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

This study is currently recruiting participants.
Verified July 2017 by Jodi Jacobson Frey, University of Maryland
Sponsor:
ClinicalTrials.gov Identifier:
NCT02785471
First Posted: May 27, 2016
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Florida State University
Information provided by (Responsible Party):
Jodi Jacobson Frey, University of Maryland
  Purpose
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.

Condition Intervention
Mental Health Wellness 1 Behavioral: Screening for Mental Health only Behavioral: Screening for Mental Health & Man Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessing Online Interventions for Men's' Mental Health and Wellbeing

Resource links provided by NLM:


Further study details as provided by Jodi Jacobson Frey, University of Maryland:

Primary Outcome Measures:
  • 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 ]
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • change in alcohol use/abuse as measured by the Alcohol Use Disorders Identification Test [ Time Frame: 2 weeks post randomization; 12 weeks post randomization ]
  • change in relationship conflicts as measured by the Psychological Aggression Scale [ Time Frame: 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 [ Time Frame: 2 weeks post randomization; 12 weeks post randomization ]
  • 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 ]
  • change in interpersonal needs as measured by the Interpersonal Needs Questionnaire [ Time Frame: 2 weeks post randomization; 12 weeks post randomization ]
  • 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 ]
  • change in physical aggression as measured by the Physical Aggression Index scale [ Time Frame: 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 [ Time Frame: 2 weeks post randomization; 12 weeks post randomization ]
  • change in help seeking behavior as measured by the General Help Seeking Questionnaire [ Time Frame: 2 weeks post randomization; 12 weeks post randomization ]
  • change in physical and mental health as measured by the Healthy Days Measures [ Time Frame: 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 [ Time Frame: Baseline; 2 weeks post randomization; 12 weeks post randomization ]

Estimated Enrollment: 300
Study Start Date: September 2016
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785471


Contacts
Contact: Jodi Jacobson Frey, PhD 410-706-3607 jfrey@ssw.umaryland.edu
Contact: Amanda Mosby 410-706-4705 amosby@ssw.umaryland.edu

Locations
United States, Maryland
University of Maryland Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Jodi Jacobson Frey    410-706-3607    jfrey@ssw.umaryland.edu   
Contact: Amanda Mosby    410-706-4705    amosby@ssw.umaryland.edu   
Sponsors and Collaborators
University of Maryland
Florida State University
Investigators
Principal Investigator: Jodi Jacobson Frey University of Maryland
  More Information

Responsible Party: Jodi Jacobson Frey, Associate Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT02785471     History of Changes
Other Study ID Numbers: HP-00066262
First Submitted: April 6, 2016
First Posted: May 27, 2016
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jodi Jacobson Frey, University of Maryland:
Suicide prevention
men's mental health
depression
suicide ideation and behaviors