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Completed

NCT Number: NCT02785471

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.

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Key information

Conditions

Mental Health Wellness 1 Behavior Behavioral Symptoms Depression Self-Injurious Behavior Suicide Suicide Prevention

Age range

25 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening for Mental Health only

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. change in alcohol use/abuse as measured by the Alcohol Use Disorders Identification Test

    Time frame: 2 weeks post randomization; 12 weeks post randomization

  3. change in relationship conflicts as measured by the Psychological Aggression Scale

    Time frame: 2 weeks post randomization; 12 weeks post randomization

  4. 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

  5. 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

  6. change in interpersonal needs as measured by the Interpersonal Needs Questionnaire

    Time frame: 2 weeks post randomization; 12 weeks post randomization

  7. 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

  8. change in physical aggression as measured by the Physical Aggression Index scale

    Time frame: 2 weeks post randomization; 12 weeks post randomization

  9. 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

  10. change in help seeking behavior as measured by the General Help Seeking Questionnaire

    Time frame: 2 weeks post randomization; 12 weeks post randomization

  11. change in physical and mental health as measured by the Healthy Days Measures

    Time frame: 2 weeks post randomization; 12 weeks post randomization

  12. 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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • University of Utah

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
May 27, 2016
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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