Positive Affect Treatment for Spanish-speaking Individuals With Depression and Anxiety: An Uncontrolled Pilot Trial
Phase: NA
Conditions: Anhedonia, Depression in Adults, Anxiety
Sponsor: Southern Methodist University

Trial Protocol for 
“Positive Affect Treatment for Spanish-speaking Individuals with Depression and Anxiety: 
An Uncontrolled Pilot Trial” 
 
Last updated October 07, 2025 
NCT Number: not yet assigned 
 
 
 
 

Study Protocol and Statistical Analysis Plan 
Study Aims 
The current study’s primary aim is to examine the feasibility and acceptability of a direct 
translation of PAT for Spanish-speaking participants living in the United States with low positive 
affect and depression, anxiety, or stress. To assess the feasibility and acceptability of treatment, we 
will examine the feasibility of recruitment, participants’ credibility ratings, participants' 
satisfaction with treatment, therapeutic alliance ratings, treatment attrition and attendance, and 
practice completion. Given that PAT is designed to be flexible to tailor to the patient's preferences 
(e.g., pleasant activities), we hypothesize that PAT will be feasible and accepted in an SSL sample. 
Secondly, we aim to assess the degree to which SSL shows a significant increase in positive affect 
and a significant decrease in depression, anxiety, and stress symptoms at posttreatment and 1-
month follow-up as a preliminary evaluation of efficacy. Lastly, we aim to gather qualitative 
information to assess if more culturally adapted modifications are needed.  
Methods 
Participants 
The sample will consist of twelve Spanish-speaking volunteers between 18 and 65 years old. The 
sample size was determined based on comparable feasibility and acceptability pilot studies for 
other psychotherapeutic interventions (e.g., Collado et al., 2014; Ramirez-Gomez et al., 2023). 
The small sample size is consistent with stage I of the NIH Stage Model for Behavioral 
Intervention Development (Onken, 2022), which does not recommend a fixed number but 
encourages researchers to determine an appropriate sample size. Participants will be volunteers 
from across the United States, ensuring diversity in symptom severity and socioeconomic levels. 
Participants enrolled will indicate Spanish as their preferred language. Participants will endorse 
(a) low positive affect determined by a score ≤ 24 on the Positive and Negative Affect Scale- 
Positive Affect Subscale (PANAS-P; Watson et al., 1998), which is one standard deviation below 
the 50th percentile, (b) moderate to severe depression determined by a score ≥ 11 on the Depression 
Anxiety Stress Scale-21 items – Depression subscale (DASS-21; Lovibond & Lovibond, 1995),  
anxiety determined by a score of ≥ 6 on the DASS – Anxiety subscale, or stress determined by a 
score of ≥ 10 on the DASS – Stress subscale, and (c) clinically significant impairment determined 
by a score ≥ 5 on any subscale of the Sheehan Disability Scale (Sheehan et al., 1996). A psychiatric 
diagnosis is not required for inclusion. All participants will need to refrain from any new 
psychological treatments. Exclusion criteria will consist of below 8th grade Spanish reading and 
writing proficiency level, severe medical conditions, active suicidal ideation, lifetime history of 
bipolar disorder, psychosis, intellectual disability or organic brain damage, substance abuse in the 
last 6 months or dependence in the last 12 months, more than 11 cigarettes per week or nicotine 
equivalent, marijuana, cocaine or stimulant use more than 4 times per week before 15 years old, 
pregnancy, use of bupropion, dopaminergic or neuroleptic medications in last 6 months, and refusal 
of video recording.  
Procedures 
Interested volunteers will complete the screening questionnaires (i.e., inclusion and exclusion 
criteria questions) online through the recruitment link or over the phone. After preliminary 
eligibility is confirmed, a Spanish-speaking doctoral-level clinician will conduct a semi-structured 

clinical interview, using the Structured Clinical Interview for DSM-5 Disorders-Research Version 
(SCID-5-RV; First et al., 2015) to assess whether they meet diagnostic criteria for any disorder, 
including disorders in the exclusion criteria. If eligibility is confirmed, participants will provide 
informed consent before starting treatment. Participants will then complete the baseline 
questionnaires, followed by 15 weeks of PAT administered by a Spanish-speaking doctoral-level 
clinician via HIPAA-compliant Zoom. The doctoral-level clinician will receive weekly supervision 
by a licensed clinical psychologist. Participants will complete weekly symptom questionnaires 
before each session. After the last therapy session, participants will complete the post-treatment 
acceptability and feasibility assessments. One month after the last treatment session, a doctoral-
level clinician will conduct a semi-structured clinical interview using the SCID-5-RV to examine 
diagnoses at posttreatment, and participants will complete follow-up questionnaires. Participants 
will be able to earn a $15 gift card for completing the post-treatment assessments and an additional 
$25 gift card for completing the 1-month follow-up assessments. The Institutional Review Board 
at Southern Methodist University will approve the study and the study will be preregistered at 
clinicaltrials.gov.    
Measures 
The following measures will all be administered in Spanish. Participants will complete a 
demographics questionnaire to gather data on their age, ethnicity, gender, income, and education 
level. In addition to the demographic data collected in previous trials of PAT (Craske, Meuret et 
al., 2019, 2023), participants will be asked the following additional demographic variables: years 
living in the United States, subethnicity, past behavioral health treatment, English proficiency, and 
immediate family in the United States to have a clear description of our sample.  
Treatment Feasibility and Acceptability Measures 
Client Satisfaction. The Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson & Zwick, 
1982) is an 8-item self-report measure used to capture satisfaction with services. Each item is 
scored on a four-point scale from 1 to 4, with a total score range from 8 to 32. Higher scores 
suggest greater satisfaction with the treatment. The Spanish version of the CSQ-8 has adequate 
internal consistency (alpha=.80) among Spanish-speaking participants (Vazquez et al., 2019). The 
CSQ-8 will be administered after the last therapy session to assess treatment acceptance.  
Therapeutic Alliance. The Working Alliance Inventory-Short (WAI-S; Tracey & 
Kokotovic, 1989) is a 12-item questionnaire used to assess the participants’ therapeutic alliance 
ratings along three domains: goal, task, and bond. Each item is scored on a five-point scale, ranging 
from 1 (Seldom) to 7 (Always), and an average score is calculated for each domain. The Spanish 
version of the WAI-S has excellent internal consistency and convergent validity (Andrade-
Gonzalez & Fernandez-Lira, 2015). The WAI-S will be administered after the last therapy session 
to assess the participant's ratings of the therapeutic alliance.  
Treatment Attrition and Attendance. Treatment attrition will be calculated as the dropout 
percentage after enrollment. In addition, treatment attendance will be operationalized as the total 
number of treatment sessions attended out of the 15 planned sessions and the average will be 
calculated across participants. The reason for termination will be recorded if a participant decides 
to discontinue treatment before completion.  
Treatment Practice Adherence. After each treatment session, the participant's practice 
completion (e.g., pleasant activities, savoring exercises) will be measured using a 0-100% scale, 
with 0% indicating that they did not complete any practice outside of therapy sessions, and 100% 

indicating that they completed all scheduled practice. Overall practice completion will be 
calculated as the average of practice outside of sessions completed across 14 sessions, since no 
homework will be assigned for the first session.  
Client Credibility and Expectancy. The Credibility/Expectancy Questionnaire (CEQ; 
Devilly & Borkovec, 2000) will be used to examine the participant's treatment expectancy of 
positive outcomes and credibility on the treatment rationale. It is a 6-item self-report measure, 
divided into credibility and outcome expectancy questions. The CEQ has been validated in 
English-speaking clinical populations (Devilly & Borkovec, 2000). The measure is currently being 
validated in a Spanish-speaking sample; therefore, we will use a direct translation of the measure, 
given that it is not yet publicly available.   
 
Recruitment feasibility. Feasibility of recruitment will be examined using three parameters: 
number of individuals screened per month, number of participants enrolled per month, and average 
time from screening to enrollment including the reason for any long delays. In addition, the reason 
for lack of enrollment (e.g., not eligible, not interested, lost to follow-up) will be recorded.  
 
Qualitative Feedback. To examine treatment feasibility and acceptability through 
qualitative data and assess if more culturally adapted modifications are needed, participants will 
complete written open-ended items in Spanish asking about (1) treatment feasibility, (2) treatment 
acceptability, (3) treatment satisfaction, (4) treatment comprehension, (5) perceived effectiveness, 
(6) suggestions, and (7) other general comments. The qualitative survey will be administered after 
the last therapy session. 
 
Preliminary Efficacy Outcome Measures 
Positive Affect. As a replication of the randomized-controlled trial of PAT (Craske, 
Meuret, et al., 2023), the Positive and Negative Affect Scale (PANAS; Watson et al., 1988) will 
be used to measure positive affect, the primary treatment target. The PANAS is a self-report 
measure of positive and negative affect. The scale includes 20 items, 10 indicating positive affect 
(e.g., excited) and 10 corresponding to negative affect (e.g., scared). Each item is rated on a five-
point scale, with higher scores indicating a higher level of positive or negative affect. Each 
subscale ranges from 10 to 50. Psychometric properties of the Spanish version of the PANAS 
mirror the English version’s properties with a two-factor structure and adequate convergent and 
discriminant validity, internal consistency (alphas=.87 and .91), and sensitivity to change in 
clinical samples (Diaz-Garcia et al., 2020). The PANAS-Positive subscale will be used as a 
screening and primary outcome measure.   
 
Depression, Anxiety, and Stress Symptoms. We will use the Depression Anxiety Stress 
Scale- 21 (DASS-21; Lovibond & Lovibond, 1995) to measure symptoms of depression, anxiety, 
and stress, which have been shown to decrease in trials of PAT (Craske, Meuret, et al., 2019, 
2023). The DASS-21 is a 21-item self-report shorter version of the original 42-item scale. The 
items are scored on a four-point scale from 0 (Did not apply to me at all) to 3 (Applied to me very 
much or most of the time) to measure how much the participant endorses each item over the past 
week. Higher scores indicate higher symptom severity. The items are summed for a total score, 
and there are three subscales, corresponding to depression, anxiety, and stress symptoms. The 
Spanish version of the DASS-21 has been validated in Spanish-speaking samples and demonstrates 
comparable psychometric properties to the English version, with internal consistency alphas 

ranging from .86 to .96 and adequate construct and convergent validity (Daza et al., 2002; Zhou et 
al., 2024). The DASS-21 subscales will be used as screening measures and the total score will be 
used as a primary outcome measure.  
 
Other Measures 
Clinical Psychological Diagnoses. The Structured Clinical Interview for DSM-5 – 
Research Version (SCID-5-RV; First et al., 2015) will be used to assess eligibility criteria (i.e., 
exclusion diagnoses) and to provide a description of the participants included in the study. At a 1-
month follow-up assessment, a trained researcher will conduct the SCID-5-RV without the 
exclusion criteria modules to describe the participants' clinical diagnoses after treatment. The 
SCID-5-RV has been translated into Spanish by an international publisher (Telesage) in 
collaboration with the American Psychiatric Association (APA) Publishing.  
Clinically Significant Impairment. The Sheehan Disability Scale (SDS; Sheehan et al., 
1996) will be used to assess clinically significant impairment for eligibility criteria. The SDS is a 
3-item measure that assesses the severity of distress resulting from impairment in work, family 
life/home responsibilities, and social/leisure activities. Each domain is rated on a 10-point scale 
from 0 (Not at all impaired) to 10 (Very severely impaired). The Spanish version of the SDS has 
been validated in a Spanish-speaking sample, demonstrating similar psychometric properties to 
the English version, with an internal consistency of alpha=.83 (Luciano et al., 2009).  
Interviewer-rated Anhedonia. As a descriptive measure of the participant’s level of 
anhedonia using an interview-like measure, a Spanish-speaking interviewer will rate the 
participant’s ‘loss of interest’, ‘loss of pleasure’, and ‘loss of motivation’ during the past week. 
The interview will be done as part of the SCID-5-RV sessions at baseline and 1-month follow-up.   
Suicidality. The Beck Depression Inventory-II (BDI-II; Beck et al., 1996) is a 21-item self-
report measure used to assess key symptoms of depression, but only item 9 will be used to assess 
suicidality before each treatment session. The item is rated on a four-point scale from 0 to 3, with 
higher scores indicating greater severity. The Spanish version has been validated in Spanish-
speaking adults, with internal consistency alphas ranging from .89 to .92 (Sanz et al., 2003).  
 
