What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) is generally well-tolerated but can cause increased anxiety or emotional discomfort as patients confront challenging thoughts and behaviors. Internet-assisted therapies, while convenient, may lead to reduced engagement, technical difficulties, and lack of immediate therapist support, potentially affecting treatment efficacy. The absence of face-to-face interaction may also be unsuitable for some patients, especially those with severe symptoms or difficulty using technology.

What prior FDA approvals exist?

The FDA has approved several treatments for mental health wellness that align with the principles of Cognitive Behavioral Therapy (CBT) and pharmacotherapy. Notably, selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine have been approved for depression and anxiety disorders. Additionally, internet-assisted CBT has gained traction as an effective modality, although specific FDA approvals for digital CBT platforms are less common. The combination of CBT with pharmacotherapy, such as SSRIs or SNRIs, is a well-established approach for treating various mental health conditions.

What other types of research exist?

Promising alternatives to iCareer for mental health wellness patients include: 1) Clinician-guided internet-based Cognitive Behavioral Therapy (iCBT) programs, which have shown efficacy in treating depression and other mental health conditions. 2) Mobile apps for smoking cessation that incorporate behavioral therapy techniques, such as QuitGuide and quitSTART, which can also be adapted for broader mental health applications. 3) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has been effective in improving sleep and overall mental health. 4) Assertive Community Treatment (ACT) programs that integrate various therapeutic approaches, including dialectical behavior therapy (DBT) and social skills training, to support individuals with severe mental illness in community settings.

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Online Soft Skills Training for Mental Health Conditions (iCareer Trial)

N/A

Recruiting

Led By Weili Lu, PhD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an online program that helps young people with mental health conditions develop job-related social and emotional skills. It aims to improve their ability to find and keep jobs by teaching them how to interact well with others and solve problems, while also providing mental health support.

Who is the study for?

This trial is for young people aged 16-24 with mental health conditions who want to improve their job-related social skills. They must speak English, have been part of a special education program or received disability services recently, and not have had recent hospitalizations or suicide attempts.

What is being tested?

The study tests an online soft-skills training program called iCareer, which includes cognitive behavioral therapy elements. It aims to help these youths get better at finding and keeping jobs as they move into adulthood.

What are the potential side effects?

Since this intervention involves educational and therapeutic activities rather than medical treatments, traditional physical side effects are not expected. However, participants may experience emotional discomfort when discussing personal issues related to employment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Higher Number of Hours Worked

Higher Rates of Employment

Improved Job Related Social Skills

+1 more

Secondary study objectives

Improved Functional Status

Increased Job Motivation

Increased Job Satisfaction

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

Soft Skills Training Intervention via telehealth

Group II: ControlActive Control1 Intervention

Treatment as Usual (TAU)

Do I qualify?Apply below to find out

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

Cognitive Behavioral Therapy (CBT) and its internet-assisted variations, such as those studied in the iCareer trial, work by addressing both cognitive and behavioral aspects of mental health conditions. CBT helps patients identify and challenge negative thought patterns and behaviors, replacing them with healthier alternatives through structured sessions, homework assignments, and self-monitoring. The internet-assisted component increases accessibility and flexibility, making it easier for patients to engage with the therapy. This structured, evidence-based approach is crucial for mental health wellness patients as it helps manage symptoms, improve coping strategies, and enhance overall quality of life.

Tailored internet-based cognitive behavioral therapy for individuals with chronic pain and comorbid psychological distress: a randomized controlled trial.Problem-Focused Psychodynamic Psychotherapies.Brief cognitive-behavioral therapy with fibromyalgia patients in routine care.