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POSTNATAL DEPRESSION: Malaysia ASPIRE* Project PHASE 2
Randomized-controlled trial on the effectiveness of managing postnatal depression mothers at primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to management by Medical Officer as compared to Medical Officer alone
This was a two-group double-blind randomized controlled trial (RCT) conducted in six primary care clinics at Klang Valley, with 27 subjects in each arms. All post-partum women at 4 to 24 weeks, registered at these clinics, were screened using self-administered Edinburgh Postnatal Depression Scale for symptoms of depression. Those who scored 12 or more and/or positive for question on suicidal behaviour, were interviewed by trained Research Assistants using Mini International Neuropsychiatric Interview, a diagnostic interview tool. Those with mild to moderate depression were invited to join this study, while severe depressed cases were referred to the Family Medicine Specialist for appropriate management. Consented eligible women were randomized into either control group; managed by Medical Officers alone, or intervention group; managed by both Medical Officers and trained nurses. Medical officers were given standard refresher course on Postnatal Depression management based on Clinical Practice Guideline while nurses were trained using brief cognitive-behavioural therapy (CBT) module, which consists of 6 modules for 6 weekly sessions. Depression level and its severity were assessed using self-administered Beck's Depression Index (BDI) and Automatic Thought Questionnaire (ATQ), at Baseline, Week 3 and Week 6.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
Klinik Kesihatan Seksyen 7,
Shah Alam, Selangor, Malaysia
Klinik Kesihatan Kuala Lumpur
Kuala Lumpur, W.P. Kuala Lumpur, Malaysia
Klinik Kesihatan Sg Besi
Kuala Lumpur, WP Kuala Lumpur, Malaysia
Klinik Kesihatan Presint 11
Putrajaya, WP Putrajaya, Malaysia
Klinik Kesihatan Presint 9
Putrajaya, WP Putrajaya, Malaysia
Klinik Kesihatan Presint 18
Putrajaya, WP Putraya, Malaysia
Start Date
March 2, 2017
Primary Completion Date
October 30, 2018
Completion Date
December 31, 2018
Last Updated
April 1, 2019
54
ACTUAL participants
Brief Cognitive Behavioral Therapy
BEHAVIORAL
standard management based on Clinical Practice Guideline
BEHAVIORAL
Lead Sponsor
Ministry of Health, Malaysia
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05275413