Modified Story Memory Technique (mSMT) in Persons With TBI

Sponsor

Kessler Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT04056312

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The current RCT is designed to:

test the efficacy of the group based mSMT in persons with TBI on NPE, the current gold-standard for measuring memory functioning
assess the effectiveness of the group mSMT on more global measures of everyday life, including an objective measure shown through our previous work to be sensitive to memory changes following the mSMT, as well as additional questionnaires to be completed by both the participant and a significant other
evaluate the changes in brain functioning following treatment with the mSMT via fMRI and
evaluate the long-term effects of the treatment protocol.

To accomplish these goals investigators will conduct a double-blind, placebo-controlled, RCT, applying the group mSMT to a sample of 60 participants with moderate to severe TBI (30 treatment; 30 control).

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Behavioral: Group Memory retraining exercises Behavioral: Placebo controlled group memory exercise training	N/A

Detailed Description

Outcome measures will assess objective memory abilities, everyday memory abilities and patterns of cerebral activation during learning. A long-term follow-up assessment will be conducted, designed to measure the impact of the mSMT 3 months following treatment completion. Alternate forms will be utilized wherever available.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Clinical Trial Examining The Efficacy of The Group Administered Modified Story Memory Technique (mSMT) in Persons With TBI

Actual Study Start Date :

Jun 29, 2016

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group memory retraining Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.	Behavioral: Group Memory retraining exercises Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.
Placebo Comparator: Placebo Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.	Behavioral: Placebo controlled group memory exercise training Placebo group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.

Arm

Intervention/Treatment

Experimental: Group memory retraining

Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.

Behavioral: Group Memory retraining exercises

Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.

Placebo Comparator: Placebo

Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.

Behavioral: Placebo controlled group memory exercise training

Placebo group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.

Outcome Measures

Primary Outcome Measures

California Verbal Learning Test [Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later]
Change on scores on memory tests will be assessed using the California Verbal Learning Test
The Traumatic Brain Injury-Quality of Life Scale [Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later]
Self-reports of emotional functioning, memory functioning and quality of life on The Traumatic Brain Injury-Quality of Life Scale, which measures these constructs. DVs will be change on the Depression subscale (range: 0-40; lower score is better) and Cognition scale (range: 0-40; higher score is better).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

I am between the ages of 18-65.
I have had a Traumatic Brain Injury at least one year ago.
I can read and speak English fluently.
I have difficulties with learning and memory skills.

Exclusion Criteria:

I am currently taking steroids and /or benzodiazepines as determined by study staff review of my medications.
I have had a prior stroke or neurological injury/disease other than a traumatic brain injury.
I have a history of significant psychiatric illness (for example, bipolar disorder or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
I have unstable or uncontrolled seizures.
I have a significant alcohol or drug abuse history.