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| ID | Type | Description | Link |
|---|---|---|---|
| PT090525 | Other Identifier | CDMRP |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| C.R.Darnall Army Medical Center | FED |
| The University of Texas Health Science Center at San Antonio | OTHER |
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The objective of this study is to directly compare 6 sessions of in-person and Internet administered Cognitive-Behavior Therapy for Insomnia (CBTi) to a Minimal Contact control (MC), within an active duty military population to determine the comparative benefits of these interventions on improvement in sleep as well as domains strongly related to insomnia such as depression, substance abuse, and PTSD symptoms. A total of 189 military personnel with chronic insomnia, aged 18-65, will be recruited and randomized to receive 6-sessions (over 6 weeks) of CBTi (n=77), ICBTi (n=35), or a MC control (n=77) condition. The investigators will compare these three groups on subjective and objective measures of sleep. The CBTi and MC control groups will be compared on other variables of interest (e.g., depression, substance abuse, and PTSD symptoms) and predictors of outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-person CBT of Insomnia | Active Comparator | CBTi consisted of 6 weekly 60-minute sessions and included identical informational material. The treatments contained the following efficacious and commonly used modules of cognitive behavioral treatments for insomnia: Stimulus Control, Sleep Restriction, Sleep Hygiene, Relaxation Training, Cognitive Restructuring. |
|
| Internet CBT of Insomnia | Active Comparator | The I-CBTi protocol was developed by the National Center for Telehealth and Technology with the first author (DJT) serving as the subject matter expert, and administered on the afterdeployment.org website. The information and instructions for I-CBTi were identical to in-person CBTi; however, their mode of delivery in I-CBTi is considerably different due to the constraints of its automated, online format. The lessons were presented as audio recordings accompanied by visual graphics and animations and several lessons, had interactive components such as games, quizzes, and prompts for participants to schedule healthy sleep habits. |
|
| Minimal Contact | No Intervention | Those assigned to the MC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week MC period. They will be called every other week to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MC participants will also be given contact information to use in case of worsening of symptoms or increasing distress. At the end of six weeks, they will complete the baseline assessments again, which will serve as the post-treatment assessment for the MC period. They will then be randomly assigned to either the CBTi or ICBTi groups. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-person Cognitive Behavioral Therapy of Insomnia | Behavioral | In-person CBTi was be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consisted of 6-sessions and included the same efficacious and commonly used modules of CBTi (i.e., sleep education & hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive therapy). |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Diary Sleep Efficiency | Provides daily self-reports of bedtime, time to fall asleep, middle of the night awakenings, and time out of bed. These data will be aggregated to determine self-reported sleep efficiency (i.e., total sleep time/time in bed X 100). Other variable to be extracted will include total sleep time and total wake time. | Change from Baseline to Post-Treatment and 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory II | Measure of self-reported depression symptoms. | Change from Baseline to Post-Treatment and 6 month follow-up |
| Substance Use | Self-reported use of sleep medications, caffeine, and nicotine obtained during the interview and on sleep diaries. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J Taylor, Ph.D. | University of North Texas Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl R. Darnall Army Medical Center | Fort Hood | Texas | 76544 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29458705 | Background | Taylor DJ, Wilkerson AK, Pruiksma KE, Williams JM, Ruggero CJ, Hale W, Mintz J, Organek KM, Nicholson KL, Litz BT, Young-McCaughan S, Dondanville KA, Borah EV, Brundige A, Peterson AL; STRONG STAR Consortium. Reliability of the Structured Clinical Interview for DSM-5 Sleep Disorders Module. J Clin Sleep Med. 2018 Mar 15;14(3):459-464. doi: 10.5664/jcsm.7000. | |
| 34600107 |
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| ID | Title | Description |
|---|---|---|
| FG000 | In-person CBT of Insomnia | CBTi consisted of 6 weekly 60-minute sessions and included identical informational material. The treatments contained the following efficacious and commonly used modules of cognitive behavioral treatments for insomnia: Stimulus Control, Sleep Restriction, Sleep Hygiene, Relaxation Training, Cognitive Restructuring. In-person Cognitive Behavioral Therapy of Insomnia: In-person CBTi was be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consisted of 6-sessions and included the same efficacious and commonly used modules of CBTi (i.e., sleep education & hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive therapy). |
| FG001 | Internet CBT of Insomnia | Internet Cognitive Behavioral Therapy of Insomnia: The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its automated, online format. Each of the 6 ICBTi sessions was divided into lessons covering different aspects of each of the components. The lessons were presented as audio recordings accompanied by visual graphics and animations. For several lessons, interactive components were included, such as games, quizzes, and prompts for participants to schedule healthy sleep habits. |
| FG002 | Minimal Contact | Those assigned to the MC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week MC period. They will be called every other week to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MC participants will also be given contact information to use in case of worsening of symptoms or increasing distress. At the end of six weeks, they will complete the baseline assessments again, which will serve as the post-treatment assessment for the MC period. They will then be randomly assigned to either the CBTi or ICBTi groups. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | In-person CBT of Insomnia | CBTi consisted of 6 weekly 60-minute sessions and included identical informational material. The treatments contained the following efficacious and commonly used modules of cognitive behavioral treatments for insomnia: Stimulus Control, Sleep Restriction, Sleep Hygiene, Relaxation Training, Cognitive Restructuring. In-person Cognitive Behavioral Therapy of Insomnia: In-person CBTi was be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consisted of 6-sessions and included the same efficacious and commonly used modules of CBTi (i.e., sleep education & hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive therapy). |
| 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 | Sleep Diary Sleep Efficiency | Provides daily self-reports of bedtime, time to fall asleep, middle of the night awakenings, and time out of bed. These data will be aggregated to determine self-reported sleep efficiency (i.e., total sleep time/time in bed X 100). Other variable to be extracted will include total sleep time and total wake time. | Posted | Mean | Standard Error | Percentage Total Sleep Time/Time in Bed | Change from Baseline to Post-Treatment and 6 month follow-up |
|
Time frame was from Baseline to Post-treatment. However, the collection rate was different among groups.
The In-Person were asked during their weekly visits by a therapist. The Internet and Minimal Contact had every other week phone calls, but participants often did not answer or respond because they were active duty military and at their jobs for the Army. Thus, the collection rate was ~>66% more often in the In-person than other two groups.
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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 | In-person CBT of Insomnia | CBTi consisted of 6 weekly 60-minute sessions and included identical informational material. The treatments contained the following efficacious and commonly used modules of cognitive behavioral treatments for insomnia: Stimulus Control, Sleep Restriction, Sleep Hygiene, Relaxation Training, Cognitive Restructuring. In-person Cognitive Behavioral Therapy of Insomnia: In-person CBTi was be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consisted of 6-sessions and included the same efficacious and commonly used modules of CBTi (i.e., sleep education & hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive therapy). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypomania | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache, Migraine | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel J. Taylor, Ph.D. | University of Arizona | 5206219289 | danieljtaylor@arizona.edu |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001519 | Behavior |
| D003863 | Depression |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| Internet Cognitive Behavioral Therapy of Insomnia | Behavioral | The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its automated, online format. Each of the six ICBTi sessions was divided into lessons covering different aspects of each of the components. The lessons were presented as audio recordings accompanied by visual graphics and animations. For several lessons, interactive components were included, such as games, quizzes, and prompts for participants to schedule healthy sleep habits. |
|
| Change from Baseline to Post-Treatment and 6 month follow-up |
| Actigraphy | A wrist worn accelerometer that measures activity level and then uses validated algorithms to determine objectively daily bedtime, time to fall asleep, middle of the night awakenings, and time out of bed. These data will be aggregated to determine objective sleep efficiency (i.e., total sleep time/time in bed X 100). Other variable to be extracted will include total sleep time and total wake time. | Change from Baseline to Post-Treatment and 6 month follow-up |
| PTSD Check List-Military | Measures self-reported Post-Traumatic Stress Disorders symptoms in military personnel. | Change from Baseline to Post-Treatment and 6 month follow-up |
| Beck Anxiety Inventory | Self-report measure of anxiety symptoms | Change from Baseline to Post-Treatment and 6 month follow-up |
| Insomnia Severity Index | Self-report insomnia symptoms. | Change from Baseline to Post-Treatment and 6 month follow-up |
| Epworth Sleepiness Scale | Self-report daytime sleepiness. | Change from Baseline to Post-Treatment and 6 month follow-up |
| Dysfunctional Beliefs and Attitudes About Sleep Scale | Self-reported beliefs and attitudes about sleep. | Change from Baseline to Post-Treatment and 6 month follow-up |
| Multidimensional Fatigue Inventory | Self-reported fatigue symptoms across multiple dimensions. | Change from Baseline to Post-Treatment and 6 month follow-up |
| Veterans Rand 12-Item Health Survey | Self-reported quality of life and health. | Change from Baseline to Post-Treatment and 6 month follow-up |
| Peterson AL, Young-McCaughan S, Roache JD, Mintz J, Litz BT, Williamson DE, Resick PA, Foa EB, McGeary DD, Dondanville KA, Taylor DJ, Wachen JS, Fox PT, Bryan CJ, McLean CP, Pruiksma KE, Yarvis JS, Niles BL, Abdallah CG, Averill LA, Back SE, Baker MT, Blount TH, Borah AM, Borah EV, Brock MS, Brown LA, Burg MM, Cigrang JA, DeBeer BB, DeVoe ER, Fina BA, Flanagan JC, Fredman SJ, Gardner CL, Gatchel RR, Goodie JL, Gueorguieva R, Higgs JB, Jacoby VM, Kelly KM, Krystal JH, Lapiz-Bluhm MD, Lopez-Roca AL, Marx BP, Maurer DM, McDevitt-Murphy ME, McGeary CA, Meyer EC, Miles SR, Monson CM, Morilak DA, Moring JC, Mysliwiec V, Nicholson KL, Rauch SAM, Riggs DS, Rosen CS, Rudd MD, Schobitz RP, Schrader CC, Shinn AM, Shiroma PR, Sloan DM, Stern SL, Strong R, Vannoy SD, Young KA, Keane TM; STRONG STAR Consortium and the Consortium to Alleviate PTSD. STRONG STAR and the Consortium to Alleviate PTSD: Shaping the future of combat PTSD and related conditions in military and veteran populations. Contemp Clin Trials. 2021 Nov;110:106583. doi: 10.1016/j.cct.2021.106583. Epub 2021 Sep 29. |
| 31176888 | Background | Brown LA, Zang Y, Benhamou K, Taylor DJ, Bryan CJ, Yarvis JS, Dondanville KA, Litz BT, Mintz J, Roache JD, Pruiksma KE, Fina BA, Young-McCaughan S, Peterson AL, Foa EB; STRONG STAR Consortium. Mediation of suicide ideation in prolonged exposure therapy for posttraumatic stress disorder. Behav Res Ther. 2019 Aug;119:103409. doi: 10.1016/j.brat.2019.103409. Epub 2019 May 23. |
| 33748530 | Background | Brown LA, Bryan CJ, Butner JE, Tabares JV, Young-McCaughan S, Hale WJ, Fina BA, Foa EB, Resick PA, Taylor DJ, Coon H, Williamson DE, Dondanville KA, Borah EV, McLean CP, Wachen JS, Pruiksma KE, Hernandez AM, Litz BT, Mintz J, Yarvis JS, Borah AM, Nicholson KL, Maurer DM, Kelly KM, Peterson AL; STRONG STAR Consortium. Identifying suicidal subtypes and dynamic indicators of increasing and decreasing suicide risk in active duty military personnel: Study protocol. Contemp Clin Trials Commun. 2021 Feb 16;21:100752. doi: 10.1016/j.conctc.2021.100752. eCollection 2021 Mar. |
| 30252077 | Background | Ben Barnes J, Presseau C, Jordan AH, Kline NK, Young-McCaughan S, Keane TM, Peterson AL, Litz BT; the Consortium to Alleviate PTSD. Common Data Elements in the Assessment of Military-Related PTSD Research Applied in the Consortium to Alleviate PTSD. Mil Med. 2019 May 1;184(5-6):e218-e226. doi: 10.1093/milmed/usy226. |
| 29618098 | Result | Taylor DJ, Peterson AL, Pruiksma KE, Hale WJ, Young-McCaughan S, Wilkerson A, Nicholson K, Litz BT, Dondanville KA, Roache JD, Borah EV, Brundige A, Mintz J; STRONG STAR Consortium. Impact of cognitive behavioral therapy for insomnia disorder on sleep and comorbid symptoms in military personnel: a randomized clinical trial. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy069. |
| 28472528 | Result | Taylor DJ, Peterson AL, Pruiksma KE, Young-McCaughan S, Nicholson K, Mintz J; STRONG STAR Consortium. Internet and In-Person Cognitive Behavioral Therapy for Insomnia in Military Personnel: A Randomized Clinical Trial. Sleep. 2017 Jun 1;40(6). doi: 10.1093/sleep/zsx075. |
| 32586427 | Result | Pruiksma KE, Hale WJ, Mintz J, Peterson AL, Young-McCaughan S, Wilkerson A, Nicholson K, Dondanville KA, Fina BA, Borah EV, Roache JD, Litz BT, Bryan CJ, Taylor DJ; STRONG STAR Consortium. Predictors of Cognitive Behavioral Therapy for Insomnia (CBTi) Outcomes in Active-Duty U.S. Army Personnel. Behav Ther. 2020 Jul;51(4):522-534. doi: 10.1016/j.beth.2020.02.001. Epub 2020 Feb 14. |
| BG001 | Internet CBT of Insomnia | Internet Cognitive Behavioral Therapy of Insomnia: The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its automated, online format. Each of the 6 ICBTi sessions was divided into lessons covering different aspects of each of the components. The lessons were presented as audio recordings accompanied by visual graphics and animations. For several lessons, interactive components were included, such as games, quizzes, and prompts for participants to schedule healthy sleep habits. |
| BG002 | Minimal Contact | Those assigned to the MC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week MC period. They will be called every other week to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MC participants will also be given contact information to use in case of worsening of symptoms or increasing distress. At the end of six weeks, they will complete the baseline assessments again, which will serve as the post-treatment assessment for the MC period. They will then be randomly assigned to either the CBTi or ICBTi groups. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Internet CBT of Insomnia | The I-CBTi protocol was developed by the National Center for Telehealth and Technology with the first author (DJT) serving as the subject matter expert, and administered on the afterdeployment.org website. The information and instructions for I-CBTi were identical to in-person CBTi; however, their mode of delivery in I-CBTi is considerably different due to the constraints of its automated, online format. The lessons were presented as audio recordings accompanied by visual graphics and animations and several lessons, had interactive components such as games, quizzes, and prompts for participants to schedule healthy sleep habits. Internet Cognitive Behavioral Therapy of Insomnia: The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its aut |
| OG002 | Minimal Contact | Those assigned to the MC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week MC period. They will be called every other week to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MC participants will also be given contact information to use in case of worsening of symptoms or increasing distress. At the end of six weeks, they will complete the baseline assessments again, which will serve as the post-treatment assessment for the MC period. They will then be randomly assigned to either the CBTi or ICBTi groups. |
|
|
| Secondary | Beck Depression Inventory II | Measure of self-reported depression symptoms. | Not Posted | Change from Baseline to Post-Treatment and 6 month follow-up | Participants |
| Secondary | Substance Use | Self-reported use of sleep medications, caffeine, and nicotine obtained during the interview and on sleep diaries. | Not Posted | Change from Baseline to Post-Treatment and 6 month follow-up | Participants |
| Secondary | Actigraphy | A wrist worn accelerometer that measures activity level and then uses validated algorithms to determine objectively daily bedtime, time to fall asleep, middle of the night awakenings, and time out of bed. These data will be aggregated to determine objective sleep efficiency (i.e., total sleep time/time in bed X 100). Other variable to be extracted will include total sleep time and total wake time. | Not Posted | Change from Baseline to Post-Treatment and 6 month follow-up | Participants |
| Secondary | PTSD Check List-Military | Measures self-reported Post-Traumatic Stress Disorders symptoms in military personnel. | Not Posted | Change from Baseline to Post-Treatment and 6 month follow-up | Participants |
| Secondary | Beck Anxiety Inventory | Self-report measure of anxiety symptoms | Not Posted | Change from Baseline to Post-Treatment and 6 month follow-up | Participants |
| Secondary | Insomnia Severity Index | Self-report insomnia symptoms. | Not Posted | Change from Baseline to Post-Treatment and 6 month follow-up | Participants |
| Secondary | Epworth Sleepiness Scale | Self-report daytime sleepiness. | Not Posted | Change from Baseline to Post-Treatment and 6 month follow-up | Participants |
| Secondary | Dysfunctional Beliefs and Attitudes About Sleep Scale | Self-reported beliefs and attitudes about sleep. | Not Posted | Change from Baseline to Post-Treatment and 6 month follow-up | Participants |
| Secondary | Multidimensional Fatigue Inventory | Self-reported fatigue symptoms across multiple dimensions. | Not Posted | Change from Baseline to Post-Treatment and 6 month follow-up | Participants |
| Secondary | Veterans Rand 12-Item Health Survey | Self-reported quality of life and health. | Not Posted | Change from Baseline to Post-Treatment and 6 month follow-up | Participants |
| 52 |
| 75 |
| 5 |
| 75 |
| 47 |
| 75 |
| EG001 | Internet CBT of Insomnia | The I-CBTi protocol was developed by the National Center for Telehealth and Technology with the first author (DJT) serving as the subject matter expert, and administered on the afterdeployment.org website. The information and instructions for I-CBTi were identical to in-person CBTi; however, their mode of delivery in I-CBTi is considerably different due to the constraints of its automated, online format. The lessons were presented as audio recordings accompanied by visual graphics and animations and several lessons, had interactive components such as games, quizzes, and prompts for participants to schedule healthy sleep habits. Internet Cognitive Behavioral Therapy of Insomnia: The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its automated, online format. Each of the six ICBTi sessions was divided into lessons covering different aspects of each of the components. The lessons were presented as audio recordings accompanied by visual graphics and animations. For several lessons, interactive components were included, such as games, quizzes, and prompts for participants to schedule healthy sleep habits. | 8 | 34 | 0 | 34 | 8 | 34 |
| EG002 | Minimal Contact | Those assigned to the MC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week MC period. They will be called every other week to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MC participants will also be given contact information to use in case of worsening of symptoms or increasing distress. At the end of six weeks, they will complete the baseline assessments again, which will serve as the post-treatment assessment for the MC period. They will then be randomly assigned to either the CBTi or ICBTi groups. | 10 | 76 | 1 | 76 | 9 | 76 |
| Accident | General disorders | Systematic Assessment | Participant had an accident outside of the study. Went to ER, not hospitalized. |
|
| Alcohol-Detox | Nervous system disorders | Systematic Assessment | Participant was admitted to 28-day inpatient program. |
|
| Anxiety, Panic | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Nervous system disorders | Systematic Assessment |
|
| Sleep Walking | Nervous system disorders | Systematic Assessment |
|
| Stress | Nervous system disorders | Systematic Assessment |
|
| Memory, Blackout | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Fatigue | Nervous system disorders | Systematic Assessment |
|
| Cold/ flu | Infections and infestations | Systematic Assessment |
|
| Allergies | General disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Pain, Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hernia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Skin Rash | General disorders | Systematic Assessment |
|
| GI disturbance | Gastrointestinal disorders | Systematic Assessment |
|
| Visual Disturbance | Eye disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D001523 |
| Mental Disorders |
| D001526 | Behavioral Symptoms |
| D064419 | Chemically-Induced Disorders |