical psychologists trained in CBT. Treatment followed a structured trauma-focused CBT protocol, with culturally adapted procedures used where appropriate. The number of sessions varied according to symptom severity and clinical need, generally ranging from 6 to 14 sessions, typically delivered once per week. PTSD, depressive, and anxiety symptoms were assessed at baseline, during treatment, at the end of treatment, and at follow-up. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Aged 15 to 60 years.
- Confirmed diagnosis of post-traumatic stress disorder (PTSD), with PTSD identified as the primary clinical condition.
- Associated symptoms of depression and anxiety at screening.
- Able to participate in face-to-face psychotherapy and perform the basic eye and hand movements required for the treatment procedures.
- Able to provide informed consent and communicate sufficiently to participate meaningfully in assessment and psychotherapy.
Key exclusion criteria (5 listed)
- Younger than 15 years or older than 60 years.
- Significant limitations in eye or hand movement, or inability to perform the basic movements required for participation in the treatment procedures.
- Prolonged unconsciousness or otherwise unable to maintain sufficient consciousness to participate meaningfully in assessment or psychotherapy.
- Does not meet the screening criteria for PTSD, or PTSD is not the primary clinical condition.
- Severe intellectual impairment that substantially limits the ability to understand, communicate, or participate in the assessment and psychotherapy procedures.
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 |
|---|---|---|
| Eye Movement Desensitization and Reprocessing (EMDR) TherapyEye Movement Desensitization and Reprocessing (EMDR) therapy was delivered face-to-face by clinical psychologists trained and certified in EMDR. Treatment followed an eight-stage EMDR protocol for post-traumatic stress disorder (PTSD), incorporating culturally adapted procedures where appropriate for the Pakistani clinical context. Treatment included history-taking and treatment planning, preparation, assessment, desensitization using bilateral stimulation, installation of adaptive cognitions, body scan, closure, and reevaluation. The number of sessions was determined according to participants' symptom severity and clinical needs and generally ranged from 6 to 14 sessions, typically delivered once per week. | Behavioural | Eye Movement Desensitization and Reprocessing (EMDR) Therapy |
| Cognitive Behavioral Therapy (CBT)Cognitive Behavioral Therapy (CBT) was delivered face-to-face by clinical psychologists trained and certified in CBT. Treatment followed a structured trauma-focused CBT protocol for post-traumatic stress disorder (PTSD), with culturally adapted procedures used where appropriate for the Pakistani clinical context. Treatment included assessment and engagement, psychoeducation, relaxation, affective modulation, cognitive coping and restructuring, trauma narrative work, exposure-based procedures, caregiver involvement where appropriate, and enhancement of safety. The number of sessions was determined according to participants' symptom severity and clinical needs and generally ranged from 6 to 14 sessions, typically delivered once per week. | Behavioural | Cognitive Behavioral Therapy (CBT) |
Primary outcome
Post-traumatic stress disorder symptoms
Time frame: Baseline (before treatment), mid-treatment (approximately halfway through the treatment course), end of treatment (following completion of treatment), and follow-up (approximately 1 to 3 months after treatment completion)
PTSD symptom severity was assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). CAPS-5 scores were collected at baseline, during treatment, at the end of treatment, and at follow-up to evaluate changes in PTSD symptoms over time and to compare the EMDR and CBT treatment groups.
2 secondary outcomes
Depressive symptoms
Time frame: Baseline (before treatment), mid-treatment (approximately halfway through the treatment course), end of treatment (following completion of treatment), and follow-up (approximately 1 to 3 months after treatment completion)
Anxiety symptoms
Time frame: Baseline (before treatment), mid-treatment (approximately halfway through the treatment course), end of treatment (following completion of treatment), and follow-up (approximately 1 to 3 months after treatment completion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study involves sensitive mental health, trauma-related, and clinical information, and the consent and ethical framework for the study did not provide for public or external sharing of individual-level participant data. Aggregate study findings may be reported in publications and other research outputs.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing (EMDR) Therapy and Cognitive Behavioral Therapy (CBT) in people with Post-Traumatic Stress Disorder and Depression, run by Khushal Khan Khattak Univeristy, Karak, Pakistan at 3 sites 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic stress disorder symptoms (time frame: Baseline (before treatment), mid-treatment (approximately halfway through the treatment course), end of treatment (following completion of treatment), and follow-up (approximately 1 to 3 months after treatment completion)). 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 29 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.