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Mindfulness-based Intervention for Postnatal Depression

30 mars 2020 uppdaterad 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Förväntat)

70

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Jingxia Lin, PhD
  • Telefonnummer: 852-39176311
  • E-post: jxlin@hku.hk

Studieorter

  • Hong Kong
      • Hong Kong, Hong Kong
        • Rekrytering
        • Queen Mary Hospital
        • Kontakt:
          • Jingxia Lin, PhD
          • Telefonnummer: 852-39176311
          • E-post: jxlin@hku.hk

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

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Mindfulness-based intervention
Beteende: 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
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from Baseline Depression at 8 weeks
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from Baseline Anxiety at 8 weeks
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The University of Hong Kong

Utredare

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

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 (Faktisk)

1 september 2019

Primärt slutförande (Förväntat)

1 juli 2020

Avslutad studie (Förväntat)

1 september 2021

Studieregistreringsdatum

Först inskickad

2 mars 2020

Först inskickad som uppfyllde QC-kriterierna

30 mars 2020

Första postat (Faktisk)

2 april 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 april 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 mars 2020

Senast verifierad

1 mars 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UW17-431

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

Within one year after the completion of the study.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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