Effectiveness of a Nurse-led Didactic Cognitive Behavioral Therapy for People with Depression: A Randomized Controlled Trial

Last registered on April 02, 2024
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Pre-Trial

Trial Information

General Information

Title
Effectiveness of a Nurse-led Didactic Cognitive Behavioral Therapy for People with Depression: A Randomized Controlled Trial
RCT ID
AEARCTR-0013249
Initial registration date
March 26, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
April 02, 2024, 10:56 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country
Hong Kong
Region

Primary Investigator

Name
Cecil WONG
Affiliation
Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2017-06-22
End date
2018-06-22
Keywords
Behavior
Additional Keywords
JEL code(s)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Cognitive-Behavioral Therapy (CBT) is widely recognized as an effective treatment for depression; however, its accessibility remains a challenge. To address this, this study aimed to evaluate the effectiveness of a culturally attuned nurse-led didactic CBT manual in reducing depressive symptoms for Chinese individuals with depression. A parallel-arm, randomized controlled trial was conducted in two psychiatric clinics in Hong Kong, comparing five weekly sessions of group CBT delivered by psychiatric nurses to usual care. Out of the 110 outpatients who provided consent, 56 received CBT with 100% attendance rate. After five weeks, significant reductions in depressive symptoms (PHQ-9 scores: β=-1.81, 95% CI=-3.34 to -0.29, p=0.021) and anxiety symptoms (GAD-7 scores: β=-1.39, 95% CI=-2.73 to -0.05, p=0.043) were observed. Additionally, participants reported increased subjective happiness (SHS scores: β=2.33, 95% CI=1.30 to 3.36, p<0.001) and improved psychological well-being (psychological subscale of WHOQOL-BREF: β=0.77, 95% CI=0.01 to 1.53, p=0.047). The study demonstrates the feasibility and potential benefits of integrating nurse-led didactic CBT into routine psychiatric outpatient care for individuals with depression.
External Link(s)

Registration Citation

Citation
WONG, Cecil. 2024. "Effectiveness of a Nurse-led Didactic Cognitive Behavioral Therapy for People with Depression: A Randomized Controlled Trial." AEA RCT Registry. April 02. https://doi.org/10.1257/rct.13249-1.0
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
Nurse-led Didactic Cognitive Behavioral Therapy
Intervention Start Date
2017-06-22
Intervention End Date
2018-06-22

Primary Outcomes

Primary Outcomes (end points)
PHQ-9 scores: β=-1.81, 95% CI=-3.34 to -0.29, p=0.021
Primary Outcomes (explanation)
Significant reduction in depression level

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Nurse-led Didactic Cognitive Behavioral Therapy
Experimental Design Details
Randomization Method
A randomization schedule was created using the online randomization program, Randomization.com (https://www.randomization.com/)
Randomization Unit
individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
Two psychiatric out-patient unit
Sample size: planned number of observations
110
Sample size (or number of clusters) by treatment arms
110
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
Research Ethics Committee of Kowloon West Cluster under the Hospital Authority
IRB Approval Date
2017-04-01
IRB Approval Number
KW/FR-17-074(111-10)
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials