Clinical trial NCT06435052: Efficacy of Eye Movement Desensitization & Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan
Official title: Efficacy of Eye Movement Desensitization & Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan: A Full-fledged Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Depression, Anxiety
Keywords: Post Traumatic Stress Disorder
EMDR
CBT
Pakistan
Lead sponsor: Khushal Khan Khattak Univeristy, Karak, Pakistan
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This Randomized Controlled Trial will check the efficacy of Eye Movement Desensitization \& Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan

Detailed description: This Randomized Controlled Trial will check the efficacy of Eye Movement Desensitization \& Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan.

It will be a single blind multi-center RCT with two arms (EMDR and CBT). This study will broadly work on following aims:

1. Initially the comparative efficacy of EMDR and CBT (i.e., standard face-to-face protcols) will be determined on large scale in Pakistan by:

   1. Examining whether EMDR is non-inferior to CBT in the treatment of PTSD and its two comorbidities in Pakistan.
   2. Studying changes in the symptoms (i.e., reduction in the PTSD and comorbid symptoms with the passage of time) after administering EMDR and CBT. The level of change in the symptoms will ultimately help in determining the extent of effectiveness of both therapies.
   3. Examine the reciprocal relationship between PTSD and comorbid symptoms for knowing whether any reduction in the PTSD symptoms can help in reducing the comorbid symptoms after administering EMDR and CBT.
2. At the mean time work on the design and development of virtual EMDR and CBT therapies (i.e., Web-based and Mobile Applications) will also be started. The initial prototypes will be tested for its comparative efficacy. Later once the final versions will be developed then it will be also tested for its comparative efficacy on large scale in Pakistan.

Eligibility criteria: Inclusion Criteria:

reverse of the exclusion critera

Exclusion Criteria:

The following patients will be excluded:

1. Patients below the age of 15 years and above 60 years, since this study is neither on children nor on old aged 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

Primary outcomes:
measure: Post-traumatic stress disorder
timeFrame: 2 years
Secondary outcomes:
measure: Depressive and Anxiety Symptoms
timeFrame: 2 years
Other outcomes:
Locations:
city: Karak
country: Pakistan
facility: Anwar Khan
Study officials:
References: