Post-Traumatic Stress Disorder, Post-traumatic Stress Disorder (PTSD)
Conditions
Keywords
RCT, PTSD,CBT,MBT,therapy
Brief 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. 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.
Interventions
BEHAVIORALCognitive Behavioral Therapy (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.
BEHAVIORALMindfulness-Based Therapy (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.
BEHAVIORALPsychoeducation
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
Sponsors
GIFT University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label randomized controlled trial. Participants and therapists are aware of the assigned intervention (Cognitive Behavioral Therapy, Mindfulness-Based Therapy, or Psychoeducation). No masking of participants, care providers, investigators, or outcome assessors is implemented.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
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 informed consent or comply with study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-Traumatic Stress Disorder (PTSD) Symptom Severity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Emotion Regulation | Baseline, immediately post-intervention, and 3-month follow-up | 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. |
| Change in Mindfulness | Baseline, immediately post-intervention, and 3-month follow-up | Mindfulness will be assessed using the Mindful Attention Awareness Scale (MAAS). Changes in mindfulness levels will be compared among the intervention groups. |
| Change in Perceived Stress | Baseline, immediately post-intervention, and 3-month follow-up | Perceived stress will be assessed using the Perceived Stress Scale (PSS). Changes in perceived stress will be compared across the three intervention groups. |
Countries
Pakistan
Outcome results
None listed