Sleep Initiation and Maintenance DisordersVIPNCT01686438
Telemedicine Management of Chronic Insomnia
A study testing Cognitive behavioral therapy for insomnia in people with Sleep Initiation and Maintenance Disorders and Post-Traumatic Stress Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Insomnia is commonly present in Veterans with post-traumatic stress disorder (PTSD). Treatment of insomnia with a specialized type of psychotherapy has been shown to be more effective than treatment with medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Post-Traumatic Stress Disorders
- What is being tested?
- Cognitive behavioral therapy for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2013to 30 Nov 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans will have to meet the following inclusion criteria in order to be enrolled in this RCT:
- Men and women at least 18 years of age.
- Meet current DSM-IV-TR criteria for PTSD as determined by the Clinician Administered PTSD Scale (CAPS)
- Insomnia Severity Index score > 14, the commonly used threshold for clinical insomnia, with self-reported duration of insomnia >6 months.
- Ability to read and speak English (assessment instruments and therapy will be available only in English)
Who cannot join
- Veterans will be excluded from participation if they meet any of the following exclusion criteria:
- Unable or unwilling to provide informed consent.
- Unwilling to participate in supervised group sessions at the community based outpatient clinic
- No telephone access or inability to return for follow-up testing.
- Individuals with an untreated sleep disorder [e.g., obstructive sleep apnea (apnea-hypopnea index 15 events/hr), periodic limb movement disorder (10 leg movements/hr of sleep with arousals), central sleep apnea ( 50% of apneas are central), Cheyne-Stokes respiration, obesity hypoventilation syndrome, and narcolepsy].
- A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months.
Show all 10Show fewer
- Evidence of substance dependence during the preceding twelve months. Evidence of "at risk" drinking behavior over the past month. Namely for men: more than 4 drinks on a given night, drinking on more than 3 nights a week, or more than 14 total drinks in a week; for women: more than 3 drinks in a given night, drinking on more than 3 nights a week, or more than 7 total drinks in a week.
- Individuals with bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia and other psychotic disorders as determined by the SCID questionnaire. A concurrent anxiety disorder or depressive disorder diagnosis will be allowed.
- Individuals with prominent current suicidal or homicidal ideation. This will be assessed by the clinical psychologist administering the SCID and CAPS. In cases of prominent current suicidal or homicidal ideation appropriate safety measures will be taken. Following stabilization, Veterans who continue to be interested in participating in the study may be re-assessed.
- Unable to perform tests due to inability to communicate verbally, inability to read and write; less than a 5th grade reading level; visual, hearing or cognitive impairment (e.g., previous head injury).
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
About this study
Official title: Telemedicine Management of Veterans With PTSD and Chronic Insomnia
Insomnia is commonly present in Veterans with post-traumatic stress disorder (PTSD). Treatment of insomnia with a specialized type of psychotherapy has been shown to be more effective than treatment with medications. Unfortunately, few psychologists are trained to provide this treatment, limiting Veterans' access to care, especially those Veterans in remote and rural areas. This project will evaluate the ability to deliver this psychotherapy to groups of Veterans by video teleconferencing. Groups of Veterans with PTSD and chronic insomnia will receive the psychotherapy treatment either by meeting in-person with the psychologist or by the psychologist delivering the treatment by video teleconferencing. Finding that video teleconferencing is a cost effective way to deliver this treatment could add an important new component to the care of Veterans with PTSD that provides an alternative to medications.
Read the detailed description
Objectives(s): The investigators are conducting a randomized, controlled trial of Veterans with PTSD and chronic insomnia to determine if cognitive behavioral therapy for insomnia (CBT-I) administered by video teleconferencing is not clinically inferior to in-person treatment in terms of improvement in insomnia symptoms. Secondary aims are 1) comparing the differences in cost and quality-adjusted life years between the treatment delivery approaches and 2) determining the effectiveness of CBT-I on functional outcomes, sleep quality, and non-sleep-related PTSD symptoms. The investigators are also conducting a patient- and provider-focused formative evaluation of CBT-I delivery by video teleconferencing to assess potential barriers to its widespread implementation.
Research Design: This prospective randomized controlled non-inferiority study will determine if Veterans with PTSD and chronic insomnia receiving CBT-I by video teleconferencing have an improvement in insomnia severity, as determined by change in Insomnia Severity Index (ISI) score, that is not clinically inferior to that in Veterans receiving in-person CBT-I. Differences in cost and quality-adjusted life years (QALY) between groups will also be compared.
