CEDARS Intervention for Stress Relief

(CEDARS Trial)

Overseen By Akram Ibrahim

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Disqualifiers: Age, Language, Internet access

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Using an adapted stress-reduction intervention called the CEDARS, the investigators will pilot the intervention in adolescents (N=40) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction. As an exploratory aim, the investigators will explore the influence of the CEDARS on CMH-related behaviors and CMH. The investigators expect that those adolescents who undergo the intervention will have the greatest improvement in mental health symptoms than their waitlisted counterparts. Our secondary hypothesis is that those who report more adversity will also report greater improvement in mental health symptoms than their peers.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the CEDARS treatment for stress relief in adolescents?

Research shows that teaching coping skills to adolescents can improve their ability to handle stress, as seen in a study where students who received coping skills training showed better problem-solving abilities and self-concept. Additionally, adolescents tend to develop more active and internal coping strategies as they grow older, which can help reduce stress perception. ^{1 2 3 4 5}

How is the CEDARS treatment different from other stress relief treatments for adolescents?

CEDARS is unique because it focuses on developing coping and emotional skills specifically for adolescents to reduce stress, which may differ from other treatments like mindfulness or aromatherapy that are more general. It emphasizes active and internal coping strategies tailored to the developmental changes in stress perception during adolescence. ^{2 6 7 8 9}

Research Team

Nia Heard-Garris, MD,MSc,FAAP

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

This trial is for adolescents aged 15-19 who can speak and understand English fluently. Participants must have reliable internet access as the intervention includes virtual focus groups. There's no mention of exclusion criteria, so it seems open to all adolescents meeting the inclusion requirements.

Inclusion Criteria

I am a teenager with reliable internet access.

I am between 15 and 19 years old.

Adolescents able to speak and understand English fluently

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group will participate in 7 weekly, 1-hour online sessions featuring stress reduction skills delivered via self-paced modules.

8 weeks

7 online sessions

Follow-up

Participants will complete a follow-up survey to assess the long-term impact of the intervention.

4 weeks

1 online survey

Treatment Details

Interventions

• CEDARS

Trial Overview The CEDARS program, a stress-reduction intervention, is being tested on teenagers to see if it's easy to implement and if they like it. The goal is also to check whether this program helps reduce stress and improves mental health compared to those who wait for the intervention.

Participant Groups

Group I: CEDARS- Waitlisted Control Experimental Treatment 1 Intervention

The investigators will use a wait-listed control for the pilot intervention in adolescents (N=20) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction.

Group II: CEDARS- Active Intervention Experimental Treatment 1 Intervention

Using an adapted stress-reduction intervention called the CEDARS, the investigators will pilot the intervention in adolescents (N=20) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction.

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Findings from Research

In a study involving children aged 9-17, common coping strategies for daily stressors included wishful thinking, problem-solving, and emotional regulation, showing that these strategies are frequently used across different types of stressors like school and family.

Older adolescents demonstrated a greater variety of coping strategies compared to younger children, suggesting that as children grow, they develop more complex ways to handle stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of children's coping with life stress: implications for clinicians. Donaldson, D., Prinstein, MJ., Danovsky, M., et al.[2019]

In a study of 200 adolescents, stress perception decreased while active coping strategies increased from ages 12 to 19, indicating a positive development in how teens manage stress during late adolescence.

High perceived stress in specific situations led to increased active coping but decreased internal coping, suggesting that adolescents adapt their coping strategies based on the stress context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in stress perception and coping during adolescence: the role of situational and personal factors. Seiffge-Krenke, I., Aunola, K., Nurmi, JE.[2014]

Teaching coping skills to at-risk high school students significantly improved their social problem-solving abilities after a 9-week intervention, compared to those who received standard counseling or no treatment.

Students in the coping skills training group also showed a trend towards a better self-concept, suggesting that this approach may enhance their overall confidence and ability to handle school-related stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The remediation of the student at-risk for failure. Stevens, R., Pihl, RO.[2019]

Coping strategies are crucial in understanding the psychopathology of children and adolescents, emphasizing that how individuals mediate stress is more important than the stressors themselves.

Therapeutic approaches should focus on helping young patients align their capabilities with their stressors, aiming for quick resolutions to crises rather than prolonging the process, which aligns with Lazarus's theory on cognitive-emotional reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Coping with stress as a paradigm of the psychopathology in childhood and adolescence]. Reinhard, HG.[2019]

A new eight-item decisional balance measure was developed to assess the pros and cons of stress management practices among adolescents, based on the transtheoretical model (TTM).

The measure demonstrated construct validity and revealed that girls are more likely to recognize the benefits of stress management, which can inform future interventions targeting adolescent stress management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the pros and cons of stress management among adolescents: development and validation of a decisional balance measure. Mauriello, LM., Rossi, JS., Fava, JL., et al.[2019]

Adolescents at high risk for depression reported more stressors related to family and peer relationships, as well as excessive use of technology, compared to their low-risk peers.

High-risk adolescents tended to use disengagement coping strategies more frequently, highlighting the need for targeted interventions by school nurses to enhance effective coping mechanisms and prevent depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stressors and Coping Methods of Turkish Adolescents With High and Low Risk of Depression: A Qualitative Study. Özkul, B., Günüşen, NP.[2021]

Aromatherapy, specifically using sandalwood and blended sandalwood-lavender essential oils, significantly improved autonomic nervous system regulation in adolescents, as indicated by changes in heart rate variability (HRV) parameters compared to a control group.

Participants with low stress levels showed better responses to blended essential oil therapy, while those with medium to high stress levels did not benefit as much from aromatherapy, suggesting varying efficacy based on initial stress levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aromatherapy on autonomic nervous system regulation with treadmill exercise-induced stress among adolescents. Lin, PH., Lin, YP., Chen, KL., et al.[2021]

Adolescents face unique neuropsychological challenges, and developing emotion regulation skills is crucial for their long-term health and wellness, highlighting the need for effective prevention strategies.

Mindfulness practices, particularly the 'Learning to BREATHE' program, show promise in reducing stress and improving emotional balance in adolescents, although more research is needed in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness for adolescents: a promising approach to supporting emotion regulation and preventing risky behavior. Broderick, PC., Jennings, PA.[2018]

The DISCOVER one-day cognitive behavioural therapy (CBT) workshops were found to be feasible and acceptable for 15- to 18-year-olds with emotional difficulties, based on a randomized controlled trial involving 24 participants.

While there were trends indicating potential improvements in anxiety and well-being among participants, the small sample size limited the ability to draw definitive conclusions about the effectiveness of the intervention for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility randomized controlled trial of a one-day CBT workshop ('DISCOVER') for 15- to 18-year-olds with anxiety and/or depression in clinic settings. Loucas, CE., Sclare, I., Stahl, D., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patterns of children's coping with life stress: implications for clinicians. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Changes in stress perception and coping during adolescence: the role of situational and personal factors. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

The remediation of the student at-risk for failure. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[Coping with stress as a paradigm of the psychopathology in childhood and adolescence]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Assessment of the pros and cons of stress management among adolescents: development and validation of a decisional balance measure. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Stressors and Coping Methods of Turkish Adolescents With High and Low Risk of Depression: A Qualitative Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of aromatherapy on autonomic nervous system regulation with treadmill exercise-induced stress among adolescents. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Mindfulness for adolescents: a promising approach to supporting emotion regulation and preventing risky behavior. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility randomized controlled trial of a one-day CBT workshop ('DISCOVER') for 15- to 18-year-olds with anxiety and/or depression in clinic settings. [2022]