Multiple SclerosisNCT04408274
Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury
A study testing Emotional Processing Training in people with Multiple Sclerosis and Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
This study will examine the efficacy of a clinical intervention for improving emotional processing in individuals with MS and TBI.(1)The main outcome measure will be changes in emotional processing measures from pre to post treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Traumatic Brain Injury
- What is being tested?
- Emotional Processing Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Multiple Sclerosis or Traumatic Brain Injury
- Fluent in English
- processing speed impairment (based on evaluation)
Who cannot join
- currently taking steroids and/or benzodiazepines
- prior stroke or neurological diease
- history of significant pyschiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
- significant alcohol or drug abuse history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury: A Piolt Study
This study will examine the efficacy of a clinical intervention for improving emotional processing in individuals with MS and TBI.(1)The main outcome measure will be changes in emotional processing measures from pre to post treatment.
(2)This study will also assess the impact of the emotional processing intervention on changes in pre and post treatment depression and anxiety, as well as fatigue.(3) This study will additionally measure the impact of the emotional processing intervention on cognitive functioning, specifically processing speed, attention and executive abilities. This will be accomplished through the completion of a neuropsychological battery prior to and following the completion of treatment.(4)Finally, the investigators will measure the impact of the intervention on quality of life and social functioning, utilizing a pre and post treatment assessment consisting of measures of self-efficacy, quality of life, functional abilities, and awareness.
- Conditions
- Multiple Sclerosis, Traumatic Brain Injury
- Being tested
- Emotional Processing Training, Placebo Control
- Keywords
- Processing Speed, Intervention, Multiple Sclerosis, Traumatic Brain Injury, Cognition
- Medical subject headings
- Multiple Sclerosis, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Processing TrainingBehavioural
Placebo ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Computerized Tests | Experimental | Not described Receives: Behavioral: Emotional Processing Training |
| Placebo Control | Placebo comparator | Not described Receives: Behavioral: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores on Facial Expression Identification Task (FEIT)
The FEIT assesses one's ability to correctly identify and discriminate emotions from faces
Measured: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Secondary outcomes (2)
Change in scores on Emotion Regulation Questionnaire (ERQ)
The ERQ is a self-report measure of the use of 2 emotional regulation strategies: cognitive reappraisal and expressive suppression
Measured: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Change in scores on Satisfaction with Life Scale (SWLS)
The SWLS is a self-report measure of quality of life
Measured: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study startMay 2013
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Lengenfelder, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408274
- Sponsor's protocol ID
- R-764-13
- Status last verified
- May 2020
- First submitted
- 17 Apr 2018
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury: A Piolt Study
- ClinicalTrials.gov ID
- NCT04408274
- Acronym / sponsor ID
- R-764-13
- Conditions
- Multiple Sclerosis, Traumatic Brain Injury
- Keywords
- Processing Speed, Intervention, Multiple Sclerosis, Traumatic Brain Injury, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 29 May 2020 (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.
This study will examine the efficacy of a clinical intervention for improving emotional processing in individuals with MS and TBI.(1)The main outcome measure will be changes in emotional processing measures from pre to post treatment.
(2)This study will also assess the impact of the emotional processing intervention on changes in pre and post treatment depression and anxiety, as well as fatigue.(3) This study will additionally measure the impact of the emotional processing intervention on cognitive functioning, specifically processing speed, attention and executive abilities. This will be accomplished through the completion of a neuropsychological battery prior to and following the completion of treatment.(4)Finally, the investigators will measure the impact of the intervention on quality of life and social functioning, utilizing a pre and post treatment assessment consisting of measures of self-efficacy, quality of life, functional abilities, and awareness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized Tests | Experimental | Behavioral: Emotional Processing Training |
| Placebo Control | Placebo comparator | Behavioral: Placebo Control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of Multiple Sclerosis or Traumatic Brain Injury
- Fluent in English
- processing speed impairment (based on evaluation)
Key exclusion criteria (4 listed)
- currently taking steroids and/or benzodiazepines
- prior stroke or neurological diease
- history of significant pyschiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
- significant alcohol or drug abuse history
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 |
|---|---|---|
| Emotional Processing Training | Behavioural | Computerized Tests |
| Placebo Control | Behavioural | Placebo Control |
Primary outcome
Change in scores on Facial Expression Identification Task (FEIT)
Time frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
The FEIT assesses one's ability to correctly identify and discriminate emotions from faces
2 secondary outcomes
Change in scores on Emotion Regulation Questionnaire (ERQ)
Time frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Change in scores on Satisfaction with Life Scale (SWLS)
Time frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Processing Training in people with Multiple Sclerosis and Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
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 3 inclusion and 4 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 May 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 United States. 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 scores on Facial Expression Identification Task (FEIT) (time frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2020.