Post-Traumatic Stress DisorderNCT04021329
Efficacy of EMDR Versus CBT for Post-Traumatic Stress and Comorbid Disorders in Pakistan: A Randomized Controlled Feasibility-Pilot Study
A study testing Eye Movement Desensitization and Reprocessing Therapy and Trauma-Focused Cognitive Behavioral Therapy in people with Post-Traumatic Stress Disorder and Depressive Symptoms, run by Khushal Khan Khattak Univeristy, Karak, Pakistan at 2 sites in Pakistan.
Trial summary
Post-Traumatic Stress Disorder (PTSD) is commonly accompanied by symptoms of depression and anxiety. Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT) are evidence-based psychological treatments for PTSD, but there has been limited research on their feasibility, cultural… Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Post-Traumatic Stress Disorder, Depressive Symptoms, Anxiety Symptoms
- What is being tested?
- Eye Movement Desensitization and Reprocessing Therapy and Trauma-Focused Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesPakistan
- Study dates
- 5 Aug 2020to 5 Dec 2021
- 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
- Age 15-60 years. Met screening criteria for PTSD, with PTSD as the primary clinical problem. Able to participate in the required assessments and psychotherapeutic procedures.
Who cannot join
- Patients below the age of 15 years and above 60 years. Patients who were unable to move their hands or eyes and/or unable to perform basic movements.
- Patients who were unconscious for prolonged periods and unable to recover consciousness.
- Patients who did not meet the screening criteria for PTSD, or for whom PTSD was not the primary problem.
- Patients with severe intellectual impairments that would substantially limit communication and participation in psychotherapy.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Psychiatry Unit & Rehabilitation Center, Lady Reading Hospital
Peshawar, KPK, 25000
Paraplegic Center Peshawar
Peshawar, 25000
About this study
Official title: Efficacy of Eye Movement Desensitization and Reprocessing Versus Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan: A Randomized Controlled Feasibility-Pilot Study
Post-Traumatic Stress Disorder (PTSD) is commonly accompanied by symptoms of depression and anxiety. Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT) are evidence-based psychological treatments for PTSD, but there has been limited research on their feasibility, cultural applicability, and comparative effects in Pakistan.
This study was conducted as a randomized controlled feasibility-pilot study before undertaking a larger definitive randomized controlled trial. The study was carried out in two main phases. In the first phase, selected diagnostic measures for PTSD, depression, and anxiety were translated into Urdu and evaluated for their psychometric and cross-language properties in a Pakistani clinical population. The measures included the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), Hamilton Depression Rating Scale (HDRS), and State-Trait Anxiety Inventory (STAI).
Read more
The study also included cultural adaptation and feasibility assessment of the EMDR and trauma-focused CBT treatment protocols, together with assessment of treatment fidelity and therapist competence.
In the randomized pilot phase, patients with PTSD and related depressive and anxiety symptoms were recruited from two rehabilitation centres in Peshawar, Pakistan. Forty eligible patients were randomly allocated in a 1:1 ratio to either EMDR (n=20) or CBT (n=20). Participants remained in their assigned treatment group.
PTSD, depressive, and anxiety symptoms were assessed at baseline, during treatment at approximately six weeks, at the end of treatment at approximately 12 weeks, and at a two-month follow-up. Treatment was delivered by trained clinical psychologists using the selected EMDR and CBT protocols.
The main purpose of this feasibility-pilot study was to determine whether the assessment procedures, culturally adapted treatment protocols, recruitment procedures, treatment delivery, and comparative evaluation of EMDR and CBT were feasible for a subsequent larger randomized controlled trial in Pakistan.
Read the detailed description
Study Rationale and Development
This study originated from an earlier planned randomized controlled trial comparing Eye Movement Desensitization and Reprocessing (EMDR) with Cognitive Behavioral Therapy (CBT) for Post-Traumatic Stress Disorder (PTSD) and associated symptoms in Pakistan. Following further methodological development, the project was implemented as a feasibility-pilot study to establish the suitability of assessment procedures, culturally adapted treatment protocols, recruitment procedures, treatment delivery, and study methods before undertaking a subsequent larger randomized controlled trial.
Phase One: Assessment-Tool Translation and Psychometric Evaluation
The first phase focused on preparation and evaluation of the assessment instruments that would subsequently be used in the randomized pilot phase. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), Hamilton Depression Rating Scale (HDRS), and State-Trait Anxiety Inventory (STAI) were used to assess PTSD, depressive symptoms, and anxiety symptoms, respectively. The instruments were translated into Urdu and their psychometric and cross-language properties were examined in a Pakistani clinical population.
