Calming Minds Study

Официальное название

Understanding the Mechanisms Driving the Reduction of Repetitive Negative Thought

Обзор

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: 1. Figure out what actually causes repetitive negative thinking to decrease when people use cognitive-behavioral therapy (CBT). 2. 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.

Подробное описание

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:

1. How anxiety and depression symptoms change during their use of the digital therapy program. 2. 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.

Вмешательства

• Поведенческое Be Specific
  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.
• Поведенческое Be Kind
  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.
• Поведенческое Be Present
  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.
• Поведенческое Break Habit
  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.
• Поведенческое 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.

Первичные конечные точки

• Change in Perseverative Thinking Questionnaire score from baseline to post-intervention [Срок оценки: Baseline, 16 weeks]

Вторичные конечные точки (7)

• Change in GAD-7 score from baseline to post-intervention [Срок оценки: Baseline, 16 weeks & 52 weeks]
• Change in PHQ-9 score from baseline to post-intervention [Срок оценки: Baseline, 16 weeks & 52 weeks]
• Change in WEMWBS from baseline to post-intervention [Срок оценки: Baseline, 16 weeks & 52 weeks]
• Change in RRS-Brooding subscale from baseline to post-intervention [Срок оценки: Baseline, 16 weeks & 52 weeks]
• Change in PSWQ score from baseline to post-intervention [Срок оценки: Baseline, 16 weeks & 52 weeks]
• Change in WSAS score from baseline to post-intervention [Срок оценки: Baseline, 16 weeks & 52 weeks]
• Change in EMA from baseline to post-intervention [Срок оценки: Baseline, 16 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Imperial Valley College — Imperial

Идентификаторы

NCT: NCT07577401 · IRB-25-1994

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