Trial Outcomes & Findings for The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse (NCT NCT01987089)
NCT ID: NCT01987089
Last Updated: 2020-08-07
Results Overview
Insomnia Severity Index (ISI): This 7-item (0-4 Likert scales) measure yields a total score of 28. The norms for the scale are as follows: 0-7 represents no clinically significant insomnia; 8-14 represents sub threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The scale provides a measure of severity of insomnia (overall), a measure of insomnia subtype, a measure of the diurnal effects of insomnia, and a measure of sleep "satisfaction". The ISI will be completed at baseline and for all the subsequent study-related visits.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
8 weeks, 3 months post-treatment, and 6 months post-treatment
Results posted on
2020-08-07
Participant Flow
83 was the anticipated recruitment target sample and our final recruitment sample was 63
Participant milestones
| Measure |
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. Session 1 serves as an orientation. No active treatment is delivered at this time. Sessions 2 \& 3 are used to deliver the three main components of the intervention which are Sleep Restriction (SRT), Stimulus Control, and Sleep Hygiene. All but two of the remaining sessions are dedicated to the titration of total sleep time and to ensuring patient adherence. One session (session 5) entails the delivery of a specific form of cognitive therapy. The final session (session 8) is used to engage in a relapse-prevention didactic, i.e., to review first, how insomnia becomes chronic and second, the strategies that are likely to abort an extended episode of insomnia.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
Quasi Desensitization Therapy (QDT)
This form of placebo therapy has been commonly used in prior studies investigating behavioral interventions for insomnia. The therapist presents the QDT as a means to eliminate "conditioned arousal," occurring after nocturnal arousal using 8 sessions on a weekly basis. The therapist initially helps the subject to develop a chronological 12-item hierarchy of commonly practiced activities on awakening at night, like opening eyes and clock watching. As a next step, the subject develops 6 imaginable scenes of himself/herself engaged in neutral activities like reading a newspaper. The therapist then helps the subject pair the neutral scenes with the items from the 12-item hierarchy, which is then practiced by the subject 2 hours before bedtime.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy for Insomnia
n=31 Participants
Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. Session 1 serves as an orientation. No active treatment is delivered at this time. Sessions 2 \& 3 are used to deliver the three main components of the intervention which are Sleep Restriction (SRT), Stimulus Control, and Sleep Hygiene. All but two of the remaining sessions are dedicated to the titration of total sleep time and to ensuring patient adherence. One session (session 5) entails the delivery of a specific form of cognitive therapy. The final session (session 8) is used to engage in a relapse-prevention didactic, i.e., to review first, how insomnia becomes chronic and second, the strategies that are likely to abort an extended episode of insomnia.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
Quasi Desensitization Therapy
n=32 Participants
This form of placebo therapy has been commonly used in prior studies investigating behavioral interventions for insomnia. The therapist presents the QDT as a means to eliminate "conditioned arousal," occurring after nocturnal arousal using 8 sessions on a weekly basis. The therapist initially helps the subject to develop a chronological 12-item hierarchy of commonly practiced activities on awakening at night, like opening eyes and clock watching. As a next step, the subject develops 6 imaginable scenes of himself/herself engaged in neutral activities like reading a newspaper. The therapist then helps the subject pair the neutral scenes with the items from the 12-item hierarchy, which is then practiced by the subject 2 hours before bedtime.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
