Vývoj intervence mHealth behaviorální spánkové medicíny pro použití během medikace asistované léčby MOUD
Vývoj mHealth Behavioral Sleep Medicine intervence pro použití během medikace asistované léčby poruchy užívání opioidů
This study is to develop and test a medical health application based on cognitive behavioral therapy for insomnia and augmented with other evidence-based sleep interventions that address common sleep-related problems in opioid use disorder. An initial program will be built utilizing input from persons beginning medications for opioid use disorders.
Přehled studie
Postavení
Detailní popis
This pilot randomized controlled trial will assess the feasibility and acceptability of an evidence-based behavioral sleep intervention delivered via a mHealth app to individuals initiating treatment with medications for opioid use disorder. Additional outcomes include changes in sleep disturbance over the course of the 6-week intervention. Participants (N=40, 20 per group) will be randomized to download the mHealth app to their smartphones and complete the intervention within 6 weeks. The control group will receive a simplified version of the app with sleep hygiene instructions. Both groups will complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity. At the end of the 6th week, they will complete an online series of questionnaires, including validated feasibility/acceptability measures and measures of insomnia severity.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Allison K Willkerson, Ph.D.
- Telefonní číslo: 843-792-4636
- E-mail: wilkersa@musc.edu
Studijní záloha kontaktů
- Jméno: Jacelyn Lane
- E-mail: lanejac@musc.edu
Studijní místa
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South Carolina
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Charleston, South Carolina, Spojené státy, 29464
- Nábor
- Medical University of South Carolina
-
Kontakt:
- Allison Wilkerson, PhD
- Telefonní číslo: 843-792-4636
- E-mail: wilkersa@musc.edu
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
-
No experience of withdrawal symptoms in past 2 weeks
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Being stabilized on buprenorphine
- Initiated buprenorphine in past 3 months
- Modified buprenorphine dose in past 3 months (e.g., reducing dose with goal of transitioning to vivitrol)
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Currently experiencing clinically significant sleep disturbance (PSQI > 5)
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Able to read and understand English
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Owns an Android or iOS smartphone
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At least 18 years of age
Exclusion Criteria:
- Current psychotic symptoms
- Current active suicidal ideation
- Severe visual impairment
- Current use of benzodiazepines
- Current severe SUD other than OUD (i.e., > 5 criteria met for any other SUD type per DSM-5)
- Peripartum women
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: mHealth application
Study participants, while being stabilized on buprenorphine, will download and engage with the developed mHealth application, completing daily electronic sleep diaries for the next 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity. |
Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will be required to complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity |
|
Experimentální: Control Group
Participants in the control group will receive a simplified version of the app with sleep hygiene (SH) instructions and will be required to complete daily electronic sleep diaries for the next 6 weeks. The SH condition will utilize the same application and entail the same daily and weekly logs, but with the didactic material replaced by detailed education about SH strategies. Each week, participants will be asked to complete a brief assessment of their experiences from the previous week and their current insomnia severity. |
Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will receive a simplified version of the app with sleep hygiene instructions and will be required to complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages
Časové okno: 6 weeks following enrollment
|
To achieve a minimum enrollment and retention percentage of 75% throughout the 6-week investigation period. |
6 weeks following enrollment
|
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Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement
Časové okno: 6 weeks following enrollment
|
Completing at least one module per week, submitting a minimum of four sleep diaries per week, and implementing stimulus control and sleep restriction on at least 90% of nights. |
6 weeks following enrollment
|
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mHealth App Usability Questionnaire
Časové okno: 6 weeks following enrollment
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Validated measure of mobile app usability with 3 sections: Ease of use/satisfaction, system information arrangement, and usefulness |
6 weeks following enrollment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Časové okno: At enrollment and 6 weeks following enrollment
|
Validated measure of difficulty falling and staying asleep and subsequent daytime function |
At enrollment and 6 weeks following enrollment
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Structured Clinical Interview for Sleep Disorders - Revised Edition
Časové okno: At enrollment and 6 weeks following enrollment
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Assessment for sleep disorders based on the DSM-5 |
At enrollment and 6 weeks following enrollment
|
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Insomnia Severity Index
Časové okno: At enrollment and 6 weeks following enrollment
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Global sleep quality; the most common self-reported sleep measure |
At enrollment and 6 weeks following enrollment
|
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Daily Sleep Diary - Sleep Onset Latency
Časové okno: Through study completion of 6 weeks
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Subjective sleep onset latency (time to fall asleep) |
Through study completion of 6 weeks
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Daily Sleep Diary - Wake-time After Sleep
Časové okno: Through study completion of 6 weeks
|
Subjective time awake after sleep onset |
Through study completion of 6 weeks
|
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Daily Sleep Diary - Total Sleep Time
Časové okno: Through study completion of 6 weeks
|
Subjective total sleep time |
Through study completion of 6 weeks
|
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Daily Sleep Diary - Sleep Efficiency
Časové okno: Through study completion of 6 weeks
|
Subjective sleep efficiency |
Through study completion of 6 weeks
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
MOUD and drug use
Časové okno: Through study completion of 6 weeks
|
Self-reported checklist |
Through study completion of 6 weeks
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Allison K Wilkerson, Ph.D., Medical University of South Carolina
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Pro128158
- 1R34DA058511 (Grant/smlouva NIH USA)
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