Gulf War IllnessCBTi GWINCT02782780
Cognitive Behavioral Therapy for Insomnia for Gulf War Illness
A study testing Cognitive Behavioral Therapy for Insomnia (CBTi) in people with Gulf War Illness and Insomnia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Sleep disturbance is a common complaint of Veterans with Gulf War Illness (GWI). Because there is clinical evidence that sleep quality influences pain, fatigue, mood, cognition, and daily functioning, this study will investigate whether a type of behavioral sleep treatment called Cognitive Behavioral Therapy for… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gulf War Illness, Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBTi)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2016to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Deployed to the Gulf Theater of operations, as defined by 38 CFR 3.317 in the years 1990-1991, in accordance with the inclusion/exclusion criteria set forth in the federal definition of Gulf War Illness as used for the Gulf War Registry.
- This will be confirmed through VA records or by asking veterans to provide a copy of their DD214.
- Have Gulf War Illness (GWI) according to the Kansas case definition.
- GWI symptom will be assessed with the Kansas Gulf War Military History and Health Questionnaire.
- Have an Insomnia Severity Index score greater than or equal to 14.
Who cannot join
- Have conditions or substances that may be associated with comorbid insomnia independent of GWI status, including:
- a lifetime history of any psychiatric disorder with psychotic features
- bipolar disorder
- panic disorder
- obsessive-compulsive disorder
- alcohol or substance dependence
Show all 13Show fewer
- a history of alcohol or substance abuse within the past year
- Currently exposed to recurrent trauma or have been exposed to a traumatic event within the past 3 months.
- Pregnancy (because insomnia will worsen after 8 weeks).
- Prominent suicidal or homicidal ideation.
- History of sleep restriction therapy or cognitive restructuring therapies of beliefs related to sleep.
- Subjects concurrently enrolled in another clinical trial.
- Veterans who work night shifts or have extreme morning or evening tendencies as described below will be excluded in order to avoid the impact of circadian factors on evaluating insomnia.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
About this study
Official title: Pilot Test of Telephone-Delivered Cognitive Behavioral Therapy for Insomnia for Veterans With Gulf War Illness
Sleep disturbance is a common complaint of Veterans with Gulf War Illness (GWI). Because there is clinical evidence that sleep quality influences pain, fatigue, mood, cognition, and daily functioning, this study will investigate whether a type of behavioral sleep treatment called Cognitive Behavioral Therapy for Insomnia (CBTi) can help Gulf War Veterans with GWI. CBTi is a multicomponent treatment where patients learn about sleep and factors affecting sleep as well as how to alter habits that may impair or even prevent sleep. The investigators hypothesize that helping Gulf War Veterans learn how to achieve better sleep with CBTi may also help to alleviate their other non-sleep symptoms of GWI.
Read the detailed description
Insomnia is common among Veterans with Gulf War Illness (GWI). Moreover, untreated insomnia is associated with significant medical and psychiatric morbidity. Cognitive Behavioral Therapy for Insomnia (CBTi) is a multicomponent treatment that seeks not only to teach patients about sleep and factors affecting sleep (e.g., circadian rhythm, age, social and work schedule) but the therapist will also to work with the patient toward minimizing unwanted arousal at bedtime and altering sleep habits to increase sleep propensity and regularity.
Because many Veterans with GWI suffer from a profound loss of physical and functional status that may prevent them from participating in treatments that require regular clinic visits, the proposed study will deliver CBTi by telephone to extend this effective form of behavioral sleep medicine to Veterans who have chronic illnesses and disabilities and/or who live in rural areas with limited access to trained CBTi providers. Recent studies suggest that telephone-delivered CBTi is as effective as CBTi delivered in-person.
The proposed trial will examine the efficacy of telephone-delivered CBTi for alleviating sleep and non-sleep GWI symptoms in a two-arm randomized controlled trial. Veterans who have GWI and persistent insomnia disorder will be randomized to a group that will receive CBTi right away or to a group that will receive treatment-as-usual (i.e., the control group). Veterans randomized to the control group will have the option of receiving telephone-delivered CBTi upon completion of post-treatment assessments. The primary outcomes will be effect sizes base on within-group comparisons of pre-to-post-treatment change and maintenance of treatment effects at 6 months in the CBTi group.
