- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02785471
Assessing Online Interventions for Men's' Mental Health and Wellbeing
January 27, 2022 updated by: Jodi Jacobson Frey, University of Maryland, Baltimore
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
554
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
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Baltimore
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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
25 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- men living in Michigan;
- 25-64 years of age at time of enrollment;
- 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
- fluent in reading English
Exclusion Criteria:
- females
- 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
- not fluent in reading English
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
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Participants in the Screening for Mental Health (SMH)-only group will complete the online depression and suicide screening and receive immediate feedback and referrals.
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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.
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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.
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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
Time Frame: Baseline; 2 weeks post randomization; 12 weeks post randomization
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Baseline; 2 weeks post randomization; 12 weeks post randomization
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Change in suicide risk as measured by the Columbia-Suicide Severity Rating Scale-Screen Version
Time Frame: Baseline; 2 weeks post randomization; 12 weeks post randomization
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Baseline; 2 weeks post randomization; 12 weeks post randomization
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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
Time Frame: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in alcohol use/abuse as measured by the Alcohol Use Disorders Identification Test
Time Frame: 2 weeks post randomization; 12 weeks post randomization
|
2 weeks post randomization; 12 weeks post randomization
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change in relationship conflicts as measured by the Psychological Aggression Scale
Time Frame: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in financial situation as measured by two items (J1 and J4) of the 2009 National Financial Capability Study, Financial Industry Regulatory Authority
Time Frame: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in social support as measured by the Perceived Social Support and/or Conflict scale
Time Frame: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in interpersonal needs as measured by the Interpersonal Needs Questionnaire
Time Frame: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in drug use/abuse as measured by the National Institute of Drug Abuse Quick Screen
Time Frame: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in physical aggression as measured by the Physical Aggression Index scale
Time Frame: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in help seeking behavior as measured by the Perceived Stigma and Barriers to Care for Psychological Problems scale
Time Frame: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in help seeking behavior as measured by the General Help Seeking Questionnaire
Time Frame: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in physical and mental health as measured by the Healthy Days Measures
Time Frame: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in anger as measures by the DSM-5 Self Rated Level 1 Cross-Cutting Symptom Measure
Time Frame: Baseline; 2 weeks post randomization; 12 weeks post randomization
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Baseline; 2 weeks post randomization; 12 weeks post randomization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jodi Jacobson Frey, University of Maryland, Baltimore
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
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
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
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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