Depression MildNCT03270943
The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens
A study testing MFY and HLG in people with Depression Mild and Resilience, Psychological, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The rate of depression increases markedly over the course of adolescence. Adolescents struggling with depression are often set on a maladaptive behavior trajectory which may lead to academic challenges, substance abuse, risky sexual behavior, impairment in relationship building, and suicidality. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression Mild, Resilience, Psychological, Adolescent Behavior
- What is being tested?
- MFY and HLG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to 3 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents age14-17 (inclusive) in high school (may turn 18 after enrollment).
- Score of at least 6 on the Quick Inventory Depressive Symptomatology (QIDS). Potential participants must be pre-screened with the QIDS assessment
- Clinical mental health assessment based on the Diagnostic Interview Schedule for Children-IV (DISC-IV) to screen for serious psychiatric illness, including current major depression
- Able to read and communicate in English
- Willing to be randomized to one of the two arms;
- Able to attend 8 weekly, 1.75 hour sessions, as well as complete self-report measures and homework
- Have access to a computer or other internet-enabled device.
Who cannot join
- Score of at least 6 on the QIDS (pre-screening);
- Suicidality or major depression as determined by Study Psychologist;
- Inability to speak, write, and read English;
- Active substance abuse, defined as active treatment for substance abuse, legal consequences/school suspensions associated with substance use, or ongoing family conflict associated with substance use;
- History of bipolar disorder, schizophrenia, severe autism, or psychiatric hospitalization within the past 2 years;
- Unable or unwilling to attend or participate in group sessions and/or self-report assessments;
- Current or prior participation in another intervention to address depression or psychiatric conditions;
- Prior formal training in mindfulness, such as a mindfulness course.
Trial locations and contacts
1 site in 1 country.
United States1 site
Christine Lathren, MD, MPH
Chapel Hill, North Carolina, 27599-7200
About this study
Official title: Making Friends With Yourself: a Depression Prevention Program for Adolescents
The rate of depression increases markedly over the course of adolescence. Adolescents struggling with depression are often set on a maladaptive behavior trajectory which may lead to academic challenges, substance abuse, risky sexual behavior, impairment in relationship building, and suicidality. The S.M.A.R.T Project (Stress Management and Resilience Training for Teens) is designed to learn about mood in teens, and whether emotional well-being can be improved with an 8 week class. The study proposes to refine and test the feasibility of a mindfulness-based self-compassion training program for adolescents who are experiencing subsyndromal depression, comparing it with a "healthy lifestyles" group program as a comparison attention-control for the treatment intervention. Secondarily, the study will explore the impact of these programs on measures of psychopathology and well-being (i.e. depressive symptoms and resilience).
Read the detailed description
Depressive symptoms are common in adolescents, with 20-25% of adolescents experiencing a depressive episode before they graduate high school, and implications into adulthood. Since depression often first appears in adolescence and unsuccessful treatment of adolescent depression increases the risk of chronic or recurrent depression in adulthood, managing depression symptoms at this critical stage of development can benefit mental health and functioning throughout the lifespan. Preliminary studies have indicated that a mindful self-compassion program is a promising intervention to prevent depression and improve wellbeing in at-risk teens.
The S.M.A.R.T Project (Stress Management and Resilience Training for Teens) is designed to learn about mood in teens, and whether emotional well-being can be improved with an 8 week class. In this study, 80 adolescents ages 14-17 ,with subsyndromal depression, will be randomized to either the 8-week mindful self-compassion intervention or the 8-week healthy lifestyles control program, followed by 6 monthly continuation sessions. Feasibility of the research protocol and of the program elements will be assessed. Focus group feedback will also inform program modifications and refinement. Additionally, baseline, mid-intervention, and 3- and 6-months post intervention measurements of depression, resilience, and other related psychosocial measures will allow preliminary exploration of the impact of each program on outcomes.
- Being tested
- MFY, HLG
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MFYBehavioural
Mindful Self-Compassion course for teens
HLGBehavioural
Healthy Lifestyles course for teens
| Study group | Role | What they receive |
|---|---|---|
| Mindful Self-Compassion (MFY) | Experimental | An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course. Receives: Behavioral: MFY |
| Healthy Lifestyles (HLG) | Active comparator | An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course. Receives: Behavioral: HLG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Incident Depression
The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. A score of 65 was used to indicate incident depression. The PROMIS measure used in lieu of the Short Mood and Feelings Questionnaire (SMFQ) due to increased measurement frequency. Higher scores indicate a greater level of depression.
Measured: weekly for up to 36 weeks
Secondary outcomes (3)
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores
The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized T-score transformation with a population mean of 50 and standard deviation of 10. Higher scores mean worse depression.
Measured: Baseline, Week 8
Change in SMFQ Scores
The Short Mood and Feelings Questionnaire-Child Version (SMFQ-C) is a measure of the level of depressive symptoms among youth. This analysis utilized the 13-item youth version. Items are symptoms of depression experienced over the past 2 weeks. Each item is scored on a 3-point Likert scale as follows: "True" (0), "Sometimes" (1), and "Not True" (2) with total scores of 0-26. Lower scores at each time point indicate improvement. Higher scores indicate a greater level of depression (worse outcome).
Measured: Baseline, Week 8
Change in Brief Resiliency Scale (BRS) Scores
.The BRS defines resiliency as the ability to "bounce back" and recover from stress; the items reflect a sense of personal agency. Six items are rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and totals divided by the number of questions answered resulting in a mean score of 1-5. Higher scores at each time point indicate increasing resilience.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start5 Sep 2017
- Primary completion3 Jun 2020
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Depression MildStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After the first two intervention-refinement groups, participants will be randomized to one of two groups: a mindful self-compassion program or an active attention control program. Randomization will be stratified by gender. As soon as 20 eligible adolescents qualify for enrollment, they will be allocated to either the MFY or healthy lifestyle groups, using a specially-designed computer program which utilizes a random number generator with a permuted block design to ensure that the number of subjects allocated to the two arms over time are equal and to conceal the allocation. This will continue through 3 additional cohorts of adolescents for a total sample size of 80 (including test groups). Randomization is designed to assess feasibility of the randomization plan, in addition to general feasibility issues of the delivery of the educational programs.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Susan Gaylord, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270943
- Sponsor's protocol ID
- 16-1864
- Other IDs
- R34AT008822-01A1
- Status last verified
- Mar 2021
- First submitted
- 25 Aug 2017
- Last updated
- 18 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bluth K, Roberson PN, Gaylord SA. A Pilot Study of a Mindfulness Intervention for Adolescents and the Potential Role of Self-Compassion in Reducing Stress. Explore (NY). 2015 Jul-Aug;11(4):292-5. doi: 10.1016/j.explore.2015.04.005. Epub 2015 Apr 28.
PubMed 26005198Bluth K, Gaylord SA, Campo RA, Mullarkey MC, Hobbs L. Making Friends With Yourself: A Mixed Methods Pilot Study of a Mindful Self-Compassion Program for Adolescents. Mindfulness (N Y). 2016 Mar 1;7(2):479-492. doi: 10.1007/s12671-015-0476-6. Epub 2015 Dec 19.
PubMed 27110301Bluth K, Roberson PN, Gaylord SA, Faurot KR, Grewen KM, Arzon S, Girdler SS. Does Self-compassion Protect Adolescents from Stress? J Child Fam Stud. 2016 Apr;25(4):1098-1109. doi: 10.1007/s10826-015-0307-3. Epub 2015 Oct 23. No abstract available.
PubMed 26997856Bluth K, Lathren C, Park J, Lynch C, Curry J, Harris-Britt A, Gaylord S. Feasibility, acceptability, and depression outcomes of a randomized controlled trial of Mindful Self-Compassion for Teens (MSC-T) for adolescents with subsyndromal depression. J Adolesc. 2024 Feb;96(2):322-336. doi: 10.1002/jad.12277. Epub 2023 Nov 27.
PubMed 38010232
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Friends With Yourself: a Depression Prevention Program for Adolescents
- ClinicalTrials.gov ID
- NCT03270943
- Acronym / sponsor ID
- 16-1864
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 3 Jun 2020 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rate of depression increases markedly over the course of adolescence. Adolescents struggling with depression are often set on a maladaptive behavior trajectory which may lead to academic challenges, substance abuse, risky sexual behavior, impairment in relationship building, and suicidality. The S.M.A.R.T Project (Stress Management and Resilience Training for Teens) is designed to learn about mood in teens, and whether emotional well-being can be improved with an 8 week class. The study proposes to refine and test the feasibility of a mindfulness-based self-compassion training program for adolescents who are experiencing subsyndromal depression, comparing it with a "healthy lifestyles" group program as a comparison attention-control for the treatment intervention. Secondarily, the study will explore the impact of these programs on measures of psychopathology and well-being (i.e. depressive symptoms and resilience).
Detailed description
Depressive symptoms are common in adolescents, with 20-25% of adolescents experiencing a depressive episode before they graduate high school, and implications into adulthood. Since depression often first appears in adolescence and unsuccessful treatment of adolescent depression increases the risk of chronic or recurrent depression in adulthood, managing depression symptoms at this critical stage of development can benefit mental health and functioning throughout the lifespan. Preliminary studies have indicated that a mindful self-compassion program is a promising intervention to prevent depression and improve wellbeing in at-risk teens.
