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

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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:
Collaborator:
New York University
Information provided by (Responsible Party):
John Rotrosen, NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Drug Dependence
Alcohol Dependence
Intervention Behavioral: IntenSati
Enrollment 40
Recruitment Details 40 Subjects consented, 4 discontinued prior to completing screening, 36 completed baseline, 4 were ineligible, 32 were randomized.
Pre-assignment Details  
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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. Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Period Title: Overall Study
Started 17 15
Completed 11 12
Not Completed 6 3
Reason Not Completed
Withdrawal by Subject             0             3
Adverse Event             1             0
completed <70% IntenSati classes             5             0
Arm/Group Title IntenSati Treatment as Usual Total
Hide Arm/Group 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. [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 17 15 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 15 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  82.4%
14
  93.3%
28
  87.5%
>=65 years
3
  17.6%
1
   6.7%
4
  12.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 15 participants 32 participants
59  (4.3) 59  (3.2) 59  (3.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 15 participants 32 participants
Female
3
  17.6%
14
  93.3%
17
  53.1%
Male
14
  82.4%
1
   6.7%
15
  46.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 15 participants 32 participants
17 15 32
1.Primary Outcome
Title Hopkins Verbal Learning Test (HVLT) Total Recall
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing each arm
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
HVLT Total (baseline) 17.27  (3.80) 18.00  (5.15)
HVLT Total (end of intervention) 15.27  (3.98) 17.50  (3.50)
2.Primary Outcome
Title Hopkins Verbal Learning Test (HVLT) Delayed Recall
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing each arm
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
HVLT Delayed (baseline) 2.82  (1.72) 5.00  (2.41)
HVLT Delayed (end of intervention) 3.91  (1.76) 3.92  (2.94)
3.Primary Outcome
Title Hopkins Verbal Learning Test (HVLT) Delayed Recognition
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing each arm
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
HVLT Delayed Recognition (baseline) 18.55  (1.29) 21.33  (3.37)
HVLT Delayed Recognition (end of intervention) 20.27  (1.62) 22.33  (2.43)
4.Primary Outcome
Title Stroop Word
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing each arm
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Stroop Word (baseline) 77.36  (18.48) 80.67  (20.15)
Stroop Word (end of intervention) 83.18  (14.66) 79.25  (20.21)
5.Primary Outcome
Title Stroop Color
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing each arm
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Stroop Color (baseline) 54.27  (14.19) 64.33  (16.55)
Stroop Color (end of intervention) 58.18  (14.74) 65.67  (15.51)
6.Primary Outcome
Title Stroop Color/Word
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing each arm
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Stroop Color/Word (baseline) 28.82  (9.38) 33.08  (11.26)
Stroop Color/Word (end of intervention) 26.27  (13.79) 31.17  (11.51)
7.Primary Outcome
Title Trailmaking Test A
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing trial
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: seconds
Trailmaking A (baseline) 49.82  (24.15) 35.99  (12.10)
Trailmaking A (end of intervention) 46.98  (21.00) 38.51  (13.25)
8.Primary Outcome
Title Trailmaking Test B
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing each arm
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: seconds
Trailmaking B (baseline) 166.07  (66.58) 126.14  (54.07)
Trailmaking B (end of intervention) 187.86  (140.23) 125.06  (66.27)
9.Primary Outcome
Title Digit Span
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing each arm
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Digit Span (baseline) 12.55  (2.54) 12.33  (3.42)
Digit Span (end of intervention) 11.91  (3.42) 12.33  (3.68)
10.Primary Outcome
Title Controlled Oral Word Association Test (COWAT)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing each arm
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
COWAT (baseline) 29.91  (10.26) 31.42  (9.22)
COWAT (end of intervention) 27.82  (9.43) 34.17  (10.70)
11.Primary Outcome
Title Wechsler Test of Adult Reading (WTAR)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing each arm
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
WTAR (baseline) 20.73  (9.88) 18.17  (10.92)
WTAR (end of intervention) 18.18  (9.24) 17.50  (9.91)
12.Primary Outcome
Title Self-Efficacy for Abstinence
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing each arm
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Self-Efficacy for Abstinence (baseline) 38.45  (13.19) 39.58  (9.95)
Self-Efficacy for Abstinence (end of intervention) 40.55  (9.53) 41.17  (10.06)
13.Primary Outcome
Title Quality of Life (QoL)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing intervention
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
QoL (baseline) 97.82  (10.00) 92.17  (10.43)
QoL (end of intervention) 92.36  (14.45) 90.17  (12.83)
14.Primary Outcome
Title Roesenberg Self Esteem
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing each arm
Arm/Group Title IntenSati Treatment as Usual
Hide Arm/Group 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.
Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Rosenberg Self-Esteem (baseline) 23.18  (3.84) 21.83  (5.01)
Rosenberg Self-Esteem (end of intervention) 24.18  (4.31) 23.33  (4.33)
Time Frame Baseline to end of intervention (week 14)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intensati Treatment As Usual
Hide Arm/Group 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. [Not Specified]
All-Cause Mortality
Intensati Treatment As Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Intensati Treatment As Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      1/15 (6.67%)    
Gastrointestinal disorders     
Viral intestinal infection, unspecified (A08.4) * 1  0/17 (0.00%)  0 1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, ICD 10
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intensati Treatment As Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/17 (5.88%)      0/15 (0.00%)    
Cardiac disorders     
dizziness (R42) and dyspnoea (R06.0) * 1 [1]  1/17 (5.88%)  1 0/15 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, ICD 10
[1]
Occurred prior to initiation of exercise intervention. Subject was excluded from participation in exercise classes.
Overall small sample size, limited exercise intensity and capacity, missed exercise classes, dropout because of placement, work schedules and non-study-related medical conditions.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Rotrosen
Organization: NYUMED
Phone: 212 951 3294
EMail: john.rotrosen@nyumc.org
Layout table for additonal information
Responsible Party: John Rotrosen, NYU Langone Health
ClinicalTrials.gov Identifier: NCT01171677    
Other Study ID Numbers: NYULMC - 10-01156
First Submitted: July 27, 2010
First Posted: July 28, 2010
Results First Submitted: October 22, 2012
Results First Posted: March 6, 2013
Last Update Posted: March 6, 2013