Trial Outcomes & Findings for CBT-I on Alcohol Treatment Outcomes Among Veterans (NCT NCT03806491)
NCT ID: NCT03806491
Last Updated: 2025-04-18
Results Overview
Assessed using the Insomnia Severity Index (ISI); ISI will be used as a 7-item measure of insomnia severity in the past two weeks. Items assess difficulty falling or staying asleep, satisfaction with current sleep pattern, interference with daily functioning, the extent to which others notice their sleep problems, and worry/distress related to sleep problems. Response options for each item range from 0 (not at all worried) to 4 (very much worried). Individual item scores are summed to a total score - the highest possible score being 28. Higher scores indicate more severe insomnia. Participants scoring 10 or higher will be classified as screening positive for insomnia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
Baseline to post-treatment (week 6) to follow up (week 12)
Results posted on
2025-04-18
Participant Flow
Participant milestones
| Measure |
CBT-I + AUD-TAU
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Cognitive Behavioral Therapy for Insomnia: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Sleep Hygiene + AUD-TAU
Sleep hygiene education delivered once to all participants
Sleep Hygiene: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
35
|
|
Overall Study
COMPLETED
|
28
|
35
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CBT-I on Alcohol Treatment Outcomes Among Veterans
Baseline characteristics by cohort
| Measure |
CBT-I + AUD-TAU
n=32 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Cognitive Behavioral Therapy for Insomnia: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Sleep Hygiene + AUD-TAU
n=35 Participants
Sleep hygiene education delivered once to all participants
Sleep Hygiene: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Multiracial or multiethnic
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White only
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic or Latinx
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Highest level of education
Some high school
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Highest level of education
High school graduate or GED
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Highest level of education
Some college
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Highest level of education
College graduate
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Housing
My own house/apt
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Housing
Someone else's house/apt
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Housing
Transitional/institutional housing
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Housing
On the street
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Marital status
Never married
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Marital status
Married or living with partner
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Marital status
Divorced, separated, widowed
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Branch
Air Force
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Branch
Army
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Branch
Marines
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Branch
Navy
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to post-treatment (week 6) to follow up (week 12)Assessed using the Insomnia Severity Index (ISI); ISI will be used as a 7-item measure of insomnia severity in the past two weeks. Items assess difficulty falling or staying asleep, satisfaction with current sleep pattern, interference with daily functioning, the extent to which others notice their sleep problems, and worry/distress related to sleep problems. Response options for each item range from 0 (not at all worried) to 4 (very much worried). Individual item scores are summed to a total score - the highest possible score being 28. Higher scores indicate more severe insomnia. Participants scoring 10 or higher will be classified as screening positive for insomnia.
Outcome measures
| Measure |
CBT-I + AUD-TAU
n=32 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Cognitive Behavioral Therapy for Insomnia: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Sleep Hygiene + AUD-TAU
n=35 Participants
Sleep hygiene education delivered once to all participants
Sleep Hygiene: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
|---|---|---|
|
Insomnia Severity
Baseline
|
17.97 score on a scale
Standard Deviation 4.66
|
19.26 score on a scale
Standard Deviation 4.01
|
|
Insomnia Severity
6 weeks
|
5.69 score on a scale
Standard Deviation 4.70
|
10.96 score on a scale
Standard Deviation 6.43
|
|
Insomnia Severity
12 weeks
|
8.07 score on a scale
Standard Deviation 7.13
|
12.42 score on a scale
Standard Deviation 6.34
|
PRIMARY outcome
Timeframe: Baseline to post-treatment (week 6) to follow-up (week 12)Assessed using the Timeline Followback (TLFB) for alcohol; TLFB allows participants to trace their alcohol use back 30 days.
Outcome measures
| Measure |
CBT-I + AUD-TAU
n=32 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Cognitive Behavioral Therapy for Insomnia: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Sleep Hygiene + AUD-TAU
n=35 Participants
Sleep hygiene education delivered once to all participants
Sleep Hygiene: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
|---|---|---|
|
Percent of Heavy-drinking Days
6 weeks
|
2.07 percentage of heavy drinking days
Standard Deviation 5.26
|
1.34 percentage of heavy drinking days
Standard Deviation 4.49
|
|
Percent of Heavy-drinking Days
Baseline
|
16.97 percentage of heavy drinking days
Standard Deviation 9.58
|
17.14 percentage of heavy drinking days
Standard Deviation 11.74
|
|
Percent of Heavy-drinking Days
12 weeks
|
5.92 percentage of heavy drinking days
Standard Deviation 11.45
|
6.57 percentage of heavy drinking days
Standard Deviation 13.56
|
PRIMARY outcome
Timeframe: Baseline to post-treatment (week 6) to follow-up (week 12)Assessed using the Short Inventory of Problems (SIP). SIP measures adverse consequences of substance use. Scores range 0 to 45, where higher scores indicate more frequent problems.
Outcome measures
| Measure |
CBT-I + AUD-TAU
n=32 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Cognitive Behavioral Therapy for Insomnia: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Sleep Hygiene + AUD-TAU
n=35 Participants
Sleep hygiene education delivered once to all participants
Sleep Hygiene: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
|---|---|---|
|
Alcohol Problems
Baseline
|
25.44 score on a scale
Standard Deviation 10.11
|
22.00 score on a scale
Standard Deviation 12.17
|
|
Alcohol Problems
6 weeks
|
4.42 score on a scale
Standard Deviation 6.19
|
5.12 score on a scale
Standard Deviation 9.10
|
|
Alcohol Problems
12 weeks
|
4.38 score on a scale
Standard Deviation 7.65
|
7.00 score on a scale
Standard Deviation 9.03
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (week 6) to follow up (week 12)Assessed using daily sleep diaries. Sleep Diaries are quotidian questionnaires that measure self-reported sleep quality, sleep \& wake time, and daily habits concerning substance use. Scores range 0 to 100, where higher scores indicate better (more favorable) sleep efficiency. Treatment goal is 85%.
Outcome measures
| Measure |
CBT-I + AUD-TAU
n=32 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Cognitive Behavioral Therapy for Insomnia: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Sleep Hygiene + AUD-TAU
n=35 Participants
Sleep hygiene education delivered once to all participants
Sleep Hygiene: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
|---|---|---|
|
Sleep Efficiency
Baseline
|
68.47 percentage
Standard Deviation 11.91
|
71.44 percentage
Standard Deviation 13.32
|
|
Sleep Efficiency
6 weeks
|
87.30 percentage
Standard Deviation 7.50
|
82.41 percentage
Standard Deviation 11.51
|
|
Sleep Efficiency
12 weeks
|
90.62 percentage
Standard Deviation 5.26
|
75.31 percentage
Standard Deviation 14.11
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (week 6) to follow up (week 12)Assessed using the Post-Traumatic Stress Disorder Checklist from the Diagnostic and Statistical Manual-5 (PCL-5); PCL-5 is a 20-item measure of Post-Traumatic Stress Disorder (PTSD). On a scale of not at all (0) to extremely (4), participants indicate how frequently in the past month they were bothered by stressful experiences such as disturbing dreams, hyper-alertness, strong negative beliefs, and irritability. PCL-5 is scored by summing the responses. Possible scores range from 0-80, where higher scores indicate higher PTSD severity.
Outcome measures
| Measure |
CBT-I + AUD-TAU
n=32 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Cognitive Behavioral Therapy for Insomnia: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Sleep Hygiene + AUD-TAU
n=35 Participants
Sleep hygiene education delivered once to all participants
Sleep Hygiene: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
|---|---|---|
|
Post-Traumatic Stress Disorder Symptoms
Baseline
|
34.3 score on a scale
Standard Deviation 22.3
|
32.0 score on a scale
Standard Deviation 21.6
|
|
Post-Traumatic Stress Disorder Symptoms
6 weeks
|
20.1 score on a scale
Standard Deviation 21.1
|
25.2 score on a scale
Standard Deviation 22.1
|
|
Post-Traumatic Stress Disorder Symptoms
12 weeks
|
21.0 score on a scale
Standard Deviation 22.1
|
28.2 score on a scale
Standard Deviation 24.8
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (week 6) to follow up (week 12)Population: Some participants lost to follow-up
Assessed using the Patient Health Questionnaire-9 (PHQ-9); PHQ-9 will be used as a 9-item measure of depressed mood and functioning that has demonstrated good sensitivity and specificity across adult samples. Participants will indicate how many days in the past two weeks (not at all, several days, more than half the days, or every day or nearly every day) they have experienced each problem. Scores range from 0 to 27, where higher scores indicate more severe symptoms of depression.
Outcome measures
| Measure |
CBT-I + AUD-TAU
n=32 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Cognitive Behavioral Therapy for Insomnia: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Sleep Hygiene + AUD-TAU
n=35 Participants
Sleep hygiene education delivered once to all participants
Sleep Hygiene: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
|---|---|---|
|
Symptoms of Depression
Baseline
|
10.9 score on a scale
Standard Deviation 5.6
|
12.3 score on a scale
Standard Deviation 5.6
|
|
Symptoms of Depression
6 weeks
|
4.7 score on a scale
Standard Deviation 4.7
|
7.4 score on a scale
Standard Deviation 6.3
|
|
Symptoms of Depression
12 weeks
|
7.3 score on a scale
Standard Deviation 6.0
|
8.9 score on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (week 6) to follow up (week 12)Population: Some participants lost to follow-up
Assessed using the Generalized Anxiety Disorder-7 (GAD-7); GAD-7 is a 7-item measure of anxiety with strong criterion and predictive validity. On a scale from not at all (0) to nearly every day (3), participants indicate how often in the past two weeks they have experienced problems such as having trouble relaxing and being so restless that it is hard to sit still. Possible total scores range from 0-21. Scores will be summed and classified as minimal anxiety (\<3), moderate anxiety (4-7), high anxiety (12-15), or severe anxiety (16-21).
Outcome measures
| Measure |
CBT-I + AUD-TAU
n=32 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Cognitive Behavioral Therapy for Insomnia: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Sleep Hygiene + AUD-TAU
n=35 Participants
Sleep hygiene education delivered once to all participants
Sleep Hygiene: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
|---|---|---|
|
Symptoms of Anxiety
12 weeks
|
7.2 score on a scale
Standard Deviation 6.6
|
8.7 score on a scale
Standard Deviation 5.6
|
|
Symptoms of Anxiety
Baseline
|
9.8 score on a scale
Standard Deviation 10.8
|
10.8 score on a scale
Standard Deviation 5.8
|
|
Symptoms of Anxiety
6 weeks
|
4.9 score on a scale
Standard Deviation 4.3
|
7.0 score on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Change from baseline to post-treatment (week 6)Assessed using the Project SAVE alcohol quiz
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to post-treatment (week 6) to follow up (week 12)Assessed using the daily sleep diary; Did you use alcohol specifically to help with sleep?
Outcome measures
| Measure |
CBT-I + AUD-TAU
n=32 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Cognitive Behavioral Therapy for Insomnia: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Sleep Hygiene + AUD-TAU
n=35 Participants
Sleep hygiene education delivered once to all participants
Sleep Hygiene: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
|---|---|---|
|
Percentage of Days Where Alcohol Was Used to Help With Sleep
Baseline
|
3.68 percentage of days
Standard Deviation 16.86
|
2.94 percentage of days
Standard Deviation 14.83
|
|
Percentage of Days Where Alcohol Was Used to Help With Sleep
6 weeks
|
4.08 percentage of days
Standard Deviation 15.48
|
4.76 percentage of days
Standard Deviation 21.82
|
|
Percentage of Days Where Alcohol Was Used to Help With Sleep
12 weeks
|
8.09 percentage of days
Standard Deviation 18.55
|
3.16 percentage of days
Standard Deviation 8.44
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (week 6) to follow up (week 12)Assessed using the Penn Alcohol Craving Scale (PACS); The Penn Alcohol Craving Scale is a 5-item measure of alcohol craving in the past week. Participants rate the intensity, frequency, and duration of cravings, as well as their ability to resist acting on those cravings and their overall "average alcohol craving" for the past week. This measure has demonstrated good internal consistency and construct validity. Scores range 0 to 30, where higher scores indicate stronger craving.
Outcome measures
| Measure |
CBT-I + AUD-TAU
n=32 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Cognitive Behavioral Therapy for Insomnia: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Sleep Hygiene + AUD-TAU
n=35 Participants
Sleep hygiene education delivered once to all participants
Sleep Hygiene: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
|---|---|---|
|
Alcohol Craving
Baseline
|
11.44 score on a scale
Standard Deviation 8.85
|
10.76 score on a scale
Standard Deviation 7.59
|
|
Alcohol Craving
6 weeks
|
7.88 score on a scale
Standard Deviation 6.73
|
7.15 score on a scale
Standard Deviation 6.25
|
|
Alcohol Craving
12 weeks
|
9.31 score on a scale
Standard Deviation 7.25
|
9.21 score on a scale
Standard Deviation 6.86
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (week 6) to follow up (week 12)Population: Some participants lost to follow-up
Assessed using the Positive and Negative Affect Schedule (PANAS); Negative affect subscale scores range from 10-50, with higher scores indicating more extreme negative affect (measured "right now").
Outcome measures
| Measure |
CBT-I + AUD-TAU
n=35 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Cognitive Behavioral Therapy for Insomnia: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Sleep Hygiene + AUD-TAU
n=32 Participants
Sleep hygiene education delivered once to all participants
Sleep Hygiene: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
|---|---|---|
|
Negative Affect
Baseline
|
20.0 score on a scale
Standard Deviation 8.7
|
20.3 score on a scale
Standard Deviation 9.0
|
|
Negative Affect
6 weeks
|
15.2 score on a scale
Standard Deviation 4.5
|
16.5 score on a scale
Standard Deviation 7.5
|
|
Negative Affect
12 weeks
|
18.2 score on a scale
Standard Deviation 7.8
|
20.0 score on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (week 6) to follow up (week 12)Population: Some participants lost to follow-up
Assessed using the Brief Difficulties in Emotion Regulation Scale (DERS-16). The 16-item Difficulties in Emotion Regulation Scale has demonstrated good convergent and discriminant validity in clinical and community samples (Bjureberg et al., 2015). Scores range from 16 to 80, with higher scores indicating more difficulties with emotion regulation.
Outcome measures
| Measure |
CBT-I + AUD-TAU
n=32 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Cognitive Behavioral Therapy for Insomnia: Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
Sleep Hygiene + AUD-TAU
n=35 Participants
Sleep hygiene education delivered once to all participants
Sleep Hygiene: Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
Alcohol Use Disorder Treatment as Usual: CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
|
|---|---|---|
|
Emotion Regulation
6 weeks
|
15.2 score on a scale
Standard Deviation 4.5
|
18.2 score on a scale
Standard Deviation 7.8
|
|
Emotion Regulation
12 weeks
|
18.2 score on a scale
Standard Deviation 7.8
|
20.0 score on a scale
Standard Deviation 10.6
|
|
Emotion Regulation
Baseline
|
20.0 score on a scale
Standard Deviation 8.7
|
20.3 score on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (week 6) to follow up (week 12)Assessed using the Monetary Choice Questionnaire (MCQ); The MCQ (Kirby, Petry, \& Bickel, 1999) will be used as a self-report measure of delay discounting. In 27 trials, participants will be asked to choose between a smaller, immediate reward or a larger, delayed reward. For example, "Would you prefer $54 today or $55 in 117 days?" Data will be used to calculate participants' discounting-rate parameter (k).
Outcome measures
Outcome data not reported
Adverse Events
CBT-I + AUD-TAU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sleep Hygiene + AUD-TAU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place