NCT03196726

Behavioural Interventions for Postnatal Depression: a RCT Study

POSTNATAL DEPRESSION: Malaysia ASPIRE* Project PHASE 2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Ministry of Health, Malaysia · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postnatal Depression

Interventions

Type	Name	Description
BEHAVIORAL	Brief Cognitive Behavioral Therapy	Week 1: Understanding postnatal depression Week 2: Relaxation techniques and tips to reduce stress Week 3: Positive thinking style and Self-Esteem Week 4: Relationship with partner Week 5: Relationship with infant Week 6: Relapse prevention
BEHAVIORAL	standard management based on Clinical Practice Guideline	Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required

Timeline

• Start date: 2017-03-02
• Primary completion: 2018-10-30
• Completion: 2018-12-31
• First posted: 2017-06-23
• Last updated: 2019-04-01

Locations

6 sites across 1 country: Malaysia