Post Traumatic Stress Disorder Clinical Trial
— TIMCOOfficial title:
The Effect of Motor Interference Therapy In Traumatic Memories: A Controlled Clinical Trial
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 |
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Neurologia Y Neurocirugia Mvs | Mexico | Ciudad De Mexico |
Lead Sponsor | Collaborator |
---|---|
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez |
Mexico,
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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