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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03196726
Other study ID # NMRR-15-2404-26677
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2, 2017
Est. completion date December 31, 2018

Study information

Verified date March 2019
Source Ministry of Health, Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 31, 2018
Est. primary completion date October 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

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
standard management based on Clinical Practice Guideline
Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required

Locations

Country Name City State
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 18 Putrajaya WP Putraya
Malaysia Klinik Kesihatan Presint 9 Putrajaya WP Putrajaya
Malaysia Klinik Kesihatan Seksyen 7, Shah Alam Selangor

Sponsors (1)

Lead Sponsor Collaborator
Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes in depression level assess changes in Beck Depression Index (BDI) score at baseline (Week 0), week 3 and Week 6
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