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

Not Applicable

Completed

• Conditions: Mental Health Wellness 1
• Interventions: Behavioral: Screening for Mental Health & Man Therapy; Behavioral: Screening for Mental Health only

• Registration Number: NCT02785471
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-27
• Study Start: 2016-09
• Primary Completion: 2019-05-30
• Study Completion: 2020-08-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 554

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Screening for Mental Health & Man Therapy	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.
Screening for Mental Health only	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.

Primary Outcome Measures

Name	Time	Method
Change in suicide risk as measured by the Columbia-Suicide Severity Rating Scale-Screen Version	Baseline; 2 weeks post randomization; 12 weeks post randomization
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

Secondary Outcome Measures

Name	Time	Method
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
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
change in alcohol use/abuse as measured by the Alcohol Use Disorders Identification Test	2 weeks post randomization; 12 weeks post randomization
change in relationship conflicts as measured by the Psychological Aggression Scale	2 weeks post randomization; 12 weeks post randomization
change in social support as measured by the Perceived Social Support and/or Conflict scale	2 weeks post randomization; 12 weeks post randomization
change in interpersonal needs as measured by the Interpersonal Needs Questionnaire	2 weeks post randomization; 12 weeks post randomization
change in drug use/abuse as measured by the National Institute of Drug Abuse Quick Screen	2 weeks post randomization; 12 weeks post randomization
change in physical aggression as measured by the Physical Aggression Index scale	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	2 weeks post randomization; 12 weeks post randomization
change in help seeking behavior as measured by the General Help Seeking Questionnaire	2 weeks post randomization; 12 weeks post randomization
change in physical and mental health as measured by the Healthy Days Measures	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	Baseline; 2 weeks post randomization; 12 weeks post randomization

Trial Locations

Locations (1)

University of Maryland Baltimore; 🇺🇸 Baltimore, Maryland, United States