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Machine Learning-Optimized Digital Therapy for Emotional Disorders
N/A
Recruiting
Research Sponsored by Boston University Charles River Campus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
Awards & highlights
Study Summary
This trial will use machine learning to develop precision treatment rules (PTRs) for three leading digital interventions for emotional disorders, which will be evaluated in a clinical trial. The goal is to understand for whom and how well these interventions work in order to optimize treatment delivery decisions.
Who is the study for?
This trial is for English-speaking adults aged 18 or older who have access to an internet-connected device. It's designed for those experiencing emotional disorders like anxiety and depression.Check my eligibility
What is being tested?
The study tests three digital mental health programs: UP, Space for Depression, and Space for Resilience. Using machine learning, it aims to find out which program works best in a large healthcare setting.See study design
What are the potential side effects?
Since this trial involves digital interventions rather than medications, traditional side effects are not expected. However, users may experience discomfort or distress related to the content of the mental health interventions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline well-being at week 12
Secondary outcome measures
Change from baseline anxiety at week 12
Mental Depression
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)Experimental Treatment1 Intervention
Digital, transdiagnostic, emotion-focused CBT intervention that consists of five "core" modules or components that have been shown to target temperamental characteristics (i.e., neuroticism) and resulting emotion dysregulation that are believed to underlie all anxiety, depressive, and emotional disorders. The core components of the program are psychoeducation, mindfulness, cognitive flexibility, behavioral strategies to counter emotion-driven behaviors, interoceptive, and emotion exposures.
Group II: Space for Resilience (SFR)Active Control1 Intervention
Digital program based on positive psychology principles and designed to promote resilience and well-being through a series of seven modules. The core components of the program include psychoeducation, values exploration, building relationships, promoting self-esteem and self-efficacy, and building gratitude and optimism.
Group III: Space from Depression (SFD)Active Control1 Intervention
Digital CBT program designed to minimize the impact of depressive symptoms. This program emphasizes the use of cognitive behavioral strategies as well as mindfulness through a series of seven structured modules. The core components of the program include psychoeducation around the relationship between thoughts, feelings, and behaviors; cognitive behavioral practices aimed at restructuring negative beliefs; behavioral strategies to improve self-esteem; and mindfulness techniques that focus attention on the present moment.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,687,967 Total Patients Enrolled
666 Trials studying Depression
249,784 Patients Enrolled for Depression
Silver Cloud HealthOTHER
9 Previous Clinical Trials
912 Total Patients Enrolled
7 Trials studying Depression
840 Patients Enrolled for Depression
Kaiser PermanenteOTHER
538 Previous Clinical Trials
24,111,293 Total Patients Enrolled
35 Trials studying Depression
119,084 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult who speaks English.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Space for Resilience (SFR)
- Group 2: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)
- Group 3: Space from Depression (SFD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an ongoing recruitment process for this experiment?
"According to clinicaltrials.gov, this study has concluded its recruitment process as it was last updated on September 30th 2022. However, there are still 1,460 other trials looking for participants at present time."
Answered by AI
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