The 28 Day Challenge

May 21, 2021 updated by: Michael Snyder, Stanford University
The purpose of this study is to determine how a 28 Day Challenge influences mental health and well-being. This is a blinded study. Participants both with and without depression and anxiety, will be included. A moderation analysis will be performed to see whether changes in depression after the intervention are a function of baseline depression and anxiety levels.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English Fluency

Exclusion Criteria:

  • Severe hearing impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1--October Start Audio Content 1
This group will listen to audio content 1 daily for 28 days beginning in October, and then will receive no further intervention
Behavioral: Audio Content 1
~30 minute daily audio recordings of content 1 for 28 days
Other: Group 2--November Start Audio Content 1
This group will not be assigned to any interventions during the first month of the trial and will act as a passive control group at that time. They will be assigned to listen to audio content 1 daily for 28 days beginning in November.
Behavioral: Audio Content 1
~30 minute daily audio recordings of content 1 for 28 days
Sham Comparator: Group 3--October Start Audio Content 2
This group will listen to audio content 2 daily for 28 days beginning in October, and then will receive no further intervention.
Behavioral: Audio Content 2
~30 minute daily audio recordings of content 2 for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Heath Questionnaire-9 (PHQ-9)
Time Frame: Baseline, 1 months

The PHQ-9 is a self-administered survey used for diagnosing depression and assessing depression severity. It measures each of the 9 DSM-IV/V diagnostic criteria for depression on a 0-3 scale. Depression Severity is measured as follows: 0 none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against structured clinical interviews. PHQ-9 scores ≥10 exhibited a sensitivity of 88% and a specificity of 88% for major depression.

DSM = The Diagnostic and Statistical Manual of Mental Disorders
Baseline, 1 months
Change in Patient Heath Questionnaire-9 (PHQ-9)
Time Frame: Baseline, 3 months

The PHQ-9 is a self-administered survey used for diagnosing depression and assessing depression severity. It measures each of the 9 DSM-IV/V diagnostic criteria for depression on a 0-3 scale. Depression Severity is measured as follows: 0 none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against structured clinical interviews. PHQ-9 scores ≥10 exhibited a sensitivity of 88% and a specificity of 88% for major depression.

DSM = The Diagnostic and Statistical Manual of Mental Disorders
Baseline, 3 months
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline, 1 months
The GAD-7 is a self report-based survey that assesses generalized anxiety disorder and severity on a 7-item scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. The GAD-7 was compared to diagnoses by mental health professionals. Using scores >/= 10, It has sensitivity of 89% and specificity of 82%.
Baseline, 1 months
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline, 3 months
The GAD-7 is a self report-based survey that assesses generalized anxiety disorder and severity on a 7-item scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. The GAD-7 was compared to diagnoses by mental health professionals. Using scores >/= 10, It has sensitivity of 89% and specificity of 82%.
Baseline, 3 months
Change in Perceived Stress Scale-10 (PSS-10)
Time Frame: Baseline, 1 months
The Perceived Stress Scale-10 (PSS-10) measures global perceived stress via self-report on a ten item scale. Scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Total scores ranging from 0-13 would be considered low stress. Total scores ranging from 14-26 would be considered moderate stress. Total scores ranging from 27-40 would be considered high perceived stress.
Baseline, 1 months
Change in Perceived Stress Scale-10 (PSS-10)
Time Frame: Baseline, 3 months
The Perceived Stress Scale-10 (PSS-10) measures global perceived stress via self-report on a ten item scale. Scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Total scores ranging from 0-13 would be considered low stress. Total scores ranging from 14-26 would be considered moderate stress. Total scores ranging from 27-40 would be considered high perceived stress.
Baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Michasel Snyder, PhD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 10, 2020

Primary Completion (Anticipated)

July 10, 2020

Study Completion (Anticipated)

October 10, 2020

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

May 1, 2019

First Posted (Actual)

May 3, 2019

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plan to share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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