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Mental Health Wellness 1NCT02785471

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

A study testing Screening for Mental Health only and Screening for Mental Health & Man Therapy in people with Mental Health Wellness 1, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 25 to 64 years, men onlyHealthy volunteers can take part
Conditions the study is for
Mental Health Wellness 1
What is being tested?
Screening for Mental Health only and Screening for Mental Health & Man Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
554 participants
Where
1 siteUnited States
Study dates
Sep 2016to 31 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 64 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • men living in Michigan;
  • 25-64 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Maryland Baltimore

    Baltimore, Maryland, 21201

Other trials in United States

About this study

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.

Being tested
Screening for Mental Health only, Screening for Mental Health & Man Therapy
Keywords
Suicide prevention, men's mental health, depression, suicide ideation and behaviors
Medical subject headings
Suicide Prevention, Depression, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Screening for Mental Health onlyBehavioural

    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 TherapyBehavioural

    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.

Study groups in NCT02785471
Study groupRoleWhat they receive
Screening for Mental Health onlyActive comparatorParticipants in the Screening for Mental Health only (control) group will complete the online depression and suicide screening and receive immediate feedback and referrals.
Receives: Behavioral: Screening for Mental Health only
Screening for Mental Health & Man TherapyExperimentalParticipants assigned to Screening for Mental Health \& Man Therapy (intervention) group will be offered the Man Therapy program in conjunction with Screening for Mental Health.
Receives: Behavioral: Screening for Mental Health & Man Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in depression symptoms as measured by The HANDS: Harvard Department of Psychiatry National Depression Screening Day Scale

    Measured: Baseline; 2 weeks post randomization; 12 weeks post randomization

  2. Change in suicide risk as measured by the Columbia-Suicide Severity Rating Scale-Screen Version

    Measured: Baseline; 2 weeks post randomization; 12 weeks post randomization

Secondary outcomes (12)

  1. change in attitudes toward help-seeking behavior as measured by the Attitudes Toward Seeking Professional Help short-form

    Measured: 2 weeks post randomization; 12 weeks post randomization

  2. change in alcohol use/abuse as measured by the Alcohol Use Disorders Identification Test

    Measured: 2 weeks post randomization; 12 weeks post randomization

  3. change in relationship conflicts as measured by the Psychological Aggression Scale

    Measured: 2 weeks post randomization; 12 weeks post randomization

  4. change in financial situation as measured by two items (J1 and J4) of the 2009 National Financial Capability Study, Financial Industry Regulatory Authority

    Measured: 2 weeks post randomization; 12 weeks post randomization

  5. change in social support as measured by the Perceived Social Support and/or Conflict scale

    Measured: 2 weeks post randomization; 12 weeks post randomization

  6. change in interpersonal needs as measured by the Interpersonal Needs Questionnaire

    Measured: 2 weeks post randomization; 12 weeks post randomization

  7. change in drug use/abuse as measured by the National Institute of Drug Abuse Quick Screen

    Measured: 2 weeks post randomization; 12 weeks post randomization

  8. change in physical aggression as measured by the Physical Aggression Index scale

    Measured: 2 weeks post randomization; 12 weeks post randomization

  9. change in help seeking behavior as measured by the Perceived Stigma and Barriers to Care for Psychological Problems scale

    Measured: 2 weeks post randomization; 12 weeks post randomization

  10. change in help seeking behavior as measured by the General Help Seeking Questionnaire

    Measured: 2 weeks post randomization; 12 weeks post randomization

  11. change in physical and mental health as measured by the Healthy Days Measures

    Measured: 2 weeks post randomization; 12 weeks post randomization

  12. change in anger as measures by the DSM-5 Self Rated Level 1 Cross-Cutting Symptom Measure

    Measured: Baseline; 2 weeks post randomization; 12 weeks post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion30 May 2019
  4. Study completion31 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
554 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02785471
Sponsor's protocol ID
HP-00066262
Status last verified
Jan 2022
First submitted
6 Apr 2016
Last updated
10 Feb 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 36412229

  • 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.

    PubMed 36373571

Questions about this trial

What is this clinical trial studying?

A study testing Screening for Mental Health only and Screening for Mental Health & Man Therapy in people with Mental Health Wellness 1, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in depression symptoms as measured by The HANDS: Harvard Department of Psychiatry National Depression Screening Day Scale (time frame: Baseline; 2 weeks post randomization; 12 weeks post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02785471, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.

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