Clinical trial NCT01171677: Impact of Exercise and Affirmations (IntenSati) on Addiction-related Cognitive and Psychosocial Deficits
Official title: Impact of Exercise and Affirmations (IntenSati) on Addiction-related Cognitive and Psychosocial Deficits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Dependence
Alcohol Dependence
Keywords: addiction
exercise
cognitive function
mood
self efficacy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: New York University
First posted: 2010-07-28
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Addiction to illicit and prescribed drugs, alcohol and tobacco is associated with a panoply of brain changes that contribute to structural and micro-structural deficits, altered metabolism and neurotransmission, and related cognitive deficits affecting executive function, decision-making, reward salience and motivation. Many of these deficits may act as barriers to recovery, compromising the same spectrum of cognitive processes that established interventions (motivational enhancement, cognitive behavioral therapy, therapeutic communities, etc.) depend on for successful outcomes. Even where there are medications that target a specific addiction (e.g., methadone for opiates), meaningful, sustained recovery relies on the acquisition of adaptive skills and strategies. As such, there is a need to develop interventions for substance use disorders that have the potential to improve health and cognitive and psychosocial functioning, and to be embraced by the treatment community. A growing body of basic and clinical research suggests that physical exercise may reduce drug use and improve cognitive-executive function, mood, and motivation. There is also a growing literature on the effectiveness of positive affirmation as a cognitive-behavioral intervention for depression and PTSD both of which frequently co-occur with addiction. Building on this, we hypothesize that a combined exercise and affirmation intervention (IntenSati) will lead to improved cognitive and psychosocial function. To test this, we propose to conduct a two-arm randomized clinical trial - in adult volunteers with a history of longstanding substance use and who are in treatment in a residential therapeutic community setting (Odyssey House) - to examine cognitive and psychosocial function before, during, and after randomization to either a twelve-week IntenSati intervention condition or to a twelve-week no-exercise/no-affirmations control condition. This is a pilot study intended to collect data on feasibility and effect size. The population and sample size were selected on the basis of likelihood to benefit from the intervention, likelihood for good adherence, and the realities of completing a low-cost pilot study within a one-year timeframe. Overall there were no substantial differences between IntenSati and TAU on measures of cognition, mood, and psychosocial functioning. Limitations include the small sample size, limited exercise intensity and capacity, missed exercise classes, dropout because of placement, work schedules and non-study-related medical conditions.

Detailed description: Addiction to illicit and prescribed drugs, alcohol and tobacco is associated with a panoply of brain changes that contribute to structural and micro-structural deficits, altered metabolism and neurotransmission, and related cognitive deficits affecting executive function, decision-making, reward salience and motivation. Many of these deficits may act as barriers to recovery, compromising the same spectrum of cognitive processes that established interventions (motivational enhancement, cognitive behavioral therapy, therapeutic communities, etc.) depend on for successful outcomes. Even where there are medications that target a specific addiction (e.g., methadone for opiates), meaningful, sustained recovery relies on the acquisition of adaptive skills and strategies. As such, there is a need to develop interventions for substance use disorders that have the potential to improve health and cognitive and psychosocial functioning, and to be embraced by the treatment community. A growing body of basic and clinical research suggests that physical exercise may reduce drug use and improve cognitive-executive function, mood, and motivation. There is also a growing literature on the effectiveness of positive affirmation as a cognitive-behavioral intervention for depression and PTSD both of which frequently co-occur with addiction. Building on this, we hypothesize that a combined exercise and affirmation intervention (IntenSati) will lead to improved cognitive and psychosocial function. To test this, we propose to conduct a two-arm randomized clinical trial - in adult volunteers with a history of longstanding substance use and who are in treatment in a residential therapeutic community setting (Odyssey House) - to examine cognitive and psychosocial function before, during, and after randomization to either a twelve-week IntenSati intervention condition or to a twelve-week no-exercise/no-affirmations control condition. This is a pilot study intended to collect data on feasibility and effect size. The population and sample size were selected on the basis of likelihood to benefit from the intervention, likelihood for good adherence, and the realities of completing a low-cost pilot study within a one-year timeframe. Overall there were no substantial differences between IntenSati and TAU on measures of cognition, mood, and psychosocial functioning. Limitations include the small sample size, limited exercise intensity and capacity, missed exercise classes, dropout because of placement, work schedules and non-study-related medical conditions.

Eligibility criteria: Inclusion Criteria:

1. male or female;
2. 55 or older (resident in OH ElderCare program);
3. able to understand and provide a written informed consent, and agree to adhere to both OH and protocol requirements;
4. meets DSM-IV criteria for drug or alcohol dependence within the previous year;
5. at least a 4 year history of drug/alcohol dependence;
6. receives medical clearance by staff physician.

Exclusion Criteria:

1. medical conditions that contra-indicate intensive physical exercise;
2. body mass index (BMI) greater than 35 kg/m2;
3. cardiovascular disease including untreated high blood pressure (\>140/90);
4. other factors that in the opinion of the investigators would either jeopardize the safety of the subject and/or the likelihood of study completion, or compromise the validity of the findings.

Primary outcomes:
measure: Hopkins Verbal Learning Test (HVLT) Total Recall
timeFrame: Baseline to end of intervention (week 14)
measure: Hopkins Verbal Learning Test (HVLT) Delayed Recall
timeFrame: Baseline to end of intervention (week 14)
measure: Hopkins Verbal Learning Test (HVLT) Delayed Recognition
timeFrame: Baseline to end of intervention (week 14)
measure: Stroop Word
timeFrame: Baseline to end of intervention (week 14)
measure: Stroop Color
timeFrame: Baseline to end of intervention (week 14)
measure: Stroop Color/Word
timeFrame: Baseline to end of intervention (week 14)
measure: Trailmaking Test A
timeFrame: Baseline to end of intervention (week 14)
measure: Trailmaking Test B
timeFrame: Baseline to end of intervention (week 14)
measure: Digit Span
timeFrame: Baseline to end of intervention (week 14)
measure: Controlled Oral Word Association Test (COWAT)
timeFrame: Baseline to end of intervention (week 14)
measure: Wechsler Test of Adult Reading (WTAR)
timeFrame: Baseline to end of intervention (week 14)
measure: Self-Efficacy for Abstinence
timeFrame: Baseline to end of intervention (week 14)
measure: Quality of Life (QoL)
timeFrame: Baseline to end of intervention (week 14)
measure: Roesenberg Self Esteem
timeFrame: Baseline to end of intervention (week 14)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU School of Medicine
name: John Rotrosen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University
name: Wendy Suzuki, PhD
role: STUDY_DIRECTOR
affiliation: Odyssey House
name: Gary Harmon, PhD
role: STUDY_DIRECTOR
References: