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| ID | Type | Description | Link |
|---|---|---|---|
| 1IK2CX000855 | U.S. NIH Grant/Contract | View source | |
| 01468 | Other Identifier | Philadelphia Veterans Affairs Medical Center |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| University of Michigan | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I | Experimental | 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. |
|
| QDT | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Behavioral | Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks, 3 months post-treatment, and 6 months post-treatment |
| 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. | 8 weeks, 3 months post-treatment and 6-months post-treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 8 weeks, 3 months post-treatment, and 6 months post-treatment |
| Change in MCS From the Short Form - 12 Item (SF-12) Measure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Subhajit Chakravorty, MD | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104 | United States |
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83 was the anticipated recruitment target sample and our final recruitment sample was 63
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All subjects randomized into either treatment arm and received had 1 or more treatment sessions. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks, 3 months post-treatment, and 6 months post-treatment |
|
9 months
This a behavioral treatment intervention study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular Accident (CVA) | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Subhajit Chakravorty | Crescenz VA Medical Center | (215)-823-5800 | Subhajit.Chakravorty@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2018 | May 23, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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). |
| 8 weeks, 3 months post-treatment, and 6 months post-treatment |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Insomnia Severity Index total score (ISI) | 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) | Mean | Standard Deviation | units on a scale |
|
| Sleep Onset Latency (SOL, sleep diary) | Mean | Standard Deviation | minutes |
|
| Wake After Sleep Onset (WASO, sleep diary) | Mean | Standard Deviation | minutes |
|
| Total Sleep Time (TST, sleep diary) | Mean | Standard Deviation | minutes |
|
| Percent Days Abstinent (PDA, last 90 days, at screening) | Mean | Standard Deviation | Percent of Days Abstinent |
|
| Drinks per day (DrPDay, last 90 days, at screening) | Mean | Standard Deviation | Number of Drinks Per Day |
|
| Penn Alcohol Craving Scale total score (PACS) | The PACS is a 5-item scale that evaluates alcohol craving over the last seven days. Item scores range from 0-6 and a total PACS score ranging from 0-30. A higher value on the PACS total score represents an increasing severity of alcohol craving. | Mean | Standard Deviation | units on a scale |
|
| Days Abstinent from Alcohol before Treatment (Abs) | Mean | Standard Deviation | Number of Days |
|
| Physical Composite Score (PCS, SF-12 scale) | The Physical Composite Scale (PCS) is a scale generated from the 12-item short-form (SF-12) measure. The PCS evaluates the self-reported physical well-being of an individual. The PCS has a range from 0-100, where 0 indicates the lowest level and 100 indicates the highest level of physical health. | Mean | Standard Deviation | units on a scale |
|
| Mental Composite Score (MCS, SF-12 scale) | The Mental Composite Scale (MCS) is another scale generated from the 12-item short-form (SF-12) measure. The MCS evaluates the self-reported emotional well-being of an individual. The MCS also has a range from 0-100, where 0 indicates the lowest level and 100 indicates the highest level of mental health. | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory total score | The Beck Depression Inventory (BDI) is a 21-item self-reported measure of depressive symptoms, and a recommended measure of next day functioning in studies evaluating insomnia disorder. The BDI generates a total score within a range from 0-63, with higher scores representing increasing severity of depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| State Trait Anxiety Inventory - trait subscale (STAI-trait) | The State-Trait Anxiety Inventory (STAI) is a 40-item self-reported measure of state and trait anxiety symptoms. The trait subscale is a recommended measure of next day functioning in studies evaluating insomnia disorder. The STAI trait subscale generates a total score within a range from 20-80, with higher scores representing greater anxiety. | Mean | Standard Deviation | units on a scale |
|
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.
| OG001 | 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. |
|
|
| 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. | All subjects randomized into either treatment arm and received had 1 or more treatment sessions. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of abstinent days | 8 weeks, 3 months post-treatment and 6-months post-treatment |
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| 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). | All subjects randomized into either treatment arm and received had 1 or more treatment sessions. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks, 3 months post-treatment, and 6 months post-treatment |
|
|
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| 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). | All subjects randomized into either treatment arm and received had 1 or more treatment sessions. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks, 3 months post-treatment, and 6 months post-treatment |
|
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|
| 0 |
| 31 |
| 7 |
| 31 |
| 0 |
| 31 |
| EG001 | 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. | 0 | 32 | 3 | 32 | 0 | 32 |
| Alcohol detoxification | Nervous system disorders | Non-systematic Assessment | Relapse to drinking |
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| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Residential Psychiatric Treatment | Nervous system disorders | Non-systematic Assessment |
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| D001523 |
| Mental Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| Change at 6 mo post-treatment F/U (Vs baseline) |
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| Change at 6 mo post-treatment F/U (Vs baseline) |
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| Change at 6 mo post-treatment F/U (Vs baseline) |
|