Intervention 
All participants will participate in a full treatment course of PAT. PAT consists of a total of 15 
sessions designed to include psychoeducation, behavioral skills, cognitive skills, positive emotions 
cultivation skills, and a relapse prevention session. The first module (sessions 1-7) consists of 
behavioral activation to rewarding experiences, followed by a savoring exercise in which the 
participant recounts positive experiences and reinforces the positive mood effects. These exercises 
are expected to continue throughout the full treatment course. The second module (sessions 8-10) 
focuses on three cognitive skills: identifying the positive aspects of a past event, taking 
responsibility for positive outcomes, and imagining future positive events. The third module 
(sessions 11-14) comprises four exercises designed to cultivate positive emotions through daily 
mental and physical practices in Loving-Kindness, Generosity, Gratitude, and Appreciative Joy. 
After each session, the participant is encouraged to complete 5-7 practice exercises of the skill 
learned in session (e.g., engaging in a pleasant activity, completing a Loving-Kindness exercise) 
between sessions. The final session includes a review of the relapse prevention plan to reinforce 
all the skills learned during treatment.  

The PAT therapist manual and client workbook have been translated into Spanish by the 
UT Southwestern Spanish Language Resources (SLR). The SLR provided an evidence-based 
translation process to ensure that the study materials are culturally appropriate and conceptually 
equivalent (“Office of Community Health & Research Engagement”, n.d.). The team was 
comprised of native speakers and individuals certified in verbal, written and medical Spanish 
language proficiency. The team followed a Translation, Editing, and Proofreading (TEP) 
methodology, where three certified individuals review the materials (compared to many translation 
vendors that use a 1-person translation process). First, the materials were translated by capturing 
the content, style, and form of the original text. Then, a second certified individual ensured that 
the translation is accurate, complete, and culturally appropriate. Lastly, the final translation was 
reviewed by a third certified translator and ensures the translation meets the highest standards. 
Data Analysis Plan  
First, baseline demographic and clinical characteristics will be summarized to describe the sample. 
For our primary aim, several a priori benchmarks will be used to evaluate the acceptability and 
feasibility of PAT based on the data from PAT trials with English-speaking samples (Craske, 
Meuret et al., 2019, 2023) and other treatment pilot studies with Spanish-speaking individuals 
(Collado et al., 2014, 2026; Reinosa et al., 2024).  
Client Satisfaction. The CSQ-8’s (Attkison & Zwick, 1982) total score ranges from 8-32, 
however, it does not have a standardized interpretation rating scale. As our Benchmark 1, 80% of 
the completed sample will score at least a 28, which was the minimum score of a telehealth BA 
trial with Spanish-speaking participants (Reinosa et al., 2024).  
Therapeutic Alliance. Therapeutic alliance using the WAI-SR (Hatcher & Gillaspy, 2006) 
was high for all categories in previous randomized controlled trials of PAT (Craske et al., 2019, 
2023); for affective bond (M=4.68; SD=0.55 and M=4.55; SD=0.58), agreement on tasks (M=4.77; 
SD=0.45 and M=4.25; SD=0.77) and goals (M=4.54; SD=0.58 and M=4.59; SD=0.56). As our 
Benchmark 2, the average scores for each subscale will be greater than 4.   
Treatment Attrition and Attendance. The average attrition rate (i.e., completed less than 10 
out of 15 sessions) across the three completed PAT trials was 27% (33% for Craske et al., 2019; 
24% for Craske et al., 2023; and 25% for Meuret et al., in prep). Overall, the average number of 
sessions attended were 11.4 (Craske et al., 2019) and 12.21 (Craske et al., 2023). Based on a review 
of internet-based CBT for depression, the average dropout rate is 32% (Schmidt et al., 2019). 
Therefore, our Benchmark 3 is 8 participants will attend at least 10 treatment sessions (30-37% 
dropout rate) and Benchmark 4 is the average number of sessions attended will be greater than 
ten.  
Treatment Practice Adherence. Benchmark 5 is that on average, participants will complete 
at least 75% of practice completion, which will be comparable to practice completion reported in 
two BA trials will Spanish-speaking participants (86.54% in Collado et al., 2014 and 75.18% in 
Collado et al., 2016).  
Client Credibility and Expectancy. The previous PAT trials reported high 
credibility/expectancy scores using the CEQ (Devilly & Borkovec, 2000) with a range of means 
across modules 6.31-6.85 on Craske et al., 2019 and M=7.28 on Craske et al., 2023. Benchmark 6 
will be an average score on the CEQ greater than 6.  

Recruitment feasibility. For Benchmark 7, we will recruit at least three participants per 
month which is on par with the approximate average rate of recruitment for the second randomized 
controlled trial of PAT (Craske et al., 2023). There will be no a priori benchmarks for the number 
of individuals screened per month or the average time from screening to enrollment. 
For our secondary aim, we will test whether there was a significant decrease in symptom severity 
after treatment as a preliminary evaluation of treatment efficacy. We will use a full intent-to-treat 
sample using two univariate multilevel modeling (MLM) to examine changes in (1) positive affect 
(PANAS-P), and (2) depression, anxiety, and stress symptoms (DASS-Total) from baseline to 1-
month follow-up. The repeated assessments (Level 1) will be nested within individuals (Level 2). 
Time will be centered at posttreatment. Given the small sample size, restricted maximum 
likelihood estimation will be used with Kenward-Roger degrees of freedom approximation 
(Kenward & Roger, 1997). We will use baseline scores as covariates.  
For our third aim, we will use Braun and Clarke’s six phase thematic analysis framework (Braun 
& Clarke, 2006; Ahmed et al., 2025) to identify themes across the participant’s response for each 
question of the qualitative feedback survey. I will follow the following six steps: 1) familiarize 
with the data, 2) generate initial codes, 3) search for themes, 4) review themes, 5) define and name 
themes, and 6) write the report.  
 
 
 

 
 
 
 
 
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Consent to Participate in Research 
Study Title:  Positive Affect Treatment Study for Depression and Anxiety in Spanish-
Speaking Individuals 
Mentor ID #:  25-093 
Principal Investigator: Sofia Uribe, M.A. 
Faculty Sponsor: Alicia Meuret, Ph.D. 
Study Site: Online (Zoom)  
 
You are being asked to participate in a research study. Your participation in this research study 
is voluntary and you do not have to participate. This document contains important information 
about this study and what to expect if you decide to participate.  Please consider the information 
carefully. Feel free to ask questions before making your decision whether or not to participate. 
The purpose of this form is to provide you with information that may affect your decision as to 
whether or not you may want to participate in this research study.  The person performing the 
research will describe the study to you and answer all your questions. Please read the information 
below and ask any questions you might have before deciding whether or not to give your 
permission to take part.  If you decide to be involved in this study, this form will be used to record 
your permission. 
 
Purpose 
If you participate in this research study, you will be invited to engage in therapy referred as 
Positive Affective Treatment (PAT) to target symptoms of low positive affect and depression, 
anxiety or stress. All components of the therapy focus on enhancing positive affect through 
changes in behaviors, thoughts, and feelings. We want to examine the feasibility and 
acceptability of PAT in a Spanish-speaking population.  
 
TREATMENT 
During participation in the study, you will engage in weekly psychotherapy sessions that will be 
conducted by a trained therapist through encrypted video-conferencing platform (i.e., Zoom). 
The total number of therapy sessions you receive will be 15. All study participants will receive the 
same treatment. There is no placebo condition. All components of the therapy have been shown 
to be effective in reducing depression, anxiety, and stress, and focus on enhancing and increasing 
positive coping and life strategies, as well as examining thoughts and modifying behaviors. 
Treatment sessions will be conducted by a fully trained therapist (senior graduate student) 
supervised by licensed, clinical psychologist with extensive experience. All of the treatment 

 
 
 
 
 
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sessions will be audio- and video-recorded. This is done in order to ensure quality in the care that 
you receive and to monitor consistency among the therapists. 
 