51.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Insomnia Severity Index total score (ISI)
|
19.7 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
19.0 units on a scale
STANDARD_DEVIATION 3.7 • n=7 Participants
|
19.3 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sleep Onset Latency (SOL, sleep diary)
|
51.6 minutes
STANDARD_DEVIATION 41.4 • n=5 Participants
|
49.3 minutes
STANDARD_DEVIATION 34.0 • n=7 Participants
|
50.5 minutes
STANDARD_DEVIATION 37.7 • n=5 Participants
|
|
Wake After Sleep Onset (WASO, sleep diary)
|
44.6 minutes
STANDARD_DEVIATION 30.0 • n=5 Participants
|
28.6 minutes
STANDARD_DEVIATION 25.5 • n=7 Participants
|
36.7 minutes
STANDARD_DEVIATION 28.8 • n=5 Participants
|
|
Total Sleep Time (TST, sleep diary)
|
317.0 minutes
STANDARD_DEVIATION 90.8 • n=5 Participants
|
345.1 minutes
STANDARD_DEVIATION 99.5 • n=7 Participants
|
330.8 minutes
STANDARD_DEVIATION 95.5 • n=5 Participants
|
|
Percent Days Abstinent (PDA, last 90 days, at screening)
|
38.3 Percent of Days Abstinent
STANDARD_DEVIATION 36.0 • n=5 Participants
|
26.9 Percent of Days Abstinent
STANDARD_DEVIATION 29.2 • n=7 Participants
|
32.5 Percent of Days Abstinent
STANDARD_DEVIATION 32.9 • n=5 Participants
|
|
Drinks per day (DrPDay, last 90 days, at screening)
|
9.1 Number of Drinks Per Day
STANDARD_DEVIATION 9.2 • n=5 Participants
|
8.8 Number of Drinks Per Day
STANDARD_DEVIATION 7.1 • n=7 Participants
|
8.9 Number of Drinks Per Day
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Penn Alcohol Craving Scale total score (PACS)
|
10.8 units on a scale
STANDARD_DEVIATION 7.5 • n=5 Participants
|
8.2 units on a scale
STANDARD_DEVIATION 7.0 • n=7 Participants
|
9.5 units on a scale
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Days Abstinent from Alcohol before Treatment (Abs)
|
86.8 Number of Days
STANDARD_DEVIATION 103.3 • n=5 Participants
|
142.6 Number of Days
STANDARD_DEVIATION 111.6 • n=7 Participants
|
115.2 Number of Days
STANDARD_DEVIATION 110.4 • n=5 Participants
|
|
Physical Composite Score (PCS, SF-12 scale)
|
42.7 units on a scale
STANDARD_DEVIATION 4.6 • n=5 Participants
|
40.4 units on a scale
STANDARD_DEVIATION 5.3 • n=7 Participants
|
41.7 units on a scale
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Mental Composite Score (MCS, SF-12 scale)
|
44.4 units on a scale
STANDARD_DEVIATION 7.5 • n=5 Participants
|
43.1 units on a scale
STANDARD_DEVIATION 6.4 • n=7 Participants
|
43.9 units on a scale
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Beck Depression Inventory total score
|
19.7 units on a scale
STANDARD_DEVIATION 12.4 • n=5 Participants
|
17.2 units on a scale
STANDARD_DEVIATION 10.7 • n=7 Participants
|
18.5 units on a scale
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
State Trait Anxiety Inventory - trait subscale (STAI-trait)
|
45.0 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
46.3 units on a scale
STANDARD_DEVIATION 6.0 • n=7 Participants
|
45.6 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks, 3 months post-treatment, and 6 months post-treatmentPopulation: All subjects randomized into either treatment arm and received had 1 or more treatment sessions.
Insomnia Severity Index (ISI): This 7-item (0-4 Likert scales) measure yields a total score of 28. The norms for the scale are as follows: 0-7 represents no clinically significant insomnia; 8-14 represents sub threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The scale provides a measure of severity of insomnia (overall), a measure of insomnia subtype, a measure of the diurnal effects of insomnia, and a measure of sleep "satisfaction". The ISI will be completed at baseline and for all the subsequent study-related visits.
Outcome measures
| Measure |
Cognitive Behavioral Therapy for Insomnia (CBT-I)
n=31 Participants
Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. Session 1 serves as an orientation. No active treatment is delivered at this time. Sessions 2 \& 3 are used to deliver the three main components of the intervention which are Sleep Restriction (SRT), Stimulus Control, and Sleep Hygiene. All but two of the remaining sessions are dedicated to the titration of total sleep time and to ensuring patient adherence. One session (session 5) entails the delivery of a specific form of cognitive therapy. The final session (session 8) is used to engage in a relapse-prevention didactic, i.e., to review first, how insomnia becomes chronic and second, the strategies that are likely to abort an extended episode of insomnia.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
Quasi Desensitization Therapy (QDT)
n=32 Participants
This form of placebo therapy has been commonly used in prior studies investigating behavioral interventions for insomnia. The therapist presents the QDT as a means to eliminate "conditioned arousal," occurring after nocturnal arousal using 8 sessions on a weekly basis. The therapist initially helps the subject to develop a chronological 12-item hierarchy of commonly practiced activities on awakening at night, like opening eyes and clock watching. As a next step, the subject develops 6 imaginable scenes of himself/herself engaged in neutral activities like reading a newspaper. The therapist then helps the subject pair the neutral scenes with the items from the 12-item hierarchy, which is then practiced by the subject 2 hours before bedtime.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
|---|---|---|
|
Change in Insomnia Severity Index - Total Score
Change at week 8 (Vs baseline)
|
-10.71 units on a scale
Interval -13.07 to -8.1
|
-8.84 units on a scale
Interval -10.82 to -6.84
|
|
Change in Insomnia Severity Index - Total Score
Change at 3 mo post-treatment F/U (Vs baseline)
|
-8.51 units on a scale
Interval -11.21 to -5.78
|
-9.30 units on a scale
Interval -11.43 to -7.26
|
|
Change in Insomnia Severity Index - Total Score
Change at 6 mo post-treatment F/U (Vs baseline)
|
-6.89 units on a scale
Interval -9.48 to -4.29
|
-7.29 units on a scale
Interval -9.5 to -4.63
|
PRIMARY outcome
Timeframe: 8 weeks, 3 months post-treatment and 6-months post-treatmentPopulation: All subjects randomized into either treatment arm and received had 1 or more treatment sessions.
Time Line Follow Back measure (TLFB): The TLFB provides assessment of drinking using a calendar format for the number of standard alcoholic beverages consumed per day. A standard drink, as defined by the National Institutes of Health, is 12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits (e.g. whiskey). Numerous indices may be derived from the TLFB, such as the Percent Days Abstinent (PDA) proposed in this study. The PDA is derived as the percentage of days an individual reports being abstinent from alcohol within a given assessment time period.
Outcome measures
| Measure |
Cognitive Behavioral Therapy for Insomnia (CBT-I)
n=31 Participants
Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. Session 1 serves as an orientation. No active treatment is delivered at this time. Sessions 2 \& 3 are used to deliver the three main components of the intervention which are Sleep Restriction (SRT), Stimulus Control, and Sleep Hygiene. All but two of the remaining sessions are dedicated to the titration of total sleep time and to ensuring patient adherence. One session (session 5) entails the delivery of a specific form of cognitive therapy. The final session (session 8) is used to engage in a relapse-prevention didactic, i.e., to review first, how insomnia becomes chronic and second, the strategies that are likely to abort an extended episode of insomnia.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
Quasi Desensitization Therapy (QDT)
n=32 Participants
This form of placebo therapy has been commonly used in prior studies investigating behavioral interventions for insomnia. The therapist presents the QDT as a means to eliminate "conditioned arousal," occurring after nocturnal arousal using 8 sessions on a weekly basis. The therapist initially helps the subject to develop a chronological 12-item hierarchy of commonly practiced activities on awakening at night, like opening eyes and clock watching. As a next step, the subject develops 6 imaginable scenes of himself/herself engaged in neutral activities like reading a newspaper. The therapist then helps the subject pair the neutral scenes with the items from the 12-item hierarchy, which is then practiced by the subject 2 hours before bedtime.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
|---|---|---|
|
Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure
Change at week 8 (Vs baseline)
|
0.56 percentage of abstinent days
Interval 0.44 to 0.68
|
0.67 percentage of abstinent days
Interval 0.55 to 0.8
|
|
Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure
Change at 3 mo post-treatment F/U (Vs baseline)
|
0.51 percentage of abstinent days
Interval 0.38 to 0.63
|
0.61 percentage of abstinent days
Interval 0.5 to 0.74
|
|
Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure
Change at 6 mo post-treatment F/U (Vs baseline)
|
0.48 percentage of abstinent days
Interval 0.36 to 0.6
|
0.62 percentage of abstinent days
Interval 0.5 to 0.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks, 3 months post-treatment, and 6 months post-treatmentPopulation: All subjects randomized into either treatment arm and received had 1 or more treatment sessions.
