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Effects of Hydrocortisone Administration on Psychological State and Beliefs
Last registered on January 11, 2017

Pre-Trial

Trial Information
General Information
Title
Effects of Hydrocortisone Administration on Psychological State and Beliefs
RCT ID
AEARCTR-0001902
Initial registration date
January 11, 2017
Last updated
January 11, 2017 11:07 PM EST
Location(s)
Region
Primary Investigator
Affiliation
Loyola Marymount University
Other Primary Investigator(s)
PI Affiliation
Princeton University
Additional Trial Information
Status
On going
Start date
2016-08-25
End date
2017-05-15
Secondary IDs
Abstract
This document describes the analysis plan for a randomized laboratory experiment examining the effects of stress on a variety of behavioral outcomes. We recruit approximately 100 respondents from the informal settlements in Nairobi, Kenya. Using a double-blind procedure, respondents are randomly given a placebo or a 20 mg dose of hydrocortisone, a drug that increases the levels of stress hormones, for seven consecutive days. This plan outlines the design of the study, the outcomes of interest, and the econometric approach.
External Link(s)
Registration Citation
Citation
Haushofer, Johannes and Prachi Jain. 2017. "Effects of Hydrocortisone Administration on Psychological State and Beliefs." AEA RCT Registry. January 11. https://doi.org/10.1257/rct.1902-2.0.
Former Citation
Haushofer, Johannes and Prachi Jain. 2017. "Effects of Hydrocortisone Administration on Psychological State and Beliefs." AEA RCT Registry. January 11. https://www.socialscienceregistry.org/trials/1902/history/13064.
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Experimental Details
Interventions
Intervention(s)
Treatment
Hydrocortisone is a stable version of cortisol and is changed by your body into cortisol (a stress hormone in the body) upon ingestion; it is a standard approved drug used against rheumatoid and inflammatory diseases.

Data Collection
We will conduct laboratory sessions with approximately 20 respondents per session, until we reach 120 respondents. Before sessions begin, we generate participant ids that are randomly assigned to a treatment and control group. Both the laboratory administrators and subjects receiving the pills are unaware of their treatment status. At the beginning of each sessions, participants that satisfy the inclusion criteria, as determined by an extensive checklist and meetings with nurses, are randomly assigned a participant id. The remainder of the sessions follow, as described in the schedule of tasks and treatments subsection.

The treatments, tasks, and questionnaires are administered using touch screen computers to enable computer-illiterate respondents to participate. Enumerators read instructions to the respondents in English and Swahili to maximize comprehension. Respondents received a cash compensation of 350 KSH on each day, plus a 50 KSH for arriving on time. In addition, participants receive 400 KSH on the first day of participation, another 300 KSH on the seventh day of participation and another 500 KSH if they attend all seven days of the study. In addition, participants may receive an additional 100 KSH for correctly guessing their treatment status. The compensation and bonus is transferred to the respondents via M-Pesa.
Intervention Start Date
2016-08-25
Intervention End Date
2016-10-19
Primary Outcomes
Primary Outcomes (end points)
PANAS, salivary cortisol, self-reported stress, STAI-S, Cohen's Subjective Stress Scale, STAI-T, CESD, Cantril's Self-Anchoring Scale, Guessing Drug
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design

We conducted laboratory session with approximately 20 respondents
per session, until we reached 120 respondents. Before each session
began, we generated participant IDs, each of which was randomly assigned
to the treatment or placebo group. At the beginning of each session,
each participant was screened by a nurse and was randomly assigned
a participant ID. The study was double-blind, such that both the laboratory
staff and participants were unaware of their treatment status. The
remainder of the sessions followed the schedule of tasks and treatments
outlined below.

The treatments, tasks, and questionnaires are administered using touch
screen computers to enable computer-illiterate respondents to participate.
Enumerators read instructions to the respondents in English and Swahili
to maximize comprehension. Respondents received a cash compensation
of 350 KES on each day, plus a 50 KES for arriving on time. In addition,
participants received 400 KES on the first day of participation, another
300 KES on the seventh day of participation, and another 500 KES if
they attend all seven days of the study. In addition, participants
could receive an additional 100 KES for correctly guessing their treatment
status. The compensation and bonus were transferred to the respondents
via MPesa.
Experimental Design Details
Randomization Method
Double-blind study, randomization done in an office by computer by researcher not associated with analysis or implementation
Randomization Unit
individual level
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
Number of sessions
Sample size: planned number of observations
At least 100 individuals
Sample size (or number of clusters) by treatment arms
60 per treatment
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Princeton Institutional Review Board
IRB Approval Date
2016-05-11
IRB Approval Number
7200
Analysis Plan
Analysis Plan Documents
HydroPAP_2017.01.09_pj.pdf

MD5: 18a635641ae124566610fc98400b68a3

SHA1: bc4d2c58933546e5f685992bb87b84d719a4b138

Uploaded At: January 11, 2017

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