Impact of Exercise and Affirmations (IntenSati) on Addiction-related Cognitive and Psychosocial Deficits
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- male or female;
- 55 or older (resident in OH ElderCare program);
- able to understand and provide a written informed consent, and agree to adhere to both OH and protocol requirements;
- meets DSM-IV criteria for drug or alcohol dependence within the previous year;
- at least a 4 year history of drug/alcohol dependence;
- receives medical clearance by staff physician.
Exclusion criteria
- medical conditions that contra-indicate intensive physical exercise;
- body mass index (BMI) greater than 35 kg/m2;
- cardiovascular disease including untreated high blood pressure (>140/90);
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal