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

NCT04021329 | Completed

• 1 other identifier: KhushalKhanKhattakU
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Efficacy of Psychotherapy

Keywords

Post-traumatic Stress Disorder, Major Depressive Disorder, Comorbidity, Eye Movement Desensitization & Reprocessing, Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• Measurement of Change in the symptoms of Post Traumatic Stress Disorder

  Clinician-Administered Post Traumatic Stress Disorder Scale-5 (Weathers, Blake, et al., 2013) These diagnostic tools will be used to assess the symptoms of Post Traumatic Stress Disorder. Any changes in the level of PTSD will be noted with respect to Pre, Mid and Post treatment stages The total symptom severity score is calculated by summing severity scores for the 20 * Criterion A (items 1-5); (Exposure to actual or threatened death) * Criterion B (items 6-7); (Presence of intrusion symptoms associated with the traumatic events) * Criterion C (items 8-14); (Persistent avoidance of stimuli associated with the traumatic events) * Criterion D (items 15-20). (Negative alterations in cognitions and mood associated with the traumatic events) Severity Rating 0. Absent: 1. Mild / subthreshold:. 2. Moderate / threshold: 3. Severe / markedly elevated: 4. Extreme / incapacitating:

  1st week (Baseline/pre-treatment screening, T-1); six weeks (during treatment screening, T-2); 12 weeks (post-treatment assessment, T-3). Finally, three months (follow up assessment, T-4).

• Measurement of Socio Demographic Profile

  Socio-demographic characteristics of the patients, like age, gender, marital status, occupation and social background

  1st week at start of treatment, i.e, from date of randomization

Secondary Outcomes (1)

• Measurement of Change in the symptoms of major depression

  1st week (Baseline/pre-treatment screening, T-1); six weeks (during treatment screening, T-2); 12 weeks (post-treatment assessment, T-3). Finally, three months (follow up assessment, T-4).

Study Arms (2)

EMDR Therapy

OTHER

One arm will be a group subjected to EMDR Therapy

Behavioral: CBT Therapy

CBT Therapy

OTHER

other arm will be a group subjected to CBT Therapy

Behavioral: CBT Therapy

Interventions

CBT Therapy BEHAVIORAL

information added previously

Also known as: EMDR Therapy

CBT Therapy; EMDR Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• The following patients will be excluded:
• Patients below the age of 18 years and above 60 years as this study is not on children or older patients;
• Patients who can't move their hands and eyes/or can't perform basic movements;
• Patients who are unconscious for longer periods and unable to recover consciousness;
• Patients not meeting the basic screening criteria of PTSD/ PTSD is not the main problem;
• Patients with severe intellectual impairments, since such patients are difficult to communicate.

Sponsors & Collaborators

• Khushal Khan Khattak Univeristy, Karak, Pakistan: lead

Study Sites (1)

Anwar Khan

Karak, KPK, 27200, Pakistan

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 16, 2019
• Study Start: October 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: February 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: it will available next year on line
• Access Criteria: will be on-line accessible

Locations

PA (1)