Clinical trial NCT05468788: Theatre in Adolescents With Chronic Medical Conditions (CMCs)
Official title: Evaluating the Use of Theatre to Decrease Depression and Anxiety Among Adolescents With Chronic Medical Conditions (CMCs)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Disease
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will receive a new behavioral intervention; the other group will receive improvisational theatre alone
Primary purpose: PREVENTION

Brief summary: Investigators are building a program that uses improvisation to teach kids and teens with medical issues healthy ways to cope. Medical issues have been linked to anxiety and depression. Doing theatre can prevent these complications. Participants will meet in groups of about ten for ten weeks to do improvisation that is fun and supportive. Participants will meet with a study team member before the program starts, after the program ends, six months after the program ends, and twelve months after the program ends. At these visits, participants will be screened for anxiety, depression, quality of life, and will be given a short interview.

Detailed description: Adolescents with chronic medical conditions are at increased risk for anxiety and depression compared to other people their age. Therapies that use role-play prevent anxiety and depression. However, often these studies do not have an underlying psychological framework, or there is not enough information to replicate the program. Investigators designed an intervention using role-play based on Integrative Community Therapy, developed in the 1980s by Dr. Adalberto Barreto. This program will help adolescents with chronic medical conditions explore their feelings about issues related to having a chronic condition, learn new coping strategies, and help one another find support among peers.

This treatment will take place once a week for 10 weeks and investigators will compare the effects to those derived from improvisational theatre alone. To evaluate this new treatment, the study team will screen participants for anxiety, depression, quality of life, and will give a short qualitative interview. This will occur before and after the intervention, 6 months after the intervention, and 1 year after the intervention.

Eligibility criteria: Inclusion Criteria:

* Identify as having a CMC
* In grades kindergarten to 12th grade during the year recruited for the study

  * 5 years of age and ≤ 19 years of age at the start of the intervention
* Able and willing to participate in improvisational theatre in spoken English
* Able to understand and answer standard questionnaires used for evaluation in English (with or without accommodation)

Exclusion Criteria:

* None

Primary outcomes:
measure: Anxiety and Depression
timeFrame: Baseline to 10 weeks
measure: Anxiety and Depression
timeFrame: Baseline to 6 months
measure: Anxiety and Depression
timeFrame: Baseline to 12 months
measure: Disease-Related Quality of Life
timeFrame: Baseline to 10 weeks
measure: Disease-Related Quality of Life
timeFrame: Baseline to 6 months
measure: Disease-Related Quality of Life
timeFrame: Baseline to 12 months
measure: Disease-Related Quality of Life
timeFrame: Baseline to 10 weeks
measure: Disease-Related Quality of Life
timeFrame: Baseline to 6 months
measure: Disease-Related Quality of Life
timeFrame: Baseline to 12 months
measure: Knowledge and Utilization of Coping Strategies
timeFrame: Baseline to 10 weeks
measure: Knowledge and Utilization of Coping Strategies
timeFrame: Baseline to 6 months
measure: Knowledge and Utilization of Coping Strategies
timeFrame: Baseline to 12 months
measure: Knowledge and Utilization of Coping Strategies
timeFrame: Baseline to 10 weeks
measure: Knowledge and Utilization of Coping Strategies
timeFrame: Baseline to 6 months
measure: Knowledge and Utilization of Coping Strategies
timeFrame: Baseline to 12 months
measure: Empathy
timeFrame: Baseline to 10 weeks
measure: Empathy
timeFrame: Baseline to 6 months
measure: Empathy
timeFrame: Baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Geisinger Primary Care South Wilkes-Barre
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Karen A Ephlin, MD
role: PRINCIPAL_INVESTIGATOR
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