Assessing Online Interventions for Men's' Mental Health and Wellbeing

The purpose of this study is to test a comprehensive, male-oriented, online screening and referral (Screening for Mental Health; SMH) and male-oriented online information and referral intervention program (Man Therapy; MT) to improve mental health and wellbeing with a focus on prevention of suicide and help-seeking behaviors among middle-aged men. The online programs will be offered together to maximize the effect on reducing suicide behavior and increasing mental health help-seeking behaviors for men. If successful in decreasing suicide behavior and ideation and increasing suicide help-seeking behavior, this intervention could be scaled up to contribute to a reduction in suicide behaviors and deaths across the country.

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness 1
• Intervention / Treatment: Behavioral: Screening for Mental Health only; Behavioral: Screening for Mental Health & Man Therapy

• Study Type: Interventional
• Enrollment (Actual): 554
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. men living in Michigan;
2. 25-64 years of age at time of enrollment;
3. scoring in the moderate- to high-risk range (or answering positively on Question 9) on the Harvard Department of Psychiatry/NDSD Scale (HANDS), scoring in the moderate- to high-risk range for anger on the DSM-5 Level 1 Cross-Cutting Symptom Measure, or identifying any risk for suicide ideation or behavior on the Columbia-Suicide Severity Rating Sale (C-SSRS); and
4. fluent in reading English

Exclusion Criteria:

1. females
2. scoring in the low risk range on the Harvard Department of Psychiatry/NDSD Scale (HANDS), scoring in the low risk range for anger on the DSM-5 Level 1 Cross-Cutting Symptom Measure, or not identifying any risk for suicide ideation or behavior on the Columbia-Suicide Severity Rating Sale (C-SSRS); and
3. not fluent in reading English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Screening for Mental Health only; Participants in the Screening for Mental Health only (control) group will complete the online depression and suicide screening and receive immediate feedback and referrals.	Behavioral: Screening for Mental Health only; Participants in the Screening for Mental Health (SMH)-only group will complete the online depression and suicide screening and receive immediate feedback and referrals.
Experimental: Screening for Mental Health & Man Therapy; Participants assigned to Screening for Mental Health & Man Therapy (intervention) group will be offered the Man Therapy program in conjunction with Screening for Mental Health.	Behavioral: Screening for Mental Health & Man Therapy; Participants assigned to Screening for Mental Health, plus Man Therapy (SMH+MT) group will be offered the Man Therapy program in conjunction with Screening for Mental Health. MT provides online early intervention services designed specifically for men who are at risk for suicide and are less likely to engage in help-seeking behavior. MT takes an innovative and humorous approach to mental health education and help seeking through a fictional "therapist" named Dr. Rich Mahogany, who is a no-nonsense "man's man" who informs men about the importance of honest talk about life's challenges in addressing their problems. The web portal allows review "manly mental health information, facts and tips," explore "man therapies," and view videos of men with lived experience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in depression symptoms as measured by The HANDS: Harvard Department of Psychiatry National Depression Screening Day Scale	Baseline; 2 weeks post randomization; 12 weeks post randomization
Change in suicide risk as measured by the Columbia-Suicide Severity Rating Scale-Screen Version	Baseline; 2 weeks post randomization; 12 weeks post randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
change in attitudes toward help-seeking behavior as measured by the Attitudes Toward Seeking Professional Help short-form	2 weeks post randomization; 12 weeks post randomization
change in alcohol use/abuse as measured by the Alcohol Use Disorders Identification Test	2 weeks post randomization; 12 weeks post randomization
change in relationship conflicts as measured by the Psychological Aggression Scale	2 weeks post randomization; 12 weeks post randomization
change in financial situation as measured by two items (J1 and J4) of the 2009 National Financial Capability Study, Financial Industry Regulatory Authority	2 weeks post randomization; 12 weeks post randomization
change in social support as measured by the Perceived Social Support and/or Conflict scale	2 weeks post randomization; 12 weeks post randomization
change in interpersonal needs as measured by the Interpersonal Needs Questionnaire	2 weeks post randomization; 12 weeks post randomization
change in drug use/abuse as measured by the National Institute of Drug Abuse Quick Screen	2 weeks post randomization; 12 weeks post randomization
change in physical aggression as measured by the Physical Aggression Index scale	2 weeks post randomization; 12 weeks post randomization
change in help seeking behavior as measured by the Perceived Stigma and Barriers to Care for Psychological Problems scale	2 weeks post randomization; 12 weeks post randomization
change in help seeking behavior as measured by the General Help Seeking Questionnaire	2 weeks post randomization; 12 weeks post randomization
change in physical and mental health as measured by the Healthy Days Measures	2 weeks post randomization; 12 weeks post randomization
change in anger as measures by the DSM-5 Self Rated Level 1 Cross-Cutting Symptom Measure	Baseline; 2 weeks post randomization; 12 weeks post randomization

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: University of Utah
• Investigators: Principal Investigator: Jodi Jacobson Frey, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 27, 2016

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: depression; Suicide prevention; men's mental health; suicide ideation and behaviors
• Other Study ID Numbers: HP-00066262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No