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

NCT ID: NCT02785471

Last Updated: 2022-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-08-31

Brief Summary

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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

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Conditions

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Mental Health Wellness 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Screening for Mental Health only

Intervention Type 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

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.

Group Type EXPERIMENTAL

Screening for Mental Health & Man Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Jodi Jacobson Frey

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jodi Jacobson Frey

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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University of Maryland Baltimore

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36412229 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36373571 (View on PubMed)

Other Identifiers

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HP-00066262

Identifier Type: -

Identifier Source: org_study_id

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