Adolescent Behavior, Depression Mild, Resilience, Psychological
Conditions
Brief 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. 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.
Interventions
BEHAVIORALMFY
Mindful Self-Compassion course for teens
BEHAVIORALHLG
Healthy Lifestyles course for teens
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The nature of the interventions tested in this study does not allow for masking of subjects, instructors, or other personnel involved in program delivery. To preserve unbiased outcome assessments, study personnel involved in clinical assessments or data analysis will be masked with respect to group assignment. To minimize differences in subject expectancy, the programs will be described to participants as two programs, both of which have been previously found to be beneficial to teens.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Incident Depression | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores | Baseline, Week 8 | 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. |
| Change in SMFQ Scores | Baseline, Week 8 | 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). |
| Change in Brief Resiliency Scale (BRS) Scores | Baseline, Week 8 | .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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Trajectory of PROMIS Depression Score Change | 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. Higher scores indicate a greater level of depression. Model predicted mean at Baseline and 36 weeks is reported based on the longitudinal mixed effects model. |
| Trajectory of BRS Score Change | up to 36 weeks | 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. This measure was collected at baseline and at weeks 4, 8, 22, and 36. |
| Trajectory of SMFQ-C Depression Score Change | Up to 36 weeks | 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). This measure was collected at baseline and at weeks 4, 8, 22, and 36. |
Countries
United States
Participant flow
Pre-assignment details
\*Note: the first two groups (Period 1: Intervention Refinement) were not randomized. Participants enrolled in those groups received the intervention, but the intervention and logistics were adapted based on participant feedback. Hence, these participants are not included in statistical analyses.
Participants by arm
| Arm | Count |
|---|---|
| Mindful Self-Compassion (MFY) An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
MFY: Mindful Self-Compassion course for teens | 30 |
| Healthy Lifestyles (HLG) An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
HLG: Healthy Lifestyles course for teens | 32 |
| Total | 62 |
Baseline characteristics
| Characteristic | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) | Total |
|---|---|---|---|
| Age, Continuous | 15.81 years STANDARD_DEVIATION 1.08 | 15.63 years STANDARD_DEVIATION 0.97 | 15.72 years STANDARD_DEVIATION 1.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 26 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a | 52.7 T-score STANDARD_DEVIATION 11 | 58.1 T-score STANDARD_DEVIATION 10 | 55.5 T-score STANDARD_DEVIATION 10.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 19 Participants | 21 Participants | 40 Participants |
| Region of Enrollment United States | 30 Participants | 32 Participants | 62 Participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 41 |
| other Total, other adverse events | 0 / 36 | 0 / 41 |
| serious Total, serious adverse events | 1 / 36 | 0 / 41 |
Outcome results
Primary
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.
Time frame: weekly for up to 36 weeks
Population: 3 participants with high baseline scores were excluded from the analysis procedure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mindful Self-Compassion (MFY) | Time to Incident Depression | 36 weeks |
| Healthy Lifestyles (HLG) | Time to Incident Depression | 18.86 weeks |
p-value: 0.02Log Rank
Secondary
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.
Time frame: Baseline, Week 8
Population: Analysis utilizes multiple imputations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindful Self-Compassion (MFY) | Change in Brief Resiliency Scale (BRS) Scores | Baseline | 3.03 score on a scale | Standard Error 0.13 |
| Mindful Self-Compassion (MFY) | Change in Brief Resiliency Scale (BRS) Scores | 8 weeks | 3.26 score on a scale | Standard Error 0.17 |
| Healthy Lifestyles (HLG) | Change in Brief Resiliency Scale (BRS) Scores | Baseline | 3.05 score on a scale | Standard Error 0.16 |
| Healthy Lifestyles (HLG) | Change in Brief Resiliency Scale (BRS) Scores | 8 weeks | 3.40 score on a scale | Standard Error 0.19 |
95% CI: [-0.15, 0.61]
95% CI: [0.07, 0.63]
Secondary
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.
Time frame: Baseline, Week 8
Population: Analysis utilized multiple imputations to account for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindful Self-Compassion (MFY) | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores | Baseline | 52.7 T-score | Standard Error 2.02 |
| Mindful Self-Compassion (MFY) | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores | Post Intervention | 51.6 T-score | Standard Error 2.46 |
| Healthy Lifestyles (HLG) | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores | Baseline | 58.1 T-score | Standard Error 1.77 |
| Healthy Lifestyles (HLG) | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores | Post Intervention | 53.6 T-score | Standard Error 2.18 |
95% CI: [-6.06, 3.84]
95% CI: [-8.7, -0.22]
Secondary
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).
