Clinical trial NCT02785471: Assessing Online Interventions for Men's' Mental Health and Wellbeing
Official title: Assessing Online Interventions for Men's' Mental Health and Wellbeing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: Suicide prevention
men's mental health
depression
suicide ideation and behaviors
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2016-05-27
Enrollment: 554
Sex: MALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

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