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Personalizing Interventions Using Real-World Interactions

10 décembre 2020 mis à jour par: Kyle S. Minor, Indiana University

Personalizing Interventions Using Real-World Interactions: Improving Symptoms and Social Functioning in Schizophrenia With Tailored Metacognitive Therapy

Social functioning deficits are among the most disabling and difficult to treat aspects of schizophrenia. An essential component of social functioning is metacognition-a process that is profoundly disrupted in schizophrenia and represents the ability to reflect upon the mental states of oneself and others. To date, treatment efforts in schizophrenia have been hindered by barriers in accurately monitoring client's real-world social interactions. Recently, wearable technologies have evolved to provide therapists with innovative, ecologically-valid tools. The Electronically Activated Recorder is a wearable audio recorder that collects behavioral samples at pre-programmed intervals; it holds great promise as a method for yielding concrete, real-world examples of social interactions that can be used by therapists in session to enhance metacognition. Despite the immense costs of social functioning deficits, no previous studies have investigated whether functioning can be improved by integrating wearable audio recorders with psychosocial interventions.

By enhancing therapy using a wearable recording device, this proposal's primary goal is to implement a novel intervention that targets metacognitive deficits to improve social functioning. The novel intervention will be tailored to individual clients-based on the content of recorded social interactions-in a way that is not possible using traditional psychotherapy. This will allow clients and therapists to step out of the therapy room by offering a window into how clients process material in real-world interactions. In this study, a randomized controlled trial will be conducted with two schizophrenia groups receiving six months of individualized: 1) Metacognition Reflection and Insight Therapy (MERIT) alone (Standard MERIT); and 2) Tailored MERIT using wearable audio recorders. In this study, our specific aims will test feasibility, effectiveness, and acceptability of Tailored MERIT.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Réel)

34

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Positive screen for metacognitive dysfunction
  • Serious Mental Illness diagnosis (schizophrenia-spectrum)
  • Age 18-60
  • English fluency
  • Currently in non-acute phase of illness

Exclusion Criteria:

  • Inability to provide informed consent
  • Current substance dependence
  • Documented intellectual disability

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Standard MERIT
24 sessions of Metacognition Reflection and Insight Therapy
see arm description
Expérimental: Tailored MERIT
24 sessions of personalized Metacognition Reflection and Insight Therapy (sessions personalized using real-world interactions)
see arm description

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Global Functioning Scale: Social (GFS)
Délai: Change from baseline social functioning to social functioning after 6 months of MERIT
10-point measure of social functioning (1 to 10, with increasing scores indicating greater social functioning)
Change from baseline social functioning to social functioning after 6 months of MERIT
Metacognitive Beliefs Questionnaire-Brief (MCQ-30)
Délai: Change from baseline metacognition to metacognition after 6 months of MERIT
30 item measure of metacognition; each item is rated on a 1 to 4 scale with decreasing scores representing better metacognitive functioning.
Change from baseline metacognition to metacognition after 6 months of MERIT
The Positive and Negative Syndrome Scale (PANSS)
Délai: Change from baseline symptoms to symptoms after 6 months of MERIT
30 item measure of symptoms; each item is rated 1 to 7, with greater scores representing more severe symptoms (and lower scores indicating better functioning)
Change from baseline symptoms to symptoms after 6 months of MERIT
EAR Adherence
Délai: Average of EAR adherence from baseline and 6 month assessment sessions
Objective measure of how often EAR was worn; 0 (not worn) and 1 (worn) scores given at each of 48 potential time points. Total score represents frequency that the EAR is worn across all time points.
Average of EAR adherence from baseline and 6 month assessment sessions
EAR Experiential Questionnaire
Délai: Average of EAR acceptability from baseline and 6 month assessment sessions
Assessment of how acceptable wearing the EAR was and how typical days were that EAR was worn. Scores for each item range from 1 to 5 with greater scores indicating greater problems (and lower acceptability).
Average of EAR acceptability from baseline and 6 month assessment sessions

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Quality of Life Scale
Délai: Change from baseline quality of life to quality of life after 6 months of MERIT
21 item measure of quality of life; each item is rated from 0 to 6, with greater scores indicating greater quality of life.
Change from baseline quality of life to quality of life after 6 months of MERIT
Metacognition Assessment Scale- Abbreviated (MAS-A)
Délai: Change from baseline metacognitive capacity to metacognitive capacity after 6 months of MERIT
Clinician-rated measure of metacognition using a semi structured clinical interview; four areas of capacity are rated (0 to 28 on overall scale); for each, increasing scores represent greater capacity.
Change from baseline metacognitive capacity to metacognitive capacity after 6 months of MERIT
Short Form Health Survey (SF-36
Délai: Change from baseline functioning to functioning after 6 months of MERIT
36 item measure of social functioning and general health behaviors; each item on a different scale but greater scores indicate better overall functioning.
Change from baseline functioning to functioning after 6 months of MERIT
Objective Behaviors from the Electronically Activated Recorder
Délai: Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)
EAR coding can be implemented to rate different forms of objective behaviors; codes generated using different scales but primarily use a 0 (not present) or 1 (present) coding scheme. Greater scores typically represent presence of that which is being coded.
Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)
Scale to Assess Unawareness of Mental Disorder
Délai: Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)
Insight measure; three items rated on 1 to 5 scale, with increasing scores indicating poorer insight.
Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

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Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juillet 2016

Achèvement primaire (Réel)

15 mars 2020

Achèvement de l'étude (Réel)

15 mars 2020

Dates d'inscription aux études

Première soumission

5 décembre 2020

Première soumission répondant aux critères de contrôle qualité

10 décembre 2020

Première publication (Réel)

11 décembre 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 décembre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 décembre 2020

Dernière vérification

1 décembre 2020

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • MERIT EAR Study

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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 .

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