Time frame: Baseline, Week 8
Population: Analysis utilized multiple imputations (chained).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindful Self-Compassion (MFY) | Change in SMFQ Scores | Baseline | 6.90 score on a scale | Standard Error 0.9 |
| Mindful Self-Compassion (MFY) | Change in SMFQ Scores | Post Intervention | 6.26 score on a scale | Standard Error 1.35 |
| Healthy Lifestyles (HLG) | Change in SMFQ Scores | Baseline | 9.67 score on a scale | Standard Error 1.02 |
| Healthy Lifestyles (HLG) | Change in SMFQ Scores | Post Intervention | 7.95 score on a scale | Standard Error 1.05 |
95% CI: [-2.72, 0.2]
95% CI: [-3.6, 0.16]
Other Pre-specified
Trajectory of BRS Score Change
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. This measure was collected at baseline and at weeks 4, 8, 22, and 36.
Time frame: up to 36 weeks
Population: Longitudinal mixed effects model
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindful Self-Compassion (MFY) | Trajectory of BRS Score Change | 4 weeks | 3.22 score on a scale | Standard Error 0.15 |
| Mindful Self-Compassion (MFY) | Trajectory of BRS Score Change | 22 weeks | 3.01 score on a scale | Standard Error 0.18 |
| Mindful Self-Compassion (MFY) | Trajectory of BRS Score Change | 8 weeks | 3.36 score on a scale | Standard Error 0.16 |
| Mindful Self-Compassion (MFY) | Trajectory of BRS Score Change | 36 weeks | 3.65 score on a scale | Standard Error 0.17 |
| Mindful Self-Compassion (MFY) | Trajectory of BRS Score Change | Baseline | 3.03 score on a scale | Standard Error 0.15 |
| Healthy Lifestyles (HLG) | Trajectory of BRS Score Change | 36 weeks | 3.38 score on a scale | Standard Error 0.16 |
| Healthy Lifestyles (HLG) | Trajectory of BRS Score Change | Baseline | 3.05 score on a scale | Standard Error 0.15 |
| Healthy Lifestyles (HLG) | Trajectory of BRS Score Change | 4 weeks | 3.10 score on a scale | Standard Error 0.15 |
| Healthy Lifestyles (HLG) | Trajectory of BRS Score Change | 8 weeks | 3.28 score on a scale | Standard Error 0.15 |
| Healthy Lifestyles (HLG) | Trajectory of BRS Score Change | 22 weeks | 3.41 score on a scale | Standard Error 0.17 |
Other Pre-specified
Trajectory of PROMIS Depression Score Change
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 indicate a greater level of depression. Model predicted mean at Baseline and 36 weeks is reported based on the longitudinal mixed effects model.
Time frame: up to 36 weeks
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindful Self-Compassion (MFY) | Trajectory of PROMIS Depression Score Change | Baseline | 53.5 score on a scale | Standard Error 1.8 |
| Mindful Self-Compassion (MFY) | Trajectory of PROMIS Depression Score Change | 36 weeks | 47.5 score on a scale | Standard Error 2 |
| Healthy Lifestyles (HLG) | Trajectory of PROMIS Depression Score Change | 36 weeks | 53.9 score on a scale | Standard Error 2 |
| Healthy Lifestyles (HLG) | Trajectory of PROMIS Depression Score Change | Baseline | 55.9 score on a scale | Standard Error 1.8 |
Other Pre-specified
Trajectory of SMFQ-C Depression Score Change
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). This measure was collected at baseline and at weeks 4, 8, 22, and 36.
Time frame: Up to 36 weeks
Population: Longitudinal mixed effects model
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindful Self-Compassion (MFY) | Trajectory of SMFQ-C Depression Score Change | 8 weeks | 6.9 score on a scale | Standard Error 1 |
| Mindful Self-Compassion (MFY) | Trajectory of SMFQ-C Depression Score Change | 22 weeks | 6.6 score on a scale | Standard Error 1.2 |
| Mindful Self-Compassion (MFY) | Trajectory of SMFQ-C Depression Score Change | 36 weeks | 5.4 score on a scale | Standard Error 1.1 |
| Mindful Self-Compassion (MFY) | Trajectory of SMFQ-C Depression Score Change | Baseline | 6.9 score on a scale | Standard Error 1 |
| Mindful Self-Compassion (MFY) | Trajectory of SMFQ-C Depression Score Change | 4 weeks | 7.2 score on a scale | Standard Error 1 |
| Healthy Lifestyles (HLG) | Trajectory of SMFQ-C Depression Score Change | 4 weeks | 8.8 score on a scale | Standard Error 1 |
| Healthy Lifestyles (HLG) | Trajectory of SMFQ-C Depression Score Change | 8 weeks | 7.9 score on a scale | Standard Error 1 |
| Healthy Lifestyles (HLG) | Trajectory of SMFQ-C Depression Score Change | Baseline | 9.8 score on a scale | Standard Error 1 |
| Healthy Lifestyles (HLG) | Trajectory of SMFQ-C Depression Score Change | 22 weeks | 7.3 score on a scale | Standard Error 1.1 |
| Healthy Lifestyles (HLG) | Trajectory of SMFQ-C Depression Score Change | 36 weeks | 8.6 score on a scale | Standard Error 1.1 |