Methodology: Veterans with PTSD and chronic insomnia receiving their primary care at community-based outpatient clinics (CBOC) affiliated with the Philadelphia VAMC are be randomized to receive one of the following interventions in a group setting at their CBOC: 1) a manual-based CBT-I program delivered via video teleconferencing, 2) the CBT-I program delivered in-person, and 3) in-person delivery of sleep hygiene education, a known active control intervention. Participants are assessed at baseline, and 2 weeks and every 3 months following the intervention. The primary outcome measure in Aim 1 is the change in the Insomnia Severity Index (ISI) score at 6 months following intervention. Non-inferiority analysis will be used to compare the effectiveness of the two delivery methods, with a pre-specified margin. Results will be ascertained via intent to treat and per-protocol procedures. The investigators hypothesize that the change in ISI score following CBT-I by video teleconferencing will not be clinically inferior to that following in-person delivery. In Aim 2, VA and non-VA total healthcare costs are being collected to test whether average cost is lower for Veterans receiving CBT-I by video teleconferencing versus in-person care. Preference is being assessed by the EuroQol and Health Utilities Index 2. Differences in the ratio of cost and quality-adjusted life years saved between CBT-I by video teleconferencing and in-person encounter will be compared to test the hypothesis that video teleconferencing will have lower cost and equivalent outcomes. Aim 3 is assessing the effect of CBT-I on functional outcomes (Short Form-12, Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index, sleep diary and wrist actigraphy), and PTSD severity (the non-sleep component of the PTSD Checklist-Military). The investigators hypothesize that these functional outcomes and sleep quality measures will improve following each method of CBT-I delivery and that CBT-I will improve non-sleep-related PTSD severity. The formative evaluation of the telemedicine delivery of CBT-I in Aim 4 is using qualitative (targeted focus groups with participants and therapist interviews) and quantitative measures (Work Alliance Inventory, Treatment Credibility Scale, attrition) that will help guide future implementation of CBT-I by video teleconferencing
Anticipated Findings: The investigators believe these results will demonstrate that: 1) Veterans in both CBT-I groups will have similar improvement in functional outcomes, and 2) treatment delivery by video teleconferencing will be more cost effective than in-person care. These findings should lead to wider acceptance of video teleconferencing, thereby increasing patient access to care and reducing treatment costs.
- Being tested
- Cognitive behavioral therapy for insomnia
- Keywords
- cost effectiveness, patient satisfaction
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Stress Disorders, Post-Traumatic, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for insomniaBehavioural
Also called CBT-I
A behavioral modification program consisting of 6 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I delivery by video teleconferencing | Experimental | Groups of participants will receive a cognitive behavioral therapy for insomnia program delivered by a trained psychologist using video teleconferencing. Receives: Behavioral: Cognitive behavioral therapy for insomnia |
| In-person CBT-I delivery | Active comparator | Groups of participants will receive a cognitive behavioral therapy for insomnia (CBT-I) program by meeting in-person with a trained psychologist. Receives: Behavioral: Cognitive behavioral therapy for insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Insomnia Severity Index Score
Self-report questionnaire used widely to assess presence of insomnia and its severity. Scores range from 0-28. Higher scores indicate increasing severity of insomnia.
Measured: Baseline to 3 months
Secondary outcomes (13)
Change From Baseline PTSD Checklist-Military (PCL-M) Scores
Self-administered validated questionnaire measuring PTSD severity. Scores range from 17-85. Higher scores indicate higher severity of symptoms.
Measured: baseline to 3 months
Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores
Self-administered validated questionnaire measuring subjective sleep quality. Scores range from 0-21. Higher score indicates worse sleep quality. Total score < 5 is associated with good sleep quality.
Measured: baseline to 3 months
Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
Measure of the sleep and dream disturbances often associated with PTSD. Scores range from 0-21. A higher score indicates higher frequency of disruptive nocturnal behaviors. Total score ≥ 4 can be used to indicate PTSD.
Measured: baseline to 3 months
Change From Baseline in Nightmare Distress Questionnaire Scores
Measure of intensity of the distress associated with a nightmare. Scores range from 0-52. Higher score indicates increased nightmare distress.
Measured: baseline to 3 month
Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score
Self-administered validated general health-related quality of life questionnaire to assess functional outcome. Scores range from 0 to 100. Higher scores indicate higher health function.
Measured: baseline to 3 months
Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score
self-administered validated health related quality of life questionnaire to assess functional outcomes. Scores range from 0 to 100. Higher scores indicate higher health function.
Measured: baseline to 3 months
Change From Baseline in Work and Social Adjustment Scale Scores
A self-report scale of functional impairment attributable to an identified problem. Scores range from 0 - 40. Higher scores indicate increasing functional impairment.
Measured: baseline to 3 months
Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks
The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.
