InsomniaNCT00310284
A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.
A study testing Computerized delivery of cognitive-behavioral treatment of insomnia and Self-help manual to improve insomnia symptoms in people with Insomnia, run by PICS, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a handheld computer is superior to a self-help manual for the treatment of chronic primary insomnia. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Computerized delivery of cognitive-behavioral treatment of insomnia and Self-help manual to improve insomnia symptoms
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to not given
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sleep less than 6.5 hours per night
- at least 30 minutes of sleep onset latency or wakefulness after sleep onset
- symptoms present for at least 6 months
- must have insomnia symptoms at least 3 days per week
Who cannot join
- Body Mass Index greater than 32
- Presence of anxiety disorder
- Secondary forms of insomnia
- Presence of a substance use disorder
- Concurrent treatment for another mental disorder
- History of other sleep disorders, including: apnea, restless legs, periodic limb movement disorder, or narcolepsy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
PICS, Inc.
Reston, Virginia, 20191
Anahi Collado-Rodriguez, B.S., 703-766-2849, acollado@lifesign.com
Bradford W. Applegate, Ph.D.
About this study
Official title: Computerized Self-Help Treatment for Primary Insomnia
The purpose of this study is to determine whether a handheld computer is superior to a self-help manual for the treatment of chronic primary insomnia.
Read the detailed description
Chronic primary insomnia is a highly prevalent condition, affecting up to 15% of the population. The condition is associated with daytime fatigue, lack of concentration, and decreased quality of life. Most people with chronic primary insomnia go untreated, because of a desire to avoid medication or lack of access to quality non-drug treatments. Therefore, an affordable, easy to use, and effective computer to help assess and treat insomnia symptoms could bring treatment to this population.
Comparison: We are comparing a new handheld computer that uses cognitive-behavioral treatment principles to a popular self-help manual for the treatment of primary insomnia symptoms.
- Conditions
- Insomnia
- Being tested
- Computerized delivery of cognitive-behavioral treatment of insomnia, Self-help manual to improve insomnia symptoms
- Keywords
- Insomnia, Sleep
- 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.
Computerized delivery of cognitive-behavioral treatment of insomniaBehavioural
Self-help manual to improve insomnia symptomsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sleep parameters via polysomnography
Changes in sleep parameters via self-reported sleep diary
Changes in symptom severity as measured by Insomnia Severity Index
Changes in symptom severity as measured by Pittsburgh Sleep Quality Index
Changes in symptom severity as measured by the Multi-dimensional Fatigue Inventory
Secondary outcomes (3)
Changes in depression symptoms as measured by Beck Depression Inventory II
Changes in quality of life as measured by a qualitative instrument
Usability of the device as measured by a qualitative questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- PICS, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Bradford W Applegate, Ph.D., Principal investigator, PICS, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310284
- Sponsor's protocol ID
- 5R44HL065893
- Other IDs
- 5R44HL065893
- Status last verified
- Mar 2006
- First submitted
- 31 Mar 2006
- Last updated
- 3 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Self-Help Treatment for Primary Insomnia
- ClinicalTrials.gov ID
- NCT00310284
- Acronym / sponsor ID
- 5R44HL065893
- Conditions
- Insomnia
- Keywords
- Insomnia, Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- PICS, Inc.University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2006
- First posted
- 3 Apr 2006 (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.
The purpose of this study is to determine whether a handheld computer is superior to a self-help manual for the treatment of chronic primary insomnia.
Detailed description
Chronic primary insomnia is a highly prevalent condition, affecting up to 15% of the population. The condition is associated with daytime fatigue, lack of concentration, and decreased quality of life. Most people with chronic primary insomnia go untreated, because of a desire to avoid medication or lack of access to quality non-drug treatments. Therefore, an affordable, easy to use, and effective computer to help assess and treat insomnia symptoms could bring treatment to this population.
Comparison: We are comparing a new handheld computer that uses cognitive-behavioral treatment principles to a popular self-help manual for the treatment of primary insomnia symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- sleep less than 6.5 hours per night
- at least 30 minutes of sleep onset latency or wakefulness after sleep onset
- symptoms present for at least 6 months
- must have insomnia symptoms at least 3 days per week
Key exclusion criteria (6 listed)
- Body Mass Index greater than 32
- Presence of anxiety disorder
- Secondary forms of insomnia
- Presence of a substance use disorder
- Concurrent treatment for another mental disorder
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 |
|---|---|---|
| Computerized delivery of cognitive-behavioral treatment of insomnia | Behavioural | – |
| Self-help manual to improve insomnia symptoms | Behavioural | – |
Primary outcome
Changes in sleep parameters via polysomnography
Changes in sleep parameters via self-reported sleep diary
Changes in symptom severity as measured by Insomnia Severity Index
Changes in symptom severity as measured by Pittsburgh Sleep Quality Index
Changes in symptom severity as measured by the Multi-dimensional Fatigue Inventory
3 secondary outcomes
Changes in depression symptoms as measured by Beck Depression Inventory II
Changes in quality of life as measured by a qualitative instrument
Usability of the device as measured by a qualitative questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2006.
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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.
Bradford W Applegate, Ph.D. principal investigator
PICS, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized delivery of cognitive-behavioral treatment of insomnia and Self-help manual to improve insomnia symptoms in people with Insomnia, run by PICS, Inc. 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Apr 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anahi Collado-Rodriguez, B.S. (703-766-2849, acollado@lifesign.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sleep parameters via polysomnography. The study lists 5 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 3 Apr 2006.