NCT03627078

Brief Summary

The aim of the study is to compare the effect of motor interference therapy (TIM) to reduce the intensity of discomfort (distress) generated by a traumatic memory compared to a relaxation control maneuver, immediately after the intervention, a week, a month and six months after intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

3.1 years

First QC Date

August 8, 2018

Last Update Submit

July 27, 2020

Conditions

Keywords

traumatic memoriespost traumatic stress disordermotor interference therapynon pharmacological therapytrauma related disorders

Outcome Measures

Primary Outcomes (1)

  • Change in Visual Analogue Scale (EVA)

    measures the distress related to traumatic memories in 1-10

    baseline, immediately, 1 week, 1 month, 6 months

Secondary Outcomes (2)

  • Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R)

    baseline, 1 week, 1 month, 6 months

  • visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D)

    baseline, 1 week, 1 month, 6 months

Study Arms (2)

Motor Interference Therapy

EXPERIMENTAL

Initial interview applying the Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R), the visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D), and a simple visual-analogue scale (VAS). After that, patients will listen to an audio track twice and follow the instructions. The first four minutes of the audio track instruct the subjects to tap their fingers in response to specific sounds. During the remaining ten minutes, the patients will be asked to recall a traumatic memory while simultaneously are tapping their fingers. Patients must complete at least 80% of the motor task in order to be included. We will reassess a week, a month and six months after the intervention, using all three scales.

Other: motor interference therapy

Relaxation Exercise

SHAM COMPARATOR

Initial interview applying the Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R), the visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D), and a simple visual-analogue scale (VAS). After that, patients will listen to an audio track twice and follow the instructions. The first four minutes of the audio track instruct the subjects in how to do the exercises. During the remaining 10 minutes will hear commands for performing progressive muscle tension-relaxation exercises while the patient evoked the traumatic memory. Patients must complete at least 80% of the motor task in order to be included. We will reassess a week, a month and six months after the intervention, using all three scales.

Other: Relaxation exercises

Interventions

Also known as: TIM
Motor Interference Therapy

In a top-down sequence, beginning with the upper body and proceeding to the lower parts. patients contract and relax a specific muscle group following the instructions given by the audio track. We use a shorter version that excludes the legs because of the time.

Also known as: Jacobson´s progressive relaxation
Relaxation Exercise

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 16 years
  • Spanish as a native language
  • Give written informed consent
  • having at least 1 traumatic memory causing distress

You may not qualify if:

  • Neurological or psychiatric disorders that affect the capacity of verbal comprehension and judgment, such as dementia, psychosis, mental retardation or other cognitive alteration that does not allow them to perform the tasks indicated in the TIM or SHAM
  • History of recent substance abuse
  • Patients with significant hearing loss or some other hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Neurologia Y Neurocirugia Mvs

Mexico City, Mexico City, 14269, Mexico

Location

Related Publications (1)

  • Morales-Rivero A, Crail-Melendez D, Reyes-Santos L, Bisanz E, Bisanz J, Ruiz-Chow A, Chavarria-Medina MM. Effect of Motor Interference Therapy on Distress Related to Traumatic Memories: A Randomized, Double-Blind, Controlled Feasibility Trial. Brain Behav. 2024 Sep;14(9):e70063. doi: 10.1002/brb3.70063.

MeSH Terms

Conditions

Psychological TraumaStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Edgar D Crail-Melendez, MD

    El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.SC.

Study Record Dates

First Submitted

August 8, 2018

First Posted

August 13, 2018

Study Start

March 1, 2016

Primary Completion

March 30, 2019

Study Completion

December 31, 2019

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations