Telemedicine Management of Chronic Insomnia (VIP)
Telemedicine Management of Veterans With PTSD and Chronic Insomnia
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Objectives(s): The investigators are conducting a randomized, controlled trial of Veterans with PTSD and chronic insomnia to determine if cognitive behavioral therapy for insomnia (CBT-I) administered by video teleconferencing is not clinically inferior to in-person treatment in terms of improvement in insomnia symptoms. Secondary aims are 1) comparing the differences in cost and quality-adjusted life years between the treatment delivery approaches and 2) determining the effectiveness of CBT-I on functional outcomes, sleep quality, and non-sleep-related PTSD symptoms. The investigators are also conducting a patient- and provider-focused formative evaluation of CBT-I delivery by video teleconferencing to assess potential barriers to its widespread implementation.
Research Design: This prospective randomized controlled non-inferiority study will determine if Veterans with PTSD and chronic insomnia receiving CBT-I by video teleconferencing have an improvement in insomnia severity, as determined by change in Insomnia Severity Index (ISI) score, that is not clinically inferior to that in Veterans receiving in-person CBT-I. Differences in cost and quality-adjusted life years (QALY) between groups will also be compared.
Methodology: Veterans with PTSD and chronic insomnia receiving their primary care at community-based outpatient clinics (CBOC) affiliated with the Philadelphia VAMC are be randomized to receive one of the following interventions in a group setting at their CBOC: 1) a manual-based CBT-I program delivered via video teleconferencing, 2) the CBT-I program delivered in-person, and 3) in-person delivery of sleep hygiene education, a known active control intervention. Participants are assessed at baseline, and 2 weeks and every 3 months following the intervention. The primary outcome measure in Aim 1 is the change in the Insomnia Severity Index (ISI) score at 6 months following intervention. Non-inferiority analysis will be used to compare the effectiveness of the two delivery methods, with a pre-specified margin. Results will be ascertained via intent to treat and per-protocol procedures. The investigators hypothesize that the change in ISI score following CBT-I by video teleconferencing will not be clinically inferior to that following in-person delivery. In Aim 2, VA and non-VA total healthcare costs are being collected to test whether average cost is lower for Veterans receiving CBT-I by video teleconferencing versus in-person care. Preference is being assessed by the EuroQol and Health Utilities Index 2. Differences in the ratio of cost and quality-adjusted life years saved between CBT-I by video teleconferencing and in-person encounter will be compared to test the hypothesis that video teleconferencing will have lower cost and equivalent outcomes. Aim 3 is assessing the effect of CBT-I on functional outcomes (Short Form-12, Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index, sleep diary and wrist actigraphy), and PTSD severity (the non-sleep component of the PTSD Checklist-Military). The investigators hypothesize that these functional outcomes and sleep quality measures will improve following each method of CBT-I delivery and that CBT-I will improve non-sleep-related PTSD severity. The formative evaluation of the telemedicine delivery of CBT-I in Aim 4 is using qualitative (targeted focus groups with participants and therapist interviews) and quantitative measures (Work Alliance Inventory, Treatment Credibility Scale, attrition) that will help guide future implementation of CBT-I by video teleconferencing
Anticipated Findings: The investigators believe these results will demonstrate that: 1) Veterans in both CBT-I groups will have similar improvement in functional outcomes, and 2) treatment delivery by video teleconferencing will be more cost effective than in-person care. These findings should lead to wider acceptance of video teleconferencing, thereby increasing patient access to care and reducing treatment costs.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis, 19104
- Philadelphia VA Medical Center, Philadelphia, PA
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Veterans will have to meet the following inclusion criteria in order to be enrolled in this RCT:
- Men and women at least 18 years of age.
- Meet current DSM-IV-TR criteria for PTSD as determined by the Clinician Administered PTSD Scale (CAPS)
- Insomnia Severity Index score > 14, the commonly used threshold for clinical insomnia, with self-reported duration of insomnia >6 months.
- Ability to read and speak English (assessment instruments and therapy will be available only in English)
Exclusion Criteria:
Veterans will be excluded from participation if they meet any of the following exclusion criteria:
- Unable or unwilling to provide informed consent.
- Unwilling to participate in supervised group sessions at the community based outpatient clinic
- No telephone access or inability to return for follow-up testing.
- Individuals with an untreated sleep disorder [e.g., obstructive sleep apnea (apnea-hypopnea index 15 events/hr), periodic limb movement disorder (10 leg movements/hr of sleep with arousals), central sleep apnea ( 50% of apneas are central), Cheyne-Stokes respiration, obesity hypoventilation syndrome, and narcolepsy].
- A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months.
- Evidence of substance dependence during the preceding twelve months. Evidence of "at risk" drinking behavior over the past month. Namely for men: more than 4 drinks on a given night, drinking on more than 3 nights a week, or more than 14 total drinks in a week; for women: more than 3 drinks in a given night, drinking on more than 3 nights a week, or more than 7 total drinks in a week.
- Individuals with bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia and other psychotic disorders as determined by the SCID questionnaire. A concurrent anxiety disorder or depressive disorder diagnosis will be allowed.
- Individuals with prominent current suicidal or homicidal ideation. This will be assessed by the clinical psychologist administering the SCID and CAPS. In cases of prominent current suicidal or homicidal ideation appropriate safety measures will be taken. Following stabilization, Veterans who continue to be interested in participating in the study may be re-assessed.
- Unable to perform tests due to inability to communicate verbally, inability to read and write; less than a 5th grade reading level; visual, hearing or cognitive impairment (e.g., previous head injury).
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: CBT-I delivery by video teleconferencing
Groups of participants will receive a cognitive behavioral therapy for insomnia program delivered by a trained psychologist using video teleconferencing.
|
A behavioral modification program consisting of 6 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.
Autres noms:
|
|
Comparateur actif: In-person CBT-I delivery
Groups of participants will receive a cognitive behavioral therapy for insomnia (CBT-I) program by meeting in-person with a trained psychologist.
|
A behavioral modification program consisting of 6 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Insomnia Severity Index Score
Délai: Baseline to 3 months
|
Self-report questionnaire used widely to assess presence of insomnia and its severity.
Scores range from 0-28.
Higher scores indicate increasing severity of insomnia.
|
Baseline to 3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline PTSD Checklist-Military (PCL-M) Scores
Délai: baseline to 3 months
|
Self-administered validated questionnaire measuring PTSD severity.
Scores range from 17-85.
Higher scores indicate higher severity of symptoms.
|
baseline to 3 months
|
|
Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores
Délai: baseline to 3 months
|
Self-administered validated questionnaire measuring subjective sleep quality.
Scores range from 0-21.
Higher score indicates worse sleep quality.
Total score < 5 is associated with good sleep quality.
|
baseline to 3 months
|
|
Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
Délai: baseline to 3 months
|
Measure of the sleep and dream disturbances often associated with PTSD.
Scores range from 0-21.
A higher score indicates higher frequency of disruptive nocturnal behaviors.
Total score ≥ 4 can be used to indicate PTSD.
|
baseline to 3 months
|
|
Change From Baseline in Nightmare Distress Questionnaire Scores
Délai: baseline to 3 month
|
Measure of intensity of the distress associated with a nightmare.
Scores range from 0-52.
Higher score indicates increased nightmare distress.
|
baseline to 3 month
|
|
Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score
Délai: baseline to 3 months
|
Self-administered validated general health-related quality of life questionnaire to assess functional outcome.
Scores range from 0 to 100.
Higher scores indicate higher health function.
|
baseline to 3 months
|
|
Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score
Délai: baseline to 3 months
|
self-administered validated health related quality of life questionnaire to assess functional outcomes.
Scores range from 0 to 100.
Higher scores indicate higher health function.
|
baseline to 3 months
|
|
Change From Baseline in Work and Social Adjustment Scale Scores
Délai: baseline to 3 months
|
A self-report scale of functional impairment attributable to an identified problem.
Scores range from 0 - 40.
Higher scores indicate increasing functional impairment.
|
baseline to 3 months
|
|
Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks
Délai: 2-8 weeks
|
The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner.
The scale focuses on task alliance, goal alliance, and bond formation.
Items range from 1- never to 7- always.
Scores range from 7-84.
Higher scores indicate better alliance.
Scores are reported from session 4.
|
2-8 weeks
|
|
Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks
Délai: 2-8 weeks
|
Self administered questionnaire of person's satisfaction with care.
Total scores range from 13 to 65, with higher scores indicating higher patient satisfaction.
Scores reported from session 5.
|
2-8 weeks
|
|
Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores
Délai: baseline to 3 months, scores converted to yearly
|
Measure of nightmare frequency in number of nights with nightmares per year, scores converted to yearly.
|
baseline to 3 months, scores converted to yearly
|
|
Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores
Délai: baseline to 3 months (converted to yearly)
|
Self-administered measure of nightmare frequency in actual number of nightmares experienced over a 3 month period, and converted to yearly
|
baseline to 3 months (converted to yearly)
|
|
Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks
Délai: 2-8 weeks
|
The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner.
The scale focuses on task alliance, goal alliance, and bond formation.
Items range from 1- never to 7- always.
Scores range from 7-84.
Higher scores indicate better alliance.
Scores are reported from session 4.
|
2-8 weeks
|
|
Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks
Délai: 2-8 weeks
|
The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner.
The scale focuses on task alliance, goal alliance, and bond formation.
Items range from 1- never to 7- always.
Scores range from 7-84.
Higher scores indicate better alliance.
Scores are reported from session 4.
|
2-8 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Samuel T. Kuna, MD, Philadelphia VA Medical Center, Philadelphia, PA
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Processus pathologiques
- Maladies du système nerveux
- Troubles du sommeil, intrinsèques
- Dyssomnies
- Troubles du sommeil et de l'éveil
- Troubles liés aux traumatismes et aux facteurs de stress
- Maladie
- Troubles de l'initiation et du maintien du sommeil
- Troubles de stress, traumatiques
- Troubles de stress, post-traumatique
Autres numéros d'identification d'étude
- IIR 11-296
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
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .