The Effectiveness and Acceptability of Formal Versus Informal Mindful Self-Compassion for Adolescents

NCT07513220 | Recruiting

• 1 other identifier: CHA-IRB-25-26-434
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if two types of mindful self-compassion programs work to improve coping in adolescents. The investigators will also learn about adolescents' liking of, and the other potential mental health and academic benefits of, these programs. The main questions this clinical trial aims to answer are:

• Do two types of mindful self-compassion programs improve coping in adolescents?
• Do two types of mindful self-compassion programs improve mental health (e.g., stress, anxiety, depression) and academic outcomes (e.g., academic engagement) in adolescents?
• How satisfactory are two types of mindful self-compassion programs for adolescents? To do this, the investigators will compare adolescents who complete two types of mindful self-compassion programs to adolescents in a "waitlist control" condition (who complete no study tasks during the program period, but will have the opportunity to complete the program at the end of the study). Participants will:
• Complete a brief phone interview to confirm their eligibility (15 min)
• Complete an online survey including questions about coping, mental health, and academic engagement (30 min)
• Complete a live, online, four-week-long mindful self-compassion program OR no study tasks during this four-week period (if randomly assigned to a waitlist condition)
• Complete an online survey 1 week after the 4-week period, including questions about coping, mental health, and academic engagement, as well as their liking of the program they completed (if applicable)
• Complete an online survey 1 month after the 4-week period, including questions about coping, mental health, and academic engagement
• (Waitlist condition only) Have the opportunity to complete one of the two mindful self-compassion programs after the study had ended

Conditions

Coping

Outcome Measures

Primary Outcomes (1)

• Coping Index (CI)

  The Coping Index (CI; Stallman, 2017) is a 20-item self-report measure of healthy (10 items) and unhealthy (10 items) coping behaviors based on the Health Theory of Coping (Stallman, 2020). Respondents rate how often they use each behavior to feel better when they are feeling stressed or distressed using a 4-point Likert scale ranging from I do not do this at all (0) to I do this most of the time (3). The item, 'Have thoughts about suicide', will be omitted for the purposes of this study; an adapted 19-item version of the CI will therefore be used. A coping index score will be computed, which is the healthy subscale mean minus the unhealthy subscale mean (possible range: 3 to -3). A higher score reflects a better outcome.

  5 weeks (From baseline to 1 week post-intervention)

Secondary Outcomes (7)

• Coping Index (CI)

  9 weeks (From baseline to 1 month post-intervention)

• 18-item Five Facets of Mindfulness Questionnaire (FFMQ-18)

  5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)

• Self-Compassion Scale - Short Form (SCS-SF)

  5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)

• Perceived Stress Scale (PSS)

  5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)

• Generalized Anxiety Disorder (GAD-7) scale

  5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)

Other Outcomes (5)

• Self-Oriented Perfectionism subscale of the Multidimensional Perfectionism Scale (MPS)

  5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)

• Self-Critical Rumination Scale (SCRS)

  5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)

• Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)

  5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)

Study Arms (3)

Formal Mindful Self-Compassion (MSC-F)

EXPERIMENTAL

Participants assigned to the MSC-F condition (n=45) will complete a four-week-long live online mindful self-compassion program, which will include the instruction of formal practices (e.g., guided meditations).

Behavioral: Formal Mindful Self-Compassion (MSC-F)

Informal Mindful Self-Compassion (MSC-I)

EXPERIMENTAL

Participants assigned to the MSC-I condition (n=45) will complete a four-week-long live online mindful self-compassion program, which will include the instruction of informal practices (e.g., noticing day-to-day sensory experiences with mindful self-compassion).

Behavioral: Informal Mindful Self-Compassion (MSC-I)

Waitlist Control

NO INTERVENTION

Participants assigned to the waitlist control condition (n=45) will complete no study tasks during the 4-week intervention period, during which participants assigned to the MSC-F and MSC-I conditions complete their assigned programs. These waitlist control participants will be invited to complete one of the two programs at the end of the 9-week study period.

Interventions

Formal Mindful Self-Compassion (MSC-F) BEHAVIORAL

The MSC-F and MSC-I programs will be adaptations of the Mindful Self-Compassion - Teen (MSC-T) program (formerly Making Friends With Yourself; Bluth et al., 2016). MSC-T includes the instruction of both formal and informal practices; the adapted programs will thus disentangle the two approaches to allow for their direct comparison. The adapted MSC-F and MSC-I programs will comprise weekly hour-long virtual group sessions held over four weeks and led in real time by IRB-approved CHA researchers and clinicians. Each session will include (i) psychoeducation related to stress, mindfulness, self-compassion, and healthy/unhealthy coping, (ii) in-session mindfulness practice, and (iii) group discussion. Content will be identical across the MSC-F and MSC-I programs aside from the specific practices taught (i.e., whether exclusively formal or informal). Weekly home practice will be assigned and supporting handouts and audio files (where applicable) will be shared following each session.

Formal Mindful Self-Compassion (MSC-F)

Informal Mindful Self-Compassion (MSC-I) BEHAVIORAL

The MSC-F and MSC-I programs will be adaptations of the Mindful Self-Compassion - Teen (MSC-T) program (formerly Making Friends With Yourself; Bluth et al., 2016). MSC-T includes the instruction of both formal and informal practices; the adapted programs will thus disentangle the two approaches to allow for their direct comparison. The adapted MSC-F and MSC-I programs will comprise weekly hour-long virtual group sessions held over four weeks and led in real time by IRB-approved CHA researchers and clinicians. Each session will include (i) psychoeducation related to stress, mindfulness, self-compassion, and healthy/unhealthy coping, (ii) in-session mindfulness practice, and (iii) group discussion. Content will be identical across the MSC-F and MSC-I programs aside from the specific practices taught (i.e., whether exclusively formal or informal). Weekly home practice will be assigned and supporting handouts and audio files (where applicable) will be shared following each session.

Informal Mindful Self-Compassion (MSC-I)

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be 14-19 years of age for the duration of the study;
• If 14-17 years of age: have a parent with sufficient literacy skills to understand the consent process and have the ability to provide written informed consent, and have sufficient English fluency and literacy skills themselves to understand the assent process, procedures, and questionnaires and have the ability to provide written assent;
• If 18-19 years of age: have sufficient English fluency and literacy skills themselves to understand the consent process, procedures, and questionnaires and have the ability to provide written informed consent;
• Have access to the internet and an electronic device with adequate data capacity to complete questionnaires online and attend online videoconference groups;
• Be available and willing to attend the scheduled online videoconference groups for 4 weeks and complete the online assessments.

You may not qualify if:

• Current or past-year treatment with mindfulness-based psychotherapy (e.g., MBCT, DBT, or ACT);
• Current or past-year participation in a mindfulness- or compassion-based program;
• A routine of, on average, 10 minutes of mindfulness practice per day over the past 30 days (greater than or equal to 300 minutes);
• Simultaneous participation in another experimental research study;
• Current or past-year diagnosis of: schizophrenia spectrum or other psychotic disorder, bipolar 1 disorder, or severe substance/alcohol use disorder;
• Current or past-month suicidal ideation;
• Hospitalization for reasons related to mental health within the past 6 months;
• Recent modifications to psychiatric medication(s) (within the last 30 days or within the last 90 days for antidepressants (e.g., SSRI, SNRI, etc.);
• Inability to complete consent/assent process or baseline assessment.

Sponsors & Collaborators

• Cambridge Health Alliance: lead

Study Sites (1)

Center for Mindfulness and Compassion

Malden, Massachusetts, 02148, United States

RECRUITING

Study Officials

• Zev Schuman-Olivier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Petrovic, PhD

CONTACT

781-605-4429; mscteen@challiance.org

Frannie Marin, BS

CONTACT

617-643-8770; fmarin@challiance.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 7, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)