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Mobile-Enhanced CBT for Mood Disorders in Adolescents
Study Summary
This trialtests if a mobile app can help teens at high risk of severe mood disorders (e.g., bipolar) adhere to treatment and improve symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2008 Phase 3 trial • 150 Patients • NCT00074802Trial Design
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Who is running the clinical trial?
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- I am between 13 and 17 years old.I may or may not be taking medications.You have behavioral problems that may affect your ability to participate in group treatment.I cannot travel to the study locations for sessions or assessments.I need more help for thoughts of harming myself.I can attend all scheduled group sessions.I can speak English and fill out written forms.You have been diagnosed with bipolar disorder type I or II, a psychotic disorder, or have severe psychiatric symptoms that require more intensive treatment, like self-harm.You are currently taking or misusing drugs that affect your mood or behavior.I am currently participating in cognitive-behavioral therapy.You have been diagnosed with a major depressive disorder or a bipolar disorder in the past.
- Group 1: Cognitive behavioral therapy (CBT)_no app
- Group 2: Cognitive behavioral therapy (CBT) with mobile app
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the age restriction for this trial above 45?
"In accordance with the rules of this trial, each patient must be between 13 and 17 years old."
With what purpose is this clinical experiment being conducted?
"The primary outcome for this research, monitored over a 3-month period, will be the Change in weekly participant adherence. The secondary measures are: Children's Depression Rating Scale Revised measuring depressive symptom severity across 14 seven-point items and three five-point items (0 to 113); KINDL assessing quality of life using 30 five-point markers (lowest score 0; highest 120), and Symptom Checklist 90 capturing participant reported psychiatric symptoms with 90 Likert item points ranging from zero to 360."
Are there any criteria needed to be eligible for this trial?
"This clinical trial is offering participation to 60 adolescents, aged 13-17 years old and diagnosed with a depressive or bipolar disorder according to the DSM-5. It is necessary that participants own a smartphone for use in conjunction with the study app, though medication consumption is not mandatory. Furthermore, attendance at prearranged group sessions must be possible."
How many participants are currently participating in this research project?
"Affirmative. According to clinicaltrials.gov, the research project first posted on August 30th 2021 is currently in need of participants. 60 patients are required for this study at one specific medical facility and it was most recently updated on October 31st 2022."
Is the enrollment period for this experiment still open?
"As per the data hosted on clinicaltrials.gov, this research is actively seeking volunteers for participation. The trial was initially published on August 30th 2021 and had its last edit made at the end of October 2022."
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