search
Back to results

Eye Movement Desensitization and Reprocessing (EMDR) for Police Personnel

Primary Purpose

Suicidal Ideation, Psychological Trauma, Stress

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Eye Movement Desensitization and Reprocessing (EMDR)
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation focused on measuring Forensic settings, EMDR, Trauma, Police Personnel, Suicidal Ideation, Stress, Pakistan, Feasibility

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Prison settings PeshawarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EMDR receiving group

Waiting list Control Group

Arm Description

EMDR is a psychotherapeutic approach that emphasizes the role of the brain's information processing system in perfecting the psychological consequences of distressing events. EMDR is an eight-phase treatment protocol, including procedure that focuses on the memories underlying current problems and those that must be specifically addressed to bring the client to a robust state of psychological health. One of its distinguishing aspects is its use of bilateral physical stimulation, such as side-to-side eye movements, alternating hand taps, or alternating auditory tones while the person undergoing treatment is mentally focusing on aspects of various life experiences.

The control group will receive their routine care as usual. Once the trial is completed they will be invited for EMDR sessions

Outcomes

Primary Outcome Measures

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.
Acceptability measure
Intervention acceptability will be assessed using data on intervention attendance. The criterion for acceptability is the intervention attendance rate of > 5 sessions.
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.

Secondary Outcome Measures

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.
The International Trauma Questionnaire
The International Trauma Questionnaire is a brief, simple-worded measure focusing on the core features of post-traumatic stress disorder.
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.
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.
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.
Coping Resource Inventory
The Coping Resource Inventory assesses the individual's stress management and coping resources with stress.

Full Information

First Posted
December 11, 2021
Last Updated
March 31, 2023
Sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester
search

1. Study Identification

Unique Protocol Identification Number
NCT05171868
Brief Title
Eye Movement Desensitization and Reprocessing (EMDR) for Police Personnel
Official Title
Eye Movement Desensitization and Reprocessing (EMDR) for Stress, Psychological Trauma and Suicidal Ideation in Police Personnel: A Feasibility Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objectives: 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. To test whether reducing stress and psychological trauma reduces suicidal ideation in police officers. 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); 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Psychological Trauma, Stress
Keywords
Forensic settings, EMDR, Trauma, Police Personnel, Suicidal Ideation, Stress, Pakistan, Feasibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EMDR receiving group
Arm Type
Experimental
Arm Description
EMDR is a psychotherapeutic approach that emphasizes the role of the brain's information processing system in perfecting the psychological consequences of distressing events. EMDR is an eight-phase treatment protocol, including procedure that focuses on the memories underlying current problems and those that must be specifically addressed to bring the client to a robust state of psychological health. One of its distinguishing aspects is its use of bilateral physical stimulation, such as side-to-side eye movements, alternating hand taps, or alternating auditory tones while the person undergoing treatment is mentally focusing on aspects of various life experiences.
Arm Title
Waiting list Control Group
Arm Type
No Intervention
Arm Description
The control group will receive their routine care as usual. Once the trial is completed they will be invited for EMDR sessions
Intervention Type
Behavioral
Intervention Name(s)
Eye Movement Desensitization and Reprocessing (EMDR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of recruitment
Description
The feasibility will be determined by collecting data on recruitment rates. The success criterion of feasibility will be to recruit > 50% of eligible participants.
Time Frame
From baseline to 8th week (at the end of intervention)
Title
Acceptability measure
Description
Intervention acceptability will be assessed using data on intervention attendance. The criterion for acceptability is the intervention attendance rate of > 5 sessions.
Time Frame
From baseline to 8th week (at the end of intervention)
Title
Feasibility of Retention
Description
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.
Time Frame
From baseline to 8th week (at the end of intervention)
Secondary Outcome Measure Information:
Title
Beck Scale for Suicide Ideation
Description
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.
Time Frame
Change in problem scores from baseline to 8th week
Title
The International Trauma Questionnaire
Description
The International Trauma Questionnaire is a brief, simple-worded measure focusing on the core features of post-traumatic stress disorder.
Time Frame
Change in problem scores from baseline to 8th week
Title
Depression Anxiety and Stress Scale
Description
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.
Time Frame
Change in problem scores from baseline to 8th week
Title
Beck Hopelessness Scale
Description
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.
Time Frame
Change in problem scores from baseline to 8th week
Title
Sleep Quality Questionnaire
Description
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.
Time Frame
Change in problem scores from baseline to 8th week
Title
Coping Resource Inventory
Description
The Coping Resource Inventory assesses the individual's stress management and coping resources with stress.
Time Frame
Change in coping resources scores from baseline to 8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MUQADDAS ASIF
Phone
042-35842310
Email
muqaddas.asif@pill.org.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Tayyeba Kiran
Phone
021-36703712
Email
tayyeba.kiran@pill.org.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nusrat Husain
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasim Chahudhry
Organizational Affiliation
Pakistan Institute of Living and Learning
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prison settings Peshawar
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umair Ahsen

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Eye Movement Desensitization and Reprocessing (EMDR) for Police Personnel

We'll reach out to this number within 24 hrs