An interventional study of Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Therapy (MBT) in Post-traumatic Stress Disorder (PTSD) and Post-Traumatic Stress Disorder, sponsored by GIFT University. Active, not recruiting at 1 site in Pakistan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by GIFT University · Not applicable, Interventional, and Treatment
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.
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.
2,683 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 60 is below the median of 69 across 2,197 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →GIFT University is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female adults aged 18 years or older. History of interpersonal or domestic violence. Meets 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 . Willing to participate in all intervention sessions and study assessments.
Exclusion Criteria:
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 or comply with study procedures.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Cognitive Behavioral Therapy (CBT)
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.
Behavioral: Mindfulness-Based Therapy (MBT)
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.
Behavioral: Psychoeducation
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.
Also known as: CBT
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.
Also known as: MBT
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
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.
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
Plan to share: 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.
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Aug 2026, 12 months after the start.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 12 months is below that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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