- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02309060
Storytelling Video Intervention for Depressed Primary Care Patients - Open Trial (sTVi-Open)
Narrative Intervention to Disseminate ACT for Depression in Primary Care
The overall aim of this program of research is to develop a collaborative narrative intervention for patients with depression being treated in primary care.
The purpose of the proposed project is to establish the feasibility, acceptability, and preliminary effects of our newly developed narrative intervention on depression.
To achieve the specific aims, the investigators will conduct an open trial to further develop and refine the intervention (n = 10).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The public health impact of existing treatments for major depression is limited by our ability to disseminate those treatments. There is a particular need to find innovative ways to disseminate key principles of empirically supported psychotherapy in primary care settings. Narrative communication is an alternative way to disseminate psychotherapy behavior change principles. Narrative communication refers to "storytelling" -real people talking about their struggles and successful ways of coping. An advantage of narrative communication is that it can be easily distributed (by video) and may reach people who do not have access to other technologies or who experience barriers to traditional psychotherapy. We propose that key principles of a type of cognitive-behavioral therapy (Acceptance and Commitment Therapy, or ACT) can be readily disseminated through a video storytelling intervention. ACT is an empirically supported therapy for depression. Together with a video production firm with a record of working in healthcare and developing documentary-style videos, we will produce a storytelling video intervention (sTVi).
Our aim is to conduct a small open trial (n = 10) of antidepressant medication treatment as usual + sTVi. Assessments will occur at baseline and 4 weeks (post-treatment). We will examine the feasibility and acceptability of sTVi (e.g., uptake and completion of sTVi, engagement with videos, and understanding of key ACT principles) and of this research design. We will examine treatment effects (within relevant confidence intervals) on outcomes (e.g., depression severity). We will examine change in potential mechanisms, i.e., ACT-consistent coping strategies derived from key ACT principles.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Rhode Island
-
Pawtucket, Rhode Island, États-Unis, 02860
- Family Care Center of Memorial Hospital
-
Providence, Rhode Island, États-Unis, 02906
- Butler Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Meets DSM-5 criteria for current or lifetime major depressive disorder.
- No Lifetime diagnosis of bipolar disorder, schizophrenia, or chronic psychotic condition.
- No current hazardous illicit drug or alcohol use.
- No suicidal ideation or behavior requiring immediate attention.
- Depression symptom severity: a Quick Inventory of Depressive Symptoms (QIDS) score >11.
- Taking an antidepressant medication for at least 6 weeks; prescribed by their primary care provider.
- Not in psychotherapy during the study period.
- Have a PCP at our enrollment site.
- If pregnant, less than 24 weeks gestation.
- English speaking.
- Aged 18 or older.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Storytelling Video Intervention (sTVi)
We will develop a series of 4 videos, each episode approximately 30 minutes long, which will illustrate the key principles of Acceptance and Commitment Therapy. We will add a short, non-narrative, epilogue at the end of each of the 4 episodes that summarizes key messages and provides information on identifying signs of depression and suggestions for efficacious treatments. In addition, we will develop an accompanying "personal journal" for participants that includes a brief self-help guide which encourages participants to write about what they learned in the videos and how they will take similar steps in their own lives to cope with depression. |
Narrative communication, video-based intervention for depressed primary care patients.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Questionnaire de satisfaction client-8 (CSQ-8)
Délai: 4 semaines
|
4 semaines
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Quick Inventory of Depressive Symptomatology-Clinician Rating (QIDS-C)
Délai: 4 weeks
|
4 weeks
|
|
Acceptance and Action Questionnaire-II (AAQ-II)
Délai: 4 week
|
4 week
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- sTVi-1
- R34MH103568 (Subvention/contrat des NIH 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 .