Clinical trial NCT03196726: Behavioural Interventions for Postnatal Depression: a RCT Study
Official title: POSTNATAL DEPRESSION: Malaysia ASPIRE* Project PHASE 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postnatal Depression
Keywords: cognitive-behavioral therapy
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
First posted: 2017-06-23
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Management of postnatal depression mothers at primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to management by Medical Officer in intervention arm, compared to management by Medical Officer alone in control arm.
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* postpartum 4-24 weeks
* registered with selected primary care clinics
* Edinburgh Postnatal Depression score: 12 or more; and Mini diagnostic interview:

positive (mild to moderate depression)

* consented to participate

Exclusion Criteria:

* severe depression or psychosis

Primary outcomes:
measure: changes in depression level
timeFrame: at baseline (Week 0), week 3 and Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Shah Alam
country: Malaysia
facility: Klinik Kesihatan Seksyen 7,
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Klinik Kesihatan Kuala Lumpur
state: W.P. Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Klinik Kesihatan Sg Besi
state: WP Kuala Lumpur
city: Putrajaya
country: Malaysia
facility: Klinik Kesihatan Presint 11
state: WP Putrajaya
city: Putrajaya
country: Malaysia
facility: Klinik Kesihatan Presint 9
state: WP Putrajaya
city: Putrajaya
country: Malaysia
facility: Klinik Kesihatan Presint 18
state: WP Putraya
Study officials:
affiliation: INSTITUTE FOR PUBLIC HEALTH
name: Tahir Aris, MD
role: STUDY_DIRECTOR
References: