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

Anxiety Clinical Trial

— M2M  

Official title:

Decreasing Stress and Anxiety in Adolescents From High-Conflict Homes: Testing a Mindfulness Group + Ecological Momentary Intervention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03869749
• Other study ID #: M2M
• Secondary ID: K01AT009592
• Status: Terminated
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: November 10, 2022

Study information

• Verified date: June 2023
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 adolescents from high conflict homes.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 10, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Stress

Intervention

Behavioral:
• Learning to BREATHE Plus
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 wellness
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.

Locations

Country	Name	City	State
United States	Colorado State University	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Colorado State University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mindfulness, self-reported	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).	Up to 3 months of follow-up
Other	Mindfulness, observed	Adolescents observed distress tolerance, an important component of mindfulness (Behavioral Indicator of Resiliency to Distress; Lejeuz et al., 2006)	Up to 3 months of follow-up
Other	Self-compassion, self-reported	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).	Up to 3 months of follow-up
Other	Adolescent reports of emotion regulation	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).	Up to 3 months of follow-up
Other	Anxiety	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.	Up to 3 months of follow-up
Other	Cortisol stress reactivity	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	Up to 3 months of follow-up
Other	Cardiovascular stress reactivity	Adolescent cardiovascular reactivity to a stressor (across three minutes intervals at baseline and during the stressor); change from baseline to stressor will be calculated	Up to 3 months of follow-up
Other	Diurnal cortisol production	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	Up to 3 months of follow-up
Primary	Safe implementation	Implementation without increase in symptomatology	Across 8-week intervention period
Primary	Recruitment of target sample size	Successful recruitment of 38 families (114 individuals)	Across 8-week intervention period
Primary	Enrollment of percent eligible	Enrolling a high percent of eligible families to the study/intervention	Across 8-week intervention period
Primary	Retention to interventions	A high proportion of adolescents will attend 4/6 sessions	Across 8-week intervention period
Secondary	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)	Across 8-week intervention period
Secondary	Acceptability of interventions	Rated by participants	Across 8-week intervention period