Post-traumatic Stress Disorder (PTSD)COMPASSNCT07801534
Comparative Efficacy of Cognitive Behavioral and Mindfulness Therapies in Reducing Post-Traumatic Stress Disorder Among Interpersonal Violence Survivors
A study testing Cognitive Behavioral Therapy (CBT), Mindfulness-Based Therapy (MBT) and Psychoeducation in people with Post-traumatic Stress Disorder (PTSD) and Post-Traumatic Stress Disorder, run by GIFT University at 1 site in Pakistan.
Trial summary
This study aims to compare the effectiveness of Cognitive Behavioral Therapy (CBT), Mindfulness-Based Therapy (MBT), and psychoeducation in reducing symptoms of post-traumatic stress disorder (PTSD) among adult survivors of interpersonal/domestic violence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-traumatic Stress Disorder (PTSD), Post-Traumatic Stress Disorder
- What is being tested?
- Cognitive Behavioral Therapy (CBT), Mindfulness-Based Therapy (MBT) and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Aug 2025to 31 Aug 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female adults aged 18 years or older. History of interpersonal or domestic violence. Meets DSM-5 diagnostic criteria for post-traumatic stress disorder (PTSD), confirmed using the Structured Clinical Interview for DSM-5 (SCID-5).
- Meets the eligibility threshold for PTSD symptoms on the PTSD Checklist for DSM-5 (PCL-5).
- Able and willing to provide written informed consent. Willing to participate in all intervention sessions and study assessments.
Who cannot join
- Current psychotic disorder or severe cognitive impairment. Active suicidal ideation or psychiatric emergency requiring immediate treatment.
- Current substance use disorder that would interfere with participation. Currently receiving another structured trauma-focused psychological intervention.
- Medical or psychiatric conditions that would prevent safe participation or completion of the study.
- Unable to provide informed consent or comply with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Comparative Efficacy of Cognitive Behavioral and Mindfulness Therapies in Reducing Post-Traumatic Stress Disorder Among Interpersonal Violence Survivors"
This study aims to compare the effectiveness of Cognitive Behavioral Therapy (CBT), Mindfulness-Based Therapy (MBT), and psychoeducation in reducing symptoms of post-traumatic stress disorder (PTSD) among adult survivors of interpersonal/domestic violence. Participants who meet the eligibility criteria will be randomly assigned to receive CBT, MBT, or psychoeducation. PTSD symptoms and related psychological outcomes, including emotion regulation, mindfulness, and perceived stress, will be assessed before treatment, after treatment, and at follow-up. The study seeks to determine whether CBT or MBT provides greater improvements in PTSD symptoms compared with psychoeducation and to identify the relative effectiveness of these evidence-based psychological interventions for survivors of interpersonal violence.
Read the detailed description
Interpersonal/domestic violence is a major public health concern that is associated with a high prevalence of post-traumatic stress disorder (PTSD) and other adverse mental health outcomes. Although Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Therapy (MBT) have each demonstrated effectiveness in reducing PTSD symptoms, few randomized controlled trials have directly compared their relative efficacy among survivors of interpersonal violence, particularly in low- and middle-income settings. This study addresses this evidence gap by evaluating and comparing CBT and MBT using a randomized controlled trial design.
This is a parallel-group randomized controlled trial with three study arms: (1) Cognitive Behavioral Therapy (CBT), (2) Mindfulness-Based Therapy (MBT), and (3) psychoeducation as an active control. Approximately 60 adult survivors of interpersonal/domestic violence who meet DSM-5 criteria for PTSD following screening and diagnostic assessment will be randomly assigned in equal numbers to one of the three intervention groups. Participants will complete baseline, post-intervention, and follow-up assessments.
The primary objective is to compare the effectiveness of CBT, MBT, and psychoeducation in reducing PTSD symptom severity. Secondary objectives include evaluating changes in emotion regulation, mindfulness, perceived stress, and other related psychological outcomes following the interventions. The study hypothesizes that both CBT and MBT will produce greater reductions in PTSD symptoms than psychoeducation, while also examining whether one active intervention demonstrates superior effectiveness for specific PTSD symptom domains and psychological outcomes.
The findings will contribute to the evidence base for trauma-informed psychological interventions and may inform clinical practice by identifying effective, culturally relevant treatment approaches for survivors of interpersonal/domestic violence.
- Being tested
- Cognitive Behavioral Therapy (CBT), Mindfulness-Based Therapy (MBT), Psychoeducation
- Keywords
- RCT, PTSD,CBT,MBT,therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
Also called CBT
Cognitive Behavioral Therapy (CBT) is a structured, trauma-informed psychological intervention designed to reduce post-traumatic stress disorder (PTSD) symptoms among adult survivors of interpersonal/domestic violence. The intervention includes psychoeducation, cognitive restructuring, behavioral activation, coping skills training, trauma-focused cognitive and behavioral techniques, and relapse prevention.
Mindfulness-Based Therapy (MBT)Behavioural
Also called MBT
Mindfulness-Based Therapy (MBT) is a structured psychological intervention that incorporates mindfulness meditation, breathing exercises, body awareness, acceptance, present-moment awareness, and emotion regulation strategies to reduce PTSD symptoms and improve psychological well-being among adult survivors of interpersonal/domestic violence.
PsychoeducationBehavioural
Psychoeducation is a structured behavioral intervention that provides information about trauma, PTSD symptoms, common psychological responses to interpersonal/domestic violence, coping strategies, stress management, safety planning, and available support resources. It serves as the active comparator and does not include the therapeutic components of CBT or MBT
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Cognitive Behavioral Therapy (CBT), a structured psychological intervention for post-traumatic stress disorder (PTSD) following interpersonal/domestic violence. The intervention aims to reduce PTSD symptoms through psychoeducation, cognitive restructuring, behavioral techniques, coping skills training, and relapse prevention. Participants will complete assessments at baseline, post-intervention, and follow-up. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| Mindfulness-Based Therapy (MBT) | Experimental | Participants assigned to this arm will receive Mindfulness-Based Therapy (MBT), a structured psychological intervention designed to reduce PTSD symptoms through mindfulness meditation, breathing exercises, body awareness, acceptance, and emotion regulation practices. Participants will complete assessments at baseline, post-intervention, and follow-up. Receives: Behavioral: Mindfulness-Based Therapy (MBT) |
| Psychoeducation | Active comparator | Participants assigned to this arm will receive a structured psychoeducation program providing information about trauma, post-traumatic stress disorder (PTSD), common trauma responses, coping strategies, stress management, safety planning, and available support services. This intervention serves as the active comparison group. Participants will complete assessments at baseline, post-intervention, and follow-up. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-Traumatic Stress Disorder (PTSD) Symptom Severity
Change in PTSD symptom severity will be assessed using the PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a validated 20-item self-report questionnaire measuring PTSD symptoms, with higher scores indicating greater symptom severity. The primary analysis will compare changes in PCL-5 scores among the Cognitive Behavioral Therapy (CBT), Mindfulness-Based Therapy (MBT), and Psychoeducation groups.
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Secondary outcomes (3)
Change in Emotion Regulation
Emotion regulation will be assessed using the Emotion Regulation Questionnaire (ERQ). Changes in participants' emotion regulation abilities will be compared across the three intervention groups.
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Change in Mindfulness
Mindfulness will be assessed using the Mindful Attention Awareness Scale (MAAS). Changes in mindfulness levels will be compared among the intervention groups.
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Change in Perceived Stress
Perceived stress will be assessed using the Perceived Stress Scale (PSS). Changes in perceived stress will be compared across the three intervention groups.
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start27 Aug 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies 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 will be randomly assigned to one of three parallel groups: Cognitive Behavioral Therapy (CBT), Mindfulness-Based Therapy (MBT), or Psychoeducation (active control). Participants will complete assessments at baseline, immediately after the intervention, and at follow-up. The study is designed to compare the effectiveness of CBT and MBT with psychoeducation in reducing PTSD symptoms and improving related psychological outcomes among adult survivors of interpersonal/domestic violence.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GIFT University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khadija Raheel, GIFT University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801534
- Sponsor's protocol ID
- GIFT/PSY/MS/2025/017
- Acronym
- COMPASS
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves sensitive information from survivors of interpersonal/domestic violence and post-traumatic stress disorder (PTSD). To protect participant privacy, confidentiality, and safety, only aggregate, de-identified study findings will be reported in publications and presentations. Data sharing is restricted in accordance with the approved ethics protocol and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparative Efficacy of Cognitive Behavioral and Mindfulness Therapies in Reducing Post-Traumatic Stress Disorder Among Interpersonal Violence Survivors"
- ClinicalTrials.gov ID
- NCT07801534
- Acronym / sponsor ID
- COMPASS / GIFT/PSY/MS/2025/017
- Keywords
- RCT, PTSD,CBT,MBT,therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GIFT UniversityUniversity, hospital or other
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 3 Sep 2026 (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 study aims to compare the effectiveness of Cognitive Behavioral Therapy (CBT), Mindfulness-Based Therapy (MBT), and psychoeducation in reducing symptoms of post-traumatic stress disorder (PTSD) among adult survivors of interpersonal/domestic violence. Participants who meet the eligibility criteria will be randomly assigned to receive CBT, MBT, or psychoeducation. PTSD symptoms and related psychological outcomes, including emotion regulation, mindfulness, and perceived stress, will be assessed before treatment, after treatment, and at follow-up. The study seeks to determine whether CBT or MBT provides greater improvements in PTSD symptoms compared with psychoeducation and to identify the relative effectiveness of these evidence-based psychological interventions for survivors of interpersonal violence.
Detailed description
Interpersonal/domestic violence is a major public health concern that is associated with a high prevalence of post-traumatic stress disorder (PTSD) and other adverse mental health outcomes. Although Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Therapy (MBT) have each demonstrated effectiveness in reducing PTSD symptoms, few randomized controlled trials have directly compared their relative efficacy among survivors of interpersonal violence, particularly in low- and middle-income settings. This study addresses this evidence gap by evaluating and comparing CBT and MBT using a randomized controlled trial design.
This is a parallel-group randomized controlled trial with three study arms: (1) Cognitive Behavioral Therapy (CBT), (2) Mindfulness-Based Therapy (MBT), and (3) psychoeducation as an active control. Approximately 60 adult survivors of interpersonal/domestic violence who meet DSM-5 criteria for PTSD following screening and diagnostic assessment will be randomly assigned in equal numbers to one of the three intervention groups. Participants will complete baseline, post-intervention, and follow-up assessments.
The primary objective is to compare the effectiveness of CBT, MBT, and psychoeducation in reducing PTSD symptom severity. Secondary objectives include evaluating changes in emotion regulation, mindfulness, perceived stress, and other related psychological outcomes following the interventions. The study hypothesizes that both CBT and MBT will produce greater reductions in PTSD symptoms than psychoeducation, while also examining whether one active intervention demonstrates superior effectiveness for specific PTSD symptom domains and psychological outcomes.
The findings will contribute to the evidence base for trauma-informed psychological interventions and may inform clinical practice by identifying effective, culturally relevant treatment approaches for survivors of interpersonal/domestic violence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: Cognitive Behavioral Therapy (CBT), Mindfulness-Based Therapy (MBT), or Psychoeducation (active control). Participants will complete assessments at baseline, immediately after the intervention, and at follow-up. The study is designed to compare the effectiveness of CBT and MBT with psychoeducation in reducing PTSD symptoms and improving related psychological outcomes among adult survivors of interpersonal/domestic violence.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT)Cognitive Behavioral Therapy (CBT), a structured psychological intervention for post-traumatic stress disorder (PTSD) following interpersonal/domestic violence. The intervention aims to reduce PTSD symptoms through psychoeducation, cognitive restructuring, behavioral techniques, coping skills training, and relapse prevention. Participants will complete assessments at baseline, post-intervention, and follow-up. |
| Mindfulness-Based Therapy (MBT) | Experimental | Behavioral: Mindfulness-Based Therapy (MBT)Participants assigned to this arm will receive Mindfulness-Based Therapy (MBT), a structured psychological intervention designed to reduce PTSD symptoms through mindfulness meditation, breathing exercises, body awareness, acceptance, and emotion regulation practices. Participants will complete assessments at baseline, post-intervention, and follow-up. |
| Psychoeducation | Active comparator | Behavioral: PsychoeducationParticipants assigned to this arm will receive a structured psychoeducation program providing information about trauma, post-traumatic stress disorder (PTSD), common trauma responses, coping strategies, stress management, safety planning, and available support services. This intervention serves as the active comparison group. Participants will complete assessments at baseline, post-intervention, and follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female adults aged 18 years or older. History of interpersonal or domestic violence. Meets DSM-5 diagnostic criteria for post-traumatic stress disorder (PTSD), confirmed using the Structured Clinical Interview for DSM-5 (SCID-5).
- Meets the eligibility threshold for PTSD symptoms on the PTSD Checklist for DSM-5 (PCL-5).
- Able and willing to provide written informed consent. Willing to participate in all intervention sessions and study assessments.
Key exclusion criteria (4 listed)
- Current psychotic disorder or severe cognitive impairment. Active suicidal ideation or psychiatric emergency requiring immediate treatment.
- Current substance use disorder that would interfere with participation. Currently receiving another structured trauma-focused psychological intervention.
- Medical or psychiatric conditions that would prevent safe participation or completion of the study.
- Unable to provide informed consent or comply with study 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 |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)Also: CBTCognitive Behavioral Therapy (CBT) is a structured, trauma-informed psychological intervention designed to reduce post-traumatic stress disorder (PTSD) symptoms among adult survivors of interpersonal/domestic violence. The intervention includes psychoeducation, cognitive restructuring, behavioral activation, coping skills training, trauma-focused cognitive and behavioral techniques, and relapse prevention. | Behavioural | Cognitive Behavioral Therapy (CBT) |
| Mindfulness-Based Therapy (MBT)Also: MBTMindfulness-Based Therapy (MBT) is a structured psychological intervention that incorporates mindfulness meditation, breathing exercises, body awareness, acceptance, present-moment awareness, and emotion regulation strategies to reduce PTSD symptoms and improve psychological well-being among adult survivors of interpersonal/domestic violence. | Behavioural | Mindfulness-Based Therapy (MBT) |
| PsychoeducationPsychoeducation is a structured behavioral intervention that provides information about trauma, PTSD symptoms, common psychological responses to interpersonal/domestic violence, coping strategies, stress management, safety planning, and available support resources. It serves as the active comparator and does not include the therapeutic components of CBT or MBT | Behavioural | Psychoeducation |
Primary outcome
Change in Post-Traumatic Stress Disorder (PTSD) Symptom Severity
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
Change in PTSD symptom severity will be assessed using the PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a validated 20-item self-report questionnaire measuring PTSD symptoms, with higher scores indicating greater symptom severity. The primary analysis will compare changes in PCL-5 scores among the Cognitive Behavioral Therapy (CBT), Mindfulness-Based Therapy (MBT), and Psychoeducation groups.
3 secondary outcomes
Change in Emotion Regulation
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
Change in Mindfulness
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
Change in Perceived Stress
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
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 3 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves sensitive information from survivors of interpersonal/domestic violence and post-traumatic stress disorder (PTSD). To protect participant privacy, confidentiality, and safety, only aggregate, de-identified study findings will be reported in publications and presentations. Data sharing is restricted in accordance with the approved ethics protocol and institutional policies.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT), Mindfulness-Based Therapy (MBT) and Psychoeducation in people with Post-traumatic Stress Disorder (PTSD) and Post-Traumatic Stress Disorder, run by GIFT University 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 3 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: under way, not looking for participants, as of the sponsor's last update on 3 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 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?
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 (PTSD) Symptom Severity (time frame: Baseline, immediately post-intervention, and 3-month follow-up). 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 3 Sep 2026.