Effects of Hydrocortisone Administration on Psychological State and Beliefs

Last registered on January 11, 2017

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Pre-Trial

Trial Information

General Information

Title

Effects of Hydrocortisone Administration on Psychological State and Beliefs: Pre-Analysis Plan

RCT ID

AEARCTR-0001902

Initial registration date

January 11, 2017

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

January 11, 2017, 5:01 PM EST

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

Locations

Country

Kenya

Region

Nairobi

Primary Investigator

Name

Prachi Jain

Affiliation

Loyola Marymount University

Contact Primary Investigator

Other Primary Investigator(s)

PI Name

Johannes Haushofer

PI Affiliation

Princeton University

Contact Investigator

Additional Trial Information

Status

On going

Start date

2016-08-25

End date

2017-05-15

Keywords

Health

Additional Keywords

Stress

JEL code(s)

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: Pre-Analysis Plan." AEA RCT Registry. January 11. https://doi.org/10.1257/rct.1902-1.0

Former Citation

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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

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?

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)

Supporting Documents and Materials

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

Post-Trial

Post Trial Information

Study Withdrawal