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Behavioural Interventions for Postnatal Depression: a RCT Study

Primary Purpose

Postnatal Depression

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Brief Cognitive Behavioral Therapy
standard management based on Clinical Practice Guideline
Sponsored by
Ministry of Health, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postnatal Depression focused on measuring cognitive-behavioral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Klinik Kesihatan Seksyen 7,
  • Klinik Kesihatan Kuala Lumpur
  • Klinik Kesihatan Sg Besi
  • Klinik Kesihatan Presint 11
  • Klinik Kesihatan Presint 9
  • Klinik Kesihatan Presint 18

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Arm

Control arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

changes in depression level
assess changes in Beck Depression Index (BDI) score

Secondary Outcome Measures

Full Information

First Posted
June 20, 2017
Last Updated
March 29, 2019
Sponsor
Ministry of Health, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT03196726
Brief Title
Behavioural Interventions for Postnatal Depression: a RCT Study
Official Title
POSTNATAL DEPRESSION: Malaysia ASPIRE* Project PHASE 2
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Depression
Keywords
cognitive-behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare Provider
Masking Description
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
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm 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.
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Cognitive Behavioral Therapy
Intervention Description
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
Intervention Name(s)
standard management based on Clinical Practice Guideline
Intervention Description
Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required
Primary Outcome Measure Information:
Title
changes in depression level
Description
assess changes in Beck Depression Index (BDI) score
Time Frame
at baseline (Week 0), week 3 and Week 6

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women postpartum 4 to 24 weeks
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tahir Aris, MD
Organizational Affiliation
INSTITUTE FOR PUBLIC HEALTH
Official's Role
Study Director
Facility Information:
Facility Name
Klinik Kesihatan Seksyen 7,
City
Shah Alam
State/Province
Selangor
ZIP/Postal Code
40000
Country
Malaysia
Facility Name
Klinik Kesihatan Kuala Lumpur
City
Kuala Lumpur
State/Province
W.P. Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Klinik Kesihatan Sg Besi
City
Kuala Lumpur
State/Province
WP Kuala Lumpur
ZIP/Postal Code
57000
Country
Malaysia
Facility Name
Klinik Kesihatan Presint 11
City
Putrajaya
State/Province
WP Putrajaya
ZIP/Postal Code
62000
Country
Malaysia
Facility Name
Klinik Kesihatan Presint 9
City
Putrajaya
State/Province
WP Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
Klinik Kesihatan Presint 18
City
Putrajaya
State/Province
WP Putraya
ZIP/Postal Code
62602
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
data sharing must be requested from Director General of Health Malaysia

Learn more about this trial

Behavioural Interventions for Postnatal Depression: a RCT Study

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