Collaborative Care for Opioid Dependence And Pain Pilot Study
Phase: NA
Conditions: Opioid Dependence, Chronic Pain
Sponsor: Indiana University

IU IRB Protocol #: 1905213338 v10.08.2021 
 
Page 1 of 10 
 
 
 Collaborative Care for Opioid Dependence And Pain (CCODAP) Pilot Study 
 
 
 
 
 
 
 
 
 
 
 
 
 
Primary Investigator: 
Michael A. Bushey, MD, PhD 
Assistant Professor of Psychiatry 
Department of Psychiatry & Behavioral Sciences 
Indiana University School of Medicine 
 
 
Mentor: 
Kurt Kroenke, MD, MACP 
Chancellor’s Professor of Medicine 
Division of General Internal Medicine and Geriatrics 
Department of Medicine 
Indiana University School of Medicine 
Research Scientist, Regenstrief Institute 
 
 
 
 
 
 

IU IRB Protocol #: 1905213338 v10.08.2021 
 
Page 2 of 10 
 
A. SPECIFIC AIMS 
Chronic opioid treatment for chronic pain has led to widespread opioid dependence. 
Prescription of opioid medications for treatment of chronic non-cancer pain rose significantly in the 1990s and 
2000s. At the prescribing peak of 2010, prescriptions outnumbered persons in many parts of the country, and 
this continues to be the case in many counties [1, 2]. The widespread availability of opioids has led to an 
increase in opioid dependence and subsequent overdose deaths, which has continued to rise despite a 
decrease in opioid prescriptions in recent years [3, 4]. One hypothesis for the increase in overdose death 
despite a reduction in opioid prescriptions is that opioid-dependent patients are turning to illicit opioids, leading 
to overdose. Trends in substances found in overdose deaths support this hypothesis [3]. Federal efforts to 
address the opioid overdose epidemic have focused primarily on educating prescribers to reduce prescribing 
and increasing access to opioid addiction treatment [5]. Less attention has been paid to ensuring that 
evidence-based treatment for chronic pain is provided alongside opioid tapering and/or addiction treatment. 
Many studies have demonstrated that opioids are non-superior to several alternatives for treating chronic pain 
[6-8]. While opioid tapering can be a challenge for both patients and providers [9, 10], structured opioid 
tapering programs have demonstrated both efficacy in opioid reduction and often either unchanged or 
decreased pain intensity [11]. However, these results have primarily been found in specialty centers providing 
intensive multi-modal treatment, often treating patients 8 hours per day for 5 days a week. Given the scarcity of 
such programs and the high prevalence of opioid-dependent patients, alternative care-models capable of 
greater scaling will be necessary to address the current epidemic. 
 
Collaborative Care is a healthcare model capable of providing specialty care to far more patients than 
can be achieved through traditional one-on-one treatment models. Collaborative Care has proven 
effective in delivering treatments for managing depression and pain in primary care settings [12-15]. A few 
recent studies have also demonstrated efficacy in treating addiction and opioid dependence using a 
collaborative care approach [16, 17]. Several different pain interventions have been effective in these 
collaborative care trials, including medication optimization, cognitive behavioral therapy, and several different 
structured self-management programs. Recently, pain researchers have found positive psychology-based 
interventions to be effective, well-received, and easy to deliver [18-20], making this intervention well-suited to 
pair with collaborative care. In the proposed clinical trial, we will assess the feasibility of utilizing collaborative 
care to facilitate opioid tapering in patients with chronic pain using a positive psychology intervention.  
 
Primary Aim: Determine the potential effectiveness of delivering Collaborative Care for reducing opioids in 
patients with chronic pain. 
 
Hypothesis: Collaborative Care will be effective (30% reduction in mean morphine equivalent dose/day 
[MMED]) in reducing opioids while maintaining pain control (< 1 point increase in 0 to 10 pain rating scale). 
 
Secondary Aim: Assess adherence to tapering and satisfaction of patients with this Collaborative Care 
approach. 
 
Hypothesis: Patients will be satisfied with (mean score ≥ 3 on 0 to 5 satisfaction scale) and adhere to (≥ 70% 
retention) the 12-week opioid tapering program. 
 
