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

NCT02785471 | Completed DMC

• 1 other identifier: HP-00066262
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Wellness 1

Keywords

Suicide prevention; men's mental health; depression; suicide ideation and behaviors

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (12)

• 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 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 social support as measured by the Perceived Social Support and/or Conflict scale

  2 weeks post randomization; 12 weeks post randomization

Study Arms (2)

Screening for Mental Health only

ACTIVE COMPARATOR

Participants in the Screening for Mental Health only (control) group will complete the online depression and suicide screening and receive immediate feedback and referrals.

Behavioral: Screening for Mental Health only

Screening for Mental Health & Man Therapy

EXPERIMENTAL

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.

Behavioral: Screening for Mental Health & Man Therapy

Interventions

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 only

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.

Screening for Mental Health & Man Therapy

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• men living in Michigan;
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• University of Utah: collaborator

Study Sites (1)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

• Gilgoff JN, Wagner F, Frey JJ, Osteen PJ. Help-seeking and Man Therapy: The impact of an online suicide intervention. Suicide Life Threat Behav. 2023 Feb;53(1):154-162. doi: 10.1111/sltb.12929. Epub 2022 Nov 22.

  PMID: 36412229 DERIVED

• Frey JJ, Osteen PJ, Sharpe TL, Mosby AO, Joiner T, Ahmedani B, Iwamoto D, Nam B, Spencer-Thomas S, Ko J, Ware OD, Imboden R, Cornette MM, Gilgoff J. Effectiveness of man therapy to reduce suicidal ideation and depression among working-age men: A randomized controlled trial. Suicide Life Threat Behav. 2023 Feb;53(1):137-153. doi: 10.1111/sltb.12932. Epub 2022 Nov 14.

  PMID: 36373571 DERIVED

MeSH Terms

Conditions

Suicide Prevention; Depression; Behavior

Interventions

Mass Screening; Mental Health

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Health; Population Characteristics

Study Officials

• Jodi Jacobson Frey

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: May 27, 2016
• Study Start: September 1, 2016
• Primary Completion: May 30, 2019
• Study Completion: August 31, 2020
• Last Updated: February 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)