- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00821041
Internet-based Treatment for Chronic Insomnia
Evaluation of an Internet-based Treatment for Chronic Insomnia
Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized. This study evaluates the impact of a 6-week, online treatment for insomnia.
Design This is a randomized controlled trial with online treatment and waiting list control conditions.
Participants
Participants are adults in Manitoba Canada with chronic insomnia.
Setting
Participants receive online treatment from their homes. Intervention. Online treatment consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help with medication tapering. Measurement and Results. The impact of online treatment on primary end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3N4
- University of Manitoba
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Access to high speed internet, insomnia duration > 6 months and occurring at least 4 nights per week, sleep-onset latency > 30 minutes and/or time awake at night > 30 minutes, and/or early morning awakening > 30 minutes before desired time, at least one type of daytime impairment.
Exclusion Criteria:
- Shift work, acute suicidality, mania, schizophrenia, head injury, alcohol intake > 14 drinks/week for males, > 12 drinks per week for females, current or past behavioral treatment for insomnia
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Ventelistekontrol
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Eksperimentel: CBT
A 6 weeks online course.
Each week participants log on to view videos and read information that focus on a variety of intervention techniques.
These include relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training.
Participants also monitor their sleep using an online sleep diary and respond to questions regarding their adherence to the program.
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6 weeks of relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Sleep Quality
Tidsramme: 6 weeks
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Sleep Quality was assessed by taking the average of two items: "How well do you feel this morning?"
And "How enjoyable was your sleep last night?"
(0 = not at all, 4 = very).
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6 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pre-Sleep Arousal
Tidsramme: 6 weeks
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Pre-sleep Arousal Scale (cognitive subscale).
8-item measure of cognitive hyperarousal associated with insomnia.
The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal.
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6 weeks
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Beliefs and Attitudes About Sleep
Tidsramme: 6 weeks
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6 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Norah Vincent, Ph.D., University of Manitoba
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H2004:112
- HSCF 176
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Kliniske forsøg med Søvnløshed
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Jack Edinger, PhDNational Institute of Mental Health (NIMH); National Institutes of Health...AfsluttetPrimær søvnløshed | Insomnia Comorbid til psykiatrisk lidelseForenede Stater, Canada
Kliniske forsøg med Cognitive Behavioral Therapy
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