During July and August 2020, patients attending two rehabilitation centres were screened for this preliminary phase. An initial sample of 50 patients was selected using consecutive sampling. Twenty-five participants were assessed using the English versions of the diagnostic tools and 25 using the Urdu versions. An additional 15 consecutive patients were later included for further English-Urdu cross-language analyses. No EMDR or CBT psychotherapy was delivered as part of this assessment-tool validation phase.
Cultural Adaptation and Treatment Feasibility
The broader feasibility programme also included translation and cultural adaptation of the EMDR and trauma-focused CBT treatment protocols. Adaptation work incorporated review of relevant literature and expert input. Treatment fidelity was subsequently examined through assessment of adherence to the treatment protocols and therapist competence.
Randomized Pilot Phase
The clinical intervention component used a prospective, single-blinded randomized controlled pilot design. It was conducted at the Paraplegic Center and the Psychiatry Unit and Rehabilitation Center at Lady Reading Hospital in Peshawar, Pakistan. The second centre was added because the COVID-19 pandemic reduced patient attendance at the initially selected centre.
Patients were recruited using consecutive sampling with rolling recruitment. A total of 108 individuals were screened for eligibility; 48 were ineligible and 20 did not proceed further. Forty eligible patients were randomized in a 1:1 ratio to either EMDR (n=20) or CBT (n=20) using a concealed computer-generated random allocation procedure. Participants remained in their assigned treatment condition; the study did not use a crossover design.
Interventions and Assessments
Psychotherapy was delivered by three clinical psychologists trained in EMDR and CBT. Treatment generally ranged from 6 to 12 sessions, usually delivered once per week, with two additional follow-up sessions approximately two months later. The EMDR intervention followed an eight-stage PTSD-focused protocol, while the CBT intervention followed a ten-stage trauma-focused CBT protocol.
PTSD, depressive, and anxiety symptoms were assessed at four time points: baseline/pre-treatment (T1), during treatment at approximately six weeks (T2), post-treatment at approximately 12 weeks (T3), and approximately two months after treatment at follow-up (T4). CAPS-5 was used for PTSD symptoms, HDRS for depressive symptoms, and STAI for anxiety symptoms.
Analysis and Purpose of the Pilot Study
The study examined changes in PTSD, depressive, and anxiety symptoms over time and explored the comparative performance of EMDR and CBT. Analyses included descriptive statistics, repeated-measures analyses, non-inferiority analyses, effect-size estimation, and longitudinal analyses examining associations between PTSD and comorbid symptoms. The final report also assessed treatment fidelity and therapist competence.
The primary purpose of this feasibility-pilot study was to generate preliminary evidence on whether the assessment procedures, culturally adapted interventions, treatment delivery, recruitment strategy, follow-up procedures, and analytic framework were suitable for a later larger randomized controlled trial in Pakistan. The final report specifically recommended subsequent testing with a substantially larger sample.
- Being tested
- Eye Movement Desensitization and Reprocessing Therapy, Trauma-Focused Cognitive Behavioral Therapy
- Keywords
- Eye Movement Desensitization and Reprocessing, Cognitive Behavioral Therapy, Post-Traumatic Stress Disorder, Depressive Symptoms, Anxiety Symptoms, Feasibility Study, Pilot Study, 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 TherapyBehavioural
Also called EMDR Therapy
Eye Movement Desensitization and Reprocessing (EMDR) therapy was delivered using an eight-stage protocol for PTSD and comorbid symptoms. Treatment was delivered individually by trained clinical psychologists and included approximately 6 to 12 sessions, generally once weekly, with follow-up sessions as required.
