NCT04021329

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

Completed NA Last updated 2 February 2023

What this trial tests

NA trial testing CBT Therapy in Efficacy of Psychotherapy in 100 participants. Completed in 1 October 2021.

Timeline

1 October 2020

Primary endpoint
1 August 2021

1 October 2021

Quick facts

Lead sponsor	Khushal Khan Khattak Univeristy, Karak, Pakistan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	1 October 2020
Primary completion	1 August 2021
Estimated completion	1 October 2021
Sites	1 location across Pakistan

Drugs / interventions tested

• CBT Therapy

Conditions studied

• Efficacy of Psychotherapy — all drugs for Efficacy of Psychotherapy →

Sponsor

Khushal Khan Khattak Univeristy, Karak, Pakistan

Who can join

Adults 18 to 60, any sex, with Efficacy of Psychotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.