Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
Phase: NA
Conditions: Pelvic Floor Disorders, Anxiety, Urinary Urgency, Urinary Incontinence, Nocturia, Urinary Frequency/Urgency, Lower Urinary Tract Symptoms, Urinary Hesitancy, Urinary Straining
Sponsor: Northwestern University

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Revised: December 1, 2017
PROTOCOL TITLE:
Enhancing Behavioral Treatment for Women with Pelvic Floor Disorders
PRINCIPAL INVESTIGATOR:
James W. Griffith, PhD
Medical Social Sciences
j-griffith@northwestern.edu
CO-INVESTIGATOR:
Kimberly S. Kenton, MD, MS
Obstetrics and Gynecology
kimberly.kenton@nm.org
VERSION DATE:
April 25, 2019
DEFINITIONS OF ACRONYMS:
BMQ = Brief Medication Questionnaire
CBT = cognitive-behavior therapy
DSM-5 = Diagnostic and Statistical Manual of Mental Disorders
HLM = hierarchical linear models
IPIP = International Personality Item Pool
MBSR = mindfulness-based stress reduction
PCL-5 = PTSD Checklist for DSM-5 with Life Events Checklist
PFDI-20 = Pelvic Floor Distress Inventory
PGI-I = Patient Global Impression of Improvement
PROMIS = Patient Reported Outcomes Measurement Information System
PTSD = posttraumatic stress disorder
RRS = Ruminative Responses Scale
UDI-6 = Urinary Distress Inventory
UP-CBT = Unified Protocol Cognitive-Behavior Therapy
IRB #: STU00207124-MOD0010 Approved by NU IRB for use on or after 6/13/2019 through 3/3/2020.

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1.0
Purpose of the study: 
1.1 Purpose
The purpose of this proposal is to test a novel behavioral treatment – Unified 
Protocol Cognitive-Behavior Therapy (UP-CBT)1 – to enhance quality of life in women 
with pelvic floor disorders. Emotional distress is treatable using behavioral procedures, and 
effective treatment would increase women’s emotional health and help to reduce urinary 
symptoms (e.g., incontinence, frequent urination). Women with pelvic floor disorders are 
often seen in the urogynecology or urology clinic, which makes this setting ideal for 
offering additional interventions that may improve their quality of life. Unfortunately, 
many women with pelvic floor disorders may not receive effective behavioral treatment, 
such as cognitive behavior therapy, because urogynecologists, urologists, and other 
medical professionals may not be aware of providers in their community who offer this 
treatment. We will enhance treatment options by 1) providing evidence for an all-purpose 
cognitive-behavioral intervention (i.e., UP-CBT), 2) offering and integrating treatment in 
the medical clinic, maximizing convenience, and 3) improving clinical outcomes for these 
patients.
1.2 Specific Aims
1. To demonstrate that UP-CBT is an effective form of therapy for women with lower 
urinary tract symptoms. 
2. To use baseline characteristics in moderation analyses to determine which women 
will be most likely to have a good response to therapy. 
3. To use mediation analyses to test a possible causal chain of events – Does treatment 
lead to lower anxiety, which in turn leads to fewer urinary symptoms? 
1.3 Hypotheses
1. We hypothesize that UP-CBT will reduce anxiety, and urinary symptoms in women 
suffering from lower urinary tract symptoms, at post treatment and follow-up.
2. UP-CBT will be compared to a control condition, supportive therapy. Supportive 
therapy, although often used in clinical settings (e.g., in support groups), is not 
expected to reduce anxiety, or urinary symptoms on average. Thus, we expect that 
the benefits of UP-CBT will be greater than benefits of the control therapy, 
supportive listening.
2.0
Background / Literature Review / Rationale for the study:
2.1 Gaps in Current Knowledge
Urinary symptoms are common health issues affecting an individual’s quality of 
life, including mental health. Urinary symptoms include urgency, frequency, incontinence, 
nocturia, and overactive bladder.2 We propose a novel behavioral intervention to improve 
quality of life in women suffering from urinary symptoms. Many women suffer from 
urinary symptoms, and these symptoms often cause emotional distress as anxiety and 
depression are both risk factors for developing urinary symptoms.3 Similarly, urinary 
symptoms can be exacerbated by emotional distress. Urinary symptoms and pelvic floor 
disorders affect nearly one in four women.4 Women with incontinence are both more likely 
IRB #: STU00207124-MOD0010 Approved by NU IRB for use on or after 6/13/2019 through 3/3/2020.

