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Motor Interference Therapy For Traumatic Memories (TIMCO)

Primary Purpose

Trauma, Psychological, Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
motor interference therapy
Relaxation exercises
Sponsored by
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma, Psychological focused on measuring traumatic memories, post traumatic stress disorder, motor interference therapy, non pharmacological therapy, trauma related disorders

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Instituto Nacional de Neurologia Y Neurocirugia Mvs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Motor Interference Therapy

Relaxation Exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Visual Analogue Scale (EVA)
measures the distress related to traumatic memories in 1-10

Secondary Outcome Measures

Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R)
Posttraumatic stress disorder scale
visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D)
as a gauge of health-related quality of lif

Full Information

First Posted
August 8, 2018
Last Updated
July 27, 2020
Sponsor
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
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1. Study Identification

Unique Protocol Identification Number
NCT03627078
Brief Title
Motor Interference Therapy For Traumatic Memories
Acronym
TIMCO
Official Title
The Effect of Motor Interference Therapy In Traumatic Memories: A Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

4. Oversight

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

5. Study Description

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.
Detailed Description
The investigators treated 10 patients with autobiographical traumatic memories using finger tapping tasks, (Motor Interference Therapy <TIM>)in a pilot study with amazing results and a solid size effect. The investigators decided to challenge the intervention using a control task (Jacobson´s progressive relaxation exercises) The hypothesis consists in achieving a 30% reduction of the distress, (measured with Visual Analogue Scale) by using TIM compared with the control task. Patients with traumatic memories will be enrolled in to one of two treatment modalities. The first group will receIve motor interference therapy and the second group will receive a control task (relaxation exercises). Both groups will be assessed using 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) immediately after, a week after, a month after and six months after the treatment for follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Psychological, Post Traumatic Stress Disorder
Keywords
traumatic memories, post traumatic stress disorder, motor interference therapy, non pharmacological therapy, trauma related disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor Interference Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Relaxation Exercise
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
motor interference therapy
Other Intervention Name(s)
TIM
Intervention Type
Other
Intervention Name(s)
Relaxation exercises
Other Intervention Name(s)
Jacobson´s progressive relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Visual Analogue Scale (EVA)
Description
measures the distress related to traumatic memories in 1-10
Time Frame
baseline, immediately, 1 week, 1 month, 6 months
Secondary Outcome Measure Information:
Title
Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R)
Description
Posttraumatic stress disorder scale
Time Frame
baseline, 1 week, 1 month, 6 months
Title
visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D)
Description
as a gauge of health-related quality of lif
Time Frame
baseline, 1 week, 1 month, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 16 years Spanish as a native language Give written informed consent having at least 1 traumatic memory causing distress Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar D Crail-Melendez, MD
Organizational Affiliation
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Neurologia Y Neurocirugia Mvs
City
Mexico
State/Province
Ciudad De Mexico
ZIP/Postal Code
14269
Country
Mexico

12. IPD Sharing Statement

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Motor Interference Therapy For Traumatic Memories

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