Impact of this research. Excessive prescribing of opioid medications for chronic pain has led to widespread 
opioid dependence, abuse, and rising overdose deaths. Preliminary research by others has demonstrated that 
multidisciplinary specialty care for patients with chronic pain on opioid therapy can produce successful opioid 
tapering without worsening of pain or mood symptoms. However, reducing opioid prescribing for chronic pain 
in the primary care setting has proven difficult given limited visit time, inadequate provider training, and 
constrained clinic resources for managing patients with opioid dependence [9, 10, 21]. This trial proposes a 
novel collaborative care approach for opioid weaning using proven, easy-to-deliver positive psychology tools 
for pain management that, if successful, could be implemented broadly in many clinics struggling to safely 
reduce opioid prescribing. 
 
 

IU IRB Protocol #: 1905213338 v10.08.2021 
 
Page 3 of 10 
 
Research Strategy 
SIGNIFICANCE 
Opioid Overdose Deaths are a Public Health Emergency. In 2016, there were over 42,245 overdose deaths 
involving opioids in the United States, representing a 292% increase from 2001[22] [3]. These deaths have 
struck the 24-35 year-old range especially hard, where 20% of deaths in 2016 in this age group were attributed 
to opioids, leading to 1,681,359 lost years of life [22]. This spike in overdose deaths follows a sharp increase in 
opioid prescribing for chronic pain, which preceded a rise in non-medical opioid use [23]. In theory, decreasing 
opioid prescribing to patients with chronic pain may reduce the risk of overdose to patients and the general 
population[24]. However, the current strategy of opioid prescription reduction actually has coincided with an 
increase in opioid-related overdose deaths [3]. 
 
Opioids are non-superior to other pain-management strategies. Although opioid medications perform 
better than placebo for the treatment of chronic non-cancer pain, the current evidence available does not 
suggest that opioids are superior to other treatments for chronic pain [6-8]. In a multidisciplinary intensive 
outpatient setting, patients were successful in opioid tapering without worsening pain, mood, or functioning 
[11]. 
 
Managing patients with opioid dependence is a challenge in primary care settings. Primary care 
providers struggle to reduce opioids for chronic pain given limited resources available to help with this [9, 10]. 
Despite clinical guidelines being available, insufficient time and difficulty having discussions about opioid 
misuse have hampered their utilization [21]. 
 
C. INNOVATION 
CCODAP is the first trial to combine collaborative care with positive psychology pain management 
tools to support opioid weaning in patients with chronic pain.  This dual focus on reducing opioids while 
simultaneously addressing the patient’s pain has been absent from many regulatory and practice initiatives 
which have focused solely or predominantly on opioid reduction or discontinuation as the principal benchmark. 
 
D. APPROACH 
Previous Work 
Symptom management trials by study team members.  As shown in Table 1, the study team has a strong 
track record in conducting symptom management RCT’s. Seven of the eight trials have focused on patients 
with pain. All of the trials have relied on collaborative telecare-delivered interventions, either fully/mostly (n=3) 
or in part (n=5). The studies have ranged from 6 to 12 months in duration and have had high retention and 
follow-up rates.  Interventions have included medications, self-management, physical therapy, and behavioral 
treatments.  Finally, this application’s trialists have complementary expertise including internal 
medicine/symptom management (Kroenke) and psychiatry/behavioral therapy (Bushey). 
Table 1.  Previous Work by Team Relevant to CCODAP Trial 
Trial 
Kroenke 
Role 
N 
Mo. 
Symptoms 
Targeted 
Patient 
Sample 
Tele-
care 
Intervention 
Benefits 
AIM[25] 
Co-PI 
176 
9 
Depression 
Neurology 
(stroke) 
Partly 
Medications 
Intervention 
> Usual care 
SCAMP[26, 
27] 
PI 
250 
12 
Pain 
Depression 
Primary care 
Partly 
Medications & Self-
management 
Intervention 
> Usual care 
INCPAD[13, 
28] 
PI 
405 
12 
Pain 
Depression 
Cancer 
(all types) 
Fully 
Medications 
Intervention  
> Usual care 
SCOPE[14, 
29] 
PI 
250 
12 
Pain 
Primary care 
Fully 
Medications 
Intervention 
> Usual care 
CAMMPS[1
5, 30] 
PI 
300 
12 
Pain, Anxiety, 
Depression 
Primary care 
Fully 
Medications & Self-
management 
NCM + ASM > 
ASM alone 
COPE[31, 
32] 
Co-Invest 
495 
6 
Function 
Pain 
Cancer 
(advanced) 
Partly 
Physical therapy & 
Pain management 
Intervention > 
Monitoring only 
SPACE[8, 
33] 
Co-Invest 
240 
12 
Pain 
Primary care 
Partly 
Medications 
Non-opioids 
= Opioids 
ESCAPE[34
] 
Co-Invest 
241 
9 
Pain 
Primary care 
Partly  Medications + CBT 
Intervention  
> Usual care 
 NCM = nurse care management, ASM = automated symptom management 

