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

Mental Health Wellness 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785471
• Other study ID #: HP-00066262
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: August 31, 2020

Study information

• Verified date: January 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: August 31, 2020
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Maryland Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression symptoms as measured by The HANDS: Harvard Department of Psychiatry National Depression Screening Day Scale		Baseline; 2 weeks post randomization; 12 weeks post randomization
Primary	Change in suicide risk as measured by the Columbia-Suicide Severity Rating Scale-Screen Version		Baseline; 2 weeks post randomization; 12 weeks post randomization
Secondary	change in attitudes toward help-seeking behavior as measured by the Attitudes Toward Seeking Professional Help short-form		2 weeks post randomization; 12 weeks post randomization
Secondary	change in alcohol use/abuse as measured by the Alcohol Use Disorders Identification Test		2 weeks post randomization; 12 weeks post randomization
Secondary	change in relationship conflicts as measured by the Psychological Aggression Scale		2 weeks post randomization; 12 weeks post randomization
Secondary	change in financial situation as measured by two items (J1 and J4) of the 2009 National Financial Capability Study, Financial Industry Regulatory Authority		2 weeks post randomization; 12 weeks post randomization
Secondary	change in social support as measured by the Perceived Social Support and/or Conflict scale		2 weeks post randomization; 12 weeks post randomization
Secondary	change in interpersonal needs as measured by the Interpersonal Needs Questionnaire		2 weeks post randomization; 12 weeks post randomization
Secondary	change in drug use/abuse as measured by the National Institute of Drug Abuse Quick Screen		2 weeks post randomization; 12 weeks post randomization
Secondary	change in physical aggression as measured by the Physical Aggression Index scale		2 weeks post randomization; 12 weeks post randomization
Secondary	change in help seeking behavior as measured by the Perceived Stigma and Barriers to Care for Psychological Problems scale		2 weeks post randomization; 12 weeks post randomization
Secondary	change in help seeking behavior as measured by the General Help Seeking Questionnaire		2 weeks post randomization; 12 weeks post randomization
Secondary	change in physical and mental health as measured by the Healthy Days Measures		2 weeks post randomization; 12 weeks post randomization
Secondary	change in anger as measures by the DSM-5 Self Rated Level 1 Cross-Cutting Symptom Measure		Baseline; 2 weeks post randomization; 12 weeks post randomization