Behavioural Interventions for Postnatal Depression: a RCT Study

Not Applicable

Completed

• Conditions: Postnatal Depression
• Interventions: Behavioral: Brief Cognitive Behavioral Therapy; Behavioral: standard management based on Clinical Practice Guideline

• Registration Number: NCT03196726
• Lead Sponsor: Ministry of Health, Malaysia

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.

Study Timeline

• Study Start: 2017-03-02
• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-23
• Primary Completion: 2018-10-30
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Brief Cognitive Behavioral Therapy	Participants will be seen by Medical Officer and manage using standard management based on Clinical Practice Guideline for management of postnatal depression. After session with Medical Officer, participants will be seen by Nurse who additionally manage them using brief Cognitive Behavioral Therapy. Participants will be follow-up at weekly basis for 6 weeks.
Intervention Arm	standard management based on Clinical Practice Guideline	Participants will be seen by Medical Officer and manage using standard management based on Clinical Practice Guideline for management of postnatal depression. After session with Medical Officer, participants will be seen by Nurse who additionally manage them using brief Cognitive Behavioral Therapy. Participants will be follow-up at weekly basis for 6 weeks.
Control arm	standard management based on Clinical Practice Guideline	Participants will be seen by Medical Officer and manage using standard management based on Clinical Practice Guideline for management of postnatal depression. Participants will be follow-up at weekly basis for 6 weeks.

Primary Outcome Measures

Name	Time	Method
changes in depression level	at baseline (Week 0), week 3 and Week 6	assess changes in Beck Depression Index (BDI) score

Trial Locations

Locations (6)

Klinik Kesihatan Presint 9; 🇲🇾 Putrajaya, WP Putrajaya, Malaysia

Klinik Kesihatan Sg Besi; 🇲🇾 Kuala Lumpur, WP Kuala Lumpur, Malaysia

Klinik Kesihatan Seksyen 7,; 🇲🇾 Shah Alam, Selangor, Malaysia

Klinik Kesihatan Kuala Lumpur; 🇲🇾 Kuala Lumpur, W.P. Kuala Lumpur, Malaysia

Klinik Kesihatan Presint 11; 🇲🇾 Putrajaya, WP Putrajaya, Malaysia

Klinik Kesihatan Presint 18; 🇲🇾 Putrajaya, WP Putraya, Malaysia