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AnxietyNCT07577401

Calming Minds Study

A study testing Be Specific, Be Kind and Be Present in people with Anxiety and Anxiety Depression, run by University of California, Los Angeles at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety, Anxiety Depression, Worry
What is being tested?
Be Specific, Be Kind and Be Present
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
8 Jun 2026to 14 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Imperial Valley College

    Imperial, California, 92251

    Research Coordinator, (310) 825-8403, calmingminds@mednet.ucla.edu

Other trials in United States

About this study

Official title: 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:

  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.

Read the 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.
  3. Who benefits most from which components, so therapy can be more personalized in the future.
Being tested
Be Specific, Be Kind, Be Present, Break Habit, Psychoeducation
Keywords
Imperial Valley College, Community College, Depression, Worry, Anxiety, Mental Health, STAND, Calming Minds
Medical subject headings
Anxiety Disorders, Depression, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Be SpecificBehavioural

    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.

  • Be KindBehavioural

    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.

  • Be PresentBehavioural

    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.

  • Break HabitBehavioural

    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.

  • PsychoeducationBehavioural

    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.

Study groups in NCT07577401
Study groupRoleWhat they receive
Psychoeducation OnlyActive comparatorParticipants receive only core psychoeducation without any additional RF-CBT components.
Receives: Behavioral: Psychoeducation
Be SpecificExperimentalParticipants receive training in increasing specificity and concreteness ("Be Specific") in addition to standard psychoeducation.
Receives: Behavioral: Be Specific; Behavioral: Psychoeducation
Be KindExperimentalParticipants receive training in self-compassion ("Be Kind") in addition to standard psychoeducation.
Receives: Behavioral: Be Kind; Behavioral: Psychoeducation
Break HabitExperimentalParticipants receive training in breaking the habit of repetitive negative thinking ("Break Habit") in addition to standard psychoeducation.
Receives: Behavioral: Break Habit; Behavioral: Psychoeducation
Be PresentExperimentalParticipants receive training in absorption in direct experience ("Be Present") in addition to standard psychoeducation.
Receives: Behavioral: Be Present; Behavioral: Psychoeducation
Be Specific + Be KindExperimentalParticipants receive training in both specificity/concreteness and self-compassion in addition to standard psychoeducation.
Receives: Behavioral: Be Specific; Behavioral: Be Kind; Behavioral: Psychoeducation
Be Specific + Be PresentExperimentalParticipants receive training in both specificity/concreteness and absorption in direct experience in addition to standard psychoeducation.
Receives: Behavioral: Be Specific; Behavioral: Be Present; Behavioral: Psychoeducation
Be Kind + Be PresentExperimentalParticipants receive training in both self-compassion and absorption in direct experience in addition to standard psychoeducation.
Receives: Behavioral: Be Kind; Behavioral: Be Present; Behavioral: Psychoeducation
Be Specific + Be Kind + Be PresentExperimentalParticipants receive training in specificity/concreteness, self-compassion, and absorption in direct experience in addition to standard psychoeducation.
Receives: Behavioral: Be Specific; Behavioral: Be Kind; Behavioral: Be Present; Behavioral: Psychoeducation
Break Habit + Be SpecificExperimentalParticipants receive training in both breaking the habit of RNT and increasing specificity/concreteness in addition to standard psychoeducation.
Receives: Behavioral: Be Specific; Behavioral: Break Habit; Behavioral: Psychoeducation
Break Habit + Be KindExperimentalParticipants receive training in both breaking the habit of RNT and self-compassion in addition to standard psychoeducation.
Receives: Behavioral: Be Kind; Behavioral: Break Habit; Behavioral: Psychoeducation
Break Habit + Be Specific + Be KindExperimentalParticipants receive training in breaking the habit of RNT, specificity/concreteness, and self-compassion in addition to standard psychoeducation.
Receives: Behavioral: Be Specific; Behavioral: Be Kind; Behavioral: Break Habit; Behavioral: Psychoeducation
Break Habit + Be PresentExperimentalParticipants receive training in both breaking the habit of RNT and absorption in direct experience in addition to standard psychoeducation.
Receives: Behavioral: Be Present; Behavioral: Break Habit; Behavioral: Psychoeducation
Break Habit + Be Specific+ Be PresentExperimentalParticipants receive training in breaking the habit of RNT, specificity/concreteness, and absorption in direct experience in addition to standard psychoeducation.
Receives: Behavioral: Be Specific; Behavioral: Be Present; Behavioral: Break Habit; Behavioral: Psychoeducation
Break Habit + Be Kind + Be PresentExperimentalParticipants receive training in breaking the habit of RNT, self-compassion, and absorption in direct experience in addition to standard psychoeducation.
Receives: Behavioral: Be Kind; Behavioral: Be Present; Behavioral: Break Habit; Behavioral: Psychoeducation
ALLExperimentalParticipants 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.
Receives: Behavioral: Be Specific; Behavioral: Be Kind; Behavioral: Be Present; Behavioral: Break Habit; Behavioral: Psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Perseverative Thinking Questionnaire score from baseline to post-intervention

    Change in repetitive negative thought as indexed by the Perseverative Thinking questionnaire

    Measured: Baseline, 16 weeks

Secondary outcomes (7)
  1. Change in GAD-7 score from baseline to post-intervention

    Change in anxiety measured with GAD-7

    Measured: Baseline, 16 weeks & 52 weeks

  2. Change in PHQ-9 score from baseline to post-intervention

    Change in depression measured with PHQ-9

    Measured: Baseline, 16 weeks & 52 weeks

  3. Change in WEMWBS from baseline to post-intervention

    Change in mental wellbeing measured with WEMWBS (Warwick-Edinburgh Mental Wellbeing Scale short-form)

    Measured: Baseline, 16 weeks & 52 weeks

  4. Change in RRS-Brooding subscale from baseline to post-intervention

    Change in levels of rumination measured with RRS-Brooding subscale

    Measured: Baseline, 16 weeks & 52 weeks

  5. Change in PSWQ score from baseline to post-intervention

    Change in levels of worry measured with PSWQ (Penn State Worry Questionnaire short-form)

    Measured: Baseline, 16 weeks & 52 weeks

  6. Change in WSAS score from baseline to post-intervention

    Change in social functioning measured with WSAS (Work and Social Adjustment Scale)

    Measured: Baseline, 16 weeks & 52 weeks

  7. Change in EMA from baseline to post-intervention

    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.

    Measured: Baseline, 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2026
  2. Study start8 Jun 2026 (estimated)
  3. Primary completion14 Jun 2028 (estimated)
  4. Study completion14 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07577401
Sponsor's protocol ID
IRB-25-1994
Status last verified
May 2026
First submitted
3 May 2026
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Be Specific, Be Kind and Be Present in people with Anxiety and Anxiety Depression, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Perseverative Thinking Questionnaire score from baseline to post-intervention (time frame: Baseline, 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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