- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04637971
Coaching Intervention in Women At-risk for Common Mental Disorders
Coaching Intervention to Improve Mental Well-being of Community Women Who Are At-risk for Common Mental Disorders in Hong Kong: a Randomised Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Participants will be recruited through online screening tool. Eligible subjects with informed consent provided will be randomly assigned to coaching group or self-help tips plus telephone support group.
To test the effectiveness of the coaching intervention, data collection will be conducted on demographics, symptoms and psychosocial aspects at baseline, immediately, 3-month and 12-month post-intervention. A self-reported brief questionnaire will be administered at every intervention as well.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Hong Kong, Hong Kong
- University of Hong Kong
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Willing to provide written informed consent
- Able to understand Cantonese and read/write Chinese
- With subsyndromal or minor common mental disorders (CMD) indicated by 10 - 20 of Depression subscale of Depression, Anxiety and Stress Scale (DASS) or 8-14 of Anxiety subscale of DASS
Exclusion Criteria:
- Those mental conditions that require other treatment priorities (e.g., suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders)
- Those medical conditions that severely limit participation, comprehension, or adherence to treatment (e.g., epilepsy, dementia, terminal medical illness)
- Those who are receiving structured psychotherapy or counseling
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Coaching
The present intervention is a structured, group-based coaching program that is facilitating an active process of change through the identification of achievable personal goals, the formulation of action plans, the provision of constructive feedback, and progressive monitoring of goal attainment.
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Participants will receive 4 sessions of group coaching intervention within 6 weeks.
Each session is in a group of 3-4 women and lasts for approximately 1.5 hours.
The sessions will be conducted by experienced social workers.
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Aktiv komparator: Self-help tips plus telephone support
Self-help tips including stress coping methods.
Our project staff will contact the subject to encourage her to make use of the tips we sent her.
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Participants will receive 4 self-help tips sent via SMS and 4 phone call from a social worker in 6-week of time.
During the telephone call, the social worker will advise the client to make use of the tips we sent to her.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in depressive symptoms
Tidsramme: 6-month post-intervention
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Score of depression subscale of Depression, Anxiety and Stress Scale (DASS) at 6-month post-intervention will be compared with that at baseline.
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6-month post-intervention
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Changes in anxiety symptoms
Tidsramme: 6-month post-intervention
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Score of anxiety subscale of Depression, Anxiety and Stress Scale (DASS) at 6-month post-intervention will be compared with that at baseline.
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6-month post-intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in depressive symptoms
Tidsramme: Immediate and 3-month post-intervention
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Score of depression subscale of Depression, Anxiety and Stress Scale (DASS) immediate and 3-month post-intervention will be compared with that at baseline.
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Immediate and 3-month post-intervention
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Changes in anxiety symptoms
Tidsramme: Immediate and 3-month post-intervention
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Score of anxiety subscale of Depression, Anxiety and Stress Scale (DASS) immediate and 3-month post-intervention will be compared with that at baseline.
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Immediate and 3-month post-intervention
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Changes in quality of life
Tidsramme: Immediate, 3- and 6-month post-intervention
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Score of 12-Item Short Form Health Survey version 2 (SF-12 v2) immediate, 3- and 6-month post-intervention will be compared with that at baseline.
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Immediate, 3- and 6-month post-intervention
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- iCMD_Coaching_RCT
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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