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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03627078
Other study ID # 69/17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2016
Est. completion date December 31, 2019

Study information

Verified date July 2020
Source El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The investigators treated 10 patients with autobiographical traumatic memories using finger tapping tasks, (Motor Interference Therapy )in a pilot study with amazing results and a solid size effect. The investigators decided to challenge the intervention using a control task (JacobsonĀ“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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date December 31, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Study Design


Intervention

Other:
motor interference therapy

Relaxation exercises
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.

Locations

Country Name City State
Mexico Instituto Nacional de Neurologia Y Neurocirugia Mvs Mexico Ciudad De Mexico

Sponsors (1)

Lead Sponsor Collaborator
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R) Posttraumatic stress disorder scale baseline, 1 week, 1 month, 6 months
Secondary visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D) as a gauge of health-related quality of lif baseline, 1 week, 1 month, 6 months
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