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Behavioural Interventions for Postnatal Depression: a RCT Study

POSTNATAL DEPRESSION: Malaysia ASPIRE* Project PHASE 2

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03196726
Enrollment
54
Registered
2017-06-23
Start date
2017-03-02
Completion date
2018-12-31
Last updated
2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postnatal Depression

Keywords

cognitive-behavioral therapy

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.

Interventions

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

BEHAVIORALstandard management based on Clinical Practice Guideline

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

Sponsors

Ministry of Health, Malaysia
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

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

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
changes in depression levelat baseline (Week 0), week 3 and Week 6assess changes in Beck Depression Index (BDI) score

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026