Sleep Initiation and Maintenance DisordersCBT-I TelemedNCT01176123
Cognitive Behavioral Therapy for Trauma-Related Insomnia in Veterans
A study testing Cognitive Behavioral Therapy for Insomnia in people with Sleep Initiation and Maintenance Disorders, run by Southeast Louisiana Veterans Health Care System at 1 site in United States.
Trial summary
Understanding the effectiveness of Cognitive Behavioral Therapy for trauma-related insomnia (CBT-I) is important because sleep difficulties often persist after traditional post-trauma treatments are completed and other trauma-related symptoms have resolved. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sleep Initiation and Maintenance 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2011to 27 Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Veterans living 30 or more miles from VA PTSD specialty services
- Diagnosis of PTSD or subthreshold PTSD symptoms
- Trauma-related insomnia
Who cannot join
- Primary sleep disorder other than insomnia(e.g., Restless Leg Syndrome)
- Psychosis
- Active alcohol dependence
- Active drug dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, 70112
About this study
Official title: Comparing Telemedicine to In Person Delivery of Cognitive Behavioral Therapy for Trauma-Related Insomnia in Rural Veterans
Understanding the effectiveness of Cognitive Behavioral Therapy for trauma-related insomnia (CBT-I) is important because sleep difficulties often persist after traditional post-trauma treatments are completed and other trauma-related symptoms have resolved. The objective of this study is to examine whether CBT-I will equivocally reduce problems falling and staying asleep (insomnia) related to military-related PTSD when administered in person versus through telephone therapy to veterans living in rural areas.
Rural populations are at a disadvantage in receiving treatment because of lack of access to healthcare services. Telemedicine uses technology (e.g., telephones) to provide distance counseling to the populations who lack access to health care. Thus, telephone-counseling strategies could provide broad access to interventions for management of trauma-related insomnia.
Read more
Veterans who live more than 30 miles from Veterans Affairs (VA) PTSD specialty services will be offered participation in this study. All veterans receive 6 weeks of individual CBT-I for trauma-related insomnia. Participants will be randomized to one of two treatment conditions: (1) CBT-I in person or (2) CBT-I via telemedicine (defined as receiving treatment by telephone). No changes will be made to the CBT-I, other than mode of delivery, for the telemedicine group.
Through this study the investigators hope to demonstrate the effectiveness of CBT-I for trauma-related insomnia can be delivered effectively to rural veterans in person and via telemedicine.
- Being tested
- Cognitive Behavioral Therapy for Insomnia
- Keywords
- Cognitive behavioral therapy, Insomnia, Traumatic Stress
- 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 InsomniaBehavioural
Cognitive Behavioral Therapy for Insomnia
| Study group | Role | What they receive |
|---|---|---|
| CBT-I in person | Active comparator | Cognitive behavioral therapy for insomnia delivered in person Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| CBT-I via telephone therapy | Experimental | Cognitive behavioral therapy for insomnia delivered by telephone Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study start3 Feb 2011
- Study completion27 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast Louisiana Veterans Health Care System
- Sponsor type
- US federal agency
- Collaborators
- VA Mental Illness Research, Education and Clinical Centers
- Responsible party
- Principal investigator, C Laurel Franklin, PhD, Southeast Louisiana Veterans Health Care System
- Investigators
- Laurel Franklin, PhD, Principal investigator, Southeast Louisiana Veterans Health Care SystemSheila Corrigan, PhD, Principal investigator, Southeast Louisiana Veterans Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176123
- Sponsor's protocol ID
- 00366
- Acronym
- CBT-I Telemed
- Status last verified
- Mar 2020
- First submitted
- 4 Aug 2010
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Telemedicine to In Person Delivery of Cognitive Behavioral Therapy for Trauma-Related Insomnia in Rural Veterans
- ClinicalTrials.gov ID
- NCT01176123
- Acronym / sponsor ID
- CBT-I Telemed / 00366
- Keywords
- Cognitive behavioral therapy, Insomnia, Traumatic Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Southeast Louisiana Veterans Health Care SystemUS federal agency
- Collaborators
- VA Mental Illness Research, Education and Clinical Centers
- Study start
- 3 Feb 2011 (actual)
- Study completion
- 27 Sep 2011 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Understanding the effectiveness of Cognitive Behavioral Therapy for trauma-related insomnia (CBT-I) is important because sleep difficulties often persist after traditional post-trauma treatments are completed and other trauma-related symptoms have resolved. The objective of this study is to examine whether CBT-I will equivocally reduce problems falling and staying asleep (insomnia) related to military-related PTSD when administered in person versus through telephone therapy to veterans living in rural areas.
Rural populations are at a disadvantage in receiving treatment because of lack of access to healthcare services. Telemedicine uses technology (e.g., telephones) to provide distance counseling to the populations who lack access to health care. Thus, telephone-counseling strategies could provide broad access to interventions for management of trauma-related insomnia.
Veterans who live more than 30 miles from Veterans Affairs (VA) PTSD specialty services will be offered participation in this study. All veterans receive 6 weeks of individual CBT-I for trauma-related insomnia. Participants will be randomized to one of two treatment conditions: (1) CBT-I in person or (2) CBT-I via telemedicine (defined as receiving treatment by telephone). No changes will be made to the CBT-I, other than mode of delivery, for the telemedicine group.
Through this study the investigators hope to demonstrate the effectiveness of CBT-I for trauma-related insomnia can be delivered effectively to rural veterans in person and via telemedicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I in person | Active comparator | Behavioral: Cognitive Behavioral Therapy for InsomniaCognitive behavioral therapy for insomnia delivered in person |
| CBT-I via telephone therapy | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaCognitive behavioral therapy for insomnia delivered by telephone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans living 30 or more miles from VA PTSD specialty services
- Diagnosis of PTSD or subthreshold PTSD symptoms
- Trauma-related insomnia
Key exclusion criteria (4 listed)
- Primary sleep disorder other than insomnia(e.g., Restless Leg Syndrome)
- Psychosis
- Active alcohol dependence
- Active drug dependence
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 InsomniaCognitive Behavioral Therapy for Insomnia | Behavioural | CBT-I in person, CBT-I via telephone therapy |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
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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.
Laurel Franklin, PhD principal investigator
Southeast Louisiana Veterans Health Care System
Sheila Corrigan, PhD principal investigator
Southeast Louisiana Veterans Health Care System
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, run by Southeast Louisiana Veterans Health Care System 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 3 inclusion and 4 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 20 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 20 Mar 2020.