What side effects are associated with this type of intervention?

Common treatments for anxiety include pharmacological options like SSRIs, SNRIs, and benzodiazepines, which can cause side effects such as nausea, dizziness, insomnia, weight gain, sexual dysfunction, and dependency risks. Psychotherapeutic techniques like Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR) generally have fewer side effects, though some patients may experience temporary increases in anxiety or emotional discomfort during therapy.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of anxiety disorders, including selective serotonin reuptake inhibitors (SSRIs) like sertraline and fluoxetine, and serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine. These medications are often used in combination with cognitive-behavioral therapy (CBT), which is a well-established psychotherapeutic technique for reducing anxiety. Other psychotherapeutic approaches, such as Acceptance and Commitment Therapy (ACT) and mindfulness-based interventions, are also being explored for their efficacy in managing anxiety symptoms. These treatments align with the goals of dyadic psychotherapy, which aims to reduce anxiety through evidence-based psychotherapeutic techniques.

What other types of research exist?

Promising novel alternatives to Dyadic Psychotherapy for anxiety patients in 2024 include AI-assisted psychotherapy, which combines medication with AI-driven therapeutic interventions, and mHealth mindfulness applications, which provide scalable, non-pharmacological treatments for anxiety through mobile health platforms.

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Behavioral Intervention

Mobile Health Mindfulness for Anxiety

N/A

Recruiting

Led By Elissa Kozlov, 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

Adults 60+

Diagnosis of or caregiver for individual with serious illnesses (e.g., ESRD, Cancer, CHF, COPD, Liver Disease)

Must not have

Not fluent in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a mobile app called Mindfulness Coach to help older adults with serious illness and their caregivers reduce anxiety. The app provides mindfulness exercises that help users focus on the present moment, making them feel less anxious. This approach aims to offer an effective, non-drug treatment for anxiety in this group. Mindfulness Coach is a mobile app designed to deliver mindfulness training and has been used in various studies to assess its impact on mental health.

Who is the study for?

This trial is for English-speaking adults over 60 with serious illnesses like cancer or heart disease, and their caregivers who are 21+. Participants must be new to mindfulness therapy, have anxiety (Hads-A > 8), and be able to use mobile devices without vision or hearing issues. Those with significant cognitive impairment or prior mindfulness experience are excluded.

What is being tested?

The study tests a mobile health (mHealth) mindfulness program aimed at reducing anxiety in older patients with serious illness and their primary caregivers. It compares the effectiveness of a Mindfulness Coach intervention against an active comparator in a primary care setting.

What are the potential side effects?

Since this trial involves non-pharmacological treatment through mindfulness coaching, there may not be direct side effects as seen with medication. However, participants might experience emotional discomfort when confronting anxious feelings during sessions.

Eligibility Criteria

Inclusion Criteria

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

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I am 60 years old or older.

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I have or care for someone with a serious illness like cancer or liver disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not fluent in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, 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

Hospital Anxiety and Depression Scale - Anxiety Sub Scale

Secondary study objectives

Hospital Anxiety and Depression Scale - Depression Sub Scale

Perceived stress scale

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: mindfulness coachExperimental Treatment1 Intervention

Mindfulness coach is an app that provides a training plan with 14 sequential levels, a "practice now" area with evidence-based mindfulness audio exercises, assessments using the Five-Factor Mindfulness Questionnaire Short Form (FFMQ-SF)90, and education about mindfulness an iOS- and Android-based app designed to deliver a mindfulness training course centered on Veteran's Affairs (VA) protocols. Developed by the VA's National Center for PTSD, the app provides an engaging introduction to MT, regardless of specific psychiatric illness or patient population. . To progress to the next level, the user must interact with every element. The training plan levels include psychoeducation and exercises (guided meditations and seated practices), which increase in duration as users progress. Levels 1,7 and 14 also include an assessment with the FFMQ-SF. The "practice now" area has guided meditations to practice new skills.

Group II: control - web MDActive Control1 Intervention

A a widely available health and wellness app that provides users with daily content on general health, WebMD, will serve as the attention control. Similar health-based apps have been used as controls in other mHealth psychotherapy intervention trials.100,101 The control group will be instructed to access the app 4x/week (same as intervention group) and will receive an orientation and 2 booster sessions as well. I considered other control group options including treatment as usual, but attention control was selected due to the variability of treatment as usual.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness Coach

2019

N/A

~370

0 / 3Eligibility 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, such as Cognitive Behavioral Therapy (CBT), Mindfulness-Based Cognitive Therapy (MBCT), and Interpersonal Psychotherapy (IPT), work through different mechanisms to reduce symptoms. CBT focuses on identifying and challenging negative thought patterns and behaviors. MBCT combines mindfulness practices with cognitive therapy to help patients accept their thoughts and feelings without judgment. IPT aims to improve interpersonal relationships and social functioning. Understanding these mechanisms helps patients and healthcare providers select the most suitable treatment based on individual needs and triggers.

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