NCT07513220

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

Formal Versus Informal Mindful Self-Compassion Programming for Adolescents

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Cambridge Health Alliance · Academic / Other
• Sex: All
• Age: 14 Years – 19 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn if two types of mindful self-compassion programs work to improve coping in adolescents. We 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, researchers 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

Detailed description

Background Over the past decade, increasing smartphone and social media usage have magnified social pressures among adolescents. In turn, these youth report heightened stress and self-criticism, and often turn to unhealthy coping behaviors (e.g., substance use, disordered eating, self-injury) that can become life-threatening, making this a critical issue in youth mental health. Emerging evidence suggests that group-based mindful self-compassion (MSC) interventions may improve adolescents' mental health and encourage their use of healthy coping behaviors. However, challenges persist regarding adherence to standard length (i.e., eight-week) programs and low engagement with formal mindfulness practice (e.g., meditation) among adolescents; briefer programs and a focus on informal practice may be better tolerated and more effective. The aims of the proposed hybrid 1 effectiveness-implementation randomized clinical trial (RCT) are thus to compare the effectiveness and acceptability of four-week-long formal (MSC-F) versus informal (MSC-I) MSC interventions for adolescents, relative to a waitlist control condition. Procedure Prior to administering a screening questionnaire, the project director (PD; Julia Petrovic) will contact the prospective participant's parent by phone (or the participant directly if 18-19 years old) to describe the study and conduct a pre-screen with inclusion/exclusion criteria. If the adolescent is deemed to be potentially eligible, a call will be scheduled with the applicant, parent (if required), and adolescent to review and sign the informed consent/assent forms together over the phone or a Zoom/Google Meet HIPAA-compliant videoconference call. After informed consent/assent have been obtained, adolescents will complete a brief phone interview to confirm their eligibility. Eligible adolescents will then be randomized, stratified by gender, to one of three trial arms with a 1:1:1 allocation ratio: MSC-F, MSC-I, or waitlist control. The PD will conduct the randomization and inform participants and their parents (if \<18 years) of their assigned condition via email (as well as share group session scheduling information if assigned to the MSC-F or MSC-I conditions). Shortly after this email has been sent, the PD will call the parents/participants to ensure that the information was received and confirm the scheduled MSC group session dates/times. The duration of the study period for participants in all three trial arms is 9 weeks. All participants will complete a 30-minute survey battery (baseline/Week 0). Participants in the MSC-F and MSC-I conditions will then complete their assigned interventions over the course of four weeks (Weeks 1-4) while those in the waitlist control condition do not complete any study tasks. Participants in the MSC-F and MSC-I conditions will also complete weekly home practice surveys from Weeks 2-5 (i.e., one following each week of the program). Participants in all three study arms will then complete a 30-minute survey battery 1 week (Week 5) and 1 month (Week 8) after the intervention period. At the end of the study period, participants assigned to the waitlist control condition will be invited to complete one of the two MSC interventions. All study procedures will be conducted virtually through phone/email, videoconference, and the secure REDCap survey platform.

Conditions

• Coping

Interventions

Type	Name	Description
BEHAVIORAL	Formal Mindful Self-Compassion (MSC-F)	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.
BEHAVIORAL	Informal Mindful Self-Compassion (MSC-I)	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States