Trauma-Focused Cognitive Behavioral TherapyBehavioural
Trauma-focused Cognitive Behavioral Therapy was delivered using a ten-stage CBT protocol for PTSD and comorbid symptoms. Treatment was delivered individually by trained clinical psychologists and included approximately 6 to 12 sessions, generally once weekly, with follow-up sessions as required.
| Study group | Role | What they receive |
|---|---|---|
| Eye Movement Desensitization and Reprocessing Therapy | Experimental | Participants assigned to this arm received Eye Movement Desensitization and Reprocessing (EMDR) therapy for PTSD and comorbid depressive and anxiety symptoms using the culturally adapted EMDR protocol. Treatment was delivered individually by trained clinical psychologists. Sessions ranged from approximately 6 to 12 sessions, generally once per week, with additional follow-up sessions as clinically indicated. Receives: Behavioral: Eye Movement Desensitization and Reprocessing Therapy |
| Cognitive Behavioral Therapy | Active comparator | Participants assigned to this arm received trauma-focused Cognitive Behavioral Therapy (CBT) for PTSD and comorbid depressive and anxiety symptoms using the culturally adapted CBT protocol. Treatment was delivered individually by trained clinical psychologists. Sessions ranged from approximately 6 to 12 sessions, generally once per week, with additional follow-up sessions as clinically indicated. Receives: Behavioral: Trauma-Focused Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-Traumatic Stress Disorder Symptom Severity Assessed by CAPS-5
Post-traumatic stress disorder symptom severity was assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 assesses the severity of DSM-5 PTSD symptoms. Symptom severity ratings range from 0 (absent) to 4 (extreme/incapacitating), with higher scores indicating greater PTSD symptom severity. Changes in CAPS-5 scores were assessed across the treatment and follow-up periods to examine change in PTSD symptoms over time and differences between the EMDR and CBT treatment groups.
Measured: Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).
Secondary outcomes (2)
Change in Depressive Symptom Severity Assessed by the Hamilton Depression Rating Scale (HDRS-17)
Depressive symptoms were assessed using the 17-item Hamilton Depression Rating Scale (HDRS-17). The instrument assesses the severity of depressive symptoms including depressed mood, guilt, suicidality, sleep disturbance, psychomotor symptoms, anxiety-related symptoms and somatic symptoms. Higher scores indicate greater depressive symptom severity. Changes in HDRS scores were assessed across treatment and follow-up to examine changes in depressive symptoms and differences between the EMDR and CBT treatment groups.
Measured: Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).
Change in Anxiety Symptoms Assessed by the State-Trait Anxiety Inventory (STAI)
Anxiety symptoms were assessed using the State-Trait Anxiety Inventory (STAI). The STAI contains 40 items comprising State Anxiety and Trait Anxiety components. Items are rated on a 4-point scale, with higher scores indicating greater anxiety symptom severity after appropriate scoring. Changes in STAI scores were assessed across treatment and follow-up to examine change in anxiety symptoms and differences between the EMDR and CBT treatment groups.
Measured: Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start5 Aug 2020
- Primary completion22 Nov 2021
- Study completion5 Dec 2021
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
- A prospective, two-arm, randomized controlled feasibility-pilot study with repeated assessments. Eligible participants were randomly allocated in a 1:1 ratio to either EMDR or CBT and remained in their assigned treatment group throughout the study. Assessments were conducted at baseline, during treatment, post-treatment, and at two-month follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 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
- NCT04021329
- Sponsor's protocol ID
- KhushalKhanKhattakU
- Status last verified
- Sep 2026
- First submitted
- 11 Jul 2019
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data will not be shared publicly because the study involves sensitive clinical and psychotherapy data. Aggregate findings may be reported in peer-reviewed publications and scientific presentations.
Study at a glance
From the registry record, last updated by the sponsor on 24 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 in Post-Traumatic Stress and Comorbid Disorders in Pakistan: A Randomized Controlled Feasibility-Pilot Study
- ClinicalTrials.gov ID
- NCT04021329
- Acronym / sponsor ID
- KhushalKhanKhattakU
- Keywords
- Eye Movement Desensitization and Reprocessing, Cognitive Behavioral Therapy, Post-Traumatic Stress Disorder, Depressive Symptoms, Anxiety Symptoms, Feasibility Study, Pilot Study, Pakistan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Khushal Khan Khattak Univeristy, Karak, PakistanUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 16 Jul 2019 (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.
Post-Traumatic Stress Disorder (PTSD) is commonly accompanied by symptoms of depression and anxiety. Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT) are evidence-based psychological treatments for PTSD, but there has been limited research on their feasibility, cultural applicability, and comparative effects in Pakistan.
This study was conducted as a randomized controlled feasibility-pilot study before undertaking a larger definitive randomized controlled trial. The study was carried out in two main phases. In the first phase, selected diagnostic measures for PTSD, depression, and anxiety were translated into Urdu and evaluated for their psychometric and cross-language properties in a Pakistani clinical population. The measures included the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), Hamilton Depression Rating Scale (HDRS), and State-Trait Anxiety Inventory (STAI).
The study also included cultural adaptation and feasibility assessment of the EMDR and trauma-focused CBT treatment protocols, together with assessment of treatment fidelity and therapist competence.
In the randomized pilot phase, patients with PTSD and related depressive and anxiety symptoms were recruited from two rehabilitation centres in Peshawar, Pakistan. Forty eligible patients were randomly allocated in a 1:1 ratio to either EMDR (n=20) or CBT (n=20). Participants remained in their assigned treatment group.
PTSD, depressive, and anxiety symptoms were assessed at baseline, during treatment at approximately six weeks, at the end of treatment at approximately 12 weeks, and at a two-month follow-up. Treatment was delivered by trained clinical psychologists using the selected EMDR and CBT protocols.
The main purpose of this feasibility-pilot study was to determine whether the assessment procedures, culturally adapted treatment protocols, recruitment procedures, treatment delivery, and comparative evaluation of EMDR and CBT were feasible for a subsequent larger randomized controlled trial in Pakistan.
Detailed description
Study Rationale and Development
This study originated from an earlier planned randomized controlled trial comparing Eye Movement Desensitization and Reprocessing (EMDR) with Cognitive Behavioral Therapy (CBT) for Post-Traumatic Stress Disorder (PTSD) and associated symptoms in Pakistan. Following further methodological development, the project was implemented as a feasibility-pilot study to establish the suitability of assessment procedures, culturally adapted treatment protocols, recruitment procedures, treatment delivery, and study methods before undertaking a subsequent larger randomized controlled trial.
Phase One: Assessment-Tool Translation and Psychometric Evaluation
The first phase focused on preparation and evaluation of the assessment instruments that would subsequently be used in the randomized pilot phase. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), Hamilton Depression Rating Scale (HDRS), and State-Trait Anxiety Inventory (STAI) were used to assess PTSD, depressive symptoms, and anxiety symptoms, respectively. The instruments were translated into Urdu and their psychometric and cross-language properties were examined in a Pakistani clinical population.
During July and August 2020, patients attending two rehabilitation centres were screened for this preliminary phase. An initial sample of 50 patients was selected using consecutive sampling. Twenty-five participants were assessed using the English versions of the diagnostic tools and 25 using the Urdu versions. An additional 15 consecutive patients were later included for further English-Urdu cross-language analyses. No EMDR or CBT psychotherapy was delivered as part of this assessment-tool validation phase.
Cultural Adaptation and Treatment Feasibility
The broader feasibility programme also included translation and cultural adaptation of the EMDR and trauma-focused CBT treatment protocols. Adaptation work incorporated review of relevant literature and expert input. Treatment fidelity was subsequently examined through assessment of adherence to the treatment protocols and therapist competence.
Randomized Pilot Phase
The clinical intervention component used a prospective, single-blinded randomized controlled pilot design. It was conducted at the Paraplegic Center and the Psychiatry Unit and Rehabilitation Center at Lady Reading Hospital in Peshawar, Pakistan. The second centre was added because the COVID-19 pandemic reduced patient attendance at the initially selected centre.
Patients were recruited using consecutive sampling with rolling recruitment. A total of 108 individuals were screened for eligibility; 48 were ineligible and 20 did not proceed further. Forty eligible patients were randomized in a 1:1 ratio to either EMDR (n=20) or CBT (n=20) using a concealed computer-generated random allocation procedure. Participants remained in their assigned treatment condition; the study did not use a crossover design.
Interventions and Assessments
Psychotherapy was delivered by three clinical psychologists trained in EMDR and CBT. Treatment generally ranged from 6 to 12 sessions, usually delivered once per week, with two additional follow-up sessions approximately two months later. The EMDR intervention followed an eight-stage PTSD-focused protocol, while the CBT intervention followed a ten-stage trauma-focused CBT protocol.
PTSD, depressive, and anxiety symptoms were assessed at four time points: baseline/pre-treatment (T1), during treatment at approximately six weeks (T2), post-treatment at approximately 12 weeks (T3), and approximately two months after treatment at follow-up (T4). CAPS-5 was used for PTSD symptoms, HDRS for depressive symptoms, and STAI for anxiety symptoms.
Analysis and Purpose of the Pilot Study
The study examined changes in PTSD, depressive, and anxiety symptoms over time and explored the comparative performance of EMDR and CBT. Analyses included descriptive statistics, repeated-measures analyses, non-inferiority analyses, effect-size estimation, and longitudinal analyses examining associations between PTSD and comorbid symptoms. The final report also assessed treatment fidelity and therapist competence.
