Anxiety, Anxiety Depression, Depression, Rumination - Thoughts, Worry
Conditions
Keywords
Imperial Valley College, Community College, Depression, Worry, Anxiety, Mental Health, STAND, Calming Minds
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBe 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.
BEHAVIORALBe 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.
BEHAVIORALBe 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.
BEHAVIORALBreak 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.
BEHAVIORALPsychoeducation
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.
Sponsors
University of California, Los Angeles
University of Exeter
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized in a factorial design to one of 16 conditions for treatment, each consisting of 1-5 treatment components from Rumination-Focused CBT (RF-CBT). All participants will be exposed to a default core common content (e.g. psychoeducation about RNT and CBT approaches to coping) such that all participants receive a minimal-level intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perseverative Thinking Questionnaire score from baseline to post-intervention | Baseline, 16 weeks | Change in repetitive negative thought as indexed by the Perseverative Thinking questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in GAD-7 score from baseline to post-intervention | Baseline, 16 weeks & 52 weeks | Change in anxiety measured with GAD-7 |
| Change in PHQ-9 score from baseline to post-intervention | Baseline, 16 weeks & 52 weeks | Change in depression measured with PHQ-9 |
| Change in WEMWBS from baseline to post-intervention | Baseline, 16 weeks & 52 weeks | Change in mental wellbeing measured with WEMWBS (Warwick-Edinburgh Mental Wellbeing Scale short-form) |
| Change in RRS-Brooding subscale from baseline to post-intervention | Baseline, 16 weeks & 52 weeks | Change in levels of rumination measured with RRS-Brooding subscale |
| Change in PSWQ score from baseline to post-intervention | Baseline, 16 weeks & 52 weeks | Change in levels of worry measured with PSWQ (Penn State Worry Questionnaire short-form) |
| Change in WSAS score from baseline to post-intervention | Baseline, 16 weeks & 52 weeks | Change in social functioning measured with WSAS (Work and Social Adjustment Scale) |
| Change in EMA from baseline to post-intervention | 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. |
Countries
United States
Outcome results
None listed