- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07577401
Calming Minds Study
Understanding the Mechanisms Driving the Reduction of Repetitive Negative Thought
The goal of this study is to understand why certain treatments help people reduce repetitive negative thinking (RNT), which is common in many mental health problems. We want to:
- Figure out what actually causes repetitive negative thinking to decrease when people use cognitive-behavioral therapy (CBT).
- Find out which parts of RNT-focused CBT are the most important - the parts that truly make a difference in reducing RNT.
The main result we will look at is how much a person's repetitive negative thought patterns change from the start of the study to the end of treatment (16 weeks). We will measure this using the Perseverative Thinking Questionnaire at baseline and week 16.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Participants in this study will be randomly assigned to one of 16 different treatment groups. Each group will get a different mix of 1-5 tools or strategies taken from Rumination-Focused Cognitive Behavioral Therapy (RF-CBT).
All participants, regardless of their treatment assignment, will get a basic set of lessons about repetitive negative thinking (RNT) and how CBT can help. This means every participant gets therapeutic support.
Participants will use a digital therapy program through the MyDataHelps app. The CBT lessons are available in English or Spanish, according to the participant's preference. Each participant will also be offered 3-6 meetings with a coach from our team, to review the lessons and tools in the digital therapy program. It is expected that the digital therapy program and coaching sessions will be completed within 4 months on study. Once 4 months have passed since their start on study, participants are asked to complete online questionnaires that will measure their recent symptom experiences. Participants are then asked to complete these questionnaires again 1 year after starting on study. These questionnaires are used to measure changes in symptom experiences from baseline (before starting the digital therapy program).
In addition to the primary goals listed in the brief summary, this study also aims to look at the following:
- How anxiety and depression symptoms change during their use of the digital therapy program.
- Whether people's mental health symptoms change over time after using the digital therapy program.
d) Who benefits most from which components, so therapy can be more personalized in the future.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
-
Imperial, California, États-Unis, 92251
- Imperial Valley College
-
Contact:
- Research Coordinator
- Numéro de téléphone: (310) 825-8403
- E-mail: calmingminds@mednet.ucla.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Aged 18+ years
- Able to provide a valid Imperial Valley College email address
- Access to a suitable smartphone/device (iPhone 8+ running iOS 16.4 or higher, or Android version 8 or higher)
- Access to internet
- Elevated repetitive negative thought (RNT) based on scores from Ruminative Response Scale Brood subscale (RSS-brood) and Penn State Worry Questionnaire (PSWQ)
Exclusion Criteria:
- Concurrent psychotherapy
- Self-reported current or past diagnosis or treatment for Psychosis
- Self-reported current or past diagnosis or treatment for Bipolar disorder
- Self-reported current or past diagnosis or currently receiving, or waiting to receive, treatment for substance abuse/dependence
- Self-reported current diagnosis or currently receiving, or waiting to receive, treatment for alcohol abuse/dependence
- Antidepressant/anxiolytic medication that has changed in dose or nature in last 6 weeks
- Current severe PTSD defined as measured by the adapted International Trauma Questionnaire
- Active suicidal thoughts or self-harm
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Psychoeducation Only
Participants receive only core psychoeducation without any additional RF-CBT components.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
|
|
Expérimental: Be Specific
Participants receive training in increasing specificity and concreteness ("Be Specific") in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
|
|
Expérimental: Be Kind
Participants receive training in self-compassion ("Be Kind") in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
|
|
Expérimental: Break Habit
Participants receive training in breaking the habit of repetitive negative thinking ("Break Habit") in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
|
|
Expérimental: Be Present
Participants receive training in absorption in direct experience ("Be Present") in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
Expérimental: Be Specific + Be Kind
Participants receive training in both specificity/concreteness and self-compassion in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
|
|
Expérimental: Be Specific + Be Present
Participants receive training in both specificity/concreteness and absorption in direct experience in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
Expérimental: Be Kind + Be Present
Participants receive training in both self-compassion and absorption in direct experience in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
Expérimental: Be Specific + Be Kind + Be Present
Participants receive training in specificity/concreteness, self-compassion, and absorption in direct experience in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
Expérimental: Break Habit + Be Specific
Participants receive training in both breaking the habit of RNT and increasing specificity/concreteness in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
|
|
Expérimental: Break Habit + Be Kind
Participants receive training in both breaking the habit of RNT and self-compassion in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
|
|
Expérimental: Break Habit + Be Specific + Be Kind
Participants receive training in breaking the habit of RNT, specificity/concreteness, and self-compassion in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
|
|
Expérimental: Break Habit + Be Present
Participants receive training in both breaking the habit of RNT and absorption in direct experience in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
Expérimental: Break Habit + Be Specific+ Be Present
Participants receive training in breaking the habit of RNT, specificity/concreteness, and absorption in direct experience in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
Expérimental: Break Habit + Be Kind + Be Present
Participants receive training in breaking the habit of RNT, self-compassion, and absorption in direct experience in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
Expérimental: ALL
Participants receive training in all four RF-CBT components: breaking the habit of RNT, specificity/concreteness, self-compassion, and absorption in direct experience; in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Perseverative Thinking Questionnaire score from baseline to post-intervention
Délai: Baseline, 16 weeks
|
Change in repetitive negative thought as indexed by the Perseverative Thinking questionnaire
|
Baseline, 16 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in GAD-7 score from baseline to post-intervention
Délai: Baseline, 16 weeks & 52 weeks
|
Change in anxiety measured with GAD-7
|
Baseline, 16 weeks & 52 weeks
|
|
Change in PHQ-9 score from baseline to post-intervention
Délai: Baseline, 16 weeks & 52 weeks
|
Change in depression measured with PHQ-9
|
Baseline, 16 weeks & 52 weeks
|
|
Change in WEMWBS from baseline to post-intervention
Délai: Baseline, 16 weeks & 52 weeks
|
Change in mental wellbeing measured with WEMWBS (Warwick-Edinburgh Mental Wellbeing Scale short-form)
|
Baseline, 16 weeks & 52 weeks
|
|
Change in RRS-Brooding subscale from baseline to post-intervention
Délai: Baseline, 16 weeks & 52 weeks
|
Change in levels of rumination measured with RRS-Brooding subscale
|
Baseline, 16 weeks & 52 weeks
|
|
Change in PSWQ score from baseline to post-intervention
Délai: Baseline, 16 weeks & 52 weeks
|
Change in levels of worry measured with PSWQ (Penn State Worry Questionnaire short-form)
|
Baseline, 16 weeks & 52 weeks
|
|
Change in WSAS score from baseline to post-intervention
Délai: Baseline, 16 weeks & 52 weeks
|
Change in social functioning measured with WSAS (Work and Social Adjustment Scale)
|
Baseline, 16 weeks & 52 weeks
|
|
Change in EMA from baseline to post-intervention
Délai: Baseline, 16 weeks
|
Change in repetitive negative thought (RNT) in everyday life measured with ecological momentary assessment (EMA) (aggregrate person-level ratings of RNT across 10 day period; variability of RNT; relationship of RNT to mood state & contextual events; automaticity of RNT, based on EMA items).
This provides an ecologically valid measure, in the real-world, of extent of RNT and how it changes pre-to-post intervention.
|
Baseline, 16 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB-25-1994
Informations sur les médicaments et les dispositifs, documents d'étude
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