IU IRB Protocol #: 1905213338 v10.08.2021 
 
Page 4 of 10 
 
 
Study Design. Forty patients with non-cancer chronic pain on long-term oral opioid therapy will be recruited 
into this pilot trial. Patients will be randomized to receive either the treatment intervention (n = 20) or usual care 
(n = 20). Assignment to treatment arm will be determined by a computer-generated randomization list in 
permuted blocks of 4 to maintain balanced assignment throughout the trial. Participants must: (1) be age 18 or 
older, (2) have an established chronic pain disorder of at least 6 months, and (3) be receiving chronic daily oral 
opioid treatment. Exclusion criteria are: (1) not speaking English, (2) significant cognitive impairment that would 
hinder participation.  
 
Theory of the Intervention and Conceptual Model 
The intervention is based on the observation that patients often have unchanged or improved pain when 
tapered from chronic opioids with a structured weaning protocol and adequate support. However, successful 
weaning in current practice is hindered by a lack of provider training and comfort in tapering and insufficient 
patient support. By providing symptom monitoring and management along with simple interventions to help 
patients increase their self-efficacy, we believe that patients can successfully wean from opioids. We postulate 
that factors such as depression, personality, catastrophizing, and severity of opioid difficulties may moderate 
this outcome, and will be measuring these at baseline and at 12 weeks. 
 
Procedures 
Recruitment and Consent. Prior work in this field has demonstrated that enrollment in trials of opioid tapering 
can be challenging due to low rates of referral by providers and high patient refusal rates [17, 35]. We will take 
2 approaches to patient recruitment. The first approach will be to invite providers who treat patients with 
chronic opioid therapy to refer patients to the study. This is our preferred method as it will engage the patients’ 
current providers with whom collaboration will be crucial. We will also directly outreach to patients. The Cerner 
electronic medical record (EMR) can be queried by Indiana University Health (IUH) information technologist to 
generate a list of patients on chronic opioid therapy within the IUH System. Eligible patients will be sent a study 
invitation letter or text providing information unless their primary care provider disapproves. Patients interested 
in participating will be scheduled for a baseline study consent session. In light of ongoing fluctuations in 
coronavirus activity, all study activities are designed to take place virtually either over telephone or video 
conferencing software. Patients will be provided a copy of the study information sheet (either through U.S. 
post, e-mail, or access to a digital download) so they can read along during their consent session. All subjects 
will provide verbal informed consent and HIPAA authorization. Documentation of the informed consent process 
and HIPAA authorization process will bedocumented via the consent log in the study binder We believe the 
activities in this trial satisfy the requirements outlined in 45 CFR 46.116 Part F.3 for a general waiver of written 
consent:  
 
(1) The research involves no more than minimal risk to subjects. All subjects eligible for the trial are 
on chronic opioid therapy, which puts them at risk for developing dependence, accidental overdose, 
and forced tapering or opioid therapy discontinuation by providers increasingly under pressure to 
reduce or discontinue opioid prescribing. Our intervention provides evidence-based, non-pharmacologic 
pain treatment that may improve pain outcomes and allow patients to decrease the doses of opioid 
medications they take, which would decrease their risk of the above opioid therapy-related adverse 
outcomes. If patients are interested in lowering their opioid dose, our program of weekly check-ins will 
provide a greater level of care than usual care. Patients in the usual care group are at no greater risk 
for adverse clinical outcomes than if they were not enrolled in the trial. The maintenance of research 
records and audio recordings from intervention sessions is associated with the minimal risk of potential 
loss of confidentiality, which is mitigated by records being maintained in a secure research environment 
on enterprise Microsoft Storage or REDCap databases.  
(2) The research could not practicably be carried out without the waiver. Written informed consent will 
be obtained whenever a participant is able to access and utilize the electronic consent system. 
However, for patients without this capability, verbal consent will be obtained instead. This is preferrable 
to the alternative approaches of either having participants return consent forms by mail or requiring 
participants to present to the clinic to sign consent forms. Our experience with attempting to recruit this 
population has demonstrated that mailing forms results in excessive delays, confusion, and frustration 
on the part of participants. In-person visits would result in unnecessary burdens (related to travel and 
parking) and potential coronavirus exposure. 

IU IRB Protocol #: 1905213338 v10.08.2021 
 
Page 5 of 10 
 
(3) The research could not practicably be carried out without identifiable data. This is a randomized 
clinical trial that requires following participants over time, as well as accessing medical records to verify 
medication prescription information and communicate with their providers. Identifying, outreaching, and 
following patients longitudinally cannot be accomplished without utilizing identifiable data.  
(4) The waiver will not adversely affect the rights and welfare of subjects. Participants will continue to 
receive clinical services as usual whether or not they participate in this study, and the waiver of written 
consent will in no way affect this.  
(5) When appropriate, subjects will be provided with additional pertinent information after 
participation. All participants will continue to receive additional pertinent information whether or not 
they complete a written informed consent electronic document.  
 
 
Baseline Data Collection and Orientation. Enrollment and baseline data collection will occur in 75-minute 
sessions over telephone or teleconferencing software. This remote approach is especially important so long as 
social distancing precautions are in effect to mitigate the spread of the novel coronavirus. During the first 30 
minutes of the enrollment session, participants will be provided a brief overview of the study by a member of 
the study team, followed by distribution and explanation of the informed consent document and an opportunity 
for participants to ask questions. In particular, they will be given information about opioid dependence, opioid 
use disorder, and the potential benefit of opioid dose reduction to improve pain and reduce adverse events. 
They will also be informed that opioid substitution therapy is a possibility if there is concern for opioid use 
disorder. Once informed consent is obtained, the next 45 minutes will provide time for participants to complete 
baseline measures, , and receive a $40 gift card. 
 
Intervention 
The intervention will be a 12-week supportive opioid taper utilizing a collaborative care program consisting of 2 
components: a telecare intervention and a telecare-reinforced positive psychology self-management program.  
 
 
Opioid Reduction` 
During the initial orientation, participants will be given 
information about opioids and the potential benefits of 
opioid dose reduction. If participants are interested in 
reducing their opioid dose, tapering approaches will be 
discussed. Participants will receive education on what to 
expect during tapering, including possible opioid 
withdrawal symptoms and common treatments for each 
symptom. A handout describing appropriate use of non-
prescription remedies for common withdrawal symptoms 
will be provided. The standard tapering guideline is 
adapted from the Mayo Clinic guidelines on opioid 
tapering [36]. Patients will decide whether they would 
like to attempt opioid dose reduction based on the 
standard guideline or a negotiated alternative approach 
as empowerment and shared decision-making can 
improve both patient satisfaction and adherence [37]. 
Any potential change in the participant’s opioid dose will 
be discussed with the patient’s treating physicians 
(including relevant specialists such as pain medicine 
providers or maternal-fetal medicine providers in 
pregnant participants),  who will prescribe the 
medication. During the trial, the taper schedule can be 
adjusted to maximize patient tolerability, so long as the 
patient’s treating physicians agree with the adjustment. 
Forced tapering can lead to negative patient outcomes 
including worsening pain, withdrawal symptoms, functional decline, and seeking illicit opioids [38, 39].  
 
Table 2.  Positive Psychology Self-Management 
Intervention 
Week Program 
1 
Noticing and capitalizing on positive events and 
gratitude 
2 
Mindfulness 
3 
Positive reappraisal 
4 
Strengths and Attainable Goals 
5 
Altruism 
6 - 12 Practice Your Favorite(s): Pick at least one of the 
prior activities you liked and practice it again. 
 

IU IRB Protocol #: 1905213338 v10.08.2021 
 
Page 6 of 10 
 
Positive psychology self-management intervention: 
Recent studies have demonstrated the efficacy of positive psychology self-interventions in the management of 
chronic pain [18-20]. Our intervention (Table 2) will be modeled on the program used by Moskowitz and 
colleagues, who have demonstrated efficacy of their intervention in numerous randomized clinical trials for a 
myriad of conditions including substance use and pain [40-43]. Patients will receive instruction on how to 
complete the intervention during their initial visit.  During the skill acquisition phase (scheduled for the first 5 
weeks of the intervention), participants work through the interventions according to the schedule and will be 
asked to record their progress into a trial logbook. If participants are unable to meet, need to cancel a session, 
or require some additional time to acquire a skill, the skill will be covered in the next session. Once participants 
finish the skills acquisition phase, they will enter the habit solidifying phase for the remainder of their 12 week 
intervention period.   
 During the habit solidifying phase, patients will be encouraged to incorporate a positive psychology technique 
into their daily routine, with the goal of forming a habit [44]. Progress in habit formation will be assessed during 
the scheduled weekly peer check-in sessions.  
 
Telecare Intervention 
We will utilize an evidence-based telecare approach to facilitate symptomatic management. We have 
successfully utilized this technique to manage pain, depression, and anxiety in several previous trials (Table 1). 
The telecare intervention consists of two main parts (1) symptom monitoring and (2) peer coach-facilitated 
treatment support. 
 
During the trial, a peer coach will contact patients weekly by telephone (with or without video) to discuss how 
they are doing. Patients will be encouraged to share their logbook information with peers to facilitate 
discussion. Peer coaches will provide reinforcement and accountability for patients to keep up their symptom 
and positive psychology intervention logging. If patients report new or worsening symptoms, peer coaches will 
discuss with patients whether they have been able to use the treatments suggested at the trial start and will 
provide reminders to use these treatments if warranted. If the patient reports elevated distress, intolerance of 
symptomatic treatments, opioid cravings or opioid use disorder behaviors, the peer and participant will relay 
this information to the physician-investigator. If an adjustment to the treatment plan is indicated, the physician-
investigator will make adjustments in collaboration with the patient’s primary treating physician.  
The peer coach will meet with the study PI (Dr. Bushey) weekly to discuss new cases and treatment plans as 
well as participants for whom treatment adjustments based upon symptom monitoring may be warranted. 
 
Usual care arm:  
Patients randomized to usual care will continue to receive care from their primary physician, with no active 
involvement by study personnel. Patients in this group will fill out the same baseline and 12 week questionnaires 
as patients in the intervention arm. 
 
Outcome measures. In addition to demographic and clinical characteristics that will be assessed at baseline, 
numerous symptom measures will be assessed at baseline and at the conclusion of 3 months of treatment 
(Table 3). Participants will receive a $40 gift card for each of the two outcome interviews (baseline and 
conclusion) that they complete. Opioid daily dose reduction is the primary outcome and will be measured in 
morphine-equivalent daily dose (MEDD). Secondary outcomes will include pain intensity, pain interference, 
positive affect, depression, anxiety, and disability. We will attempt to collect follow-up questionnaire data for up 
to 3 additional months after the conclusion of the trial to maximize the likelihood of data capture.   
 
Qualitative Interview. At the conclusion of the study, participants will be invited to participate in semi-
structured individual interviews to discuss their experience with chronic pain and the trial, what worked well, 
what could be improved, and potential strategies to bolster recruitment of additional patients in future studies. 
We will aim to conduct interviews of 10 patients in the intervention arm. Each interview will be audiotaped, 
transcribed, and independently analyzed by 2 reviewers to determine key themes related to barriers and 
facilitators using qualitative methods used in previous trials by Dr. Kroenke [49, 50]. Participants will receive a 
$50 gift card for completion of a qualitative interview. 
 

IU IRB Protocol #: 1905213338 v10.08.2021 
 
Page 7 of 10 
 
Data Analysis Plan. Descriptive statistics (means, medians, standard deviations, inter-quartile ranges, and 
frequencies) will be computed to assess variables’ distributional properties and to describe the sample when 
disseminating results. Since this is a small pilot study to test feasibility and patient acceptance, it is not formally 
powered to test a specific treatment effect size. Instead, whatever treatment effect is found will be useful in 
planning the sample size for a more definitive trial. However, a sample of 20 participants per arm has 80% 
power with an alpha of .05 to detect a 30 mg MEDD greater dose reduction in the intervention group (e.g., from 
70 MMED to 40 MMED) assuming a SD for the MEDD of 30[8] and 20% attrition (i.e., 32 of the 40 participants 
completing the trial). We will also explore treatment effect moderators, including medical comorbidity (using a 
9-item checklist), personality (TIPI scores), baseline pain interference, pain catastrophizing, pain self-efficacy, 
baseline somatic symptoms (SSS-8), mental health (PROMIS depression and anxiety), and baseline opioid 
difficulties (PODS). 
 
Feasibility. Several factors support the feasibility of our trial. First, as noted in the Preliminary Work section 
(Table 1), our team has successfully conducted multiple telecare-centered intervention trials [8, 13, 15, 25-33, 
51]. Second, several of these trials have demonstrated efficacy in managing pain [8, 13, 15, 25-33, 51]. Third, 
we will be utilizing a positive psychology intervention that has been shown to improve pain outcomes in 
patients with chronic pain [42]. Finally, others have demonstrated success in recruiting patients for and 
completing an opioid tapering program [17, 35] 
 
Potential Problems and Alternative Approaches. As described above, should patient recruitment prove 
challenging, we have several recruitment strategies. Further, adding additional clinical sites for recruitment 
would be another potential approach. High drop-out rates are an additional concern. If this occurs, identifying 
factors contributing to drop-out can inform further refinement of the treatment protocol in a subsequent study.   
 
 
Table 3. Outcome Assessment:  Measures and Schedule of Administration 
Domain 
Measure 
# 
Items 
Schedule 
(month) 
0 
3 
Primary outcome 
 
 
 
 
Opioid Daily Dose  
Morphine-Equivalent Daily Dose (MEDD). 
1 
X 
X 
Secondary outcomes 
 
 
 
 
Pain 
PROMIS Pain 
9 
X 
X 
Pain Catastrophizing 
CSQ Catastrophizing 
4 
X 
X 
Pain Efficacy 
Pain Self Efficacy Questionnaire (PSEQ) 
4 
X 
X 
Depression, Suicidality 
PROMIS Depression / *P4 Screener 
5 
X 
X 
Remission Evaluation and Mood Inventory 
Tool (REMIT) 
5 
X 
X 
Anxiety 
PROMIS Anxiety 
4 
X 
X 
Positive Affect 
Positive and Negative Affect Scale – Short 
Form (PANAS – SF) 
10 
X 
X 
Somatic Symptoms  
Somatic Symptom Scale – 8 (SSS8) 
8 
X 
X 
Disability 
Sheehan Disability Scale (SDS) 
3 
X 
X 
Opioid Problems 
Prescription Opioids Difficulties Scale 
(PODS) 
16 
X 
X 
PROMIS Prescription Opioid 
7 
X 
X 
Craving State, OUD Intensity/Interference 
Scale (ORG) 
4 
X 
X 
Substance Use 
Substance Use Questionnaire 
13 
X 
 
Medical Co-Morbidity 
Chronic disease checklist 
9 
X 
 
Demographics 
 
8 
X 
 
Personality 
Ten Item Personality Inventory (TIPI) 
10 
X 
X 
Global Rating of Change 
 
2 
 
X 
Satisfaction with treatment 
 
2 
 
X 

IU IRB Protocol #: 1905213338 v10.08.2021 
 
Page 8 of 10 
 
*P4 screener only used at baseline 
 
 
   
Benchmarks of Success. The following will provide benchmarks to evaluate the success of the proposed 
study: (1) Secure IRB approval for the study; (2) Recruit and consent the first 20 participants, conduct the 
interventions with these participants, and collect data; (3) Repeat with the second set of 20 participants; (4) 
Enter and clean the data; (5) Analyze data; (6) Write manuscript(s) and submit for publication; and (7) Develop 
an NIH K-23 grant application based on results of this trial.   
 
E. POTENTIAL FOR FUTURE FUNDING AND TRANSLATION 
 
We will use the results of CCODAP as preliminary data to prepare a K-23 application to either NIDA or the 
NIMH. 
 
F. REFERENCES 
 
1. 
Guy, G.P., Jr., et al., County-Level Opioid Prescribing in the United States, 2015 and 2017. JAMA Intern 
Med, 2019. 
2. 
Schieber, L.Z., et al., Trends and Patterns of Geographic Variation in Opioid Prescribing Practices by 
State, United States, 2006-2017. JAMA Netw Open, 2019. 2(3): p. e190665. 
3. 
Seth, P., et al., Quantifying the Epidemic of Prescription Opioid Overdose Deaths. Am J Public Health, 
2018. 108(4): p. 500-502. 
4. 
Bohnert, A.S.B., G.P. Guy, Jr., and J.L. Losby, Opioid Prescribing in the United States Before and After 
the Centers for Disease Control and Prevention's 2016 Opioid Guideline. Ann Intern Med, 2018. 
169(6): p. 367-375. 
5. 
Johnson, K., et al., Federal Response to the Opioid Crisis. Curr HIV/AIDS Rep, 2018. 15(4): p. 293-
301. 
6. 
Kalso, E., et al., Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain, 
2004. 112(3): p. 372-80. 
7. 
Furlan, A.D., et al., Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side 
effects. CMAJ, 2006. 174(11): p. 1589-94. 
8. 
Krebs, E.E., et al., Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With 
Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial. JAMA, 
2018. 319(9): p. 872-882. 
9. 
Matthias, M.S., et al., The patient-provider relationship in chronic pain care: providers' perspectives. 
Pain Med, 2010. 11(11): p. 1688-97. 
10. 
Upshur, C.C., R.S. Luckmann, and J.A. Savageau, Primary care provider concerns about management 
of chronic pain in community clinic populations. J Gen Intern Med, 2006. 21(6): p. 652-5. 
11. 
Townsend, C.O., et al., A longitudinal study of the efficacy of a comprehensive pain rehabilitation 
program with opioid withdrawal: comparison of treatment outcomes based on opioid use status at 
admission. Pain, 2008. 140(1): p. 177-89. 
12. 
Kroenke, K., et al., Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study. 
General Hospital Psychiatry, 2007. 29: p. 506-517. 
13. 
Kroenke, K., et al., Effect of telecare management on pain and depression in patients with cancer: a 
randomized trial. JAMA, 2010. 304(2): p. 163-71. 
14. 
Kroenke, K., et al., Stepped Care to Optimize Pain Care Effectiveness (SCOPE) Trial: study design and 
sample characteristics. Contemp.Clin Trials, 2013. 34: p. 270-281. 
15. 
Kroenke, K., et al., Automated self-management (ASM) vs. ASM-enhanced collaborative care for 
chronic pain and mood symptoms: the CAMMPS randomized clinical trial. J Gen Intern Med, 2019. 
16. 
Watkins, K.E., et al., Collaborative Care for Opioid and Alcohol Use Disorders in Primary Care: The 
SUMMIT Randomized Clinical Trial. JAMA Intern Med, 2017. 177(10): p. 1480-1488. 
Interview time in minutes (est.) 
 
 
45 
45 

IU IRB Protocol #: 1905213338 v10.08.2021 
 
Page 9 of 10 
 
17. 
Sullivan, M.D., et al., Prescription Opioid Taper Support for Outpatients With Chronic Pain: A 
Randomized Controlled Trial. J Pain, 2017. 18(3): p. 308-318. 
18. 
Hausmann, L.R.M., et al., Testing a Positive Psychological Intervention for Osteoarthritis. Pain Med, 
2017. 18(10): p. 1908-1920. 
19. 
Peters, M.L., et al., Happy Despite Pain: A Randomized Controlled Trial of an 8-Week Internet-delivered 
Positive Psychology Intervention for Enhancing Well-being in Patients With Chronic Pain. Clin J Pain, 
2017. 33(11): p. 962-975. 
20. 
Muller, R., et al., Effects of a Tailored Positive Psychology Intervention on Well-Being and Pain in 
Individuals With Chronic Pain and a Physical Disability: A Feasibility Trial. Clin J Pain, 2016. 32(1): p. 
32-44. 
21. 
Morasco, B.J., J.P. Duckart, and S.K. Dobscha, Adherence to clinical guidelines for opioid therapy for 
chronic pain in patients with substance use disorder. J Gen Intern Med, 2011. 26(9): p. 965-71. 
22. 
Gomes, T., et al., The Burden of Opioid-Related Mortality in the United States. JAMA Netw Open, 2018. 
1(2): p. e180217. 
23. 
Kolodny, A., et al., The prescription opioid and heroin crisis: a public health approach to an epidemic of 
addiction. Annu Rev Public Health, 2015. 36: p. 559-74. 
24. 
Nelson, L.S., D.N. Juurlink, and J. Perrone, Addressing the Opioid Epidemic. JAMA, 2015. 314(14): p. 
1453-4. 
25. 
Williams, L.S., et al., Care management of poststroke depression - A randomized, controlled trial. 
Stroke, 2007. 38(3): p. 998-1003. 
26. 
Kroenke, K., et al., Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study: 
design and practical implications of an intervention for comorbid pain and depression. Gen Hosp 
Psychiatry, 2007. 29(6): p. 506-17. 
27. 
Kroenke, K., et al., Optimized antidepressant therapy and pain self-management in primary care 
patients with depression and musculoskeletal pain: a randomized controlled trial. JAMA, 2009. 
301(20): p. 2099-110. 
28. 
Kroenke, K., et al., The Indiana Cancer Pain and Depression (INCPAD) trial Design of a telecare 
management intervention for cancer-related symptoms and baseline characteristics of study 
participants. Gen Hosp Psychiatry, 2009. 31(3): p. 240-53. 
29. 
Kroenke, K., et al., Telecare collaborative management of chronic pain in primary care: a randomized 
clinical trial. JAMA, 2014. 312(3): p. 240-8. 
30. 
Kroenke, K., et al., Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) 
trial: study design and sample characteristics. Contemporary clinical trials, 2018. 64: p. 179-187. 
31. 
Cheville, A.L., et al., The rationale, design, and methods of a randomized, controlled trial to evaluate 
the effectiveness of collaborative telecare in preserving function among patients with late stage cancer 
and hematologic conditions. Contemp Clin Trials, 2018. 64: p. 254-264. 
32. 
Cheville, A.L., et al., Effect of Collaborative Telerehabilitation on Functional Impairment and Pain 
Among Patients With Advanced-Stage Cancer: A Randomized Clinical Trial. JAMA Oncol, 2019. 
33. 
Krebs, E.E., et al., Design, recruitment outcomes, and sample characteristics of the Strategies for 
Prescribing Analgesics Comparative Effectiveness (SPACE) trial. Contemp Clin Trials, 2017. 62: p. 130-
139. 
34. 
Bair, M.J., et al., Evaluation of Stepped Care for Chronic Pain (ESCAPE) in Veterans of the Iraq and 
Afghanistan Conflicts: A Randomized Clinical Trial. JAMA Intern Med, 2015. 175(5): p. 682-9. 
35. 
Seal, K.H., et al., Optimizing pain treatment interventions (OPTI): A pilot randomized controlled trial of 
collaborative care to improve chronic pain management and opioid safety-Rationale, methods, and 
lessons learned. Contemp Clin Trials, 2019. 77: p. 76-85. 
36. 
Berna, C., R.J. Kulich, and J.P. Rathmell, Tapering Long-term Opioid Therapy in Chronic Noncancer 
Pain: Evidence and Recommendations for Everyday Practice. Mayo Clin Proc, 2015. 90(6): p. 828-42. 
37. 
Matthias, M.S., et al., "I'm Not Gonna Pull the Rug out From Under You": Patient-Provider 
Communication About Opioid Tapering. J Pain, 2017. 18(11): p. 1365-1373. 
38. 
Pergolizzi, J.V., Jr., M. Rosenblatt, and J.A. LeQuang, Three Years Down the Road: The Aftermath of 
the CDC Guideline for Prescribing Opioids for Chronic Pain. Adv Ther, 2019. 36(6): p. 1235-1240. 
39. 
Pergolizzi, J.V., Jr., et al., Clinical considerations about opioid withdrawal syndrome. Pain Manag, 2019. 
9(2): p. 111-113. 

