Trial Outcomes & Findings for Impact of Exercise and Affirmations (IntenSati) on Addiction-related Cognitive and Psychosocial Deficits (NCT NCT01171677)
NCT ID: NCT01171677
Last Updated: 2013-03-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline to end of intervention (week 14)
Results posted on
2013-03-06
Participant Flow
40 Subjects consented, 4 discontinued prior to completing screening, 36 completed baseline, 4 were ineligible, 32 were randomized.
Participant milestones
| Measure |
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.
|
Treatment as Usual
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 Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
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.
|
Treatment as Usual
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 Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
completed <70% IntenSati classes
|
5
|
0
|
Baseline Characteristics
Impact of Exercise and Affirmations (IntenSati) on Addiction-related Cognitive and Psychosocial Deficits
Baseline characteristics by cohort
| Measure |
IntenSati
n=17 Participants
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.
|
Treatment as Usual
n=15 Participants
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age Continuous
|
59 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
59 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
59 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing each arm
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
|
Treatment as Usual
n=12 Participants
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.
|
|---|---|---|
|
Hopkins Verbal Learning Test (HVLT) Total Recall
HVLT Total (baseline)
|
17.27 units on a scale
Standard Deviation 3.80
|
18.00 units on a scale
Standard Deviation 5.15
|
|
Hopkins Verbal Learning Test (HVLT) Total Recall
HVLT Total (end of intervention)
|
15.27 units on a scale
Standard Deviation 3.98
|
17.50 units on a scale
Standard Deviation 3.50
|
PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing each arm
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
|
Treatment as Usual
n=12 Participants
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.
|
|---|---|---|
|
Hopkins Verbal Learning Test (HVLT) Delayed Recall
HVLT Delayed (baseline)
|
2.82 units on a scale
Standard Deviation 1.72
|
5.00 units on a scale
Standard Deviation 2.41
|
|
Hopkins Verbal Learning Test (HVLT) Delayed Recall
HVLT Delayed (end of intervention)
|
3.91 units on a scale
Standard Deviation 1.76
|
3.92 units on a scale
Standard Deviation 2.94
|
PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing each arm
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
|
Treatment as Usual
n=12 Participants
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.
|
|---|---|---|
|
Hopkins Verbal Learning Test (HVLT) Delayed Recognition
HVLT Delayed Recognition (baseline)
|
18.55 units on a scale
Standard Deviation 1.29
|
21.33 units on a scale
Standard Deviation 3.37
|
|
Hopkins Verbal Learning Test (HVLT) Delayed Recognition
HVLT Delayed Recognition (end of intervention)
|
20.27 units on a scale
Standard Deviation 1.62
|
22.33 units on a scale
Standard Deviation 2.43
|
PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing each arm
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
|
Treatment as Usual
n=12 Participants
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.
|
|---|---|---|
|
Stroop Word
Stroop Word (baseline)
|
77.36 units on a scale
Standard Deviation 18.48
|
80.67 units on a scale
Standard Deviation 20.15
|
|
Stroop Word
Stroop Word (end of intervention)
|
83.18 units on a scale
Standard Deviation 14.66
|
79.25 units on a scale
Standard Deviation 20.21
|
PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing each arm
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
|
Treatment as Usual
n=12 Participants
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.
|
|---|---|---|
|
Stroop Color
Stroop Color (baseline)
|
54.27 units on a scale
Standard Deviation 14.19
|
64.33 units on a scale
Standard Deviation 16.55
|
|
Stroop Color
Stroop Color (end of intervention)
|
58.18 units on a scale
Standard Deviation 14.74
|
65.67 units on a scale
Standard Deviation 15.51
|
PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing each arm
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
|
Treatment as Usual
n=12 Participants
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.
|
|---|---|---|
|
Stroop Color/Word
Stroop Color/Word (baseline)
|
28.82 units on a scale
Standard Deviation 9.38
|
33.08 units on a scale
Standard Deviation 11.26
|
|
Stroop Color/Word
Stroop Color/Word (end of intervention)
|
26.27 units on a scale
Standard Deviation 13.79
|
31.17 units on a scale
Standard Deviation 11.51
|
PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing trial
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
|
Treatment as Usual
n=12 Participants
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.
