The Moving 2 Mindful (M2M) Study: Mindfulness Group + Ecological Momentary Intervention (M2M)
Primary Purpose
Anxiety, Stress
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Learning to BREATHE Plus
Health and wellness
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Colorado State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Learning to BREATHE Plus
Health and wellness
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Safe implementation
Implementation without increase in symptomatology
Recruitment of target sample size
Successful recruitment of 38 families (114 individuals)
Enrollment of percent eligible
Enrolling a high percent of eligible families to the study/intervention
Retention to interventions
A high proportion of adolescents will attend 4/6 sessions
Secondary Outcome Measures
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)
Acceptability of interventions
Rated by participants
Full Information
NCT ID
NCT03869749
First Posted
February 14, 2019
Last Updated
June 21, 2023
Sponsor
Colorado State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT03869749
Brief Title
The Moving 2 Mindful (M2M) Study: Mindfulness Group + Ecological Momentary Intervention
Acronym
M2M
Official Title
Decreasing Stress and Anxiety in Adolescents From High-Conflict Homes: Testing a Mindfulness Group + Ecological Momentary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped early due to lack of enrollment.
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
November 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to one of two study interventions in an open randomized trial.
Masking
InvestigatorOutcomes Assessor
Masking Description
The majority of study personnel, including the PI and study statistician, will be blinded until database lock. All individuals who will be involved with endpoint assessment will be blinded until database lock. Intervention facilitators will not be blinded, but will not be involved in endpoint assessment.
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Learning to BREATHE Plus
Arm Type
Experimental
Arm Description
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.
Arm Title
Health and wellness
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Learning to BREATHE Plus
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health and wellness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safe implementation
Description
Implementation without increase in symptomatology
Time Frame
Across 8-week intervention period
Title
Recruitment of target sample size
Description
Successful recruitment of 38 families (114 individuals)
Time Frame
Across 8-week intervention period
Title
Enrollment of percent eligible
Description
Enrolling a high percent of eligible families to the study/intervention
Time Frame
Across 8-week intervention period
Title
Retention to interventions
Description
A high proportion of adolescents will attend 4/6 sessions
Time Frame
Across 8-week intervention period
Secondary Outcome Measure Information:
Title
Feasibility of implementation
Description
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)
Time Frame
Across 8-week intervention period
Title
Acceptability of interventions
Description
Rated by participants
Time Frame
Across 8-week intervention period
Other Pre-specified Outcome Measures:
Title
Mindfulness, self-reported
Description
Adolescents reported mindfulness (Mindfulness Awareness and Attention Scale, Adolescent Version; Brown, West, Loverich, & Biegel, 2011). There are 14 items on this scale, each answered on a scale from 1 (almost always) to 6 (almost never). Answer across 14 items are averaged such that higher scores indicate higher trait mindfulness (minimum = 1; maximum = 6).
Time Frame
Up to 3 months of follow-up
Title
Mindfulness, observed
Description
Adolescents observed distress tolerance, an important component of mindfulness (Behavioral Indicator of Resiliency to Distress; Lejeuz et al., 2006)
Time Frame
Up to 3 months of follow-up
Title
Self-compassion, self-reported
Description
Self-Compassion Scale, short form (Raes, Pommier, Neff, & Van Gucht, 2011). This scale has 12 items, answered on a scale from 1 (almost never) to 5 (almost always). There are 6 subscales measured on this scale, each with 2 items: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Subscale and total scores are calculated based on means after reverse scoring so that high scores indicate higher self-compassion (minimum: 1; maximum: 5).
Time Frame
Up to 3 months of follow-up
Title
Adolescent reports of emotion regulation
Description
Emotion regulation (Difficulties in Emotion Regulation Scale; Gratz & Roemer, 2004). This scale has 36 items that measure difficulties in 6 sub-dimensions of emotion regulation: nonacceptance of emotional responses (6 items: minimum: 1; maximum: 36), difficulties engaging in goal-directed behavior (5 items: minimum: 1; maximum: 30), impulse control difficulties (6 items: minimum: 1; maximum: 36), lack of emotional awareness (6 items: minimum: 1; maximum: 36), limited access to emotion regulation strategies (8 items: minimum: 1, maximum 48), and lack of emotional clarity (5 items: minimum: 1; maximum: 30). Questions are answered on a scale from 1 (almost never) to 5 (almost always). Subscale and total scores are summed such that higher scores indicate greater difficulties with emotion regulation (total scores: minimum: 1, maximum: 180).
Time Frame
Up to 3 months of follow-up
Title
Anxiety
Description
Parent and adolescent reported youth anxiety (Revised Child Anxiety and Depression Scale; Chorpita, Yim, Moffitt, Umemoto, & Francis, 2000). This scale has 47 items answered on a scale from 0 (never) to 3 (always), and answers are summed. Total scores range from 0 to 141, with higher scores reflecting more symptoms of anxiety and depression. Subscales can also be used to calculate scores for separation anxiety (7 items; minimum: 0, maximum: 21), social anxiety (9 items; minimum: 0, maximum 27), obsessive/compulsions (6 items; minimum: 0, maximum: 18), panic/agoraphobia (9 items; minimum: 0, maximum: 27), generalized anxiety (6 items; minimum: 0, maximum: 18), and major depression (10 items; minimum: 0, maximum: 30), with higher scores reflecting more symptoms.
Time Frame
Up to 3 months of follow-up
Title
Cortisol stress reactivity
Description
Cortisol reactivity to a stressor (saliva samples after baseline and immediately as well as 10 and 20m after stressor); area under the curve will be calculated
Time Frame
Up to 3 months of follow-up
Title
Cardiovascular stress reactivity
Description
Adolescent cardiovascular reactivity to a stressor (across three minutes intervals at baseline and during the stressor); change from baseline to stressor will be calculated
Time Frame
Up to 3 months of follow-up
Title
Diurnal cortisol production
Description
Cortisol production across the day (participants will be asked to provide samples upon awakening, 30 minutes after waking, at 4:00 PM, and before brushing their teeth for bed) to calculate cortisol awakening responses and decreases in cortisol production from morning to evening
Time Frame
Up to 3 months of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
31784436
Citation
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.
Results Reference
background
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The Moving 2 Mindful (M2M) Study: Mindfulness Group + Ecological Momentary Intervention
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