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Mindfulness-based Intervention for Postnatal Depression

30. mars 2020 oppdatert av: Dr. Jingxia Lin, The University of Hong Kong

The Impacts of Mindfulness-based Intervention on Symptoms and Cognition in Chinese Women With Postnatal Depressive Symptoms - A Randomized Controlled Clinical Trial

Postnatal psychopathology have adverse impact on both mothers and infants. Few postnatal women with depressive symptoms receive treatment, and pharmacological intervention has not been well accepted due to the medication side-effects. Recently, mindfulness-based interventions were found to be beneficial for symptoms in perinatal and antenatal women with depression. These non-pharmacological interventions require less resources and are more feasible for postnatal women to practice at home. To date, no randomized controlled trial has examined mindfulness-based intervention program as a treatment for women with postnatal depression. The proposed randomized controlled trial aims to examine the effects of an 8-week mindfulness-based intervention program on symptom and cognition for postnatal females with depressive symptoms.

A total of 70 postnatal women with depressive symptoms will be recruited from the psychiatric outpatient clinics in Hong Kong, and will be randomized into two groups: 1) an 8-week mindfulness-based intervention program (n=35); 2) a booklet-based psychoeducation control group (n=35). All participants will be assessed for depression, anxiety, stress, cognition, role functioning, quality of life, sleep quality and mindfulness ability at the baseline, 8 weeks, and 3 months after intervention. The intervention sessions will be held once weekly lasting 90 minutes for 8 weeks.

The investigators primarily hypothesize that participants in the mindfulness-based intervention group will improve depressive symptom after 8 weeks compared with the control group. Secondary, the mindfulness-based intervention will improve anxiety, stress, cognitive functions, sleep quality, quality of life and mindfulness ability.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

70

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Hong Kong
      • Hong Kong, Hong Kong
        • Rekruttering
        • Queen Mary Hospital
        • Ta kontakt med:
          • Jingxia Lin, PhD
          • Telefonnummer: 852-39176311
          • E-post: jxlin@hku.hk

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Females aged from 18 and above
  • The Edinburgh Postnatal Depression Scale cut-off score of >=9
  • At least 6 weeks, and up to one and half years after childbirth
  • Cantonese-speaking Chinese

Exclusion Criteria:

