Comparative Efficacy of Cognitive Behavioral and Mindfulness Therapies in Reducing Post-Traumatic Stress Disorder Among Interpersonal Violence Survivors (COMPASS)
"Comparative Efficacy of Cognitive Behavioral and Mindfulness Therapies in Reducing Post-Traumatic Stress Disorder Among Interpersonal Violence Survivors"
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Punjab Province
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Gujranwala, Punjab Province, Pakistan, 52250
- Shelter Homes
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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.
Andere namen:
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Experimenteel: 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.
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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.
Andere namen:
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Actieve vergelijker: Psychoeducation
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.
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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
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Post-Traumatic Stress Disorder (PTSD) Symptom Severity
Tijdsspanne: Baseline, immediately post-intervention, and 3-month follow-up
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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.
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Baseline, immediately post-intervention, and 3-month follow-up
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Emotion Regulation
Tijdsspanne: Baseline, immediately post-intervention, and 3-month follow-up
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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.
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Baseline, immediately post-intervention, and 3-month follow-up
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Change in Mindfulness
Tijdsspanne: Baseline, immediately post-intervention, and 3-month follow-up
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Mindfulness will be assessed using the Mindful Attention Awareness Scale (MAAS).
Changes in mindfulness levels will be compared among the intervention groups.
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Baseline, immediately post-intervention, and 3-month follow-up
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Change in Perceived Stress
Tijdsspanne: Baseline, immediately post-intervention, and 3-month follow-up
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Perceived stress will be assessed using the Perceived Stress Scale (PSS).
Changes in perceived stress will be compared across the three intervention groups.
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Baseline, immediately post-intervention, and 3-month follow-up
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Medewerkers en onderzoekers
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GIFT/PSY/MS/2025/017
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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