Trauma, PsychologicalTIMCONCT03627078
Motor Interference Therapy For Traumatic Memories
A study testing motor interference therapy and Relaxation exercises in people with Trauma, Psychological and Post Traumatic Stress Disorder, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Trauma, Psychological, Post Traumatic Stress Disorder
- What is being tested?
- motor interference therapy and Relaxation exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients older than 16 years
- Spanish as a native language
- Give written informed consent
- having at least 1 traumatic memory causing distress
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Neurologia Y Neurocirugia Mvs
Mexico City, Mexico City, 14269
About this study
Official title: The Effect of Motor Interference Therapy In Traumatic Memories: A Controlled Clinical Trial
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.
Read the 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.
- Being tested
- motor interference therapy, Relaxation exercises
- Keywords
- traumatic memories, post traumatic stress disorder, motor interference therapy, non pharmacological therapy, trauma related disorders
- Medical subject headings
- Psychological Trauma, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor interference therapyOther
Also called TIM
Relaxation exercisesOther
Also called Jacobson´s progressive relaxation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Relaxation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Scale (EVA)
measures the distress related to traumatic memories in 1-10
Measured: baseline, immediately, 1 week, 1 month, 6 months
Secondary outcomes (2)
Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R)
Posttraumatic stress disorder scale
Measured: baseline, 1 week, 1 month, 6 months
visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D)
as a gauge of health-related quality of lif
Measured: baseline, 1 week, 1 month, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Mar 2016
- Primary completion30 Mar 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trauma, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edgar Daniel Crail Melendez, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Investigators
- Edgar D Crail-Melendez, MD, Principal investigator, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627078
- Sponsor's protocol ID
- 69/17
- Acronym
- TIMCO
- Status last verified
- Jul 2020
- First submitted
- 8 Aug 2018
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39317994
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motor Interference Therapy In Traumatic Memories: A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03627078
- Acronym / sponsor ID
- TIMCO / 69/17
- Keywords
- traumatic memories, post traumatic stress disorder, motor interference therapy, non pharmacological therapy, trauma related disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor Interference Therapy | Experimental | Other: motor interference therapyInitial 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. |
| Relaxation Exercise | Sham comparator | Other: Relaxation exercisesInitial 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 16 years
- Spanish as a native language
- Give written informed consent
- having at least 1 traumatic memory causing distress
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motor interference therapyAlso: TIM | Other | Motor Interference Therapy |
| Relaxation exercisesAlso: Jacobson´s progressive relaxationIn 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. | Other | Relaxation Exercise |
Primary outcome
Change in Visual Analogue Scale (EVA)
Time frame: baseline, immediately, 1 week, 1 month, 6 months
measures the distress related to traumatic memories in 1-10
2 secondary outcomes
Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R)
Time frame: baseline, 1 week, 1 month, 6 months
visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D)
Time frame: baseline, 1 week, 1 month, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 39317994Morales-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edgar D Crail-Melendez, MD principal investigator
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor interference therapy and Relaxation exercises in people with Trauma, Psychological and Post Traumatic Stress Disorder, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analogue Scale (EVA) (time frame: baseline, immediately, 1 week, 1 month, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03627078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.