AnxietyM2MNCT03869749
The Moving 2 Mindful (M2M) Study: Mindfulness Group + Ecological Momentary Intervention
A study testing Learning to BREATHE Plus and Health and wellness in people with Anxiety and Stress, run by Colorado State University at 1 site in United States.
Trial summary
This study will evaluate the feasibility and acceptability of Learning to BREATHE (a mindfulness intervention for adolescents) plus an ecological momentary intervention (Learning to Breathe Plus), and will examine the extent to which mindfulness reduces dysregulated stress physiology, perceived stress, and anxiety in… Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- What is being tested?
- Learning to BREATHE Plus and Health and wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- two parents in the home
- an adolescent who is between 14 and 18 years of age
- marital distress and/or problematic interparental conflict (based on parent or youth reports)
- youth reports of stress or anxiety
Who cannot join
- two parents in the home, but they are pursuing legal divorce or separation
- parents are not willing to receive marital education/support
- adolescents are severely clinically depressed or report suicidal ideation at baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80525
About this study
Official title: Decreasing Stress and Anxiety in Adolescents From High-Conflict Homes: Testing a Mindfulness Group + Ecological Momentary Intervention
This study will evaluate the feasibility and acceptability of Learning to BREATHE (a mindfulness intervention for adolescents) plus an ecological momentary intervention (Learning to Breathe Plus), and will examine the extent to which mindfulness reduces dysregulated stress physiology, perceived stress, and anxiety in adolescents from high conflict homes.
Read the detailed description
Adolescents from homes with interparental conflict will be randomly assigned to Learning to BREATHE Plus (the standard group program designed to increase mindfulness, plus a multi-method adaptive intervention that will be comprised of an ecological momentary intervention and online library of mindfulness practices) or to a health and wellness active control condition to determine feasibility, acceptability, and potential effectiveness of Learning to BREATHE Plus.
- Being tested
- Learning to BREATHE Plus, Health and wellness
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning to BREATHE PlusBehavioural
Activities include psycho-education about stress and emotion regulation, and practices of body scanning, non-aerobic yoga, and meditation, which are designed to cultivate and provide opportunities to practice present-focused, non-judgmental attention.
Health and wellnessBehavioural
The Health Education Wellness Program (modeled after Hey Durham) (Bravender, 2005) will provide didactic information on substance use, nutrition/body image, stress management, exercise, and signs of depression/suicide.
| Study group | Role | What they receive |
|---|---|---|
| Learning to BREATHE Plus | Experimental | It is a 6-week manualized program; each meeting is 1.5 hours, for a total of 9 contact hours. It will be administered in a classroom at Colorado State University. Adolescents will be sent ecological momentary intervention text messages several times a day (with reminders, encouragement, and guides to practice mindfulness), and also have access to an on demand online library of mindfulness resources. Receives: Behavioral: Learning to BREATHE Plus |
| Health and wellness | Active comparator | It is a 6-week program; each meeting is 1.5 hours, for a total of 9 contact hours. It will be administered in a classroom at Colorado State University. Receives: Behavioral: Health and wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe implementation
Implementation without increase in symptomatology
Measured: Across 8-week intervention period
Recruitment of target sample size
Successful recruitment of 38 families (114 individuals)
Measured: Across 8-week intervention period
Enrollment of percent eligible
Enrolling a high percent of eligible families to the study/intervention
Measured: Across 8-week intervention period
Retention to interventions
A high proportion of adolescents will attend 4/6 sessions
Measured: Across 8-week intervention period
Secondary outcomes (2)
Feasibility of implementation
Successful implementation and retention to study (i.e., fidelity of intervention delivery >=80%, <=5% reports of not receiving ecological momentary intervention from adolescents, >=90% attendance at 4/6 sessions, >= retainment at post-group and follow-up)
Measured: Across 8-week intervention period
Acceptability of interventions
Rated by participants
Measured: Across 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start17 Feb 2021
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Why it stopped: Study was stopped early due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Model description
- Participants will be assigned to one of two study interventions in an open randomized trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869749
- Sponsor's protocol ID
- M2M
- Other IDs
- K01AT009592
- Acronym
- M2M
- Status last verified
- Jun 2023
- First submitted
- 14 Feb 2019
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers interested in using these data to test novel hypotheses can contact the corresponding author and submit a data proposal form to be reviewed by the study team.
Publications
Lucas-Thompson R, Seiter N, Broderick PC, Coatsworth JD, Henry KL, McKernan CJ, Smyth JM. Moving 2 Mindful (M2M) study protocol: testing a mindfulness group plus ecological momentary intervention to decrease stress and anxiety in adolescents from high-conflict homes with a mixed-method longitudinal design. BMJ Open. 2019 Nov 28;9(11):e030948. doi: 10.1136/bmjopen-2019-030948.
PubMed 31784436
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Stress and Anxiety in Adolescents From High-Conflict Homes: Testing a Mindfulness Group + Ecological Momentary Intervention
- ClinicalTrials.gov ID
- NCT03869749
- Acronym / sponsor ID
- M2M / M2M
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped early due to lack of enrollment.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the feasibility and acceptability of Learning to BREATHE (a mindfulness intervention for adolescents) plus an ecological momentary intervention (Learning to Breathe Plus), and will examine the extent to which mindfulness reduces dysregulated stress physiology, perceived stress, and anxiety in adolescents from high conflict homes.
Detailed description
Adolescents from homes with interparental conflict will be randomly assigned to Learning to BREATHE Plus (the standard group program designed to increase mindfulness, plus a multi-method adaptive intervention that will be comprised of an ecological momentary intervention and online library of mindfulness practices) or to a health and wellness active control condition to determine feasibility, acceptability, and potential effectiveness of Learning to BREATHE Plus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two study interventions in an open randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Learning to BREATHE Plus | Experimental | Behavioral: Learning to BREATHE PlusIt is a 6-week manualized program; each meeting is 1.5 hours, for a total of 9 contact hours. It will be administered in a classroom at Colorado State University. Adolescents will be sent ecological momentary intervention text messages several times a day (with reminders, encouragement, and guides to practice mindfulness), and also have access to an on demand online library of mindfulness resources. |
| Health and wellness | Active comparator | Behavioral: Health and wellnessIt is a 6-week program; each meeting is 1.5 hours, for a total of 9 contact hours. It will be administered in a classroom at Colorado State University. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- two parents in the home
- an adolescent who is between 14 and 18 years of age
- marital distress and/or problematic interparental conflict (based on parent or youth reports)
- youth reports of stress or anxiety
Key exclusion criteria (3 listed)
- two parents in the home, but they are pursuing legal divorce or separation
- parents are not willing to receive marital education/support
- adolescents are severely clinically depressed or report suicidal ideation at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Learning to BREATHE PlusActivities include psycho-education about stress and emotion regulation, and practices of body scanning, non-aerobic yoga, and meditation, which are designed to cultivate and provide opportunities to practice present-focused, non-judgmental attention. | Behavioural | Learning to BREATHE Plus |
| Health and wellnessThe Health Education Wellness Program (modeled after Hey Durham) (Bravender, 2005) will provide didactic information on substance use, nutrition/body image, stress management, exercise, and signs of depression/suicide. | Behavioural | Health and wellness |
Primary outcome
Safe implementation
Time frame: Across 8-week intervention period
Implementation without increase in symptomatology
Recruitment of target sample size
Time frame: Across 8-week intervention period
Successful recruitment of 38 families (114 individuals)
Enrollment of percent eligible
Time frame: Across 8-week intervention period
Enrolling a high percent of eligible families to the study/intervention
Retention to interventions
Time frame: Across 8-week intervention period
A high proportion of adolescents will attend 4/6 sessions
2 secondary outcomes
Feasibility of implementation
Time frame: Across 8-week intervention period
Acceptability of interventions
Time frame: Across 8-week intervention period
Results and safety
The study was stopped early (reason given: Study was stopped early due to lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Background: PubMed 31784436Lucas-Thompson R, Seiter N, Broderick PC, Coatsworth JD, Henry KL, McKernan CJ, Smyth JM. Moving 2 Mindful (M2M) study protocol: testing a mindfulness group plus ecological momentary intervention to decrease stress and anxiety in adolescents from high-conflict homes with a mixed-method longitudinal design. BMJ Open. 2019 Nov 28;9(11):e030948. doi: 10.1136/bmjopen-2019-030948.
- Individual participant dataSharing planned: No. Researchers interested in using these data to test novel hypotheses can contact the corresponding author and submit a data proposal form to be reviewed by the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning to BREATHE Plus and Health and wellness in people with Anxiety and Stress, run by Colorado State University 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 23 Jun 2023. 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?
The study was stopped early (reason given: Study was stopped early due to lack of enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safe implementation (time frame: Across 8-week intervention period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03869749, which also lists 1 linked publication.
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 23 Jun 2023.