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

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ClinicalTrials.gov Identifier: NCT02785471
Recruitment Status : Recruiting
First Posted : May 27, 2016
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Florida State University
Information provided by (Responsible Party):
Jodi Jacobson Frey, University of Maryland

April 6, 2016
May 27, 2016
July 11, 2017
September 2016
August 2018   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT02785471 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Assessing Online Interventions for Men's' Mental Health and Wellbeing
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Mental Health Wellness 1
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Screening for Mental Health only
  • 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.
    Intervention: Behavioral: Screening for Mental Health & Man Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Same as current
August 2020
August 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
25 Years to 64 Years   (Adult)
Yes
Contact: Jodi Jacobson Frey, PhD 410-706-3607 jfrey@ssw.umaryland.edu
Contact: Amanda Mosby 410-706-4705 amosby@ssw.umaryland.edu
United States
 
 
NCT02785471
HP-00066262
Yes
Not Provided
Plan to Share IPD: No
Jodi Jacobson Frey, University of Maryland
University of Maryland
Florida State University
Principal Investigator: Jodi Jacobson Frey University of Maryland
University of Maryland
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP