CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 221 enrolled
Drug / intervention
Behavioral Activation (BA) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01299766
NCT01299766Phase 3Completed

Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment

Thomas Jefferson University·interventional·Posted Feb 18, 2011·Updated Dec 12, 2018

In Brief

A Phase 3 clinical trial evaluating Behavioral Activation (BA) and Supportive Therapy (ST) for Mild Cognitive Impairment (MCI). Completed, enrolled 221 participants across 1 site.

Detailed Summary

The goal of this study is to determine whether increasing participation in cognitive, physical, and/or social activities prevents cognitive decline in older African Americans (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for Alzheimer's Disease (AD); we propose that increasing participation in activities will prevent cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test this hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years and older) will be randomized to Behavior Activation (BA) (a behavioral intervention that increases participation in daily activities) or Supportive Therapy (ST) (a person-centered psychotherapy that involves active listening and offering support focusing on participants' problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and better quality of life than ST-treated subjects at 24 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 18, 2011
Enrollment StartJun 21, 2011
Primary CompletionDec 13, 2016
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 15.4 years ago

Interventions

Behavioral Activation (BA)behavioral

BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.

Supportive Therapy (ST)behavioral

ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.