  • Severe physical illness (myocardial infarction, hypertension, fracture, spinal problems in which yoga may be contraindicated), and seizure disorders.
  • Comorbid substance dependence
  • Women with psychotic depression, severe eating disorders, actively suicidal or obsessive-compulsive disorders
  • Known pregnancy
  • A history of bipolar disorder, schizophrenia, brain trauma or organic brain disease, mental retardation, or antisocial personality disorder
  • Practice of mindfulness (in forms of Tai Chi, Qi gong or yoga etc.) more than twice a week during the previous three months.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Mindfulness-based intervention
Atferdsmessig: Mindfulness-based program (MBI-p-R)
The MBI-p-R was developed in line with the model of Mindfulness-based Stress Reducation (MBSR) proposed by Kabat-Zinn. It will be conducted for 1.5 hours for each session, once a week for 8 weeks. There are four key operational components to be included in each session: engagement and introduction, mindfulness practices, daily life application, and consolidation of learning.
Aktiv komparator: Booklet-based psychoeducation group
Atferdsmessig: Booklet-based psychoeducation
The participants in the control group will be provided a booklet at baseline, including general information in handling every day stress by a new mother, as well as a record for their weekly activities. The contents covered a range of topics including work-stress, balanced diet, physical exercise, sleeping quality, bonding with baby and the treatment for depression. The participants will be contacted by phone call and/or whatsapp weekly for a short talk based on the record and content on the booklet. They will also be asked to record their daily life weekly for discussion.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline Depression at 8 weeks
Tidsramme: Change from baseline to 8 weeks
The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
Change from baseline to 8 weeks
Change from 8 weeks Depression at 3 months
Tidsramme: Change from 8 weeks to 3 months
The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
Change from 8 weeks to 3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline Anxiety at 8 weeks
Tidsramme: Change from baseline to 8 weeks
Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.
Change from baseline to 8 weeks
Change from 8 weeks Anxiety at 3 months
Tidsramme: Change from 8 weeks to 3 months
Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.
Change from 8 weeks to 3 months
Change from Baseline Stress at 8 weeks
Tidsramme: Change from baseline to 8 weeks
Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.
Change from baseline to 8 weeks
Change from 8 weeks Stress at 3 months
Tidsramme: Change from 8 weeks to 3 months
Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.
Change from 8 weeks to 3 months
Change from Baseline Executive Function at 8 weeks
Tidsramme: Change from baseline to 8 weeks
Trial Making Test, reaction time is recorded, shorter time means better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Executive Function at 3 months
Tidsramme: Change from 8 weeks to 3 months
Trial Making Test, reaction time is recorded, shorter time means better outcome.
Change from 8 weeks to 3 months
Change from Baseline Attention at 8 weeks
Tidsramme: Change from baseline to 8 weeks
Letter Cancellation Test, correct rate and time are recorded, higher correct rate and shorter time mean better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Attention at 3 months
Tidsramme: Change from 8 weeks to 3 months
Letter Cancellation Test, correct rate and time are recorded, higher correct rate and shorter time mean better outcome.
Change from 8 weeks to 3 months
Change from Baseline Working Memory at 8 weeks
Tidsramme: Change from baseline to 8 weeks
Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Working Memory at 3 months
Tidsramme: Change from 8 weeks to 3 months
Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.
Change from 8 weeks to 3 months
Change from Baseline Visual-Motor Coordination at 8 weeks
Tidsramme: Change from baseline to 8 weeks
Digit-Symbol-Coding Test, minimum 0, maximum 133, higher scores mean better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Visual-Motor Coordination at 3 months
Tidsramme: Change from 8 weeks to 3 months
Digit-Symbol-Coding Test, minimum 0, maximum 133, higher scores mean better outcome.
Change from 8 weeks to 3 months
Change from Baseline Role Functioning at 8 weeks
Tidsramme: Change from baseline to 8 weeks
Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Role Functioning at 3 months
Tidsramme: Change from 8 weeks to 3 months
Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.
Change from 8 weeks to 3 months
Change from Baseline Quality of Life at 8 weeks
Tidsramme: Change from baseline to 8 weeks
The Short Form Health Survey, minimum score 0, and maximum score 100, higher scores mean better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Quality of Life at 3 months
Tidsramme: Change from 8 weeks to 3 months
The Short Form Health Survey, minimum score 0, and maximum score 100, higher scores mean better outcome.
Change from 8 weeks to 3 months
Change from Baseline Sleep Quality at 8 weeks
Tidsramme: Change from baseline to 8 weeks
Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.
Change from baseline to 8 weeks
Change from 8 weeks Sleep Quality at 3 months
Tidsramme: Change from 8 weeks to 3 months
Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.
Change from 8 weeks to 3 months
Change from Baseline Mindfulness Levels at 8 weeks
Tidsramme: Change from baseline to 8 weeks
The Five Facet Mindfulness Questionnaire-Revised, minimum 39, maximum 195, higher scores mean better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Mindfulness Levels at 3 months
Tidsramme: Change from 8 weeks to 3 months
The Five Facet Mindfulness Questionnaire-Revised, minimum 39, maximum 195, higher scores mean better outcome.
Change from 8 weeks to 3 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total attendant classes during the 8-week interventions
Tidsramme: At 8 weeks
The number of classes the participants attended during the 8-week period will be recorded
At 8 weeks
Self-practice time
Tidsramme: At 8 weeks
How much time the participants spend for self-practice at home will be recorded
At 8 weeks
Self-practice time
Tidsramme: At 3 months
How much time the participants spend for self-practice at home will be recorded
At 3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The University of Hong Kong

Etterforskere

  • Hovedetterforsker: Jingxia Lin, PhD, The University of Hong Kong

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2019

Primær fullføring (Forventet)

1. juli 2020

Studiet fullført (Forventet)

1. september 2021

Datoer for studieregistrering

Først innsendt

2. mars 2020

Først innsendt som oppfylte QC-kriteriene

30. mars 2020

Først lagt ut (Faktiske)

2. april 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. april 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. mars 2020

Sist bekreftet

1. mars 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UW17-431

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

The study protocol, statistical analysis plan and clinical study report will be shared through email.

IPD-delingstidsramme

Within one year after the completion of the study.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Postnatal depresjon

Kliniske studier på Mindfulness-based program (MBI-p-R)

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