Développement d'une intervention de médecine comportementale du sommeil mHealth à utiliser pendant le traitement médicamenteux du MOUD
Développement d'une intervention de médecine comportementale du sommeil mHealth à utiliser pendant le traitement médicamenteux des troubles liés à l'usage d'opioïdes
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.
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Allison K Willkerson, Ph.D.
- Numéro de téléphone: 843-792-4636
- E-mail: wilkersa@musc.edu
Sauvegarde des contacts de l'étude
- Nom: Jacelyn Lane
- E-mail: lanejac@musc.edu
Lieux d'étude
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South Carolina
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Charleston, South Carolina, États-Unis, 29464
- Recrutement
- Medical University of South Carolina
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Contact:
- Allison Wilkerson, PhD
- Numéro de téléphone: 843-792-4636
- E-mail: wilkersa@musc.edu
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
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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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages
Délai: 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
Délai: 6 weeks following enrollment
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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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Délai: 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
Délai: 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
Délai: 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
|
|
Daily Sleep Diary - Sleep Onset Latency
Délai: Through study completion of 6 weeks
|
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
Délai: Through study completion of 6 weeks
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Subjective time awake after sleep onset |
Through study completion of 6 weeks
|
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Daily Sleep Diary - Total Sleep Time
Délai: Through study completion of 6 weeks
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Subjective total sleep time |
Through study completion of 6 weeks
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Daily Sleep Diary - Sleep Efficiency
Délai: Through study completion of 6 weeks
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Subjective sleep efficiency |
Through study completion of 6 weeks
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
MOUD and drug use
Délai: Through study completion of 6 weeks
|
Self-reported checklist |
Through study completion of 6 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Allison K Wilkerson, Ph.D., Medical University of South Carolina
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro128158
- 1R34DA058511 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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