The 28 Day Challenge

NCT03936946 | Withdrawn

• 1 other identifier: 50298
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Anxiety; Stress; Hope

Outcome Measures

Primary Outcomes (6)

• Change in Patient Heath Questionnaire-9 (PHQ-9)

  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)

  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)

  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)

  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)

  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)

  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

Study Arms (3)

Group 1--October Start Audio Content 1

EXPERIMENTAL

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

Group 2--November Start Audio Content 1

OTHER

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

Group 3--October Start Audio Content 2

SHAM COMPARATOR

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

Interventions

Audio Content 1 BEHAVIORAL

\~30 minute daily audio recordings of content 1 for 28 days

Group 1--October Start Audio Content 1; Group 2--November Start Audio Content 1

Audio Content 2 BEHAVIORAL

\~30 minute daily audio recordings of content 2 for 28 days

Group 3--October Start Audio Content 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English Fluency

You may not qualify if:

• Severe hearing impairment

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Michasel Snyder, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told what the intervention is until they are assigned (i.e. each group will not know what they will be listening to ahead of time or what other groups are listening to).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman and Professor of Genetics

Model Details: Participants will be randomly assigned to Group 1, Group 2, or Group 3. Group 1 begins the 28 day challenge in October (while group 2 acts as a passive control) and Group 2 begins the 28 day challenge 1 months late (while Group 1 receives no further intervention). Group 3 will begin the 28 day challenge concurrent with Group 1, but will listen to different audio clips than Group 1 (blinded).

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: May 3, 2019
• Study Start: June 10, 2020
• Primary Completion: July 10, 2020
• Study Completion: October 10, 2020
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)