The Moving 2 Mindful (M2M) Study: Mindfulness Group + Ecological Momentary Intervention

NCT03869749 | Terminated DMC

• 2 other identifiers: M2MK01AT009592
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Stress

Outcome Measures

Primary Outcomes (4)

• Safe implementation

  Implementation without increase in symptomatology

  Across 8-week intervention period

• Recruitment of target sample size

  Successful recruitment of 38 families (114 individuals)

  Across 8-week intervention period

• Enrollment of percent eligible

  Enrolling a high percent of eligible families to the study/intervention

  Across 8-week intervention period

• Retention to interventions

  A high proportion of adolescents will attend 4/6 sessions

  Across 8-week intervention period

Secondary Outcomes (2)

• Feasibility of implementation

  Across 8-week intervention period

• Acceptability of interventions

  Across 8-week intervention period

Other Outcomes (8)

• Mindfulness, self-reported

  Up to 3 months of follow-up

• Mindfulness, observed

  Up to 3 months of follow-up

• Self-compassion, self-reported

  Up to 3 months of follow-up

Study Arms (2)

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.

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.

Behavioral: Health and wellness

Interventions

Learning to BREATHE Plus BEHAVIORAL

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.

Learning to BREATHE Plus

Health and wellness BEHAVIORAL

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.

Health and wellness

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80525, United States

Location

Related Publications (1)

• 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.

  PMID: 31784436 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Health

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to one of two study interventions in an open randomized trial.

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 11, 2019
• Study Start: February 17, 2021
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)