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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by University of Maryland
Sponsor:
Collaborator:
Florida State University
Information provided by (Responsible Party):
Jodi Jacobson Frey, University of Maryland
ClinicalTrials.gov Identifier:
NCT02785471
First received: April 6, 2016
Last updated: April 11, 2017
Last verified: April 2017
  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: No masking
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 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 ]

Estimated Enrollment: 300
Study Start Date: September 2016
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2017 (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

Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. men living in Michigan;
  2. 35-64 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) or identifying any risk for suicide ideation or behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS); and
  4. fluent in reading English -

Exclusion Criteria:

  1. females
  2. men 34 years old and younger and men older than 65
  3. men who score in the low risk range on the HANDS and/or C-SSRS)
  4. not fluent in reading English
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 6, 2016
Last Updated: April 11, 2017
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on April 28, 2017