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Reasons and Remedies for the Omission of Sexual Orientation and Gender

Identity Data in Randomized Controlled Trials for Anxiety and Depression


Manuel Hurtado and Nicholas Heck, PhD, Marquette University,
Annesa Flentje, PhD, University of California, San Francisco

Background Figure 1. Study Overview


Data Analysis
Sexual orientation (SO) and transgender/gender nonconforming identity
Recruitment: To test our hypothesis we will use an Analysis of Variance (ANOVA) to test
(TGNC) data is rarely reported in the psychotherapy and substance abuse
Initially contacted: 181 whether participants in Condition 3 (i.e., those receiving both information and
literatures.1, 2
items) report significantly higher ratings on the item that assesses the likelihood
Sent Follow up email: 151
that they will collect SO and TGNC-related data going forward. We will also use a
This is problematic because a growing body of literature highlights health Contacted via phone: 130 chi-square test of equivalences to determine whether participants in Condition 3
disparities among sexual minorities. Lesbian, gay, bisexual, and transgender Sent final email: 8 are more likely to request items to assess SO and TGNC identities, relative to
(LBGT) people are at a two to threefold increased risk for mental health participants in the other conditions.
disorders, such as anxiety and mood disorders, compared to heterosexual
individuals.3, 4 Next, descriptive statistics will be used to assess how frequently SO and TGNC
Total respondents: 20 data are collected by PIs; exploratory analyses will evaluate whether
The results of randomized controlled trials (RCTs) suggest that there are a demographic characteristics of PIs are associated with collecting this data.
Completion rate: ~11%
number of efficacious treatments for anxiety and depressive disorders, yet these Finally, a basic content analysis will be used to identify barriers to collecting SO
treatments may not address LGBT-specific stressors.5, 6 Survey Questionnaire: and TGNC-related data and to identify factors that might facilitate the collection
of such data.7-8 We will also use a content analysis to determine how PIs are
Principal investigators (PIs) that conduct RCTs to evaluate psychotherapeutic What is the current recruitment status of your currently collecting SO and TGNC-related data.
treatments for anxiety and depression must consistently collect SO and TGNC clinical trial? Preliminary Results
data going forward and investigate whether SO and TGNC identities moderate Most participants (n= 12) stated they are not currently collecting (or do not plan
treatment outcomes.1, 2 to collect) SO data. Half (n= 6) of the participants stated they are currently
collecting (or plan to collect) TGNC identity data.
Using the Information-Motivation-Behavior (IMB) Model of Behavior Change7, Included: n= 14 Excluded: n= 6 Collection or Assessment of SO Data:
we posit that PIs will be most likely to collect SO and TGNC data when they are 1. Barriers preventing researchers from collecting or assessing:
highly motivated AND when they are provided with skills or resources • Not yet/ • Recruitment • “Not relevant to their particular study” (n= 9)
necessary to efficiently collect SO and TGNC data. currently complete • “Not feasible to ask due to nature of the research study” (n= 2)
recruiting 2. Factors that can assist researchers collect or assess:
Objective, Hypothesis, and Secondary Aims • “Easily understood questions” (n= 4)
• “Required by the NIH for funding” (n= 1)
The present study sought to identify under which conditions PIs conducting Collection or Assessment of TGNC Identity Data:
NIH-funded psychotherapy research for depression and anxiety would be most Are you collecting sexual orientation and 1. Barriers preventing researchers from collecting or assessing:
likely to collect SO and TGNC data. gender identity information? • “Not relevant to their particular study” (n=4)
• “Not feasible to ask due to nature of the research study” (n=1)
We hypothesized that PIs would be most likely to collect this data when
2. Factors that would assist researchers collect or assess:
provided information about LGBT health disparities (presumably increasing
• “Easily understood questions” (n=1)
motivation to collect the data) and specific question items to assess SO and Yes No • “Required by the NIH for funding” (n=1)
TGNC identities.
Table 1 Table 2
In addition, we aim to: 1) Determine how frequently SO and TGNC data are Frequencies of the Likelihood of Collecting or Willingness to receive an email
Assessing SO and TGNC Identity Data Going containing SO and TGNC
collected by PIs; 2) Identify barriers to collecting and factors that might increase How? Why not? Forward Likert Rating Scale identity assessment items
the likelihood of collecting SO and TGNC data; and 3) Evaluate the assessment
SO TGNC Yes No
methods PIs use to collect SO and TGNC data.
Likert Rating Scale n n n n
What can help Not at all likely 2 2 5 8
Method assess? Probably not likely 6 1
Participants Possibly likely 4 5
Using publically available email addresses and telephone numbers reported in Extremely likely 0 0
the ClinicalTrials.gov database, 181 PIs of NIH-funded RCTs for anxiety and
depression were asked to complete an online research study. A total of 14 Experimental manipulation
participants are included in this preliminary analysis; recruitment is ongoing. Discussion
Most participants (n= 12) self-identified as heterosexual. Eight participants self- Previous research suggests that LGBT individuals are at higher risks for negative
identified as cisgender females. All participants identified their ethnicity as physical and mental health outcomes, such as anxiety and depression, compared
White. to heterosexual people. Yet, most PIs of RCTs for anxiety and depression report
CID1: CID2: CID3: CID4: not collecting SO and TGNC identity data. Most participants state that these
Procedure variables are not relevant, and thus should not be investigated. However,
All study procedures were IRB approved. The ClinicalTrials.gov database LGBT Items to LGBT Control literature highlighting associations between SO and TGNC identities and mental
provides access to information about federally-funded research on various Health Assess Health No health outcomes suggests researchers should actively collect and report this
diseases and conditions; it is maintained by the National Library of Medicine Disparity SO and Info & Items demographic information to provide evidence on whether there should be further
(NLM) and National Institute of Health (NIH). The recruitment procedure Info TGNC Items or Info investigation.
includes an initial email, a follow-up email, a telephone call, and a final “last To assess LGBT identity, it is recommended to add a separate measure of SO
chance to participate” email. Participants are told that $1 will be donated to the identity. Participants’ responses indicate they follow this approach by allowing
National Alliance on Mental Illness (up to $200) for each completed survey. participants to self-identify their own SO, and also their sexual attraction. A two-
step process is recommended for measuring TGNC identity data (i.e. question
Survey Questionnaire items regarding gender identity and sex assigned at birth). 9 Responses of
Online survey questionnaire contained demographic questions, and questions
Outcome variables:
methods used to assess TGNC identity data do not follow a two-step process, and
regarding their current clinical trial. Additionally, the survey contained an What is the likelihood of collecting SO and
only include a single question item to allow participants to indicate their gender
experimental manipulation where, under four different conditions, those not TGNC data going forward? identity, and not their sex assigned at birth. Using a two-step approach, opposed
collecting SO or TGNC data would be asked about the likelihood of collecting Likert Rating Scale to a single gender identity item, is recommended for high specificity and high
this data in the future. Participants were provided one of the four conditions: sensitivity.
Condition 1: Specific information highlighting LGBT mental health disparities. Would you like to receive items to assess
Study limitations must be considered (i.e. low response rate). Without ample
Condition 2: Items to assess SO and TGNC identities. sexual orientation and gender identity data?
Condition 3: Both information about health disparities and items.
data, there is not yet enough power to our hypothesis and answer our primary
Yes/No Response Option research questions. Data collection is ongoing and we hope to increase our
Condition 4: Control group, receives neither information or items.
response rate.

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