If you are on any medications, you will be asked to remain on a consistent dose/regimen of your 
medication until after completion of the study, including throughout treatment (15 weeks), and 
post-treatment assessment (to be completed one month after your final treatment session). You 
should always consult with your primary provider before making changes to medication, dose, or 
discontinuation of current medication. Also, you will be asked to inform us if you seek other forms 
of medical or psychological treatment for depression, anxiety, or stress before completion of the 
treatment study.  
 
Treatment will consist of 15 weekly therapy sessions. You may be removed from the study if you 
miss more than three treatment sessions without notifying study staff within 24-hours of your 
scheduled session. 
 
ASSESSEMENTS 
You will also be asked to complete a short series of clinical monitoring surveys before each weekly 
therapy session to track your progress. The therapist will send you the questionnaires the 
morning of your session so that you complete them at any time before your session. In addition, 
you will be asked to complete them again one month after completing treatment. 
 
TIMELINE AND DURATION 
Overall, your involvement will be approximately 19 weeks, with 15 weeks for treatment and 1-
month follow-up diagnostic interview. 
 
Study Stage 
Activity 
Approximate Duration 
Screening 
Online or Phone Screening 
30 minutes 
Eligibility Diagnostic Interview  
90-120 minutes 
Informed Consent 
Informed Consent 
30 minutes 
Baseline Questionnaires 
15 minutes 
Study Participation 
Weekly Questionnaires 
Sessions 1-15: 10 minutes 
Weekly Therapy Sessions 
Session 1: 90 minutes  
Sessions 2-15: 60 minutes  
Post-first session Questionnaire 
5 minutes 
Post-treatment Questionnaires 
30 minutes 
1-month Follow-Up Questionnaires 
10 minutes 
1-month Follow-Up Interview 
60 minutes  
APPROXIMATE TOTAL STUDY DURATION 1380 minutes = 23 hours  

 
 
 
 
 
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You have the right to refuse to answer any question that you do not wish to answer, and to refuse 
any task that you do not wish to do. You can stop your participation in the study at any time 
without penalty.  
 
Risks or Discomforts 
Potential risks, stress and/or discomforts of participation may include discomfort you might 
experience talking about your medical and psychological history. During the treatment phase of 
the study, you may experience anxiety from being asked to face things that cause you distress or 
from being asked to confront situations and feelings that you find anxiety provoking. Because 
this is a research study, there may be some unknown risks that are currently unforeseeable. You 
will be informed of any significant new findings. 
 
Audio or video recordings will be transcribed and then destroyed or modified to eliminate the 
possibility that study participants could be identified. The identifiable audio and video recordings 
will not be used at scientific meetings or training sessions, only during supervision between the 
therapist and supervisor the active data collection stage. The data will be deleted after five years.  
 
Benefits 
The potential benefits which may reasonably be expected to result from this study may include 
significant reductions in your symptoms of anxiety, depression or stress, and increases in your 
experience of positive (i.e., pleasurable) emotions. We cannot and do not guarantee or promise 
that you will receive any benefits from this study.  
 
Findings from this study may help clinicians provide more effective treatments for psychological 
disorders. Research has shown that these treatment approaches are likely to be of benefit to 
those who show symptoms similar to yours. It is important to note that individuals respond 
differently to therapy, and so it is not possible to know in advance if the treatment will be helpful 
in your particular case. 
 
Confidentiality of Information 
Any information obtained in connection with this study that can be identified with you will 
remain confidential to the extent allowed by law. No identifying information will be revealed in 
the presentation or publication of any results from the project. 
 
Some identifiable information about you will be replaced with a code. A list linking the code and 
your identifiable information will be kept separate from the research data. All research data and 
records will be maintained in a secure network with password protection through SMU.  
 
All of the diagnostic evaluations and treatment sessions will be video-taped and later reviewed 
by the therapist and supervisor for educational purposes and determine whether the 
assessments and treatment have been delivered appropriately (quality assurance) as well as 

 
 
 
 
 
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subsequent analysis. The data and video/audiotapes will be stored in a password protected 
folder for five years after the study has been completed, and then they will be destroyed.  
 
