Diminution of Psychological Distress through EMDR Integrative Group Treatment Protocol among Secondary School Students: A Pilot Randomized Controlled Trial from Pakistan

Last registered on September 04, 2023

Pre-Trial

Trial Information

General Information

Title
Diminution of Psychological Distress through EMDR Integrative Group Treatment Protocol among Secondary School Students: A Pilot Randomized Controlled Trial from Pakistan
RCT ID
AEARCTR-0012024
Initial registration date
September 03, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
September 04, 2023, 7:00 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
EMDR Pakistan

Other Primary Investigator(s)

PI Affiliation
EMDR Pakistan

Additional Trial Information

Status
On going
Start date
2023-05-01
End date
2023-09-30
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
EMDR-IGTP Clinical Trial Summary

Background and Objectives
Eye Movement Desensitization and Reprocessing – Integrative Group Treatment Protocol (EMDR-IGTP) has been in use since 1998 with wide age range of individuals both children and adults around the globe. Keeping in view the high vulnerability of children for the development of psychological Distress after experiencing traumatic events in their lives and existing treatment gap in Pakistan, a pilot randomized controlled trial was premeditated with the objectives of translation and adaptation of EMDR-IGTP (Jarero & Artigas, 2022) in cultural context of Pakistan along with establishment of fidelity, acceptability, feasibility and efficacy of adapted protocol in reducing psychological Distress among secondary school students.
Methodology
Study encompassed of two phases; where in Phase-I, EMDR-IGTP has been translated into Urdu and adapted according the cultural context of Pakistani society. However, phase II dealt with mapping the fidelity, acceptability and feasibility of protocol along with testing its efficacy. A sample of 94 children aged 11-16 years were selected from two Government schools and randomized into the intervention group (EMDR-IGTP session) and control group (routine care) after Pre- assessment through Urdu Version of Depression, Anxiety, and Stress Scale (DASS-21). The administration of the EMDR-IGTP comprises the eight phased standard EMDR procedure with a group therapy model. The responses were collected in an art therapy format following original IGTP protocol. Mode of bilateral stimulation was self-administered in the form of Butterfly Hugs as an established exercise, thus enhancing more extensive reach to multiple individuals in a group than the individual EMDR application. After intervention, post-assessment was done immediately and it was planned to be carryout after 3months was well as Follow-up assessment.
Current Stage of Study
Follow-Up Assessment
Future Plan
After follow-up assessment, data will be analyzed for fidelity of the program through inter-rater reliability, acceptability and feasibility from children through quantitative and qualitative measures and efficacy through Mixed between-within subjects’ analysis of variance (ANOVA). Article will be written and will be submitted for publication.


External Link(s)

Registration Citation

Citation
Mustafa, Nazia and Kiran Shehzadi. 2023. "Diminution of Psychological Distress through EMDR Integrative Group Treatment Protocol among Secondary School Students: A Pilot Randomized Controlled Trial from Pakistan." AEA RCT Registry. September 04. https://doi.org/10.1257/rct.12024-1.0
Experimental Details

Interventions

Intervention(s)
Eye Movement Desensitization and Reprocessing – Integrative Group Treatment Protocol (EMDR-IGTP) has been in use since 1998 with wide age range of individuals both children and adults around the globe
Intervention (Hidden)
Eye Movement Desensitization and Reprocessing – Integrative Group Treatment Protocol (EMDR-IGTP) has been in use since 1998 with wide age range of individuals both children and adults around the globe. Keeping in view the high vulnerability of children for the development of psychological Distress after experiencing traumatic events in their lives and existing treatment gap in Pakistan, a pilot randomized controlled trial was premeditated with the objectives of translation and adaptation of EMDR-IGTP (Jarero & Artigas, 2022) in cultural context of Pakistan along with establishment of fidelity, acceptability, feasibility and efficacy of adapted protocol in reducing psychological Distress among secondary school students.
Intervention Start Date
2023-05-10
Intervention End Date
2023-09-14

Primary Outcomes

Primary Outcomes (end points)
Reduction in psychological Distress among secondary school students.
Primary Outcomes (explanation)
. Keeping in view the high vulnerability of children for the development of psychological Distress after experiencing traumatic events in their lives and existing treatment gap in Pakistan, a pilot randomized controlled trial was premeditated with the objectives of translation and adaptation of EMDR-IGTP (Jarero & Artigas, 2022) in cultural context of Pakistan along with establishment of fidelity, acceptability, feasibility and efficacy of adapted protocol in reducing psychological Distress among secondary school students.

Secondary Outcomes

Secondary Outcomes (end points)
no
Secondary Outcomes (explanation)
no

Experimental Design

Experimental Design
Pilot randomized controlled trial was premeditated with the objectives of translation and adaptation of EMDR-IGTP (Jarero & Artigas, 2022) in cultural context of Pakistan along with establishment of fidelity, acceptability, feasibility and efficacy of adapted protocol in reducing psychological Distress among secondary school students.
Experimental Design Details
Pilot randomized controlled trial was premeditated with the objectives of translation and adaptation of EMDR-IGTP (Jarero & Artigas, 2022) in cultural context of Pakistan along with establishment of fidelity, acceptability, feasibility and efficacy of adapted protocol in reducing psychological Distress among secondary school students.
Randomization Method
randomization done in office by a computer
Randomization Unit
clusters (school as Unit )
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
two schools
Sample size: planned number of observations
pre, post and Follow-up
Sample size (or number of clusters) by treatment arms
120 (from two schools)
66 in Experimental group (one school)
54 in Control group (other school)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
As a pilot study, we did not aim to detect statistically significant differences in the outcome of protocol but rather wanted to explore the feasibility of implementation of protocol and recruitment parameters to inform the design of the subsequent fully powered randomized controlled trial. That why, we didn’t calculate the sample size.
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
Psychological Research Wing
IRB Approval Date
2023-03-01
IRB Approval Number
EAC09
Analysis Plan

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Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials