Mindfulness-based Intervention for Postnatal Depression
30 marzo 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Anticipato)
70
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Jingxia Lin, PhD
- Numero di telefono: 852-39176311
- Email: jxlin@hku.hk
Luoghi di studio
-
-
-
Hong Kong, Hong Kong
- Reclutamento
- Queen Mary Hospital
-
Contatto:
- Jingxia Lin, PhD
- Numero di telefono: 852-39176311
- Email: jxlin@hku.hk
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Mindfulness-based intervention
|
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.
|
|
Comparatore attivo: Booklet-based psychoeducation group
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from Baseline Depression at 8 weeks
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from Baseline Anxiety at 8 weeks
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Total attendant classes during the 8-week interventions
Lasso di tempo: At 8 weeks
|
The number of classes the participants attended during the 8-week period will be recorded
|
At 8 weeks
|
|
Self-practice time
Lasso di tempo: At 8 weeks
|
How much time the participants spend for self-practice at home will be recorded
|
At 8 weeks
|
|
Self-practice time
Lasso di tempo: At 3 months
|
How much time the participants spend for self-practice at home will be recorded
|
At 3 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Jingxia Lin, PhD, The University of Hong Kong
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 settembre 2019
Completamento primario (Anticipato)
1 luglio 2020
Completamento dello studio (Anticipato)
1 settembre 2021
Date di iscrizione allo studio
Primo inviato
2 marzo 2020
Primo inviato che soddisfa i criteri di controllo qualità
30 marzo 2020
Primo Inserito (Effettivo)
2 aprile 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 aprile 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 marzo 2020
Ultimo verificato
1 marzo 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UW17-431
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
The study protocol, statistical analysis plan and clinical study report will be shared through email.
Periodo di condivisione IPD
Within one year after the completion of the study.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .