CopingNCT07513220
The Effectiveness and Acceptability of Formal Versus Informal Mindful Self-Compassion for Adolescents
A study testing Formal Mindful Self-Compassion (MSC-F) and Informal Mindful Self-Compassion (MSC-I) in people with Coping, run by Cambridge Health Alliance at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Coping
- What is being tested?
- Formal Mindful Self-Compassion (MSC-F) and Informal Mindful Self-Compassion (MSC-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Mindfulness and Compassion
Malden, Massachusetts, 02148
Julia Petrovic, PhD, 781-605-4429, mscteen@challiance.org
About this study
Official title: Formal Versus Informal Mindful Self-Compassion Programming for Adolescents
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?
Read more
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
Read the 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
- Being tested
- Formal Mindful Self-Compassion (MSC-F), Informal Mindful Self-Compassion (MSC-I)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formal Mindful Self-Compassion (MSC-F)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks (From baseline to 1 week post-intervention)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?).
Measured: 5 weeks (From baseline to 1 week post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start13 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zev Schuman-Olivier, MD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513220
- Sponsor's protocol ID
- CHA-IRB-25-26-434
- Status last verified
- Jan 2026
- First submitted
- 1 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formal Versus Informal Mindful Self-Compassion Programming for Adolescents
- ClinicalTrials.gov ID
- NCT07513220
- Acronym / sponsor ID
- CHA-IRB-25-26-434
- Conditions
- Coping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Formal Mindful Self-Compassion (MSC-F) | Experimental | Behavioral: Formal Mindful Self-Compassion (MSC-F)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). |
| Informal Mindful Self-Compassion (MSC-I) | Experimental | Behavioral: Informal Mindful Self-Compassion (MSC-I)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). |
| 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Formal Mindful Self-Compassion (MSC-F) |
| 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. | Behavioural | Informal Mindful Self-Compassion (MSC-I) |
Primary outcome
Coping Index (CI)
Time frame: 5 weeks (From baseline to 1 week post-intervention)
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.
7 secondary outcomes
Coping Index (CI)
Time frame: 9 weeks (From baseline to 1 month post-intervention)
18-item Five Facets of Mindfulness Questionnaire (FFMQ-18)
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Self-Compassion Scale - Short Form (SCS-SF)
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Perceived Stress Scale (PSS)
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Generalized Anxiety Disorder (GAD-7) scale
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)
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Theoretical Framework of Acceptability (TFA) questionnaire
Time frame: 5 weeks (From baseline to 1 week post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zev Schuman-Olivier, MD principal investigator
Cambridge Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formal Mindful Self-Compassion (MSC-F) and Informal Mindful Self-Compassion (MSC-I) in people with Coping, run by Cambridge Health Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Petrovic, PhD (781-605-4429, mscteen@challiance.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coping Index (CI) (time frame: 5 weeks (From baseline to 1 week post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.