What side effects are associated with this type of intervention?

Common treatments for anxiety that are similar to skills-based resilience education delivered through a mobile app include Cognitive Behavioral Therapy (CBT) and other therapeutic interventions that focus on stress management and resilience training. These treatments are generally well-tolerated with minimal side effects. However, some individuals may experience temporary increases in anxiety or emotional discomfort as they confront and work through their stressors. Additionally, the use of mobile apps for delivering these interventions may lead to issues such as screen fatigue or technical difficulties, but these are typically manageable and do not pose significant health risks.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for anxiety, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, and serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine. While the FDA has not specifically approved mobile app-based interventions like PRISM for anxiety, cognitive-behavioral therapy (CBT) is a well-established, evidence-based treatment for anxiety that can be delivered through various formats, including digital platforms. The PRISM program, which focuses on skills-based resilience education, aligns with the principles of CBT and other psychosocial interventions that aim to improve coping mechanisms and reduce anxiety symptoms.

What other types of research exist?

Promising, novel alternatives to PRISM for anxiety patients include: 1) CLIMB (Creating Live Interactions to Mitigate Barriers), a mobile intervention aimed at enhancing social functioning and social cognition in people with chronic psychotic disorders, which may be adapted for anxiety. 2) Multiplayer game-based dual-task training using augmented reality (AR) and personal health records (PHR) for social skills and cognitive function in children with autism, which could be tailored for anxiety management. 3) Mobile-based vocational skill-building coaching technology (Mobile Coach) for people with cognitive disabilities, which could be adapted to include anxiety management skills.

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Behavioral Intervention

Resilience-Building Program for Young Cancer Survivors

N/A

Recruiting

Led By Abby Rosenberg, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All genders ≥ 12 and ≤ 25 years of age at baseline

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, 3 months, and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the PRISM program, a mobile app designed to help people facing serious illnesses manage stress better. It teaches practical skills through multiple sessions delivered via an app, texts, or video calls. The goal is to help participants become more resilient and handle tough situations more effectively.

Who is the study for?

This trial is for young individuals aged 12 to 25 who are dealing with anxiety or stress due to a serious illness. They must be able to speak and read English or Spanish, and be cognitively capable of participating in sessions and completing surveys as judged by the investigator.

What is being tested?

The study tests the 'Promoting Resilience in Stress Management' (PRISM) program, which includes an app with six sessions aimed at teaching skills to manage stress better and improve resilience during tough times.

What are the potential side effects?

Since PRISM is a non-medical intervention focusing on education through an app and coaching, it does not have typical medical side effects. However, participants may experience emotional discomfort while discussing personal stressors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 12 and 25 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 3 months, and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 3 months, and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 3 months, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Connor Davidson Resilience Scale (CDRISC-10) Score

Secondary study objectives

CDRISC-10 Score for App-Only Cohort Responders

CDRISC-10 Score for Text Coach Cohort Responders

Change in Adolescent Participant Quality of Life Total Score

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: PRISM Program Mobile AppExperimental Treatment1 Intervention

Participants will be randomized to "app-only" group and will complete: * Baseline questionnaire. * mPRISM App self guided modules * 3 month questionnaire. * mPRISM App self guided modules until final survey at 6 months and end of participation.

Group II: PRISM Program Video CoachActive Control2 Interventions

Participants will be randomized to "video" group and will complete: * Baseline questionnaire. * PRISM sessions. * 3 month questionnaire with re-randomization to either "app-only" or "text" groups or referral to specialty psychosocial support. * After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation.

Group III: PRISM Program Text CoachActive Control2 Interventions

Participants will be randomized to "text" group and will complete: * Baseline questionnaire. * PRISM sessions. * 3 month questionnaire with re-randomization to "app-only," "text," or "video" groups. * After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for anxiety include cognitive-behavioral therapy (CBT), mindfulness-based interventions, and pharmacotherapy with medications such as selective serotonin reuptake inhibitors (SSRIs). CBT works by helping patients identify and change negative thought patterns and behaviors that contribute to anxiety. Mindfulness-based interventions focus on increasing awareness and acceptance of the present moment, reducing the impact of stress. SSRIs increase serotonin levels in the brain, which can improve mood and reduce anxiety. Skills-based resilience education, like the PRISM program, teaches coping strategies and stress management techniques, empowering patients to handle anxiety more effectively. Understanding these mechanisms is crucial for anxiety patients as it helps them choose the most suitable treatment and enhances their ability to manage symptoms.

Treatment for the concerned significant others of gamblers: A systematic review.Problem-Focused Psychodynamic Psychotherapies.