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to have baseline emotional distress and to develop emotional distress as a result of their 
incontinence. Yet, current methods to treat incontinence do not address the emotional 
impact that urinary symptoms may have on women. In fact, one in five women will have 
surgery for these disorders with 30% needing a second surgery for the same condition.5,6 
Therefore, more research is desperately needed on non-surgical treatments for these 
problems that affect millions of women. 
2.2 Background
This study addresses how treatment of overall emotional distress affects anxiety, 
and in turn urinary symptoms. By experimentally manipulating the trajectory of anxiety 
through treatment, this study will also give insight into emotional distress as a mechanism 
of urinary symptoms. Although there is a strong connection between emotional distress 
and urinary symptoms, evidence on their causal connections remain unexplored.7-11 
Furthermore, research on cognitive-behavior therapy (CBT) for people with urinary 
symptoms is lacking. Our study will be the first to apply an empirically-supported, 
transdiagnostic cognitive- and behaviorally-based treatment to women suffering from 
urinary symptoms, carried out in accord with high quality psychotherapy trials. The 
existing evidence base is limited to mindfulness-based stress reduction (MBSR)12,13 and 
physical therapy techniques (e.g., pelvic floor exercises) as treatments for urinary 
symptoms, which did not address co-occurring symptoms of emotional distress. 
Cognitive-behavior therapy has a well-developed protocol and thus can be 
administered to women of all ages, and of all economic backgrounds. The intervention is 
time-limited and low-cost, requiring only visits with the behavior therapist and a low-cost 
workbook that is widely available. This project will also facilitate systemic change by 
bringing a behavioral intervention directly to the woman, as opposed to asking the patient 
to schedule appointments in a different location. Delivering cognitive-behavior therapy in 
the medical setting, such as in primary care, has been used successfully in previous 
studies,14-17 but currently does not exist at Northwestern Medicine. This study can also 
bring systematic change to the practice of medicine by advancing another possible 
treatment (i.e., UP-CBT) at the disposal of doctors who are treating women with pelvic 
floor disorders.
3.0
Inclusion and Exclusion Criteria:
3.1 Criteria
Women must be 18 years of age or older to participate. They must have one or more 
urinary symptoms, including frequency, nocturia, urgency, leakage, hesitancy, straining, 
or dribbling. Women who present with clinical signs of anxiety based on the physician 
exam, have any documented anxiety disorder in the medical record and/or are taking 
medication for anxiety will be eligible for the study. Women must consent to 
randomization to treatment, and be willing to complete 12 sessions of treatment, as well as 
to complete baseline and outcome questionnaires. Women that screen positively for an 
alcohol or substance use disorder (based on the medical record) will be excluded from the 
study. Any women with blood in the urine, a positive urine culture, or other signs of 
possible infection will be deferred until they have been evaluated and treated as needed. 
Women who are pregnant or who have given birth within the past 6 months will be 
IRB #: STU00207124-MOD0010 Approved by NU IRB for use on or after 6/13/2019 through 3/3/2020.

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excluded from the study. Other exclusion criteria include serious disease that would impede 
participation (e.g., Alzheimer’s dementia, Parkinson’s disease); recent (within 6 months) 
pelvic or endoscopic surgery, urethral stricture, pelvic malignancy, current chemotherapy 
or other cancer therapy, pelvic device or implant complication; recent (within 12 months) 
Botox injection to the bladder or pelvic structures; or difficulties communicating in 
English. Women who are currently in their own psychotherapy are ineligible for the study.
In addition, participants must be willing to defer from usual treatment for urinary 
problems until after completing the 12-week therapy intervention. For these women with 
lower urinary tract symptoms, there are multiple treatment options that can be tried 
sequentially, including the management of anxiety. Thus, if the person consents to be in 
the study, they will agree to these procedures before trying an alternative management 
strategy. Some alternatives include physical therapy (e.g., pelvic floor therapy), which can 
by uncomfortable and/or painful, or even surgery, which has other complications. Thus, 
psychotherapy is a reasonable and viable alternative. Lower urinary tract symptoms are not 
life threatening, so waiting to start an alternate therapy will cause waiting for the 
participant, but no harm. The participant will of course have the choice not to agree to the 
study and pursue other treatments, or no treatment, if they wish. If a patient is eligible, they 
will then be given the opportunity to provide informed consent.
Table 1. Summary of Inclusion and Exclusion Criteria
Inclusion Criteria
Exclusion Criteria
1. Female
2. Age 18 years or older
3. Presence of one or more of the 
following urinary symptoms in 
past 12 months and currently 
seeking treatment: frequency, 
nocturia, urgency, leakage, 
hesitancy, straining, or dribbling
4. Willing and able to provide 
informed consent 
5. Anxious presentation and/or 
history of anxiety
6. English speaking
7. Willing to defer usual treatment 
for urinary problems
1. Blood in the urine, positive urine 
culture, signs of infection
2. Pregnant, or 6 months or less 
postpartum
3. Psychosis, dementia, or other 
cognitive impairment that would 
preclude participation
4. Recent (within 6 months) pelvic 
or endoscopic surgery, urethral 
stricture, pelvic malignancy, 
current chemotherapy or other 
cancer therapy, pelvic device or 
implant complication
5. Recent (within 12 months) Botox 
injection to the bladder or pelvic 
structures 
6. Currently in psychotherapy
7. Current alcohol or substance use 
disorder
8. Difficulty communicating in 
English
3.2 Special populations
This study will not include any special populations.
IRB #: STU00207124-MOD0010 Approved by NU IRB for use on or after 6/13/2019 through 3/3/2020.

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4.0
Sample Size:
This study will include up to 40 participants. UP-CBT has been shown to have quite 
large effects (Cohen’s d values of 1.7 or greater).18 For this study, we have chosen a slightly 
more conservative estimate for Cohen’s d of 1.5, which represents 1.5 standard deviations 
between the treatment effect of UP-CBT versus the control group. Based on a power 
analysis,19 we would require 16 women per group, in the data analyzed, to detect a 
treatment effect with > 98% power with a Type I error rate of α = .05, two-tailed. Study 
withdrawal is estimated at roughly 20%, leaving an estimated final sample of 32 
participants for data analysis (see CONSORT diagram below).
5.0
Research Locations:
Participant recruitment and consent will occur at the Northwestern Medicine 
Integrated Pelvic Health Program (IPHP) clinic within the Department of Obstetrics and 
Gynecology and through the Northwestern Medicine Urology clinic. Dr. Kenton will 
oversee recruitment at the IPHP and Dr. Flury will oversee recruitment at the urology 
clinic. Use of IPHP space has been approved by Dr. Kenton, the chief of Urogynecology. 
Therapist training will take place in the Griffith lab space in the Department of Medical 
Social Sciences (MSS). Dr. Griffith has approved use of this space for this research project. 
Therapy sessions will take place in the Griffith lab space in MSS and in the IPHP clinic 
space in the Arkes Pavillion of Northwestern Memorial Hospital. Data will be stored at the 
Griffith lab space, and specific secure cabinets have been designated for this study.
6.0
Multiple sites: 
NA
7.0
Reliance Agreements/Single IRB:
NA
8.0
Procedures Involved:
8.1 Randomization and Study Design
This is a pilot study to test pre-post changes associated with UP-CBT, urinary 
symptoms, and emotional distress. Women eligible for the study will be randomized to 
treatment based on a predetermined list created using the blockrand package of R.20,21 
Randomization will occur by blocks, with varying block sizes, in accord with 
recommended methods for RCTs.22-24 The randomization key will be linked to a unique 
study ID number, as well as to a treatment condition (UP-CBT or Supportive Therapy). 
IRB #: STU00207124-MOD0010 Approved by NU IRB for use on or after 6/13/2019 through 3/3/2020.

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Assessed for eligibility (n = 100)
Excluded (n = 60)
•
Not meeting inclusion 
criteria
•
Declined to participate
•
Other reasons 
Analyzed (n = 16)
Lost to follow-up/Discontinued (n = 4)
Allocated to UP-CBT (n = 20)
Lost to follow-up/Discontinued (n = 4)
Allocated to Control (n = 20)
Analyzed (n = 16)
Allocation
Analysis
Follow-Up
Randomized (n = 40)
Enrollment
Figure 1. Study Design CONSORT Flow Diagram
8.2 Use of Electronic Medical Record
The electronic medical record (Epic) will be used to extract the following social 
and medical history. Demographic data (e.g., age, date of birth, gender, race/ethnicity, 
and insurance type) will be obtained from the patient’s electronic medical record, and 
verified via self-report. Demographic variables will likely be used as covariates in 
analyses. Results of physical examinations, particularly urological and gynecological 
history as well as urinary symptoms, will be used to determine inclusion criteria. History 
and diagnoses of serious illness that would preclude study participation will be extracted 
to determine exclusion criteria (see section 3.2 above).  In addition, substance and alcohol 
use history and diagnoses will be accessed through Epic to establish the exclusion 
criterion of substance use disorder. Lastly, mental health history and diagnoses will be 
pulled from Epic for inclusion/exclusion criteria, and to provide background information 
for therapists. 
8.3 Measures
Participants will be asked to complete questionnaires at baseline, mid-treatment 
(after 6 sessions), posttreatment (after 12 sessions), at a 3-month follow-up, and at a 6-
month follow-up. Baseline, mid-treatment, and posttreatment assessments will be 
completed on tablets with a link from REDcap, though participants will have the option to 
IRB #: STU00207124-MOD0010 Approved by NU IRB for use on or after 6/13/2019 through 3/3/2020.

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respond on paper forms. Both follow-up assessments will be carried out online with a link 
sent via email. The primary outcome tool for this study will be the six-item Urinary Distress 
Inventory (UDI-6), which is a subscale of the Pelvic Floor Distress Inventory (PFDI), as 
measure of urinary symptoms.25 We will also measure anxiety using a short form from the 
NIH Patient Reported Outcomes Measurement Information System (PROMIS), which has 
been shown to be reliable and valid;26 this form is brief and easy to complete. Secondary 
measures include the PROMIS profile27 (depression, fatigue, pain, physical function, sleep 
disturbance, and social roles), trauma history assessed with the PTSD Checklist for DSM-
5 with Life Events Checklist (PCL-5),28 the Mini-IPIP, a 20-item short form of the 
International Personality Item Pool measure of the Big Five personality traits,29 the 
Ruminative Responses Scale (RRS) short form,30 and the Patient Global Impression of 
Improvement (PGI-I) – a one item self-report assessment of improvement of urinary 
symptoms.31 In addition, at both follow-up assessments, participants will be asked whether 
they have received any treatment outside of the study for their urinary symptoms and/or 
their anxiety. Any treatment participants receive outside of the study will be tracked in this 
manner and included in data analyses.
Table 2. Timing of Assessments
Measure
Estimated 
Completion 
Time 
Baseline
Session 6
Session 
12
3 Month 
Post-
Treatment 
Follow-up
6 Month 
Post-
Treatment 
Follow-up
Medical history and physical 
exam
0 (part of 
regular 
medical visit 
and extracted 
from EMR)
X
Demographic questionnaire
1 min
X
Single Item Literacy 
Screener (SILS)
< 1 min
X
Brief Medication 
Questionnaire (BMQ)32
3-5 min
X
X
X
Primary outcome 1:
PROMIS Anxiety subscale 
of profile (4 of 29 items 
below) 
See below for 
entire profile
X
X
X
X
X
Primary outcome 2: Urinary 
symptoms using the Urinary 
Distress Inventory (UDI-6) 
of the Pelvic Floor Distress 
Inventory (PFDI)
1-3 min
X
X
X
X
X
5-10 min
X
X
X
X
X
Secondary outcomes: 

PROMIS Profile 
(29 items)

PGI-I
< 1 min
X
X
X
IRB #: STU00207124-MOD0010 Approved by NU IRB for use on or after 6/13/2019 through 3/3/2020.

