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Using a Self-report Card to Improve Mental Health: Evidence from a clustered Randomized Controlled Trial
Last registered on November 04, 2019

Pre-Trial

Trial Information
General Information
Title
Using a Self-report Card to Improve Mental Health: Evidence from a clustered Randomized Controlled Trial
RCT ID
AEARCTR-0004627
Initial registration date
November 01, 2019
Last updated
November 04, 2019 10:19 AM EST
Location(s)
Region
Primary Investigator
Affiliation
Nudge Lebanon
Other Primary Investigator(s)
PI Affiliation
Nudge Lebanon
PI Affiliation
Nudge Lebanon
PI Affiliation
Ministry of Public Health Lebanon
Additional Trial Information
Status
Completed
Start date
2018-08-06
End date
2019-10-31
Secondary IDs
Abstract
Following the launch of the 2015-2020 National Mental Health Strategy by the Ministry of Public Health (MoPH) Lebanon, the National Mental Health Programme (NMHP) proceeded with the integration of Mental Health (MH) into Primary Healthcare (PHC) centres across Lebanon, in collaboration with the PHC Department. An important component of this integration aims at increasing the detection, assessment and management of depression. As a result, the MNHP trained social workers and medical staff in 75 PHC centres to screen patients for depression using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a diagnostic tool that consists of nine questions designed to detect the presence and severity of depression. Patients who score more than 4 points on the PHQ9 questionnaire should ideally follow-up with their health provider to determine whether or not symptoms are improving, and which symptoms are, or are not, improving. Follow-up can take place any time within 2 to 4 weeks.

Against this background, Nudge Lebanon, in collaboration with the MNHP designed and implemented a behavioral intervention to: a) increase the likelihood of patients diagnosed with depression to come back within 2 to 4 weeks for a follow-up assessment; and b) improve patients’ self-awareness of their daily mood changes and mental health state prior to the appointment date. The intervention consisted of a self-report card that tracks daily mood changes of patients who were diagnosed with depression (PHQ-9 > 4) over a period of two to three weeks. The self-assessment card also acted as a constant reminder for patients to attend their pre-scheduled follow-up appointment.

The intervention was conducted in one PHC that operates under the supervision of the MoPH, and that is highly compliant with mental health requirements and procedures.
External Link(s)
Registration Citation
Citation
El Chammay, Rabih et al. 2019. "Using a Self-report Card to Improve Mental Health: Evidence from a clustered Randomized Controlled Trial." AEA RCT Registry. November 04. https://doi.org/10.1257/rct.4627-1.0.
Experimental Details
Interventions
Intervention(s)
The intervention involved offering the treatment group a self-assessment card to complete in the 15-21 days leading up to the appointment. The self-assessment card tracks patients' mood changes on daily basis for a period of two to three weeks, as well as acts as a constant reminder for patients to attend their prescheduled follow-up appointment.

The intervention aims to: a) increase the likelihood of patients diagnosed with depression to come back within 2 to 4 weeks for a follow-up assessment; and b) improve patients’ self-awareness of their daily mood changes and mental health state prior to the appointment date.
Intervention Start Date
2018-08-06
Intervention End Date
2019-08-31
Primary Outcomes
Primary Outcomes (end points)
Outcome 1: Follow-up status of patients (whether or not patients attended the follow-up appointment)
Outcome 2: Pre-post change in PHQ9 score
Primary Outcomes (explanation)
The pre-post change in PHQ9 score is the difference in PHQ9 score between the first visit and the follow-up visit.
Secondary Outcomes
Secondary Outcomes (end points)
Delay in attending the follow-up appointment
Secondary Outcomes (explanation)
The delay outcome variable is the difference in days between the date of the scheduled appointment and the date of attendance.
Experimental Design
Experimental Design
Randomization: The intervention was designed as a clustered randomised controlled trial (RCT) such that patients were randomly assigned to control and treatment groups based on their day of visit. The pilot involved 327 intervention days, consisting of 163 and 164 control and treatment days, respectively.

Touchpoint: A pre-specified randomisation schedule with the control and treatment days was provided to the social worker in advance. Treatment days were marked green to reduce error.

Target Population: Patients diagnosed with depressive symptoms (those who score at least 5 on PHQ9 during their first visit to the center).

The final sample consisted of a total of 405 patients who visited the centre over 206 days during a period of 12 months [control days = 105; treatment days = 101]. The difference between the initial number of intervention days and the actual number of intervention days was due to unexpected public holidays [4 days], personal leave [6 days], training sessions for social worker [2 days], or lack of patients diagnosed with depression [109 days].
Experimental Design Details
Randomization Method
Randomization was done using a statistics software
Randomization Unit
Randomization occurred at the day level. Patients who were diagnosed with depression (PHQ9 score>4) and visited during a treatment day were considered part of the treatment group and were offered the self-assessment card.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
Original: 327 days
Actual: 206 days

The difference between the initial number of intervention days and the actual number of intervention days was due to unexpected public holidays [4 days], personal leave [6 days], training sessions for social worker [2 days], or lack of patients diagnosed with depression [109 days].
Sample size: planned number of observations
405 patients
Sample size (or number of clusters) by treatment arms
105 control days [195 patients] and 101 treatment days [210 patients]
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Outcome 1: minimum detectable effect size is a 15 percentage points increase in the proportion of those who attend the follow-up appointment Outcome 2: minimum detectable effect size is a 2 points increase in the pre-post PHQ9 change outcome variable
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Université Saint-Joseph de Beyrouth
IRB Approval Date
2018-03-27
IRB Approval Number
CEHDF 1178
Analysis Plan

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Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers