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

• ClinicalTrials.gov Identifier: NCT01171677
• Recruitment Status: Completed
• First Posted: July 28, 2010
• Results First Posted: March 6, 2013
• Last Update Posted: March 6, 2013
• Sponsor: NYU Langone Health
• Collaborator: New York University
• Information provided by (Responsible Party): John Rotrosen, NYU Langone Health

Tracking Information

• First Submitted Date: July 27, 2010
• First Posted Date: July 28, 2010
• Results First Submitted Date: October 22, 2012
• Results First Posted Date: March 6, 2013
• Last Update Posted Date: March 6, 2013
• Study Start Date: July 2010
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 30, 2013)

• Hopkins Verbal Learning Test (HVLT) Total Recall [ Time Frame: Baseline to end of intervention (week 14) ]
  The Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Total Recall is the sum of 3 trials in which twelve words are read to and repeated back by subject. The HVLT Total Recall scale ranges from 0-36, the higher score associated with greater verbal learning.
• Hopkins Verbal Learning Test (HVLT) Delayed Recall [ Time Frame: Baseline to end of intervention (week 14) ]
  Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Delayed Recall is administered 20-25 minutes after the HVLT Total Recall. The HVLT Delayed Recall scale ranges from 0-12, the higher score associated with greater retention.
• Hopkins Verbal Learning Test (HVLT) Delayed Recognition [ Time Frame: Baseline to end of intervention (week 14) ]
  Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Delayed Recognition is administered immediately after the HVLT Delayed Recall subscale and involves 12 forced choice responses. The HVLT Delayed Recognition scale ranges from 0-24, the higher score associated with greater recognition ability.
• Stroop Word [ Time Frame: Baseline to end of intervention (week 14) ]
  Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Word test is the first subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.
• Stroop Color [ Time Frame: Baseline to end of intervention (week 14) ]
  Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Color test is the second subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.
• Stroop Color/Word [ Time Frame: Baseline to end of intervention (week 14) ]
  Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Color-Word test is the third subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility and resistance to interference.
• Trailmaking Test A [ Time Frame: Baseline to end of intervention (week 14) ]
  Trailmaking Test A and B measures cognitive shifting, visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. The test generally requires ability to sequence (Parts A and B), ability to shift cognitive set (Part B), and processing speed (Parts A and B). Part A and Part B are scored separately and expressed in terms of the number of seconds it takes the participant to complete each section, the higher the score the longer it took the subject to complete the test. Trailmaking Part A assesses cognitive processing speed. The lower the score the faster the processing speed.
• Trailmaking Test B [ Time Frame: Baseline to end of intervention (week 14) ]
  Trailmaking Test A and B measures cognitive shifting, visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. The test generally requires ability to sequence (Parts A and B), ability to shift cognitive set (Part B), and processing speed (Parts A and B). Part A and Part B are scored separately and expressed in terms of the number of seconds it takes the participant to complete each section, the higher the score the longer it took the subject to complete the test. Trailmaking Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set.
• Digit Span [ Time Frame: Baseline to end of intervention (week 14) ]
  Digit span measures attention efficiency. The Digit-span task is used to measure verbal working memory. Two subscales, Digits Forward and Digits Backward, were combined for a total scale range from 0-30, the higher the score the better the working memory.
• Controlled Oral Word Association Test (COWAT) [ Time Frame: Baseline to end of intervention (week 14) ]
  Controlled Oral Word Association Test (COWAT) measures verbal fluency. The assessment consists of three trials; the total score is a sum of all three trials. The scale ranges from 0-90, the higher the score the higher the verbal fluency.
• Wechsler Test of Adult Reading (WTAR) [ Time Frame: Baseline to end of intervention (week 14) ]
  Wechsler Test of Adult Reading (WTAR) measures reading ability. The test involves 50 incorrectly spelled words. The score is computed based on the number of correctly pronounced words. The scale ranges from 0-50, the higher the score the higher the reading ability.
• Self-Efficacy for Abstinence [ Time Frame: Baseline to end of intervention (week 14) ]
  The Self-Efficacy for Abstinence assessment is adapted from DiClemente (1994)'s Alcohol Abstinence Self-Efficacy. The modified 10-item, 5-point Likert scale (Not at all to Extremely) assesses confidence in abstaining from alcohol. The scale is comprised of four subscales: negative affect, social/positive, physical and other concerns, and withdrawal and urges. Overall abstinence self-efficacy score is calculated by summing each item. The scale ranges from 10-50, the higher the score the higher the self-efficacy for abstinence.
• Quality of Life (QoL) [ Time Frame: Baseline to end of intervention (week 14) ]
  The Quality of Life (QoL) assessment is adapted from Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The 23-item QoL consists of five subscales: physical health/activities, feelings, leisure time activities, social relations, and general activities. The scale ranges from 23-115; the higher score indicates higher quality of life enjoyment and satisfaction.
• Roesenberg Self Esteem [ Time Frame: Baseline to end of intervention (week 14) ]
  The Rosenberg Self-Esteem Scale is a 10-item, 4-point Likert scale used to assess global self-esteem. The scale ranges from 0-30 with higher scores indicating higher the self-esteem.

• Original Primary Outcome Measures (submitted: July 27, 2010): Cognitive improvement [ Time Frame: at end of 3 months of intervention ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: July 27, 2010): Mood improvement [ Time Frame: at end of three months of intervention ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Drug Dependence
• Alcohol Dependence

Intervention

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:

• exercise
• aerobics
• verbal affirmations

Study Arms

• 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.
  Intervention: Behavioral: IntenSati
• No Intervention: Treatment as Usual

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 30, 2013): 40
• Original Estimated Enrollment (submitted: July 27, 2010): 90
• Actual Study Completion Date: November 2010
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT01171677
• Other Study ID Numbers: NYULMC - 10-01156
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: John Rotrosen, NYU Langone Health
• Original Responsible Party: John Rotrosen, MD, NYU School of Medicine
• Current Study Sponsor: NYU Langone Health
• Original Study Sponsor: Same as current
• Collaborators: New York University

Investigators

• Principal Investigator: John Rotrosen, MD; NYU School of Medicine
• Study Director: Wendy Suzuki, PhD; New York University
• Study Director: Gary Harmon, PhD; Odyssey House

• PRS Account: NYU Langone Health
• Verification Date: January 2013