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8.4 Therapy
Participants will be scheduled to come to an individual treatment session once per 
week for 12 weeks, at a convenient time for them, on the Northwestern Campus. This 
arrangement allows for a one-stop experience for the patient, maximizing their 
convenience. As described above, participants will be randomized to one of two therapy 
conditions: UP-CBT or supportive therapy. All sessions, in both conditions, will be 45 
minutes in duration. If a participant happens to miss or cancel a session they will be 
rescheduled. 
Unified-Protocol Cognitive Behavior Therapy (UP-CBT) is a form of therapy that 
draws upon various forms of cognitive-behavior therapy to “unify” the most important 
tools into one protocol. Cognitive-behavior therapy has been a leading treatment for 
depression and anxiety for decades, but historically has focused on specific disorders (e.g., 
major depression, social anxiety disorder, panic disorder). UP-CBT includes a variety of 
general-purpose techniques to help people cope more skillfully with emotionally stressful 
situations. This includes dealing with emotional situations by reappraising negative 
thoughts (e.g., “If I get nervous at work, the stress I feel will be temporary and won’t kill 
me” rather than “I can’t deal with my life”). UP-CBT focuses on dealing with stress in 
general, but its techniques are readily adaptable to dealing with urinary symptoms. For 
example, a woman might have catastrophic thinking about urine leakage (“What if 
someone notices that I’ve leaked?”). These catastrophic thoughts can result in strong fear 
responses, as well as potentially problematic behaviors (e.g., avoidance of social situations 
or even skipping work). In general, UP-CBT teaches people to track emotions, thoughts, 
and behavior in an effort to identify maladaptive patterns. In addition, participants learn to 
restructure their thoughts, and to more confidently confront situations that they find 
challenging. Towards the end of treatment, patients learn to prevent relapses through 
practice of therapy skills. Participants in the UP-CBT group will be asked to complete 
homework outside of the therapy session, to practice therapy skills. Homework will be 
completed in their therapy workbook, and they will be instructed to bring their workbook 
to each session. After completing the 12 sessions, participants will be able to keep their 
workbook.
Supportive therapy is a non-active form of psychotherapy that has been widely used 
as a control condition in therapy studies.33-36 Many of the elements of supportive therapy 
may be beneficial to some participants, just as pill placebos benefit some participants in 
drug trials. As such, it is an excellent control condition because it is not merely “sham 
10 min 
X
3-5 min
X
1-3 min
X
Secondary correlates:

PTSD Checklist 
for DSM-5 with 
Life Events 
Checklist (PCL-5)

Mini-IPIP

Ruminative 
Response Scale 
(RRS)

Follow-up 
treatment 
questions
1-3 min
X
X
IRB #: STU00207124-MOD0010 Approved by NU IRB for use on or after 6/13/2019 through 3/3/2020.

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therapy”. Supportive therapy is widely-used in clinical community settings. In this 
condition, no cognitive-behavioral exercises will be used. Supportive Therapy allows for 
careful control over the number of therapy sessions and time per session. Thus, it is ideal 
for being able to match to UP-CBT. The protocol for supportive therapy will include 1) 
education about urinary symptoms, anxiety, and depression, 2) discussion of patient goals, 
3) sharing of concerns in a nonjudgmental environment, 4) discussion of the possible 
connections between urinary symptoms and emotional distress, and 5) reflective listening. 
Participants in supportive therapy will not be given homework.
8.4.1 Therapy Progress Notes
Therapists will complete brief progress for each participant after each session in 
both therapy conditions. Progress notes will be used only for research purposes, and will 
not be added to the medical record. Progress notes will be available to participants upon 
their request after study completion (including completion of follow-up assessments). 
8.5 Analysis Plan
Primary analyses. We will create hierarchical linear models (HLM) to test the primary 
hypotheses of the study. One model will determine the effect of type of therapy on anxiety. 
A separate model will determine the effect of type of therapy on urinary symptoms. The 
dependent variables for these models will be the UDI-6 subscale of the PFDI-20 and 
anxiety as measured by the anxiety subscale of the PROMIS Profile-29. The structure of 
the HLM model is shown below. Note that these models create a response profile for each 
person across all time points as described in the protocol.
Level 1 
Y = P0 + P1(T2) + P2(T3) + P3(T4) + P4(T5) + E
Level 2
P0 = B00 + B01(Condition)
P1 = B10 + B11(Condition) + R1
P2 = B20 + B21(Condition) + R2
P3 = B30 + B31(Condition) + R3
P4= B40 + B41(Condition) + R4
The dummy variables P1-P4 are dummy codes for the five time points. These will 
allow us to determine the degree of change from baseline. Each of the “P” coefficients is 
influenced by Level-2 variables. T2 - T5 are dummy variables of the time differences from 
baseline. E, R1-R4 represent error terms in the model. Condition will be dummy coded 
(UP-CBT = 1, Supportive Therapy = 0).
Testing Key endpoints. We have two primary endpoints and therefore we will have two 
models. For both anxiety (PROMIS T score) and urinary symptoms (UDI-6), the full model 
(see above) will be compared to a reduced model with all of the terms involving condition 
removed (i.e., B01, B11, B21, B31, and B41). If this comparison is significant (p < .05), 
then we will test individual parameters at a Type I error rate of alpha = .05 (two-tailed). 
Note, these tests will only be carried out if the full-reduced model comparison is 
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significant. The key prediction for anxiety is that parameters B21, B31, and B41 
(representing the effect of UP-CBT at post-treatment and beyond) will be significant and 
negative (representing fewer symptoms). The key prediction for urinary symptoms is that 
parameters B21, B31, and B41 (representing the effect of UP-CBT at post-treatment and 
beyond) will be significant and negative (representing fewer symptoms).
Missing data. All participants with baseline data will be included in the modeling using 
an intent-to-treat approach. The HLM approach described above can accommodate cases 
with missing follow-up data.
Mediation analysis. We will also carry out mediation analysis in Mplus using bias-correct 
bootstrapped 95% confidence intervals. We will hypothesize that these confidence 
intervals will not contain zero for the following mediated effects:
Condition  Mid-treatment anxiety  Post-treatment urinary symptoms
Condition  Post-treatment anxiety  3-month urinary symptoms
Condition  3-month anxiety  6-month urinary symptoms
In addition to testing statistical significance, our hypothesis is directional. Condition (i.e., 
receiving UP-CBT) should lead to lower anxiety, in turn leading to lower urinary 
symptoms.
Exploratory analyses. Although our primary focus is anxiety and urinary symptoms, we 
will conduct HLM analyses on each scale of the PROMIS Profile (depression, fatigue, 
sleep, pain interference, pain, social function) and other subscales of the PFDI (total score, 
colorectal symptoms, pelvic organ prolapse symptoms). These analyses will be clearly 
marked as exploratory in all write-ups. We will also create a prediction model of treatment 
response (i.e., trajectory of symptoms) based on baseline characteristics. These will also 
be clearly marked as exploratory in all study write-ups.
Table 3. Project Timeline
Months 
1-2
Months 
3-4
Months 
5-6
Months 
7-8
Months 
9-10
Months 
11-12
Months 
13-14
IRB Approval
Staff Training
Recruitment 
Pilot RCT Study
Follow-up Assessments
Data Analysis
Manuscript write-up
9.0
Incomplete Disclosure or Deception:
There is no deception involved in this study. Participants will be made aware that 
they will be randomized to one of two therapies.
10.0
Recruitment Methods:
Participants will be recruited by research coordinators through the IPHP. If an IPHP 
clinician identifies a patient as meeting the eligibility criteria, a research coordinator will 
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be called in to speak with the participant about the study. Coordinators will follow a 
recruitment script. In addition, recruitment flyers and postcards will be placed in the 
waiting area of the IPHP, and will be shared with IPHP clinicians. 
11.0
Consent Process: 
The consent process will be carried out by the research coordinators at the IPHP. 
Written informed consent including HIPAA authorization will be obtained at same visit as 
screening and determination of eligibility. All participants will be asked about their 
understanding of their participation, and will have an opportunity to ask questions about 
the study prior to agreeing to participate. Participants will be free to consult with others 
(e.g., family members) prior to providing informed consent. Participants will provide 
written informed consent before beginning the study. Participants will be informed that 
they are free to withdraw from the study at any time without consequence. Ongoing consent 
will not be formally assessed after participants provide informed consent, but research team 
members will be trained to discuss any questions that may arise and what to do if a 
participant chooses to withdraw from the study. See consent form attachment. 
12.0
Financial Compensation:
Each participant, irrespective of treatment group, will be compensated $100. 
Participant payment will occur in three blocks: once they have completed the 12 therapy 
sessions they will receive $70 total ($5 per session, with a $10 bonus for completing all 12 
sessions), then they will receive an additional $15 for each follow-up assessment. 
Compensation will be prorated to $5 per session completed if the participant withdraws 
from the study. Payments will be provided in the form of a Stored Value Card (Visa) for 
therapy sessions and via virtual gift card for online follow-up surveys. If a participant 
withdraws from the study they will be given the option to receive their pro-rated payment 
either via Stored Value Card or virtual gift card based on their preference.
13.0
Audio Recording:
Audio recording of therapy sessions will be optional. For participants that provide 
consent for audio recordings, therapy sessions will be audio recorded to be reviewed later 
by the principal investigator, to ensure fidelity of treatment and for supervision of 
therapists. Recording devices will be stored in a locked cabinet in Dr. Griffith’s lab space. 
Dr. Griffith and the study therapists will have keys to the cabinet. Study therapists will be 
required to return the recording devices to the cabinet directly after completing sessions 
for the day. Recordings will be destroyed one year after study completion.
14.0
Potential Benefits to Participants: 
Participants will not necessarily benefit from taking part in this research. However, 
possible benefits include: 1) We can improve behavioral treatment for patients with lower 
urinary tract symptoms and comorbid emotional distress. 2) This study will provide 
important information about the causal link between emotional distress and urinary 
symptoms. 3) Participants may directly experience a reduction in their urinary symptoms 
and emotional distress. The potential benefits of this study should outweigh the risk to 
individual participants.
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15.0
Risks to Participants:
Participating in this study involves minimal risks. It is possible that participants 
may feel some shame, emotional discomfort, distress, boredom/fatigue when completing 
the assessments of urinary symptoms, depression, and anxiety, or when participating in 
therapy. If we find that participants in the study are at risk for harming themselves or others, 
we will follow the protocol to connect the participant with crisis services, and document 
the situation accordingly. We will inform participants that their participation in this study 
may result in a loss of privacy. This includes data from questionnaires entered into a 
computerized database, questionnaires completed online, as well as written therapy notes. 
Several steps will be taken to protect confidentiality and minimize the above risks.
If a participant withdraws from any part of the study (e.g., does not complete one 
of the surveys), they are welcome to participate in other aspects of the study. If a participant 
chooses to withdraw from the study, data that has been collected during their participation 
will be analyzed unless the participant specifies otherwise. 
16.0
Provisions to Protect the Privacy and Confidentiality of Participants and the 
Research Data:
Participants will provide written informed consent. Participants will be given a 
copy of the consent materials for their records. To protect confidentiality, participants will 
not be identified by name, but by a unique participant identification number. The key 
linking participant name to identification number will be stored in a password-protected 
file. Any other identifying information (e.g., contact information) will be kept separate 
from the research data. All information, data, and recordings will be kept in secure, 
password-protected files. Any physical data and forms (e.g., consent) will be kept in a 
locked cabinet in a locked room. We will inform participants that unless required by law, 
only the research team and representatives of the Institutional Review Board have the 
authority to review any study records. All parties with access to the data will be required 
to maintain confidentiality. Using trained graduate students as therapists will ensure that 
any potential safety issues are identified and referred to appropriate services. Further, 
therapists will be supervised by a licensed clinical psychologist. All members of the 
research team will complete the ethics courses required by Northwestern, including the 
CITI web-based course on human subjects protection.
17.0
Data Monitoring Plan to Ensure the Safety of Participants:
17.1 Data Monitoring
Each participant will be assigned an anonymous study identification number, which 
will be used on all study forms. A list of participant names with study IDs will be kept in 
a secure location separate from study materials. Participants will respond to questionnaires 
on tablets with a link from REDcap, but have the option to respond on paper forms if 
preferred, for baseline, mid-treatment, and posttreatment assessments. All paper forms will 
be de-identified and stored in locked storage using only study ID numbers. After the study 
visits where measures are given, for any surveys completed on paper the study coordinators 
will copy the data into REDCap. Subject name, date of birth, and copy of consent will be 
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entered into StudyTracker. Follow-up assessments will be completed online and connected 
to REDCap. Data exported from REDCap in a spreadsheet will be stored on the department 
shared drive (FSMFiles), where only study personnel have access. The spreadsheet will be 
shared between the study team via their shared drive access, REDCap access, Box.com 
access, or if necessary secured @northwestern email accounts. The research team will 
assure complete protection of all data behind Northwestern University’s firewalls.
Participants will meet with a therapist on a weekly basis. Any adverse events 
discussed in therapy will be reported to principal investigators to determine whether the 
event is study related and if further assessment is needed. Moreover, at the end of the study, 
each participant will receive a list of referrals for therapy if they would like or need further 
treatment. Dr. Griffith is a licensed clinical psychologist; he can assist in connecting 
participants with a therapist if needed.
17.2 Risk Protocol
Should a participant endorse thoughts of harming themselves or others, the study 
team will intervene. The therapist will first seek consultation with the supervising 
psychologist (Dr. Griffith) and study physician (Dr. Kenton). If necessary, the therapist 
will complete a risk assessment using the Columbia- Suicide Severity Rating Scale, 
develop a verbal safety plan, and provide the participant with a crisis number if necessary. 
In the rare event that a participant endorses active suicidal or homicidal plan or intent, the 
therapist will escort the participant to the emergency room at Northwestern. Furthermore, 
in the rare event that a participant is not cooperative in this instance, the therapist would 
call 911.
18.0
Data, and if applicable, Specimen Banking: 
Data from baseline, mid-treatment, and posttreatment assessments will be collected 
on tablets with a link from REDcap. If participants choose to respond via paper 
questionnaires, their responses will be entered onto a secure computerized database (i.e., 
REDCap) by trained research assistants, then forms will be stored in a locked cabinet in 
Dr. Griffith’s lab space. Follow-up assessments will be completed online, and data will be 
connected to the secure computerized database. Therapy progress notes will be entered as 
a word processing document and then saved on a secure server.
19.0
Data Sharing:
For the purpose of open science, data may be shared as supplemental material in 
publications. Data will be de-identified.
20.0
Qualifications to Conduct Research and Resources Available:
This is an inter-disciplinary project being conducted by both Dr. James Griffith and Dr. 
Kimberly Kenton in collaboration. Dr. Griffith is listed as the PI for study contact.
PI and Supervising Psychologist: James W. Griffith, PhD. Research Assistant Professor, 
Department of Medical Social Sciences. Dr. Griffith is a close collaborator of Dr. Kenton 
(see below). They currently work together on LURN, which is focused on patient 
assessment, so they are well situated to execute this trial focused on treatment. He is a 
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recognized expert on quality-of-life issues in patients with urinary symptoms as well as 
advanced data-analytic techniques used for clinical trials, including growth curve models, 
mixed modelling, and calculating predicted probabilities of medical state. He has over 50 
publications in a variety of clinical areas including urology, depression, anxiety, and 
cognitive difficulties. He has contributed to the design, execution, and data analyses of 
clinical trials and large observational studies with aggressive recruitment goals. He is also 
a licensed clinical psychologist with extensive experience in cognitive-behavior therapy. 
Co-I and Urogynecologist: Kimberly S. Kenton, MD, MS. Professor of Obstetrics and 
Gynecology and Urology, Division of Female Pelvic Medicine and Reconstructive 
Surgery. Dr. Kenton will co-lead this project along with Dr. Griffith. She possesses 
advanced training in study design, participant recruitment, and statistics. Dr. Kenton and 
Dr. Griffith also work closely together on a variety of projects, all focused on women’s 
health including pelvic floor disorders. As a specialist in urogynecology, Dr. Kenton is 
well aware of the role of anxiety in urinary symptoms, so she will oversee the study to 
ensure that its results can be integrated into clinical care in the future. 
Project Manager and Acting PI: Bayley J. Taple, MS. Graduate student in the Northwestern 
University Feinberg School of Medicine Clinical Psychology PhD program, Graduate 
Student Research Assistant in Medical Social Sciences, and T32 Predoctoral Fellow on the 
Basic Science Training Grant in Urology (PI: David J. Klumpp). Ms. Taple’s research is 
focused on precise symptom assessment of urology patients – including pain, urinary 
symptoms, and mental health comorbidities – in order to understand etiological 
mechanisms and to develop novel therapies. Her research employs rigorous statistical 
methods, providing her with the skills to plan and lead the analytical aspects of this project.
Urologist: Sarah C. Flury, MD. Assistant Professor of Urology. Dr. Flury will assist with 
participant recruitment by expanding recruitment efforts outside of the IPHP to the general 
Urology clinic. She will offer the option to participate in this research study to women in 
her clinic who meet the inclusion criteria, and refer those women to the research 
coordinators and/or project manager.
Study Therapists. Therapists for both treatment arms will be qualified PhD students from 
the Northwestern University Feinberg School of Medicine Clinical Psychology PhD 
program. Graduate student therapists will have current and/or prior therapy experience. 
Therapists will be closely supervised by Dr. Griffith (PI), a licensed clinical psychologist 
in the state of Illinois. This study has been approved as an additional practicum experience, 
thus students will earn direct clinical contact hours for their work on the study. They will 
have completed CITI training.
Research Coordinators. RCs will have a Bachelor’s degree or a higher degree, and previous 
experience with clinical research. They will have completed CITI training. RCs will report 
directly to PIs. 
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