Impact of Exercise and Affirmations (IntenSati) on Addition-related Cognitive and Psychosocial Deficits
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Purpose
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. Positive findings would inform the development of a full NIH grant proposal to conduct a larger more rigorous study.
| Condition | Intervention |
|---|---|
|
Drug Dependence Alcohol Dependence |
Behavioral: IntenSati |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Impact of Exercise and Affirmations (IntenSati) on Addition-related Cognitive and Psychosocial Deficits |
- Cognitive improvement [ Time Frame: at end of 3 months of intervention ] [ Designated as safety issue: No ]
- Mood improvement [ Time Frame: at end of three months of intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IntenSati
IntenSati (a blending of the words "intention" and "sati," the Pali term for "mindfulness") combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. "I believe I will succeed", "I am strong" and "I am confident") that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to "stick in your head" long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem.
|
Behavioral: IntenSati
IntenSati (a blending of the words "intention" and "sati," the Pali term for "mindfulness") combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. "I believe I will succeed", "I am strong" and "I am confident") that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to "stick in your head" long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem.
Other Names:
|
| No Intervention: Treatment as Usual |
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. Positive findings would inform the development of a full NIH grant proposal to conduct a larger more rigorous study
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, New York | |
| Odyssey House | |
| New York, New York, United States, 10005 | |
| Principal Investigator: | John Rotrosen, MD | NYU School of Medicine |
| Study Director: | Wendy Suzuki, PhD | New York University |
| Study Director: | Gary Harmon, PhD | Odyssey House |
More Information
No publications provided
| Responsible Party: | John Rotrosen, MD, NYU School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01171677 History of Changes |
| Other Study ID Numbers: | NYULMC - 10-01156 |
| Study First Received: | July 27, 2010 |
| Last Updated: | October 13, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York University School of Medicine:
|
addiction exercise cognitive function mood self efficacy |
Additional relevant MeSH terms:
|
Alcoholism Substance-Related Disorders Alcohol-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on October 17, 2012
