CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
IntenSatibehavioral
Likely dose
Not stated in record
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Search/NCT01171677
NCT01171677N/ACompleted

Impact of Exercise and Affirmations (IntenSati) on Addiction-related Cognitive and Psychosocial Deficits

NYU Langone Health·interventional·Posted Jul 28, 2010·Updated Mar 6, 2013

In Brief

A clinical study evaluating IntenSati for Drug Dependence and Alcohol Dependence. Completed, enrolled 40 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsNew York University

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 28, 2010
Enrollment StartJul 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.9 years ago

Interventions

IntenSatibehavioral

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.