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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02785471
Other study ID # HP-00066262
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date August 31, 2020

Study information

Verified date January 2022
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 554
Est. completion date August 31, 2020
Est. primary completion date May 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of Maryland Baltimore Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
University of Maryland, Baltimore University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary change in alcohol use/abuse as measured by the Alcohol Use Disorders Identification Test 2 weeks post randomization; 12 weeks post randomization
Secondary change in relationship conflicts as measured by the Psychological Aggression Scale 2 weeks post randomization; 12 weeks post randomization
Secondary 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
Secondary change in social support as measured by the Perceived Social Support and/or Conflict scale 2 weeks post randomization; 12 weeks post randomization
Secondary change in interpersonal needs as measured by the Interpersonal Needs Questionnaire 2 weeks post randomization; 12 weeks post randomization
Secondary change in drug use/abuse as measured by the National Institute of Drug Abuse Quick Screen 2 weeks post randomization; 12 weeks post randomization
Secondary change in physical aggression as measured by the Physical Aggression Index scale 2 weeks post randomization; 12 weeks post randomization
Secondary 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
Secondary change in help seeking behavior as measured by the General Help Seeking Questionnaire 2 weeks post randomization; 12 weeks post randomization
Secondary change in physical and mental health as measured by the Healthy Days Measures 2 weeks post randomization; 12 weeks post randomization
Secondary 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
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