Eye Movement Desensitization and Reprocessing (EMDR) for Police Personnel

Stress Clinical Trial

Official title:

Eye Movement Desensitization and Reprocessing (EMDR) for Stress, Psychological Trauma and Suicidal Ideation in Police Personnel: A Feasibility Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05171868
• Other study ID #: SAHAR M-EMDR-001
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: Pakistan Institute of Living and Learning
• Contact: MUQADDAS ASIF
• Phone: 042-35842310
• Email: muqaddas.asif[@]pill.org.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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); 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Having suicidal ideation measured as a score > 2 on Beck scale of suicidal ideation
• Aged 18 years - 60 years' old
• Police officer with psychological trauma measured with the International Trauma Questionnaire and stress measured with stress subscale of Depression, Anxiety and Stress scale

Exclusion Criteria:

• Less than 12 months' experience in the police officer.
• Participants reporting active suicidal ideation measured as a score of 2 on item no 4 of BSSI will be excluded and referred to a psychiatric service.
• With current history of use of hard/psychoactive substances (excluding tobacco and caffeine).
• Unable to provide consent due to severe mental or physical illness.
• Unlikely to be available for the entire duration of the study.

Related Conditions & MeSH terms

• Psychological Trauma
• Stress
• Suicidal Ideation
• Wounds and Injuries

Intervention

Behavioral:
• Eye Movement Desensitization and Reprocessing (EMDR)
Each participant in the intervention group 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 participant. Trained EMDR therapists will deliver the intervention.

Locations

Country	Name	City	State
Pakistan	Prison settings Peshawar	Peshawar	KPK

Sponsors (2)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning	University of Manchester

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	The feasibility will be determined by collecting data on recruitment rates. The success criterion of feasibility will be to recruit > 50% of eligible participants.	From baseline to 8th week (at the end of intervention)
Primary	Acceptability measure	Intervention acceptability will be assessed using data on intervention attendance. The criterion for acceptability is the intervention attendance rate of > 5 sessions.	From baseline to 8th week (at the end of intervention)
Primary	Feasibility of Retention	The feasibility of retention will be determined by collecting data on retention rates. The success criterion of feasibility of retention will be to retain > 50% participants.	From baseline to 8th week (at the end of intervention)
Secondary	Beck Scale for Suicide Ideation	Beck Scale for Suicide Ideation is a 19-item instrument for detecting and measuring the current intensity of patient-specific attitude, behavior, and specificity of patient thoughts to kill themselves during the past week.	Change in problem scores from baseline to 8th week
Secondary	The International Trauma Questionnaire	The International Trauma Questionnaire is a brief, simple-worded measure focusing on the core features of post-traumatic stress disorder.	Change in problem scores from baseline to 8th week
Secondary	Depression Anxiety and Stress Scale	Depression Anxiety and Stress Scale is consist of three subscales that measure the negative emotional states of depression, anxiety, and stress and consist of 7 items per subscale. The participants are requested to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week.	Change in problem scores from baseline to 8th week
Secondary	Beck Hopelessness Scale	Beck hopelessness scale measure three aspects of hopelessness; feelings about the future, loss of motivation and expectations. The scale consists of 20 statements each of which is scored as 0 or 1.	Change in problem scores from baseline to 8th week
Secondary	Sleep Quality Questionnaire	Sleep Quality Questionnaire consists of eight items rated on a 5-point scale. It measures self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep and problems during waking hours within the past seven days.	Change in problem scores from baseline to 8th week
Secondary	Coping Resource Inventory	The Coping Resource Inventory assesses the individual's stress management and coping resources with stress.	Change in coping resources scores from baseline to 8th week