Measured: 2-8 weeks
Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks
Self administered questionnaire of person's satisfaction with care. Total scores range from 13 to 65, with higher scores indicating higher patient satisfaction. Scores reported from session 5.
Measured: 2-8 weeks
Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores
Measure of nightmare frequency in number of nights with nightmares per year, scores converted to yearly.
Measured: baseline to 3 months, scores converted to yearly
Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores
Self-administered measure of nightmare frequency in actual number of nightmares experienced over a 3 month period, and converted to yearly
Measured: baseline to 3 months (converted to yearly)
Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks
The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.
Measured: 2-8 weeks
Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks
The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.
Measured: 2-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study start1 Apr 2013
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies 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
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Samuel T. Kuna, MD, Principal investigator, Philadelphia VA Medical Center, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686438
- Sponsor's protocol ID
- IIR 11-296
- Acronym
- VIP
- Status last verified
- Jul 2019
- First submitted
- 6 Sep 2012
- Last updated
- 29 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gehrman P, Shah MT, Miles A, Kuna S, Godleski L. Feasibility of Group Cognitive-Behavioral Treatment of Insomnia Delivered by Clinical Video Telehealth. Telemed J E Health. 2016 Dec;22(12):1041-1046. doi: 10.1089/tmj.2016.0032. Epub 2016 Jun 10.
PubMed 27286369
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Management of Veterans With PTSD and Chronic Insomnia
- ClinicalTrials.gov ID
- NCT01686438
- Acronym / sponsor ID
- VIP / IIR 11-296
- Keywords
- cost effectiveness, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Pennsylvania
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Posted 29 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insomnia is commonly present in Veterans with post-traumatic stress disorder (PTSD). Treatment of insomnia with a specialized type of psychotherapy has been shown to be more effective than treatment with medications. Unfortunately, few psychologists are trained to provide this treatment, limiting Veterans' access to care, especially those Veterans in remote and rural areas. This project will evaluate the ability to deliver this psychotherapy to groups of Veterans by video teleconferencing. Groups of Veterans with PTSD and chronic insomnia will receive the psychotherapy treatment either by meeting in-person with the psychologist or by the psychologist delivering the treatment by video teleconferencing. Finding that video teleconferencing is a cost effective way to deliver this treatment could add an important new component to the care of Veterans with PTSD that provides an alternative to medications.
Detailed description
Objectives(s): The investigators are conducting a randomized, controlled trial of Veterans with PTSD and chronic insomnia to determine if cognitive behavioral therapy for insomnia (CBT-I) administered by video teleconferencing is not clinically inferior to in-person treatment in terms of improvement in insomnia symptoms. Secondary aims are 1) comparing the differences in cost and quality-adjusted life years between the treatment delivery approaches and 2) determining the effectiveness of CBT-I on functional outcomes, sleep quality, and non-sleep-related PTSD symptoms. The investigators are also conducting a patient- and provider-focused formative evaluation of CBT-I delivery by video teleconferencing to assess potential barriers to its widespread implementation.
Research Design: This prospective randomized controlled non-inferiority study will determine if Veterans with PTSD and chronic insomnia receiving CBT-I by video teleconferencing have an improvement in insomnia severity, as determined by change in Insomnia Severity Index (ISI) score, that is not clinically inferior to that in Veterans receiving in-person CBT-I. Differences in cost and quality-adjusted life years (QALY) between groups will also be compared.
Methodology: Veterans with PTSD and chronic insomnia receiving their primary care at community-based outpatient clinics (CBOC) affiliated with the Philadelphia VAMC are be randomized to receive one of the following interventions in a group setting at their CBOC: 1) a manual-based CBT-I program delivered via video teleconferencing, 2) the CBT-I program delivered in-person, and 3) in-person delivery of sleep hygiene education, a known active control intervention. Participants are assessed at baseline, and 2 weeks and every 3 months following the intervention. The primary outcome measure in Aim 1 is the change in the Insomnia Severity Index (ISI) score at 6 months following intervention. Non-inferiority analysis will be used to compare the effectiveness of the two delivery methods, with a pre-specified margin. Results will be ascertained via intent to treat and per-protocol procedures. The investigators hypothesize that the change in ISI score following CBT-I by video teleconferencing will not be clinically inferior to that following in-person delivery. In Aim 2, VA and non-VA total healthcare costs are being collected to test whether average cost is lower for Veterans receiving CBT-I by video teleconferencing versus in-person care. Preference is being assessed by the EuroQol and Health Utilities Index 2. Differences in the ratio of cost and quality-adjusted life years saved between CBT-I by video teleconferencing and in-person encounter will be compared to test the hypothesis that video teleconferencing will have lower cost and equivalent outcomes. Aim 3 is assessing the effect of CBT-I on functional outcomes (Short Form-12, Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index, sleep diary and wrist actigraphy), and PTSD severity (the non-sleep component of the PTSD Checklist-Military). The investigators hypothesize that these functional outcomes and sleep quality measures will improve following each method of CBT-I delivery and that CBT-I will improve non-sleep-related PTSD severity. The formative evaluation of the telemedicine delivery of CBT-I in Aim 4 is using qualitative (targeted focus groups with participants and therapist interviews) and quantitative measures (Work Alliance Inventory, Treatment Credibility Scale, attrition) that will help guide future implementation of CBT-I by video teleconferencing
Anticipated Findings: The investigators believe these results will demonstrate that: 1) Veterans in both CBT-I groups will have similar improvement in functional outcomes, and 2) treatment delivery by video teleconferencing will be more cost effective than in-person care. These findings should lead to wider acceptance of video teleconferencing, thereby increasing patient access to care and reducing treatment costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I delivery by video teleconferencing | Experimental | Behavioral: Cognitive behavioral therapy for insomniaGroups of participants will receive a cognitive behavioral therapy for insomnia program delivered by a trained psychologist using video teleconferencing. |
| In-person CBT-I delivery | Active comparator | Behavioral: Cognitive behavioral therapy for insomniaGroups of participants will receive a cognitive behavioral therapy for insomnia (CBT-I) program by meeting in-person with a trained psychologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veterans will have to meet the following inclusion criteria in order to be enrolled in this RCT:
- Men and women at least 18 years of age.
- Meet current DSM-IV-TR criteria for PTSD as determined by the Clinician Administered PTSD Scale (CAPS)
- Insomnia Severity Index score > 14, the commonly used threshold for clinical insomnia, with self-reported duration of insomnia >6 months.
- Ability to read and speak English (assessment instruments and therapy will be available only in English)
Key exclusion criteria (10 listed)
- Veterans will be excluded from participation if they meet any of the following exclusion criteria:
- Unable or unwilling to provide informed consent.
- Unwilling to participate in supervised group sessions at the community based outpatient clinic
- No telephone access or inability to return for follow-up testing.
- Individuals with an untreated sleep disorder [e.g., obstructive sleep apnea (apnea-hypopnea index 15 events/hr), periodic limb movement disorder (10 leg movements/hr of sleep with arousals), central sleep apnea ( 50% of apneas are central), Cheyne-Stokes respiration, obesity hypoventilation syndrome, and narcolepsy].
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 insomniaAlso: CBT-IA behavioral modification program consisting of 6 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring. | Behavioural | CBT-I delivery by video teleconferencing, In-person CBT-I delivery |
Primary outcome
Change From Baseline in Insomnia Severity Index Score
Time frame: Baseline to 3 months
Self-report questionnaire used widely to assess presence of insomnia and its severity. Scores range from 0-28. Higher scores indicate increasing severity of insomnia.
13 secondary outcomes
Change From Baseline PTSD Checklist-Military (PCL-M) Scores
Time frame: baseline to 3 months
Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores
Time frame: baseline to 3 months
Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
Time frame: baseline to 3 months
Change From Baseline in Nightmare Distress Questionnaire Scores
Time frame: baseline to 3 month
Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score
Time frame: baseline to 3 months
Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score
Time frame: baseline to 3 months
Change From Baseline in Work and Social Adjustment Scale Scores
Time frame: baseline to 3 months
Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks
Time frame: 2-8 weeks
Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks
Time frame: 2-8 weeks
Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores
Time frame: baseline to 3 months, scores converted to yearly
Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores
Time frame: baseline to 3 months (converted to yearly)
Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks
Time frame: 2-8 weeks
Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks
Time frame: 2-8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27286369Gehrman P, Shah MT, Miles A, Kuna S, Godleski L. Feasibility of Group Cognitive-Behavioral Treatment of Insomnia Delivered by Clinical Video Telehealth. Telemed J E Health. 2016 Dec;22(12):1041-1046. doi: 10.1089/tmj.2016.0032. Epub 2016 Jun 10.
- 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.
Samuel T. Kuna, MD principal investigator
Philadelphia VA Medical Center, Philadelphia, PA
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 in people with Sleep Initiation and Maintenance Disorders and Post-Traumatic Stress Disorders, 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 10 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 29 Aug 2019. 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 29 Aug 2019). 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?
Change From Baseline in Insomnia Severity Index Score (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01686438, which also lists 1 linked publication.
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 29 Aug 2019.