Efficacy of Eye Movement Desensitization & Reprocessing Versus Cognitive Behavioral Therapy in Post-Traumatic Stress and Depressive Disorders
Condition: Efficacy of Psychotherapy
MeSH terms: Depressive Disorder; Depression
Study type: Interventional

Summary: 
      Post-Traumatic Stress Disorder(PTSD) develops after exposure to or witnessing traumatic
      events. PTSD is highly comorbid and individuals with PTSD usually report Major Depressive
      Disorder(MDD). Common treatment choices for PTSD and MDD are either EMDR or CBT, however,
      little is known about their comparative efficacy, especially in Pakistan. Therefore, this
      Randomized Controlled Trial(RCT) aims at determining the comparative efficacy of EMDR vs CBT
      in Pakistan. This study will also examine the association between reduction in symptoms of
      PTSD and MDD over course of treatment. In this regard, two arms Crossover Randomized
      Controlled Trial(RCT) with Repeated Measures Design will be selected. This study will be
      conducted at two rehabilitation centres and patients will be screened at Time:01, baseline;
      Time:02, during treatment; Time:03, post treatment and Time:04, 06 months follow-up. All
      analyses will be performed according to intention-to-treat principle. Variations in symptoms
      will be analysed by using descriptive statistics, χ2 tests, t-tests, and one way ANOVA. To
      examine changes in PTSD and MDD across time and to check efficacy of each treatment, a series
      of Linear Mixed Models will be run. Furthermore, a series of multi-level lagged mediation
      analysis will be performed to check bi-directional mediation between changes PTSD and MDD
      over time. This protocol has outlined the rationale for determining efficacy of EMDR and CBT
      in Pakistan. It will help in answering a broad range of questions concerning efficacy of
      newly developed evidence-based treatments. Moreover, it may also guide future research on the
      treatment of PTSD and MDD in the developing countries.
    

Detailed description: 
      Study Background: Post-Traumatic Stress Disorder (PTSD) and its associated comorbidities
      develop after exposure to the traumatic events. In the recent years a global increase in the
      rate of PTSD and its comorbidities has been observed, especially in the developing countries
      like Pakistan that is continually suffering from war on terrorism, domestic violence, coupled
      by poverty and cultural constraints. Due to increasing rates of PTSD and lack of treatment
      facilities in Pakistan, it is imperative to find a mechanism for controlling mental illnesses
      in Pakistan. This situation also motivates research on testing the efficacy of modern
      psychotherapies like EMDR and CBT. Aim: The present study aims at determining the efficacy of
      EMDR by comparing it with CBT for the treatment of PTSD and comorbid Major Depressive
      Disorder(MDD) in Pakistan. Research Design: A two arms Crossover Randomized Controlled Trial
      (RCT) with Repeated Measures Design will be selected. Consolidated Standards of Reporting
      Trials (CONSORT) group flow diagram will be followed to carry out and report this study.
      Participants and Setting: This study will be conducted at two rehabilitation centres situated
      in the district Peshawar, Pakistan. A formal sample size cannot be calculated at this stage
      because the exact number of PTSD patients located in the selected area is not known. However,
      participants will be recruited through consecutive sampling technique with a rolling
      recruitment strategy. The outdoor and indoor patients, who pass exclusion criteria and are
      positively screen for PTSD symptoms will be recruited for this study. The sample size will be
      100 patients depending on the availability and willingness of patients. The patients will be
      randomly allocated either to EMDR or CBT with an allocation ratio of 1:1. Interventions:
      Patients will be screened (Time: 01, baseline) then they will undertake 06 psychotherapy
      sessions. After completing 06 sessions, patients will be assessed (Time: 02, during
      treatment). Additional 08 psychotherapy sessions will be carried out and after completing 14
      sessions, the patients will be once again assessed (Time: 03, post treatment) and then
      assessed after 06 months (Time: 04, follow-up). Statistical Analyses: All analyses will be
      performed according to the intention-to-treat (ITT) principle. Variations in symptoms with
      regard to demographic/baseline characteristics will be analysed by using descriptive
      statistics, χ2 tests for categorical variables, t-tests, and one way ANOVA for continuous
      variables. Non-inferiority testing will be used to know whether EMDR is not worse than CBT.
      To examine changes in PTSD and its associated comorbidities across Time :01, Time: 02, Time:
      03 and Time :04 and to check the efficacy of each treatment, a series of Linear Mixed Models,
      with Maximum Like hood Estimation will be run, including main effects of treatment and time
      and the interaction effects of treatment*time. Moreover, a series of multi-level lagged
      mediation analysis along with moderated mediation analysis will be performed to check the
      bi-directional mediation between changes PTSD (as mediator) and changes in outcome variables
      (comorbid symptoms) over time. Means and standard deviations will be used to compute effect
      sizes (Cohen's d) for pre and post treatment and 6 months follow up
    

Intervention name(s): CBT Therapy
Intervention type(s): Behavioral
Intervention description(s): information added previously
Other intervention name(s): EMDR Therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The current study will be a two arms cross over Randomized Controlled Trial (RCT) with Repeated Measures.
Moreover, the Consolidated Standards of Reporting Trials (CONSORT) group flow diagram and SPIRIT Checklist will be followed to carry out and report this study.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Post-traumatic Stress Disorder, Major Depressive Disorder, Comorbidity, Eye Movement Desensitization & Reprocessing, Cognitive Behavioral Therapy