The S.M.A.R.T Project (Stress Management and Resilience Training for Teens) is designed to learn about mood in teens, and whether emotional well-being can be improved with an 8 week class. In this study, 80 adolescents ages 14-17 ,with subsyndromal depression, will be randomized to either the 8-week mindful self-compassion intervention or the 8-week healthy lifestyles control program, followed by 6 monthly continuation sessions. Feasibility of the research protocol and of the program elements will be assessed. Focus group feedback will also inform program modifications and refinement. Additionally, baseline, mid-intervention, and 3- and 6-months post intervention measurements of depression, resilience, and other related psychosocial measures will allow preliminary exploration of the impact of each program on outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- After the first two intervention-refinement groups, participants will be randomized to one of two groups: a mindful self-compassion program or an active attention control program. Randomization will be stratified by gender. As soon as 20 eligible adolescents qualify for enrollment, they will be allocated to either the MFY or healthy lifestyle groups, using a specially-designed computer program which utilizes a random number generator with a permuted block design to ensure that the number of subjects allocated to the two arms over time are equal and to conceal the allocation. This will continue through 3 additional cohorts of adolescents for a total sample size of 80 (including test groups). Randomization is designed to assess feasibility of the randomization plan, in addition to general feasibility issues of the delivery of the educational programs.
| Arm | Type | Receives |
|---|---|---|
| Mindful Self-Compassion (MFY) | Experimental | Behavioral: MFYAn 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course. |
| Healthy Lifestyles (HLG) | Active comparator | Behavioral: HLGAn 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Adolescents age14-17 (inclusive) in high school (may turn 18 after enrollment).
- Score of at least 6 on the Quick Inventory Depressive Symptomatology (QIDS). Potential participants must be pre-screened with the QIDS assessment
- Clinical mental health assessment based on the Diagnostic Interview Schedule for Children-IV (DISC-IV) to screen for serious psychiatric illness, including current major depression
- Able to read and communicate in English
- Willing to be randomized to one of the two arms;
Key exclusion criteria (8 listed)
- Score of at least 6 on the QIDS (pre-screening);
- Suicidality or major depression as determined by Study Psychologist;
- Inability to speak, write, and read English;
- Active substance abuse, defined as active treatment for substance abuse, legal consequences/school suspensions associated with substance use, or ongoing family conflict associated with substance use;
- History of bipolar disorder, schizophrenia, severe autism, or psychiatric hospitalization within the past 2 years;
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 |
|---|---|---|
| MFYMindful Self-Compassion course for teens | Behavioural | Mindful Self-Compassion (MFY) |
| HLGHealthy Lifestyles course for teens | Behavioural | Healthy Lifestyles (HLG) |
Primary outcome
Time to Incident Depression
Time frame: weekly for up to 36 weeks
The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. A score of 65 was used to indicate incident depression. The PROMIS measure used in lieu of the Short Mood and Feelings Questionnaire (SMFQ) due to increased measurement frequency. Higher scores indicate a greater level of depression.
3 secondary outcomes
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores
Time frame: Baseline, Week 8
Change in SMFQ Scores
Time frame: Baseline, Week 8
Change in Brief Resiliency Scale (BRS) Scores
Time frame: Baseline, Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26005198Bluth K, Roberson PN, Gaylord SA. A Pilot Study of a Mindfulness Intervention for Adolescents and the Potential Role of Self-Compassion in Reducing Stress. Explore (NY). 2015 Jul-Aug;11(4):292-5. doi: 10.1016/j.explore.2015.04.005. Epub 2015 Apr 28.
- Background: PubMed 27110301Bluth K, Gaylord SA, Campo RA, Mullarkey MC, Hobbs L. Making Friends With Yourself: A Mixed Methods Pilot Study of a Mindful Self-Compassion Program for Adolescents. Mindfulness (N Y). 2016 Mar 1;7(2):479-492. doi: 10.1007/s12671-015-0476-6. Epub 2015 Dec 19.
- Background: PubMed 26997856Bluth K, Roberson PN, Gaylord SA, Faurot KR, Grewen KM, Arzon S, Girdler SS. Does Self-compassion Protect Adolescents from Stress? J Child Fam Stud. 2016 Apr;25(4):1098-1109. doi: 10.1007/s10826-015-0307-3. Epub 2015 Oct 23. No abstract available.
- Derived from this study: PubMed 38010232Bluth K, Lathren C, Park J, Lynch C, Curry J, Harris-Britt A, Gaylord S. Feasibility, acceptability, and depression outcomes of a randomized controlled trial of Mindful Self-Compassion for Teens (MSC-T) for adolescents with subsyndromal depression. J Adolesc. 2024 Feb;96(2):322-336. doi: 10.1002/jad.12277. Epub 2023 Nov 27.
- 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. This study is not recruiting at the moment.
Susan Gaylord, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MFY and HLG in people with Depression Mild and Resilience, Psychological, run by University of North Carolina, Chapel Hill 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 18 May 2021. 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?
Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Incident Depression (time frame: weekly for up to 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03270943, which also lists 4 linked publications.
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 18 May 2021.