Efficacy of Eye Movement Desensitization & Reprocessing Versus Cognitive Behavioral Therapy in Post-Traumatic Stress and Depressive Disorders

NCT ID: NCT04021329

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-10-01

Brief 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

Conditions

Efficacy of Psychotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EMDR Therapy

One arm will be a group subjected to EMDR Therapy

Group Type: OTHER

CBT Therapy

Intervention Type: BEHAVIORAL

information added previously

CBT Therapy

other arm will be a group subjected to CBT Therapy

Group Type: OTHER

CBT Therapy

Intervention Type: BEHAVIORAL

information added previously

Interventions

CBT Therapy

information added previously

Intervention Type: BEHAVIORAL

Other Intervention Names

EMDR Therapy

Eligibility Criteria

Exclusion Criteria

The following patients will be excluded:

1. Patients below the age of 18 years and above 60 years as this study is not on children or older patients;

2. Patients who can't move their hands and eyes/or can't perform basic movements;

3. Patients who are unconscious for longer periods and unable to recover consciousness;

4. Patients not meeting the basic screening criteria of PTSD/ PTSD is not the main problem;

5. Patients with severe intellectual impairments, since such patients are difficult to communicate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khushal Khan Khattak Univeristy, Karak, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Dr. Anwar Khan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anwar Khan

Karak, KPK, Pakistan

Countries

Pakistan

Other Identifiers

KhushalKhanKhattakU

Identifier Type: -

Identifier Source: org_study_id