Emergency contact: We ask you to provide us with your emergency contact. We will contact your 
emergency contact only if we have consistently failed to reach you using a variety of channels 
(phone, email) and if we are concerned about your safety. We will disclose to your emergency 
contact only that you are participating in a SMU research study and that we have been trying to 
reach you but failed to do so. We will disclose that we are concerned about your safety if that is 
the case. We will not disclose the nature of the study or any other information you have provided 
to us. 
 
Limits to confidentiality 
All of the information you provide will be confidential.  However, there are some situations in 
which clinicians are legally obligated to take actions, such as when a clinician believes actions are 
necessary to attempt to protect others from harm. Under these circumstances, your therapist 
may release some information about your treatment. 
 
• If there is cause to believe that a child under 18 has been or may be abused or neglected 
(including physical injury, substantial threat of harm, mental or emotional injury, or any kind of 
sexual contact or conduct), or that an elderly or disabled person is in a state of abuse, neglect, or 
exploitation, the law requires that a report is made to the appropriate governmental agency, 
usually the Texas Department of Family and Protective Services. Once such a report is filed, your 
therapist may be required to provide additional information. 
 
• If a clinician determines that there is a probability that a client will inflict imminent physical, 
mental, or emotional harm upon him/herself or others, he/she may be required to take 
protective action by disclosing information to medical or law enforcement personnel or by 
securing hospitalization of the client. Depending on how intense the thoughts are or how much 
you feel like hurting yourself, the research staff may provide you with referrals for treatment; 
work with you to contact your personal physician or trusted family member to discuss your 
thoughts of harming yourself; or work with you on a plan that may include getting you to a 
hospital for safety.  
 
If such a situation arises, your therapist will make every effort to fully discuss it with you before 
taking any action and limit the disclosure to what is necessary 
 
Government or university staff sometimes review studies such as this one to make sure they 
are being done safely and legally.  If a review of this study takes place, your records may be 
examined.  The reviewers will protect your privacy.  The study records will not be used to put 
you at legal risk of harm.   
 

 
 
 
 
 
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ClinicalTrials.gov Registration 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law.  This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results.  You can search this Web site at any time. 
 
Use of your information for future research  
All identifiable information (e.g., your name, date of birth) will be removed from the information 
or samples collected in this project.  After we remove all identifiers, the information or samples 
may be used for future research or shared with other researchers without your additional 
informed consent. 
 
Incentives to participate 
You will be able to earn a $15 gift card sent to your email for completing the post-treatment 
assessments and an additional $25 gift card for completing the 1-month follow-up assessments. 
 
Consent to video / audio recording / photography solely for purposes of this research 
This study involves video recording of all therapy sessions and diagnostic interviews. If you do 
not agree to be recorded, you CANNOT take part in the study. 
 
_____   YES, I agree to be video/audio recorded/photographed. 
 
_____   NO, I do not agree to be video/audio recorded/photographed. 
 
Questions 
For questions, concerns, or complaints about the study you may contact Alicia E. Meuret, Ph.D., 
Professor of Psychology, Director of the Anxiety and Depression Research Center at SMU, at (214) 
768-3422 or Sofia Uribe, M.A., Clinical Psychology Graduate Student at SMU at (214) 768-6014. 
 
If you are not satisfied with how this study is being conducted, or if you have any concerns, 
complaints, or general questions about the research or your rights as a participant, please contact 
the Southern Methodist University (SMU) Institutional Review Board to speak to someone 
independent of the research team at (at ResearchCompliance@smu.edu. 
 
 
 
 
 
 
 

 
 
 
 
 
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Signing the consent form 
I have read (or someone has read to me) this form, and I am aware that I am being asked to 
participate in a research study.  I have had the opportunity to ask questions and have had them 
answered to my satisfaction.  I voluntarily agree to participate in this study.  
 
I am not giving up any legal rights by signing this form.  I will be given a copy of this form. 
 
 
 
 
 
 
 
 
Printed name of subject 
 Signature of subject 
 
Date