Behavioural Interventions for Postnatal Depression: a RCT Study

Postnatal Depression Clinical Trial

Official title:

POSTNATAL DEPRESSION: Malaysia ASPIRE* Project PHASE 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196726
• Other study ID #: NMRR-15-2404-26677
• Status: Completed
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: Ministry of Health, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postnatal Depression

Intervention

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
• standard management based on Clinical Practice Guideline
Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required

Locations

Country	Name	City	State
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 18	Putrajaya	WP Putraya
Malaysia	Klinik Kesihatan Presint 9	Putrajaya	WP Putrajaya
Malaysia	Klinik Kesihatan Seksyen 7,	Shah Alam	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in depression level	assess changes in Beck Depression Index (BDI) score	at baseline (Week 0), week 3 and Week 6