An interventional study of Formal Mindful Self-Compassion (MSC-F) and Informal Mindful Self-Compassion (MSC-I) in Coping, sponsored by Cambridge Health Alliance. Recruiting at 1 site in United States. Open to participants aged 14 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Cambridge Health Alliance · Not applicable, Interventional, and Other
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:
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:
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.
Cambridge Health Alliance is the lead sponsor of 52 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
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.
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.
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.
Time frame: 5 weeks (From baseline to 1 week post-intervention)
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.
Time frame: 9 weeks (From baseline to 1 month post-intervention)
18-item Five Facets of Mindfulness Questionnaire (FFMQ-18)
The 18-item Five Facets of Mindfulness Questionnaire (FFMQ-18; Medvedev et al., 2018) is a self-report measure of dispositional (i.e., trait) mindfulness. It consists of five subscales, each reflecting one facet of mindfulness (acting with awareness, nonjudgmental acceptance, nonreactivity, observing, and describing). Items are rated on a 5-point Likert scale ranging from Never or very rarely true (1) to Very often or always true (5). The FFMQ-18 is the most reliable and valid short form of the full-scale (39-item) FFMQ (Medvedev et al., 2018). A global mean will be computed (possible range: 1 to 5) whereby a higher score reflects a better outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Self-Compassion Scale - Short Form (SCS-SF)
The Self-Compassion Scale - Short Form (SCS-SF; Raes et al., 2011) is a 12-item self-report measure of self-compassion. Respondents are asked to indicate how often they behave in the stated manner using a 5-point Likert scale ranging from Almost never (1) to Almost always (5). The SCS-SF has a near-perfect correlation with the full-scale SCS and is a reliable alternative when assessing overall self-compassion (Raes et al., 2011). A global mean will be computed (possible range: 1 to 5) whereby a higher score reflects a better outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS; Cohen et al., 1983) is a 10-item self-report measure of perceived stress. Respondents are asked to rate each item on a 5-point Likert scale (0 = Never to 4 = Very often) based on how often they feel or think a certain away. A sum score will be computed (possible range: 0 to 40) whereby a higher score reflects a worse outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Generalized Anxiety Disorder (GAD-7) scale
The Generalized Anxiety Disorder scale (GAD-7; Spitzer et al., 2006) is a widely used 7-item self-report measure of anxiety. Respondents are prompted to indicate using a 4-point Likert scale ranging from Not at all (0) to Nearly every day (3) how often they experienced each anxiety symptom listed over the past two weeks. A sum score will be computed (possible range: 0 to 21) whereby a higher score reflects a worse outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Patient Health Questionnaire - Modified for Adolescents (PHQ-A)
The Patient Health Questionnaire - Modified for Adolescents (PHQ-A; Johnson, 2002) is a 9-item self-report measure of depression for adolescents, adapted from the widely-used adult version. Respondents are asked to indicate how often they experienced each depressive symptom listed over the past two weeks using a 4-point Likert scale ranging from Not at all (0) to Nearly every day (3). The item, 'Thoughts that you would be better off dead, or of hurting yourself in some way?', will be omitted for the purposes of this study; an adapted 8-item version of the PHQ-A will therefore be used. A sum score will be computed (possible range: 0 to 24) whereby a higher score reflects a worse outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Theoretical Framework of Acceptability (TFA) questionnaire
The Theoretical Framework of Acceptability questionnaire (TFA; Sekhon et al., 2022) is an 8-item self-report measure of intervention acceptability that will only be administered 1-week post-intervention to those in the MSC-F and MSC-I conditions. The TFA questionnaire is adaptable and can be used to evaluate a variety of healthcare interventions (including mental healthcare). It consists of seven items, each pertaining to one of the components listed above, as well as an eighth item that assesses general acceptability. Items are rated on 5-point Likert scales (with varying labels depending on the item). A global mean will be computed (possible range: 1 to 5) whereby a higher score reflects a better outcome. In addition, 5 researcher-developed, follow-up open-ended questions will be asked at the end of the TFA to obtain more detailed information regarding intervention acceptability (e.g., What did you like the most about the program?).
Time frame: 5 weeks (From baseline to 1 week post-intervention)
Self-Oriented Perfectionism subscale of the Multidimensional Perfectionism Scale (MPS)
The Self-Oriented Perfectionism subscale of the Multidimensional Perfectionism Scale (MPS; Hewitt \& Flett, 1991, 2004) is a 15-item measure of perfectionism. Respondents are asked to indicate their agreement with each item using a 7-point Likert scale ranging from Strongly disagree (1) to Strongly agree (7). A sum score will be computed (possible range: 15 to 105) whereby a higher score reflects a worse outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Self-Critical Rumination Scale (SCRS)
The Self-Critical Rumination Scale (SCRS; Smart et al., 2016) is a 10-item self-report measure of self-critical rumination. Respondents are asked to indicate how well each item describes them using a 4-point Likert scale ranging from Not at all (1) to Very well (4). A global mean will be computed (possible range: 1 to 4) whereby a higher score reflects a worse outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
The Difficulties in Emotion Regulation Scale - Short Form (DERS-SF; Kaufman et al., 2015) is an 18-item measure of emotion dysregulation. Respondents are asked to indicate how often each statement applies to them using a 5-point Likert scale ranging from Almost never (1) to Almost always (5). A sum score will be computed (possible range: 18 to 90) whereby a higher score reflects a worse outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Utrecht Work Engagement Scale for Students (UWES-9S)
The Utrecht Work Engagement Scale for Students (UWES-9S; Schaufeli et al., 2002) is a 9-item self-report measure of academic engagement. Items are rated on a 7-point Likert scale ranging from Never (1) to Always/every day (7) based on the frequency with which the respondent experiences each statement. A global mean will be computed (possible range: 1 to 7) whereby a higher score reflects a better outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Home Practice Survey
A brief researcher-developed Home Practice Survey will be used to assess, on a weekly basis, the amount of independent mindfulness practice participants complete throughout the 4-week intervention period. This measure consists of 2-4 items (depending on participants' responses) which ask about participants' frequency of practice and specific practices used over the last week.
Time frame: 4 weeks (Week 2, 3, and 4 of intervention and 1 week post-intervention)
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Apr 2027, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cambridge Health Alliance