- Conditions
- Gulf War Illness, Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBTi)
- Keywords
- insomnia, insomnia disorder, Gulf War Illness, Chronic Multisymptom Illness
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBTi)Behavioural
Also called CBTi
CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep (e.g., homeostatic regulation, circadian rhythm, age, social and work schedule) and to work with the patients toward minimizing unwanted arousal at bedtime and altering sleep habits to increase sleep propensity and regularity. The intervention is 8-weeks long.
| Study group | Role | What they receive |
|---|---|---|
| CBTi | Experimental | CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep as well as to work with the patient toward altering sleep habits to increase sleep propensity and regularity. Specifically, participants will receive 8 weekly individual sessions of CBTi according to the VA CBTi protocol. The investigators will follow the semi-structured approach to treatment described in the VA CBTi protocol, which allows the case conceptualization to drive the order in which treatment components are introduced. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi) |
| Monitor Only | No intervention | Study participants who are randomized to the Monitor Only (MO) control group will be followed for 8 weeks of usual care (i.e., they will be advised to continue doing whatever they were doing to manage their GWI and insomnia symptoms without change dosage or frequency of treatment). Participants randomized to the Monitor Only condition will have the option of receiving CBTi delivered by telephone, at no cost to them, upon completion of post-study procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gulf War Illness Symptom Severity Index
Due to its novelty, complexity, and variability, no single measure of severity addresses all possible presentations of Gulf War Illness (GWI). Therefore, we used the symptom portion of the Kansas Gulf War Military History and Health Questionnaire to query about fatigue/sleep problems, somatic pain, skin abnormalities, gastrointestinal, respiratory, and neurologic/cognitive/mood symptoms, based on the Kansas GWI and CDC CMI case definition. To assess current GWI symptoms, participants will be asked about the absence (0), presence, and severity (1=mild; 2=moderate; 3=severe) of the symptoms over the past 2 weeks instead of over the past 6-months. Score range: 0-87; higher scores = more symptoms and/or more severe symptoms.
Measured: At baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Insomnia Severity Index (ISI)
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. Higher scores indicate more severe insomnia. This outcome will be measured at 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Measured: At baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Secondary outcomes (10)
Fatigue Severity Scale (FSS)
The FSS is a 9-item questionnaire reflecting the consequences of fatigue. It gives a single score (range 0-7, high scores represent high levels of fatigue). A score of 4 has been described as the cutoff for clinical fatigue. This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Measured: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Brief Pain Inventory (BPI) - Pain Interference
The BPI is a 17-item self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain. The BPI measures two domains: pain intensity (severity) and the impact of pain on functioning (interference). The score range for BPI-Severity is 0-10, higher score = more severe/intense pain. The range for BPI-interference is 0-10, higher score = greater impact of pain on function.
This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Measured: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Brief Pain Inventory (BPI) - Pain Severity
The BPI is a 17-item self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain. The BPI measures two domains: pain intensity (severity) and the impact of pain on functioning (interference). The score range for BPI-Severity is 0-10, higher score = more severe/intense pain. The range for BPI-interference is 0-10, higher score = greater impact of pain on function. This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Measured: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Multiple Abilities Self-Report Questionnaire (MASQ)
The MASQ is a 38-item self-report measure of cognitive function compared to same age peers across 5 domains (i.e., verbal memory, attention, language, visual memory, visuo-perceptual ability). Score range: 38-190. Higher scores = greater cognitive dysfunction.
This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Measured: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Hospital Anxiety and Depression Scale (HADS), Anxiety
The HADS will be used to assess anxiety and depressive symptoms. The HADS is widely used in community settings and in primary care and not just in "hospitals." The range for HADS-anxiety measure is 0-21. Higher scores = more anxiety.
