Behavioural Interventions for Postnatal Depression: a RCT Study

NCT03196726 | Completed DMC

• 1 other identifier: NMRR-15-2404-26677
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 6

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

Conditions

Postnatal Depression

Keywords

cognitive-behavioral therapy

Outcome Measures

Primary Outcomes (1)

• changes in depression level

  assess changes in Beck Depression Index (BDI) score

  at baseline (Week 0), week 3 and Week 6

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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; Behavioral: standard management based on Clinical Practice Guideline

Control arm

PLACEBO COMPARATOR

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

Interventions

Brief Cognitive Behavioral Therapy 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

Intervention Arm

standard management based on Clinical Practice Guideline BEHAVIORAL

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

Control arm; Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women postpartum 4 to 24 weeks
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• severe depression or psychosis

Sponsors & Collaborators

• Ministry of Health, Malaysia: lead

Study Sites (6)

Klinik Kesihatan Seksyen 7,

Shah Alam, Selangor, 40000, Malaysia

Location

Klinik Kesihatan Kuala Lumpur

Kuala Lumpur, W.P. Kuala Lumpur, 50400, Malaysia

Location

Klinik Kesihatan Sg Besi

Kuala Lumpur, WP Kuala Lumpur, 57000, Malaysia

Location

Klinik Kesihatan Presint 11

Putrajaya, WP Putrajaya, 62000, Malaysia

Location

Klinik Kesihatan Presint 9

Putrajaya, WP Putrajaya, 62250, Malaysia

Location

Klinik Kesihatan Presint 18

Putrajaya, WP Putraya, 62602, Malaysia

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Tahir Aris, MD

  INSTITUTE FOR PUBLIC HEALTH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants randomized by offering 2 opaque envelope to group them into either as control or intervention group. Medical officers were responsible in the management of all participants using standard Clinical Practice Guideline (CPG). Participants from intervention group will see Medical Officer first before being given CBT by nurse
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Public Health Specialist

Model Details: Management of postnatal depression mothers at primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to management by Medical Officer in intervention arm, compared to management by Medical Officer alone in control arm.

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 23, 2017
• Study Start: March 2, 2017
• Primary Completion: October 30, 2018
• Study Completion: December 31, 2018
• Last Updated: April 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (6)