NCT01684293CompletedNot Applicable
Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study
University of California, San Francisco1 site in 1 country50 target enrollmentStarted: July 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in cognitive impairment
Study Overview
Brief Summary
This study integrates a model of occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan for cocaine abusers. We hypothesize that cognitive impairment and quality of life would improve and that cocaine use would decrease in those participants receiving occupational-therapy based cognitive rehabilitation.
Detailed Description
occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan for cocaine abusers
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primary cocaine use disorder (based on DSM-5 criteria) and in at least 3 months of remission
- •At least mild cognitive impairment, defined as = or > 1.5 standard deviations impairment on any 2 performance-based neurocognitive measures
- •Needing to change quality of life, defined as self-identifying at least 2 life areas as needing to change on the Drug User Quality of Life Scale
- •A Veteran at the San Francisco Veterans Affairs Medical Center
- •Currently receiving weekly drug counseling (individual or group; at least 1 hour/week) through an outpatient substance use disorder treatment program
Exclusion Criteria
- •Inability to speak, read, write, and understand English
- •Inadequate hearing or vision
- •Concurrent substance use disorder (except tobacco or caffeine) not in at least 3 months of remission
- •A psychiatric disorder that will interfere with study participation or will make participation hazardous (e.g., psychosis, suicidal or homicidal ideations, severe anxiety)
- •A depressive disorder classified as severe, defined as a Beck Depression Inventory-II score >29
- •Current diagnosis of a bipolar disorder needing acute inpatient psychiatric hospitalization
- •Currently symptomatic from attention-deficit/hyperactivity disorder (DSM-5 criteria)
- •Any learning disorder, any type of dementia, any type of delirium, or an amnestic disorder due to any general medical condition
- •Wechsler Test of Adult Reading standard score <70
- •Mini-Mental State Examination score <24
- •Current use of scheduled (i.e., prescribed) regular (i.e., daily) psychotropics or other medicines with a high likelihood of sedation & cognitive impairment (e.g., benzodiazepines, clozapine, anticholinergics)
- •Currently prescribed stimulants (e.g., methylphenidate) or cognitive enhancers (e.g., donepezil, memantine)
- •Active medical illnesses - uncontrolled diabetes, uncontrolled hypertension, uncontrolled thyroid dysfunction, or uncontrolled B12/folate deficiency; central nervous system illness with potential cognitive aspects (Parkinson's, or Huntington's dementia); Cirrhosis with complications (e.g., ascites, encephalopathy, jaundice, gastrointestinal bleeding); Needing acute medical hospitalization from HIV sequelae, such as HIV-related opportunistic infection
- •Any history of any type of stroke or brain hemorrhage
- •Any history of traumatic brain injury, intracranial pathology (e.g., tumor), or brain surgery
- •Currently on probation or parole
- •Concurrent participation in another study that medically/administratively interferes with this study
Arms & Interventions
Psychoeducation/games
Placebo Comparator
Psychoeducation/games
Intervention: Psychoeducation/games (Behavioral)
Cognitive Rehabilitation
Experimental
Occupational therapy-based cognitive rehabilitation
Intervention: Occupational therapy-based cognitive rehabilitation (Behavioral)
Outcomes
Primary Outcomes
Change in cognitive impairment
Time Frame: baseline through 6 months
Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Not Applicable
eHealth Interventions for Breast Cancer Cognitive ImpairmentCognitive DysfunctionBreast CancerNCT06103318Institut Català d'Oncologia176
Not yet recruiting
Not Applicable
Occupational therapy intervention for cognitive and functional training in patients with brain tumorCTRI/2022/04/041795Tata Memorial Hospital
Unknown
Not Applicable
HIV Medication Adherence in Underserved PopulationsHuman Immunodeficiency VirusAcquired Immunodeficiency SyndromeNCT02392884Cedars-Sinai Medical Center60
Completed
Phase 4
The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain InjuryTraumatic Brain Injury With Brief Loss of ConsciousnessTraumatic Brain Injury With No Loss of ConsciousnessNCT01339806Brooke Army Medical Center143
Enrolling By Invitation
Not Applicable
Combined Activity and Cognitive Intervention for ICU SurvivorsPost Intensive Care SyndromeLoss of Muscle MassCognitive FunctionARDS: Acute Respiratory Distress SyndromeLoss of Muscle StrengthDeliriumNCT06117761The University of Hong Kong60