Behavioural Interventions for Postnatal Depression: a RCT Study

NCT ID: NCT03196726

Last Updated: 2019-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-02
• Study Completion Date: 2018-12-31

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.

Conditions

Postnatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Arm

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.

Group Type: EXPERIMENTAL

Brief Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required

Control arm

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.

Group Type: PLACEBO_COMPARATOR

standard management based on Clinical Practice Guideline

Intervention Type: BEHAVIORAL

Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required

Interventions

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

Intervention Type: BEHAVIORAL

standard management based on Clinical Practice Guideline

Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role: lead

Responsible Party

NOOR ANI AHMAD

Public Health Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tahir Aris, MD

Role: STUDY_DIRECTOR

INSTITUTE FOR PUBLIC HEALTH

Locations

Klinik Kesihatan Seksyen 7,

Shah Alam, Selangor, 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 9

Putrajaya, WP Putrajaya, Malaysia

Klinik Kesihatan Presint 18

Putrajaya, WP Putraya, Malaysia

Countries

Malaysia

Other Identifiers

NMRR-15-2404-26677

Identifier Type: -

Identifier Source: org_study_id