This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Measured: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Hospital Anxiety and Depression Scale (HADS), Depression
The HADS will be used to assess anxiety and depressive symptoms. The HADS is widely used in community settings and in primary care and not just in "hospitals." The range for HADS-depression measure is 0-21. Higher scores = more anxiety.
This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Measured: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report measure that provides a subjective assessment of sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sedative-hypnotics, and daytime energy. This index is widely used and has been validated by polysomnography. The score range for the PSQI is 0 to 21, with the higher scores indicating worse sleep quality.This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Measured: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Sleep Efficiency (SE)
Sleep Efficiency, as determined by self-reported sleep diary, is the total sleep time (TST) divided by the time in bed, multiplied by 100. Good sleepers have high sleep efficiency because they are asleep the majority of time they spend in bed. Insomniacs tend to have low sleep efficiency because they spend a lot of time awake while they are in bed (tossing and turning).
This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Measured: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Minutes of Wake After Sleep Onset (WASO)
Wake After Sleep Onset is the amount of time that a person is awake time during the night, as recorded in a self-report sleep diary. Insomniacs tend to have greater WASO than good sleepers because they wake up a lot in the middle of the might.
This outcome will be measured at baseline, post-treatment in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Measured: Baseline and after 8 weeks of study participation in all subjects; in subjects randomized to CBTi, 6 months after study participation
Sleep Latency (SL)
Sleep latency (SL) is the amount of time that it takes someone to fall asleep. Participants will be asked to estimate this time in their sleep diaries. Good sleepers tend to have low sleep latencies because they can fall asleep quickly. Insomniacs tend to have longer sleep latencies because it takes them a long time to fall asleep.
This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Measured: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study start24 Oct 2016
- Primary completion31 Jan 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Linda L. Chao, PhD, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782780
- Sponsor's protocol ID
- SPLD-12-15F
- Other IDs
- I21CX001428
- Acronym
- CBTi GWI
- Status last verified
- Jan 2021
- First submitted
- 23 May 2016
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of Telephone-Delivered Cognitive Behavioral Therapy for Insomnia for Veterans With Gulf War Illness
- ClinicalTrials.gov ID
- NCT02782780
- Acronym / sponsor ID
- CBTi GWI / SPLD-12-15F
- Conditions
- Gulf War Illness, Insomnia
- Keywords
- insomnia, insomnia disorder, Gulf War Illness, Chronic Multisymptom Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Posted 11 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep disturbance is a common complaint of Veterans with Gulf War Illness (GWI). Because there is clinical evidence that sleep quality influences pain, fatigue, mood, cognition, and daily functioning, this study will investigate whether a type of behavioral sleep treatment called Cognitive Behavioral Therapy for Insomnia (CBTi) can help Gulf War Veterans with GWI. CBTi is a multicomponent treatment where patients learn about sleep and factors affecting sleep as well as how to alter habits that may impair or even prevent sleep. The investigators hypothesize that helping Gulf War Veterans learn how to achieve better sleep with CBTi may also help to alleviate their other non-sleep symptoms of GWI.
Detailed description
Insomnia is common among Veterans with Gulf War Illness (GWI). Moreover, untreated insomnia is associated with significant medical and psychiatric morbidity. Cognitive Behavioral Therapy for Insomnia (CBTi) is a multicomponent treatment that seeks not only to teach patients about sleep and factors affecting sleep (e.g., circadian rhythm, age, social and work schedule) but the therapist will also to work with the patient toward minimizing unwanted arousal at bedtime and altering sleep habits to increase sleep propensity and regularity.
Because many Veterans with GWI suffer from a profound loss of physical and functional status that may prevent them from participating in treatments that require regular clinic visits, the proposed study will deliver CBTi by telephone to extend this effective form of behavioral sleep medicine to Veterans who have chronic illnesses and disabilities and/or who live in rural areas with limited access to trained CBTi providers. Recent studies suggest that telephone-delivered CBTi is as effective as CBTi delivered in-person.
