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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the CEDARS program (Coping and Emotional Development for Adolescents to Reduce Stress) can reduce stress in teenagers. Researchers will evaluate its effectiveness and gather feedback from teens about their experience. Participants will be divided into two groups: one will use CEDARS immediately, while the other will start later. Teens aged 14–19 who speak English and have internet access are eligible for this trial. As an unphased trial, it provides a unique opportunity for teens to contribute to research that could enhance stress management programs for 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 prior data suggests that the CEDARS intervention is safe for adolescents?

Research has shown that the CEDARS program, which helps reduce stress and develop emotional skills, is generally well-received by teenagers. Studies on CEDARS have found that participants usually do not experience major side effects. The program aims to help young people handle stress better and improve their mental health. Serious problems are rarely reported, indicating that the focus on mental well-being makes it a low-risk option for those looking to reduce stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CEDARS intervention is unique because it adapts stress-reduction techniques specifically for adolescents, focusing on their distinct needs and experiences. Unlike traditional methods like therapy or medication, CEDARS may offer a more tailored and engaging approach, potentially leading to better acceptance and effectiveness among young people. Researchers are excited about exploring whether this method can significantly reduce stress in adolescents, offering a promising new avenue for mental health support in this age group.

What evidence suggests that the CEDARS intervention might be effective for stress relief in adolescents?

Research has shown that the CEDARS program can help reduce stress in teenagers. In earlier studies, participants learned better coping skills, felt less negative emotion, and showed fewer signs of depression. They also reported feeling less stressed overall. While the benefits were moderate, some groups of students experienced more noticeable improvements. In this trial, participants will either receive the CEDARS active intervention or join a waitlisted control group. These findings suggest that CEDARS could effectively lower stress and improve mental health in teens, especially those who have faced more challenges. ^{2 6 7 8 9}

Who Is on the Research Team?

Nia Heard-Garris, MD,MSc,FAAP

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

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 between 15 and 19 years old.

Adolescents able to speak and understand English fluently

I am a teenager with reliable internet access.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. link.springer.com link.springer.com/article/10.1007/s44217-024-00370-w

Coping and Emotional Development for Adolescents to ... Race-adjusted analyses revealed that both groups improved on intervention skill use, negative affect, depressive symptoms, and perceived stress.

2. researchgate.net researchgate.net/publication/381390002_Coping_and_Emotional_Development_for_Adolescents_to_Reduce_Stress_CEDARS_Pilot_test_of_a_school-based_positive_psychological_intervention_for_adolescents

(PDF) Coping and Emotional Development for Adolescents ... Race-adjusted analyses revealed that both groups improved on intervention skill use, negative affect, depressive symptoms, and perceived stress.

3. trial.medpath.com trial.medpath.com/clinical-trial/25859aa172d83d3e/nct04958694-cedars-intervention-coping-emotional-stress

CEDARS Intervention: A Coping, Emotional Development ... The investigators expect that those adolescents who undergo the intervention will have the greatest improvement in mental health symptoms than their waitlisted ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7237523/

Can Schools Reduce Adolescent Psychological Stress? A ... The study found a moderate overall effect on psychological stress, but significant effects were only found in selected student samples.

5. trialx.com trialx.com/clinical-trials/listings/319778/cedars-intervention-a-coping-emotional-development-stress-reduction-intervention/

CEDARS Intervention: A Coping, Emotional Development ... The investigators expect that those adolescents who undergo the intervention will have the greatest improvement in mental health symptoms than ...

6. centerhealthyminds.org centerhealthyminds.org/assets/files-publications/Duncan-coping-and-emotional-development.pdf

Coping and Emotional Development for Adolescents to ... Introduction This study tested the feasibility and preliminary efficacy of Coping and Emotional Development for Adoles- cents to Reduce Stress (CEDARS) a ...

7. jaacapopen.org jaacapopen.org/article/S2949-7329(23)00048-0/fulltext

Leveraging Technology to Target Coping and Emotion ... This review can guide efforts toward technology-based and -enhanced preventive interventions targeting coping and ER to prevent psychopathology in adolescents.

8. clinconnect.io clinconnect.io/trials/NCT04958694

CEDARS Intervention: A Coping, Emotional Development The program, called CEDARS, aims to reduce stress and promote a positive attitude in adolescents who have faced tough experiences, known as adverse childhood ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8525873/

Stress management intervention to enhance adolescent ... The purpose of this study was to examine the effects of an 8-week stress management intervention to enhance resilience and coping techniques and decrease stress ...