Viewing Study NCT05171868


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Study NCT ID: NCT05171868
Status: RECRUITING
Last Update Posted: 2024-05-17
First Post: 2021-12-11
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Eye Movement Desensitization and Reprocessing (EMDR) for Police Personnel
Sponsor: Pakistan Institute of Living and Learning
Organization:

Study Overview

Official Title: Eye Movement Desensitization and Reprocessing (EMDR) for Stress, Psychological Trauma and Suicidal Ideation in Police Personnel: A Feasibility Randomised Controlled Trial
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Objectives:

1. To examine the feasibility of Eye Movement Desensitization and Reprocessing (EMDR) as an intervention to reduce psychological trauma and stress amongst police officers in Pakistan.
2. To test whether reducing stress and psychological trauma reduces suicidal ideation in police officers.
3. To explore participants' experiences with EMDR Intervention.

Study design and setting:

The study will be a mixed-method feasibility randomized controlled trial of EMDR as an intervention in treating symptoms such as stress, trauma and suicidal ideation in police officers. The study will be conducted in five major cities in Pakistan: Rawalpindi, Karachi, Peshawar, Quetta, and Lahore.

Sample size:

A total of N=80 eligible police officers will be recruited and randomized in the study.
Detailed Description: EMDR intervention is an evidence-based psychological intervention that has been proven effective for stress and trauma, however, research evidence on feasibility of EMDR in forensic settings in Pakistan is limited. The current study aims to establish the feasibility and acceptability of EMDR intervention for management of stress, psychological trauma and suicidal ideation amongst police officers in Pakistan. The study will recruit a total of 80 police officers from police stations in the participating study sites, and prospective participants will be screened against eligibility criteria. Eligible consented participants will be enrolled in the study. An independent statistician will randomize participants to one of the two study arms: 1) EMDR (Intervention)Íž or 2) waiting list control arm. Each participant in the intervention arm will receive 8 individual, weekly EMDR sessions over 8 weeks. Each session will take approximately 60-90 minutes. The sessions will be delivered at a place convenient to the participants. Trained EMDR therapists will deliver the intervention. The waiting list control arm will receive their routine care as usual, As part of the safety protocol, the details of any services each participant receives in the control group will be obtained. EMDR treatment will be offered to the control group (waiting control group) after the active intervention is complete. Assessment measures will be administered before and after the intervention at 8th week. All assessments will be rater blind. After post-assessments at 8th week, a purposefully selected subset (stratified by age \& gender) of participants will be invited for qualitative interviews to explore their experiences and satisfaction with the intervention. Participants will be interviewed within 1 week of their post-intervention by a trained qualitative researcher exploring their experience with EMDR, the barriers and facilitators to engagement, and perceived benefits or negative experiences with the intervention. A sample of up to 15 interviews would be enough to achieve category saturation. On average, interviews will last for 60 minutes. The interview will be face-to-face or through telephone as an alternative to a face-to-face meeting to reduce the number of in-person meetings given the current context of COVID-19.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: