Behavioural Interventions for Postnatal Depression: a RCT Study

POSTNATAL DEPRESSION: Malaysia ASPIRE* Project PHASE 2

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

Study Overview

• Status: Completed
• Conditions: Postnatal Depression
• Intervention / Treatment: Behavioral: Brief Cognitive Behavioral Therapy; Behavioral: standard management based on Clinical Practice Guideline

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Shah Alam, Selangor, Malaysia, 40000
      • Klinik Kesihatan Seksyen 7,
  • W.P. Kuala Lumpur
    • Kuala Lumpur, W.P. Kuala Lumpur, Malaysia, 50400
      • Klinik Kesihatan Kuala Lumpur
  • WP Kuala Lumpur
    • Kuala Lumpur, WP Kuala Lumpur, Malaysia, 57000
      • Klinik Kesihatan Sg Besi
  • WP Putrajaya
    • Putrajaya, WP Putrajaya, Malaysia, 62000
      • Klinik Kesihatan Presint 11
    • Putrajaya, WP Putrajaya, Malaysia, 62250
      • Klinik Kesihatan Presint 9
  • WP Putraya
    • Putrajaya, WP Putraya, Malaysia, 62602
      • Klinik Kesihatan Presint 18

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Placebo Comparator: 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.	Behavioral: standard management based on Clinical Practice Guideline; Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in depression level	assess changes in Beck Depression Index (BDI) score	at baseline (Week 0), week 3 and Week 6

Collaborators and Investigators

• Sponsor: Ministry of Health, Malaysia
• Investigators: Study Director: Tahir Aris, MD, INSTITUTE FOR PUBLIC HEALTH

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2017
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: cognitive-behavioral therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: NMRR-15-2404-26677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: data sharing must be requested from Director General of Health Malaysia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No