Insomnia
Conditions
Keywords
Insomnia, Sleep initiation and maintenance disorder, Alcoholism, Cognitive behavioral therapy for insomnia
Brief summary
Insomnia is a highly prevalent disorder in those recovering from alcoholism. It has been associated with anxiety and depressive symptoms, as well as an increased risk of relapse back to the drinking. Cognitive Behavioral Therapy for Insomnia (CBT-I), a non-pharmacologic approach is the recommended standard of care for insomnia. Some preliminary studies have shown that CBT-I may be efficacious for insomnia during recovery. The current study proposes to use a standard 8-week CBT-I to treat the insomnia with a post-treatment follow-up at 3- and 6-months (after treatment). Further, it will evaluate if an improvement in the insomnia is associated with an improvement in the underling alcoholism and the daytime functioning. On an exploratory basis, the association of a first-degree family history of alcoholism with the insomnia severity and treatment response will also be evaluated.
Detailed description
Eligible subjects will be Veterans with alcohol dependence during their first year of recovery, 21-65 years old, with ISI total score of 15 or more, medically and psychiatrically stable, and without dependence on other drugs (with the exception of nicotine and marijuana). The proposed study will consist of a single-blind trial comparing CBT-I against a behavioral placebo intervention (Quasi-Desensitization Therapy, QDT). Baseline assessments conducted over a month will comprehensively evaluate for the addiction, psychiatric, sleep and medical disorders, as well as for a family history of alcohol dependence. Once the subject is seen to be eligible for the study he will be randomized to either the CBT-I or the QDT arm, and treated for the next weeks. The primary outcome measure for insomnia will be the Insomnia Severity Index. The primary outcome measure for alcohol dependence will be the percent days abstinent (on the Time Line Follow Back measure, TLFB), and the daytime symptoms will be assessed using the Short Form-12 item scale (SF-12, for self reported well-being), the Beck Depression Inventory (BDI, for depressive symptoms), and the State Trait Anxiety Inventory (STAI, for anxiety symptoms). After completion of the treatment phase, subjects will be followed up 3 months and 6 months later, to assess for changes over time in their insomnia, alcohol use, and daytime functioning.
Interventions
BEHAVIORALCognitive Behavioral Therapy for Insomnia (CBT-I)
Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
Sponsors
University of Pennsylvania
University of Michigan
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male and female Veterans between the ages of 21 and 70 years * DSM IV diagnosis of alcohol dependence over the past year (as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders \[SCID-I\]) * Self-reported sleep latency or wake time after sleep onset \>30 min on three or more nights per week for 1 month and a score of 15 or more on the Insomnia Severity Index (ISI) * No current alcohol withdrawal symptoms at baseline: CIWA score \< 8 (CIWA is the Clinical Institute Withdrawal Assessment scale for alcohol withdrawal signs and symptoms) * Abstain for at least 4 weeks from heavy drinking, and \< 12 months of abstinence from heavy drinking prior to the baseline study assessments, as assessed by subjective report or breathalyzer * Ability to speak, understand and print in English * Capacity to give written informed consent
Exclusion criteria
* DSM-IV criteria for dependence on any other substance including benzodiazepines (and excluding nicotine dependence) * Positive urine drug screen for opioids, cocaine, or amphetamine (positive screen for Tetra Hydro Cannabinol is not considered an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Severity Index - Total Score | 8 weeks, 3 months post-treatment, and 6 months post-treatment | 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. |
| Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure | 8 weeks, 3 months post-treatment and 6-months post-treatment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in PCS From the Short Form - 12 Item (SF-12) Measure | 8 weeks, 3 months post-treatment, and 6 months post-treatment | 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). |
| Change in MCS From the Short Form - 12 Item (SF-12) Measure | 8 weeks, 3 months post-treatment, and 6 months post-treatment | 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). |
Countries
United States
Participant flow
Recruitment details
83 was the anticipated recruitment target sample and our final recruitment sample was 63
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Behavioral Therapy for Insomnia 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. | 31 |
| Quasi Desensitization Therapy 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. | 32 |
| Total | 63 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Therapy for Insomnia | Total | Quasi Desensitization Therapy |
|---|---|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 10.9 | 51.6 years STANDARD_DEVIATION 9.5 | 51.5 years STANDARD_DEVIATION 8.2 |
| Beck Depression Inventory total score | 19.7 units on a scale STANDARD_DEVIATION 12.4 | 18.5 units on a scale STANDARD_DEVIATION 11.6 | 17.2 units on a scale STANDARD_DEVIATION 10.7 |
| Days Abstinent from Alcohol before Treatment (Abs) | 86.8 Number of Days STANDARD_DEVIATION 103.3 | 115.2 Number of Days STANDARD_DEVIATION 110.4 | 142.6 Number of Days STANDARD_DEVIATION 111.6 |
| Drinks per day (DrPDay, last 90 days, at screening) | 9.1 Number of Drinks Per Day STANDARD_DEVIATION 9.2 | 8.9 Number of Drinks Per Day STANDARD_DEVIATION 8.1 | 8.8 Number of Drinks Per Day STANDARD_DEVIATION 7.1 |
| Insomnia Severity Index total score (ISI) | 19.7 units on a scale STANDARD_DEVIATION 3.5 | 19.3 units on a scale STANDARD_DEVIATION 3.6 | 19.0 units on a scale STANDARD_DEVIATION 3.7 |
| Mental Composite Score (MCS, SF-12 scale) | 44.4 units on a scale STANDARD_DEVIATION 7.5 | 43.9 units on a scale STANDARD_DEVIATION 6.9 | 43.1 units on a scale STANDARD_DEVIATION 6.4 |
| Penn Alcohol Craving Scale total score (PACS) | 10.8 units on a scale STANDARD_DEVIATION 7.5 | 9.5 units on a scale STANDARD_DEVIATION 7.3 | 8.2 units on a scale STANDARD_DEVIATION 7 |
| Percent Days Abstinent (PDA, last 90 days, at screening) | 38.3 Percent of Days Abstinent STANDARD_DEVIATION 36 | 32.5 Percent of Days Abstinent STANDARD_DEVIATION 32.9 | 26.9 Percent of Days Abstinent STANDARD_DEVIATION 29.2 |
| Physical Composite Score (PCS, SF-12 scale) | 42.7 units on a scale STANDARD_DEVIATION 4.6 | 41.7 units on a scale STANDARD_DEVIATION 5 | 40.4 units on a scale STANDARD_DEVIATION 5.3 |
| Race/Ethnicity, Customized African-American | 23 Participants | 52 Participants | 29 Participants |
| Race/Ethnicity, Customized Caucasian | 8 Participants | 11 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 28 Participants | 58 Participants | 30 Participants |
| Sleep Onset Latency (SOL, sleep diary) | 51.6 minutes STANDARD_DEVIATION 41.4 | 50.5 minutes STANDARD_DEVIATION 37.7 | 49.3 minutes STANDARD_DEVIATION 34 |
| State Trait Anxiety Inventory - trait subscale (STAI-trait) | 45.0 units on a scale STANDARD_DEVIATION 5.9 | 45.6 units on a scale STANDARD_DEVIATION 5.9 | 46.3 units on a scale STANDARD_DEVIATION 6 |
| Total Sleep Time (TST, sleep diary) | 317.0 minutes STANDARD_DEVIATION 90.8 | 330.8 minutes STANDARD_DEVIATION 95.5 | 345.1 minutes STANDARD_DEVIATION 99.5 |
| Wake After Sleep Onset (WASO, sleep diary) | 44.6 minutes STANDARD_DEVIATION 30 | 36.7 minutes STANDARD_DEVIATION 28.8 | 28.6 minutes STANDARD_DEVIATION 25.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 32 |
| other Total, other adverse events | 0 / 31 | 0 / 32 |
| serious Total, serious adverse events | 7 / 31 | 3 / 32 |
Outcome results
Primary
Change in Insomnia Severity Index - Total Score
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.
Time frame: 8 weeks, 3 months post-treatment, and 6 months post-treatment
Population: All subjects randomized into either treatment arm and received had 1 or more treatment sessions.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Change in Insomnia Severity Index - Total Score | Change at 3 mo post-treatment F/U (Vs baseline) | -8.51 units on a scale |
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Change in Insomnia Severity Index - Total Score | Change at 6 mo post-treatment F/U (Vs baseline) | -6.89 units on a scale |
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Change in Insomnia Severity Index - Total Score | Change at week 8 (Vs baseline) | -10.71 units on a scale |
| Quasi Desensitization Therapy (QDT) | Change in Insomnia Severity Index - Total Score | Change at week 8 (Vs baseline) | -8.84 units on a scale |
| Quasi Desensitization Therapy (QDT) | Change in Insomnia Severity Index - Total Score | Change at 6 mo post-treatment F/U (Vs baseline) | -7.29 units on a scale |
| Quasi Desensitization Therapy (QDT) | Change in Insomnia Severity Index - Total Score | Change at 3 mo post-treatment F/U (Vs baseline) | -9.30 units on a scale |
Primary
Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure
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.
Time frame: 8 weeks, 3 months post-treatment and 6-months post-treatment
Population: All subjects randomized into either treatment arm and received had 1 or more treatment sessions.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | 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 |
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | 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 |
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | 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 |
| Quasi Desensitization Therapy (QDT) | Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure | Change at week 8 (Vs baseline) | 0.67 percentage of abstinent days |
| Quasi Desensitization Therapy (QDT) | Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure | Change at 3 mo post-treatment F/U (Vs baseline) | 0.61 percentage of abstinent days |
| Quasi Desensitization Therapy (QDT) | Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure | Change at 6 mo post-treatment F/U (Vs baseline) | 0.62 percentage of abstinent days |
Other Pre-specified
Change in MCS From the Short Form - 12 Item (SF-12) Measure
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).
Time frame: 8 weeks, 3 months post-treatment, and 6 months post-treatment
Population: All subjects randomized into either treatment arm and received had 1 or more treatment sessions.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Change in MCS From the Short Form - 12 Item (SF-12) Measure | Change at week 8 (Vs baseline) | -3.06 units on a scale |
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | 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 |
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | 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 |
| Quasi Desensitization Therapy (QDT) | Change in MCS From the Short Form - 12 Item (SF-12) Measure | Change at week 8 (Vs baseline) | -1.90 units on a scale |
| Quasi Desensitization Therapy (QDT) | Change in MCS From the Short Form - 12 Item (SF-12) Measure | Change at 3 mo post-treatment F/U (Vs baseline) | 1.12 units on a scale |
| Quasi Desensitization Therapy (QDT) | Change in MCS From the Short Form - 12 Item (SF-12) Measure | Change at 6 mo post-treatment F/U (Vs baseline) | 0.89 units on a scale |
Other Pre-specified
Change in PCS From the Short Form - 12 Item (SF-12) Measure
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).
Time frame: 8 weeks, 3 months post-treatment, and 6 months post-treatment
Population: All subjects randomized into either treatment arm and received had 1 or more treatment sessions.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Change in PCS From the Short Form - 12 Item (SF-12) Measure | Change at week 8 (Vs baseline) | -1.00 units on a scale |
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | 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 |
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | 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 |
| Quasi Desensitization Therapy (QDT) | Change in PCS From the Short Form - 12 Item (SF-12) Measure | Change at week 8 (Vs baseline) | 0.48 units on a scale |
| Quasi Desensitization Therapy (QDT) | Change in PCS From the Short Form - 12 Item (SF-12) Measure | Change at 3 mo post-treatment F/U (Vs baseline) | 0.54 units on a scale |
| Quasi Desensitization Therapy (QDT) | Change in PCS From the Short Form - 12 Item (SF-12) Measure | Change at 6 mo post-treatment F/U (Vs baseline) | -0.25 units on a scale |