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

Primary Purpose

Drug Dependence, Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IntenSati
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Dependence focused on measuring addiction, exercise, cognitive function, mood, self efficacy

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    IntenSati

    Treatment as Usual

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Hopkins Verbal Learning Test (HVLT) Total Recall
    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
    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
    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
    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
    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
    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
    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
    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
    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)
    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)
    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
    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)
    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 27, 2010
    Last Updated
    January 30, 2013
    Sponsor
    NYU Langone Health
    Collaborators
    New York University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01171677
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    November 2010 (Actual)
    Study Completion Date
    November 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    NYU Langone Health
    Collaborators
    New York University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Drug Dependence, Alcohol Dependence
    Keywords
    addiction, exercise, cognitive function, mood, self efficacy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IntenSati
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Treatment as Usual
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    IntenSati
    Other Intervention Name(s)
    exercise, aerobics, verbal affirmations
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Hopkins Verbal Learning Test (HVLT) Total Recall
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)
    Title
    Hopkins Verbal Learning Test (HVLT) Delayed Recall
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)
    Title
    Hopkins Verbal Learning Test (HVLT) Delayed Recognition
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)
    Title
    Stroop Word
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)
    Title
    Stroop Color
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)
    Title
    Stroop Color/Word
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)
    Title
    Trailmaking Test A
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)
    Title
    Trailmaking Test B
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)
    Title
    Digit Span
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)
    Title
    Controlled Oral Word Association Test (COWAT)
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)
    Title
    Wechsler Test of Adult Reading (WTAR)
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)
    Title
    Self-Efficacy for Abstinence
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)
    Title
    Quality of Life (QoL)
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)
    Title
    Roesenberg Self Esteem
    Description
    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.
    Time Frame
    Baseline to end of intervention (week 14)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Rotrosen, MD
    Organizational Affiliation
    NYU School of Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Wendy Suzuki, PhD
    Organizational Affiliation
    New York University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Gary Harmon, PhD
    Organizational Affiliation
    Odyssey House
    Official's Role
    Study Director

    12. IPD Sharing Statement

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