- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02785471
Assessing Online Interventions for Men's' Mental Health and Wellbeing
27 januari 2022 uppdaterad av: Jodi Jacobson Frey, University of Maryland, Baltimore
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
554
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- University of Maryland Baltimore
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
25 år till 64 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: 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.
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Participants in the Screening for Mental Health (SMH)-only group will complete the online depression and suicide screening and receive immediate feedback and referrals.
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Experimentell: 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.
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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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Change in depression symptoms as measured by The HANDS: Harvard Department of Psychiatry National Depression Screening Day Scale
Tidsram: Baseline; 2 weeks post randomization; 12 weeks post randomization
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Baseline; 2 weeks post randomization; 12 weeks post randomization
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Change in suicide risk as measured by the Columbia-Suicide Severity Rating Scale-Screen Version
Tidsram: Baseline; 2 weeks post randomization; 12 weeks post randomization
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Baseline; 2 weeks post randomization; 12 weeks post randomization
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
change in attitudes toward help-seeking behavior as measured by the Attitudes Toward Seeking Professional Help short-form
Tidsram: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in alcohol use/abuse as measured by the Alcohol Use Disorders Identification Test
Tidsram: 2 weeks post randomization; 12 weeks post randomization
|
2 weeks post randomization; 12 weeks post randomization
|
change in relationship conflicts as measured by the Psychological Aggression Scale
Tidsram: 2 weeks post randomization; 12 weeks post randomization
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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
Tidsram: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in social support as measured by the Perceived Social Support and/or Conflict scale
Tidsram: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in interpersonal needs as measured by the Interpersonal Needs Questionnaire
Tidsram: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
|
change in drug use/abuse as measured by the National Institute of Drug Abuse Quick Screen
Tidsram: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in physical aggression as measured by the Physical Aggression Index scale
Tidsram: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in help seeking behavior as measured by the Perceived Stigma and Barriers to Care for Psychological Problems scale
Tidsram: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in help seeking behavior as measured by the General Help Seeking Questionnaire
Tidsram: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in physical and mental health as measured by the Healthy Days Measures
Tidsram: 2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in anger as measures by the DSM-5 Self Rated Level 1 Cross-Cutting Symptom Measure
Tidsram: Baseline; 2 weeks post randomization; 12 weeks post randomization
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Baseline; 2 weeks post randomization; 12 weeks post randomization
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Jodi Jacobson Frey, University of Maryland, Baltimore
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2016
Primärt slutförande (Faktisk)
30 maj 2019
Avslutad studie (Faktisk)
31 augusti 2020
Studieregistreringsdatum
Först inskickad
6 april 2016
Först inskickad som uppfyllde QC-kriterierna
24 maj 2016
Första postat (Uppskatta)
27 maj 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 februari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 januari 2022
Senast verifierad
1 januari 2022
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- HP-00066262
Plan för individuella deltagardata (IPD)
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Nej
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