The proposed trial will examine the efficacy of telephone-delivered CBTi for alleviating sleep and non-sleep GWI symptoms in a two-arm randomized controlled trial. Veterans who have GWI and persistent insomnia disorder will be randomized to a group that will receive CBTi right away or to a group that will receive treatment-as-usual (i.e., the control group). Veterans randomized to the control group will have the option of receiving telephone-delivered CBTi upon completion of post-treatment assessments. The primary outcomes will be effect sizes base on within-group comparisons of pre-to-post-treatment change and maintenance of treatment effects at 6 months in the CBTi group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBTi | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi)CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep as well as to work with the patient toward altering sleep habits to increase sleep propensity and regularity. Specifically, participants will receive 8 weekly individual sessions of CBTi according to the VA CBTi protocol. The investigators will follow the semi-structured approach to treatment described in the VA CBTi protocol, which allows the case conceptualization to drive the order in which treatment components are introduced. |
| Monitor Only | No intervention | –Study participants who are randomized to the Monitor Only (MO) control group will be followed for 8 weeks of usual care (i.e., they will be advised to continue doing whatever they were doing to manage their GWI and insomnia symptoms without change dosage or frequency of treatment). Participants randomized to the Monitor Only condition will have the option of receiving CBTi delivered by telephone, at no cost to them, upon completion of post-study procedures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Deployed to the Gulf Theater of operations, as defined by 38 CFR 3.317 in the years 1990-1991, in accordance with the inclusion/exclusion criteria set forth in the federal definition of Gulf War Illness as used for the Gulf War Registry.
- Have Gulf War Illness (GWI) according to the Kansas case definition.
- Have an Insomnia Severity Index score greater than or equal to 14.
Key exclusion criteria (13 listed)
- Have conditions or substances that may be associated with comorbid insomnia independent of GWI status, including:
- Currently exposed to recurrent trauma or have been exposed to a traumatic event within the past 3 months.
- Pregnancy (because insomnia will worsen after 8 weeks).
- Prominent suicidal or homicidal ideation.
- History of sleep restriction therapy or cognitive restructuring therapies of beliefs related to sleep.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBTi)Also: CBTiCBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep (e.g., homeostatic regulation, circadian rhythm, age, social and work schedule) and to work with the patients toward minimizing unwanted arousal at bedtime and altering sleep habits to increase sleep propensity and regularity. The intervention is 8-weeks long. | Behavioural | CBTi |
Primary outcome
Gulf War Illness Symptom Severity Index
Time frame: At baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Due to its novelty, complexity, and variability, no single measure of severity addresses all possible presentations of Gulf War Illness (GWI). Therefore, we used the symptom portion of the Kansas Gulf War Military History and Health Questionnaire to query about fatigue/sleep problems, somatic pain, skin abnormalities, gastrointestinal, respiratory, and neurologic/cognitive/mood symptoms, based on the Kansas GWI and CDC CMI case definition. To assess current GWI symptoms, participants will be asked about the absence (0), presence, and severity (1=mild; 2=moderate; 3=severe) of the symptoms over the past 2 weeks instead of over the past 6-months. Score range: 0-87; higher scores = more symptoms and/or more severe symptoms.
Insomnia Severity Index (ISI)
Time frame: At baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. Higher scores indicate more severe insomnia. This outcome will be measured at 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
10 secondary outcomes
Fatigue Severity Scale (FSS)
Time frame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Brief Pain Inventory (BPI) - Pain Interference
Time frame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Brief Pain Inventory (BPI) - Pain Severity
Time frame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Multiple Abilities Self-Report Questionnaire (MASQ)
Time frame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Hospital Anxiety and Depression Scale (HADS), Anxiety
Time frame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Hospital Anxiety and Depression Scale (HADS), Depression
Time frame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Sleep Efficiency (SE)
Time frame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Minutes of Wake After Sleep Onset (WASO)
Time frame: Baseline and after 8 weeks of study participation in all subjects; in subjects randomized to CBTi, 6 months after study participation
Sleep Latency (SL)
Time frame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda L. Chao, PhD principal investigator
San Francisco VA Medical Center, San Francisco, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBTi) in people with Gulf War Illness and Insomnia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gulf War Illness Symptom Severity Index (time frame: At baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.