Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Connecticut
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West Haven, Connecticut, Verenigde Staten, 06516
- VA Connecticut Healthcare System
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Inability to sleep within 30 minutes of going to bed or awakening during the night for 30 minutes for greater than or equal to 3 days per week
- Above Criteria occurring every week for greater than or equal to 3 months
- At least one symptom of daytime impairment: (reduced motivation, sleepiness, fatigue, lack of concentration, performance at home, work, social life, relationships impaired)
- Able to provide valid consent
- Willing to participate in an internet-based cognitive behavioral therapy for insomnia
- English speaking
Exclusion Criteria:
- Self-reported or provider diagnosed sleep apnea or related nighttime respiratory problem, restless legs syndrome or related nighttime movement disorder
- Acute psychiatric decompensation requiring inpatient admission or emergency department services within the last month (suicidality, homicidally, mania, psychotic decompensation)
- Current treatment or treatment within the last month for opiate addiction with methadone maintenance or buprenorphine.
- Has a conservator E. Shift work interfering with the establishment of regular sleep patterns F. Previous or ongoing cognitive behavioral therapy for insomnia
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Internet-based Cognitive Behavioral Therapy for Insomnia
This is an internet-based Cognitive Behavioral treatment for insomnia.
It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log.
The intervention is self administered.
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This is an internet-based Cognitive Behavioral treatment for insomnia.
It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log.
The intervention is self administered.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Insomnia Severity Index (Total), Change From Baseline to Follow-up
Tijdsspanne: pre-intervention, intervention completion (expected average of 7 weeks)
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Insomnia Severity Index (Total) following completion of the intervention (expected average of 7 weeks) The Insomnia Severity Index is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia as well as the degree of concerns or distress caused by those difficulties, and corresponds to the diagnostic criteria of insomnia. Scores range from 0-28, higher scores indicate more severe insomnia, and scores ≥15 suggest moderate to severe insomnia. |
pre-intervention, intervention completion (expected average of 7 weeks)
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Completion of All 7 Modules of the Intervention
Tijdsspanne: on average 7 weeks
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Participants will be followed for the duration of the intervention (7 individual modules, completed weekly, for an expected average of 7 weeks). Outcome measure will be characterized as the number completing all 7 modules of the program (dichotomous variable). The intervention is a 7-week, self-administered course accessed via the Internet that includes instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, cognitive distortions, and mindfulness integrated into each module. Homework is assigned after each module. Participants are instructed to complete the sleep diary included in the program daily while participating in the program. |
on average 7 weeks
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 01633
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