Behavioural Interventions for Postnatal Depression: a RCT Study

Ministry of Health, Malaysia

Status: Completed

Conditions: Postnatal Depression

Treatments: Behavioral: Brief Cognitive Behavioral Therapy; Behavioral: standard management based on Clinical Practice Guideline

Study type: Interventional

Funder types: Other

Identifiers

NCT03196726

NMRR-15-2404-26677

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

Intervention Arm

Experimental group

Description:

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.

Treatment:

Behavioral: standard management based on Clinical Practice Guideline

Behavioral: Brief Cognitive Behavioral Therapy

Control arm

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: standard management based on Clinical Practice Guideline