|
|---|---|---|
|
Trailmaking Test A
Trailmaking A (baseline)
|
49.82 seconds
Standard Deviation 24.15
|
35.99 seconds
Standard Deviation 12.10
|
|
Trailmaking Test A
Trailmaking A (end of intervention)
|
46.98 seconds
Standard Deviation 21.00
|
38.51 seconds
Standard Deviation 13.25
|
PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing each arm
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
|
Treatment as Usual
n=12 Participants
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.
|
|---|---|---|
|
Trailmaking Test B
Trailmaking B (baseline)
|
166.07 seconds
Standard Deviation 66.58
|
126.14 seconds
Standard Deviation 54.07
|
|
Trailmaking Test B
Trailmaking B (end of intervention)
|
187.86 seconds
Standard Deviation 140.23
|
125.06 seconds
Standard Deviation 66.27
|
PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing each arm
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
|
Treatment as Usual
n=12 Participants
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.
|
|---|---|---|
|
Digit Span
Digit Span (baseline)
|
12.55 units on a scale
Standard Deviation 2.54
|
12.33 units on a scale
Standard Deviation 3.42
|
|
Digit Span
Digit Span (end of intervention)
|
11.91 units on a scale
Standard Deviation 3.42
|
12.33 units on a scale
Standard Deviation 3.68
|
PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing each arm
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
|
Treatment as Usual
n=12 Participants
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.
|
|---|---|---|
|
Controlled Oral Word Association Test (COWAT)
COWAT (baseline)
|
29.91 units on a scale
Standard Deviation 10.26
|
31.42 units on a scale
Standard Deviation 9.22
|
|
Controlled Oral Word Association Test (COWAT)
COWAT (end of intervention)
|
27.82 units on a scale
Standard Deviation 9.43
|
34.17 units on a scale
Standard Deviation 10.70
|
PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing each arm
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
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Treatment as Usual
n=12 Participants
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.
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Wechsler Test of Adult Reading (WTAR)
WTAR (baseline)
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20.73 units on a scale
Standard Deviation 9.88 • Interval 10.92 to
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18.17 units on a scale
Standard Deviation 10.92
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Wechsler Test of Adult Reading (WTAR)
WTAR (end of intervention)
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18.18 units on a scale
Standard Deviation 9.24
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17.50 units on a scale
Standard Deviation 9.91
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PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing each arm
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
|
Treatment as Usual
n=12 Participants
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.
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Self-Efficacy for Abstinence
Self-Efficacy for Abstinence (baseline)
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38.45 units on a scale
Standard Deviation 13.19
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39.58 units on a scale
Standard Deviation 9.95
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Self-Efficacy for Abstinence
Self-Efficacy for Abstinence (end of intervention)
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40.55 units on a scale
Standard Deviation 9.53
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41.17 units on a scale
Standard Deviation 10.06
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PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing intervention
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
|
Treatment as Usual
n=12 Participants
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.
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Quality of Life (QoL)
QoL (baseline)
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97.82 units on a scale
Standard Deviation 10.00
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92.17 units on a scale
Standard Deviation 10.43
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Quality of Life (QoL)
QoL (end of intervention)
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92.36 units on a scale
Standard Deviation 14.45
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90.17 units on a scale
Standard Deviation 12.83
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PRIMARY outcome
Timeframe: Baseline to end of intervention (week 14)Population: participants completing each arm
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.
Outcome measures
| Measure |
IntenSati
n=11 Participants
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.
|
Treatment as Usual
n=12 Participants
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.
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Roesenberg Self Esteem
Rosenberg Self-Esteem (baseline)
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23.18 units on a scale
Standard Deviation 3.84
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21.83 units on a scale
Standard Deviation 5.01
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Roesenberg Self Esteem
Rosenberg Self-Esteem (end of intervention)
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24.18 units on a scale
Standard Deviation 4.31
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23.33 units on a scale
Standard Deviation 4.33
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Adverse Events
Intensati
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment As Usual
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intensati
n=17 participants at risk
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.
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Treatment As Usual
n=15 participants at risk
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Gastrointestinal disorders
Viral intestinal infection, unspecified (A08.4)
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0.00%
0/17 • Baseline to end of intervention (week 14)
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6.7%
1/15 • Number of events 1 • Baseline to end of intervention (week 14)
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Other adverse events
| Measure |
Intensati
n=17 participants at risk
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.
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Treatment As Usual
n=15 participants at risk
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Cardiac disorders
dizziness (R42) and dyspnoea (R06.0)
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5.9%
1/17 • Number of events 1 • Baseline to end of intervention (week 14)
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0.00%
0/15 • Baseline to end of intervention (week 14)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place