The Physical Component Summary (PCS) scale has a range from 0 (indicating the lowest level of health) to 100 (indicating the best level of health).
Outcome measures
| Measure |
Cognitive Behavioral Therapy for Insomnia (CBT-I)
n=31 Participants
Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. Session 1 serves as an orientation. No active treatment is delivered at this time. Sessions 2 \& 3 are used to deliver the three main components of the intervention which are Sleep Restriction (SRT), Stimulus Control, and Sleep Hygiene. All but two of the remaining sessions are dedicated to the titration of total sleep time and to ensuring patient adherence. One session (session 5) entails the delivery of a specific form of cognitive therapy. The final session (session 8) is used to engage in a relapse-prevention didactic, i.e., to review first, how insomnia becomes chronic and second, the strategies that are likely to abort an extended episode of insomnia.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
Quasi Desensitization Therapy (QDT)
n=32 Participants
This form of placebo therapy has been commonly used in prior studies investigating behavioral interventions for insomnia. The therapist presents the QDT as a means to eliminate "conditioned arousal," occurring after nocturnal arousal using 8 sessions on a weekly basis. The therapist initially helps the subject to develop a chronological 12-item hierarchy of commonly practiced activities on awakening at night, like opening eyes and clock watching. As a next step, the subject develops 6 imaginable scenes of himself/herself engaged in neutral activities like reading a newspaper. The therapist then helps the subject pair the neutral scenes with the items from the 12-item hierarchy, which is then practiced by the subject 2 hours before bedtime.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
|---|---|---|
|
Change in PCS From the Short Form - 12 Item (SF-12) Measure
Change at week 8 (Vs baseline)
|
-1.00 units on a scale
Interval -3.29 to 1.3
|
0.48 units on a scale
Interval -2.7 to 3.8
|
|
Change in PCS From the Short Form - 12 Item (SF-12) Measure
Change at 3 mo post-treatment F/U (Vs baseline)
|
-1.69 units on a scale
Interval -5.13 to 1.59
|
0.54 units on a scale
Interval -2.21 to 3.13
|
|
Change in PCS From the Short Form - 12 Item (SF-12) Measure
Change at 6 mo post-treatment F/U (Vs baseline)
|
-1.18 units on a scale
Interval -3.1 to 1.0
|
-0.25 units on a scale
Interval -3.41 to 3.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks, 3 months post-treatment, and 6 months post-treatmentPopulation: All subjects randomized into either treatment arm and received had 1 or more treatment sessions.
The Mental Component Summary (MCS) scale has a range from 0 (indicating the lowest level of health) to 100 (indicating the best level of health).
Outcome measures
| Measure |
Cognitive Behavioral Therapy for Insomnia (CBT-I)
n=31 Participants
Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. Session 1 serves as an orientation. No active treatment is delivered at this time. Sessions 2 \& 3 are used to deliver the three main components of the intervention which are Sleep Restriction (SRT), Stimulus Control, and Sleep Hygiene. All but two of the remaining sessions are dedicated to the titration of total sleep time and to ensuring patient adherence. One session (session 5) entails the delivery of a specific form of cognitive therapy. The final session (session 8) is used to engage in a relapse-prevention didactic, i.e., to review first, how insomnia becomes chronic and second, the strategies that are likely to abort an extended episode of insomnia.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
Quasi Desensitization Therapy (QDT)
n=32 Participants
This form of placebo therapy has been commonly used in prior studies investigating behavioral interventions for insomnia. The therapist presents the QDT as a means to eliminate "conditioned arousal," occurring after nocturnal arousal using 8 sessions on a weekly basis. The therapist initially helps the subject to develop a chronological 12-item hierarchy of commonly practiced activities on awakening at night, like opening eyes and clock watching. As a next step, the subject develops 6 imaginable scenes of himself/herself engaged in neutral activities like reading a newspaper. The therapist then helps the subject pair the neutral scenes with the items from the 12-item hierarchy, which is then practiced by the subject 2 hours before bedtime.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
|---|---|---|
|
Change in MCS From the Short Form - 12 Item (SF-12) Measure
Change at week 8 (Vs baseline)
|
-3.06 units on a scale
Interval -8.04 to 1.71
|
-1.90 units on a scale
Interval -5.92 to 2.16
|
|
Change in MCS From the Short Form - 12 Item (SF-12) Measure
Change at 3 mo post-treatment F/U (Vs baseline)
|
-2.60 units on a scale
Interval -7.83 to 2.42
|
1.12 units on a scale
Interval -2.8 to 5.02
|
|
Change in MCS From the Short Form - 12 Item (SF-12) Measure
Change at 6 mo post-treatment F/U (Vs baseline)
|
-2.07 units on a scale
Interval -5.9 to 1.64
|
0.89 units on a scale
Interval -4.32 to 5.84
|
Adverse Events
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Quasi Desensitization Therapy (QDT)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cognitive Behavioral Therapy for Insomnia (CBT-I)
n=31 participants at risk
Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. Session 1 serves as an orientation. No active treatment is delivered at this time. Sessions 2 \& 3 are used to deliver the three main components of the intervention which are Sleep Restriction (SRT), Stimulus Control, and Sleep Hygiene. All but two of the remaining sessions are dedicated to the titration of total sleep time and to ensuring patient adherence. One session (session 5) entails the delivery of a specific form of cognitive therapy. The final session (session 8) is used to engage in a relapse-prevention didactic, i.e., to review first, how insomnia becomes chronic and second, the strategies that are likely to abort an extended episode of insomnia.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
Quasi Desensitization Therapy (QDT)
n=32 participants at risk
This form of placebo therapy has been commonly used in prior studies investigating behavioral interventions for insomnia. The therapist presents the QDT as a means to eliminate "conditioned arousal," occurring after nocturnal arousal using 8 sessions on a weekly basis. The therapist initially helps the subject to develop a chronological 12-item hierarchy of commonly practiced activities on awakening at night, like opening eyes and clock watching. As a next step, the subject develops 6 imaginable scenes of himself/herself engaged in neutral activities like reading a newspaper. The therapist then helps the subject pair the neutral scenes with the items from the 12-item hierarchy, which is then practiced by the subject 2 hours before bedtime.
Cognitive Behavioral Therapy for Insomnia (CBT-I): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular Accident (CVA)
|
0.00%
0/31 • 9 months
This a behavioral treatment intervention study.
|
3.1%
1/32 • 9 months
This a behavioral treatment intervention study.
|
|
Nervous system disorders
Alcohol detoxification
|
12.9%
4/31 • 9 months
This a behavioral treatment intervention study.
|
6.2%
2/32 • 9 months
This a behavioral treatment intervention study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.2%
1/31 • 9 months
This a behavioral treatment intervention study.
|
0.00%
0/32 • 9 months
This a behavioral treatment intervention study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.2%
1/31 • 9 months
This a behavioral treatment intervention study.
|
0.00%
0/32 • 9 months
This a behavioral treatment intervention study.
|
|
Nervous system disorders
Residential Psychiatric Treatment
|
3.2%
1/31 • 9 months
This a behavioral treatment intervention study.
|
0.00%
0/32 • 9 months
This a behavioral treatment intervention study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place