What side effects are associated with this type of intervention?

Common treatments for mental health conditions, such as cognitive-behavioral therapy (CBT) and other psychotherapeutic approaches, generally have minimal side effects, primarily involving emotional discomfort as patients confront challenging thoughts and behaviors. Pharmacotherapy, often used alongside psychotherapy, can have more pronounced side effects. Antidepressants may cause nausea, weight gain, sexual dysfunction, and insomnia, while antipsychotics can lead to drowsiness, weight gain, and metabolic changes. Mood stabilizers might cause tremors, increased thirst, and gastrointestinal issues. It is essential to discuss potential side effects with a healthcare provider to tailor treatment to individual needs.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for mental health conditions, including SSRIs like fluoxetine (Prozac) and sertraline (Zoloft) for depression and anxiety, and SNRIs like venlafaxine (Effexor) for similar conditions. Additionally, cognitive-behavioral therapy (CBT) is a widely recognized and evidence-based psychotherapeutic approach for treating various mental health issues, including depression, anxiety, and PTSD. These treatments align with the evidence-informed strategies that the Messy Memories mobile application aims to provide.

What other types of research exist?

Promising alternatives to the Messy Memories mobile application for mental health patients include: 1) Smartphone-assisted cognitive-behavioral therapy (CBT) applications, which have shown efficacy in treating various mental health conditions, including binge eating disorder and depression. 2) Internet-based guided self-help programs, which provide structured therapeutic content and have been effective in managing conditions like binge eating disorder. 3) Health coach-delivered smartphone-guided self-help applications, which combine digital tools with human support to enhance treatment outcomes. These alternatives leverage technology to provide accessible, evidence-based mental health interventions.

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Behavioral Intervention

Mental Health App for Stress Management in Healthcare Workers (Messy-Memories Trial)

N/A

Waitlist Available

Led By Sheila A.M. Rauch, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Participants will be male and female frontline healthcare employees between ages of 18 and 89.

Participants will be male and female frontline healthcare employees between ages of 18 and 89

Must not have

Adults unable to consent

Individuals who are not yet adults (infants, children, teenagers)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the 'Messy Memories' mobile app designed to help frontline healthcare workers manage stress and improve mental health. The app provides easy access to proven strategies for dealing with stress, anxiety, and other mental health issues. The study focuses on healthcare workers at Emory, including adults aged 18-89 and potentially pregnant women.

Who is the study for?

This trial is for male and female frontline healthcare workers aged 18-89, employed at Emory Healthcare/University. They must understand their role in the study and associated risks. Excluded are those not fluent in English, unable to consent, minors, prisoners, cognitively impaired individuals or those with decision-making impairments, people without stressful experiences, or high risk for suicide/self-harm.

What is being tested?

The Messy Memories mobile app is being tested as a mental health intervention for stress-related issues among healthcare workers. The app incorporates practices proven effective in managing stress and aims to provide accessible mental health support through technology.

What are the potential side effects?

Since this trial involves a mobile application designed to help manage stress rather than a drug or medical procedure, traditional physical side effects are not expected. However, users may experience emotional discomfort when engaging with content related to personal stressors.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am a healthcare worker aged 18 to 89.

Select...

I am a healthcare worker aged 18 to 89.

Exclusion Criteria

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

Select...

I am unable to give consent for myself.

Select...

I am under 18 years old.

Select...

I have difficulty making decisions due to cognitive impairment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Affect Assessments with Messy Memories Apps

Secondary study objectives

Change in Maslach-Burnout Inventory

Change in PTSD Checklist for DSM-5 (PCL-5)

Change in Patient Health Questionnaire (PHQ-9)

+6 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: Messy Memories App GroupExperimental Treatment1 Intervention

Subjects will download and have access to the Messy Memories application in addition to completing self-report measures electronically at pre-determined time points. While the subject uses the app, the participant will input information related to their mood over the past few days (affect rating sliders), their level of distress before and after the memory processing, answers to questions about revisiting the memory, answers to questions in the social connection and self-care modules including assessment of, for example, sleep pattern, eating habits, and exercise habits. The Messy Memories app will also collect data on how frequently and for how long each participant uses the app. Each response will trigger a prompt within the app, and will be recorded with a timestamp (date and time) to indicate when the participant provided a particular response. For all participants, self-report measures will be collected at weeks 4, 8, 12, and 16.

Group II: Treatment as usual (TAU) GroupActive Control1 Intervention

Subjects will not receive any study treatments or have access to the app but may seek standard treatment if they choose, in addition to completing self-report measures. For 8 weeks, TAU group will participate in the study under treatment as usual. For weeks 9-16, the TAU group will then switch and have full access to the Messy Memories App to review and use for a limited amount of time. Subjects will download and have access to the Messy Memories application in addition to completing self-report measures electronically at pre-determined time points. While the subject uses the app, the participant will input information related to their mood over the past few days, their level of distress before and after the memory processing, answers to questions about revisiting the memory, answers to questions in the social connection and self-care modules including assessment of, for example, sleep pattern, eating habits, and exercise habits.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Messy Memories App

2022

N/A

~60

0 / 5Eligibility 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 mental health include cognitive-behavioral therapy (CBT), dialectical behavior therapy (DBT), and psychoeducation. CBT works by helping patients identify and change negative thought patterns and behaviors, thereby improving emotional regulation and coping strategies. DBT, a form of CBT, emphasizes managing suicidal and self-destructive behaviors and improving interpersonal effectiveness. Psychoeducation involves teaching patients and their families about the nature of mental health disorders and how to manage them, which can improve treatment adherence and outcomes. These treatments are crucial as they provide patients with tools to manage their symptoms, improve their quality of life, and reduce the risk of relapse. The Messy Memories mobile application aims to make these evidence-based strategies more accessible, which is particularly important for overcoming barriers to mental health care.

Illness Beliefs, Treatment Beliefs and Information Needs as Starting Points for Patient Information: The Evaluation of an Intervention for Patients with Depression.Psychological therapies for anxiety and depression in children and adolescents with long-term physical conditions.What outcomes to measure in routine mental health services, and how to assess them: a systematic review.