The primary purpose of this feasibility-pilot study was to generate preliminary evidence on whether the assessment procedures, culturally adapted interventions, treatment delivery, recruitment strategy, follow-up procedures, and analytic framework were suitable for a later larger randomized controlled trial in Pakistan. The final report specifically recommended subsequent testing with a substantially larger sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, two-arm, randomized controlled feasibility-pilot study with repeated assessments. Eligible participants were randomly allocated in a 1:1 ratio to either EMDR or CBT and remained in their assigned treatment group throughout the study. Assessments were conducted at baseline, during treatment, post-treatment, and at two-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Eye Movement Desensitization and Reprocessing Therapy | Experimental | Behavioral: Eye Movement Desensitization and Reprocessing TherapyParticipants assigned to this arm received Eye Movement Desensitization and Reprocessing (EMDR) therapy for PTSD and comorbid depressive and anxiety symptoms using the culturally adapted EMDR protocol. Treatment was delivered individually by trained clinical psychologists. Sessions ranged from approximately 6 to 12 sessions, generally once per week, with additional follow-up sessions as clinically indicated. |
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Trauma-Focused Cognitive Behavioral TherapyParticipants assigned to this arm received trauma-focused Cognitive Behavioral Therapy (CBT) for PTSD and comorbid depressive and anxiety symptoms using the culturally adapted CBT protocol. Treatment was delivered individually by trained clinical psychologists. Sessions ranged from approximately 6 to 12 sessions, generally once per week, with additional follow-up sessions as clinically indicated. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Age 15-60 years. Met screening criteria for PTSD, with PTSD as the primary clinical problem. Able to participate in the required assessments and psychotherapeutic procedures.
Key exclusion criteria (4 listed)
- Patients below the age of 15 years and above 60 years. Patients who were unable to move their hands or eyes and/or unable to perform basic movements.
- Patients who were unconscious for prolonged periods and unable to recover consciousness.
- Patients who did not meet the screening criteria for PTSD, or for whom PTSD was not the primary problem.
- Patients with severe intellectual impairments that would substantially limit communication and participation in psychotherapy.
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 TherapyAlso: EMDR TherapyEye Movement Desensitization and Reprocessing (EMDR) therapy was delivered using an eight-stage protocol for PTSD and comorbid symptoms. Treatment was delivered individually by trained clinical psychologists and included approximately 6 to 12 sessions, generally once weekly, with follow-up sessions as required. | Behavioural | Eye Movement Desensitization and Reprocessing Therapy |
| Trauma-Focused Cognitive Behavioral TherapyTrauma-focused Cognitive Behavioral Therapy was delivered using a ten-stage CBT protocol for PTSD and comorbid symptoms. Treatment was delivered individually by trained clinical psychologists and included approximately 6 to 12 sessions, generally once weekly, with follow-up sessions as required. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Change in Post-Traumatic Stress Disorder Symptom Severity Assessed by CAPS-5
Time frame: Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).
Post-traumatic stress disorder symptom severity was assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 assesses the severity of DSM-5 PTSD symptoms. Symptom severity ratings range from 0 (absent) to 4 (extreme/incapacitating), with higher scores indicating greater PTSD symptom severity. Changes in CAPS-5 scores were assessed across the treatment and follow-up periods to examine change in PTSD symptoms over time and differences between the EMDR and CBT treatment groups.
2 secondary outcomes
Change in Depressive Symptom Severity Assessed by the Hamilton Depression Rating Scale (HDRS-17)
Time frame: Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).
Change in Anxiety Symptoms Assessed by the State-Trait Anxiety Inventory (STAI)
Time frame: Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).
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 24 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant-level data will not be shared publicly because the study involves sensitive clinical and psychotherapy data. Aggregate findings may be reported in peer-reviewed publications and scientific presentations.
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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.
2 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 Therapy and Trauma-Focused Cognitive Behavioral Therapy in people with Post-Traumatic Stress Disorder and Depressive Symptoms, run by Khushal Khan Khattak Univeristy, Karak, Pakistan at 2 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 1 inclusion and 4 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 24 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 2 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?
Change in Post-Traumatic Stress Disorder Symptom Severity Assessed by CAPS-5 (time frame: Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).). 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 24 Sep 2026.