Remediation of Emotional Processing Deficits in MS
Remediation of Emotional Processing Deficits in MS: A Randomized Clinical Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial RCT). We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS, as well.
All participants will undergo a baseline evaluation assessing emotional processing abilities, cognitive functioning, and psychological functioning. Participants will then be randomized into two groups. During the treatment phase, the experimental group will receive the proposed intervention while the control group will receive a "placebo" treatment. Neuropsychological assessment will be repeated at the end of the intervention.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
New Jersey
-
East Hanover, New Jersey, Förenta staterna, 07936
- Kessler Foundation
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- between the ages of 18-65.
- diagnosis of Relapsing-Remitting Multiple Sclerosis.
- can read and speak English fluently.
Exclusion Criteria:
- history of prior stroke or other neurological disease or injury.
- history of significant psychiatric 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Experimental Group
Participants in the experimental group will receive emotional processing training exercises administered on a laptop computer.
They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
|
Participants in the experimental group will receive computerized exercises administered on a laptop computer.
They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
|
|
Placebo-jämförare: Control Group
Participants in the control group will meet with the examiner the same frequency and for the same duration as those in the experimental group. They will receive placebo control exercises administered on a laptop computer. |
Participants in the control group will receive computerized control exercises administered on a laptop computer.
They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Emotional Processing
Tidsram: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
Change in scores on computerized tests of emotional processing
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Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Emotional Function
Tidsram: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
Change in scores on self-report of emotional functioning, measured via questionnaire
|
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
|
Self report of Quality of Life
Tidsram: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
Change in scores on self-report of quality of life, measured via questionnaire
|
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Helen Genova, PhD, Research Scientist
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R-920-16
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