IU IRB Protocol #: 1905213338 v10.08.2021 
 
Page 10 of 10 
 
40. 
Cohn, M.A., et al., An online positive affect skills intervention reduces depression in adults with type 2 
diabetes. J Posit Psychol, 2014. 9(6): p. 523-534. 
41. 
Moskowitz, J.T., et al., A positive affect intervention for people experiencing health-related stress: 
development and non-randomized pilot test. J Health Psychol, 2012. 17(5): p. 676-92. 
42. 
Addington, E.L., E.O. Cheung, and J.T. Moskowitz, Positive affect skills may improve pain management 
in people with HIV. J Health Psychol, 2018: p. 1359105318769355. 
43. 
Carrico, A.W., et al., Randomized controlled trial of a positive affect intervention to reduce HIV viral 
load among sexual minority men who use methamphetamine. J Int AIDS Soc, 2019. 22(12): p. 
e25436. 
44. 
Lally, P., et al., How are habits formed: Modelling habit formation in the real world. European Journal 
of Social Psychology, 2010. 40(6): p. 998-1009. 
45. 
Kroenke, K., et al., Core Outcome Measures for Chronic Musculoskeletal Pain Research: 
Recommendations from a Veterans Health Administration Work Group. Pain Med, 2019. 
46. 
Kroenke, K., et al., PROMIS 4-Item measures and numeric rating scales efficiently assess SPADE 
symptoms compared to legacy measures. J Clin Epidemiol, in press. 
47. 
Bellg, A.J., et al., Enhancing treatment fidelity in health behavior change studies: best practices and 
recommendations from the NIH Behavior Change Consortium. Health Psychol, 2004. 23(5): p. 443-51. 
48. 
Robb, S.L., et al., Ensuring treatment fidelity in a multi-site behavioral intervention study: implementing 
NIH Behavior Change Consortium recommendations in the SMART trial. Psychooncology, 2011. 20(11): 
p. 1193-201. 
49. 
Bair, M.J., et al., Barriers and facilitators to chronic pain self-management: a qualitative study of 
primary care patients with comorbid musculoskeletal pain and depression. Pain Med, 2009. 10(7): p. 
1280-90. 
50. 
Matthias, M.S., et al., Self-management support and communication from nurse care managers 
compared with primary care physicians: a focus group study of patients with chronic musculoskeletal 
pain. Pain Manag Nurs, 2010. 11(1): p. 26-34. 
51. 
Kroenke, K., et al., Stepped Care to Optimize Pain care Effectiveness (SCOPE) trial study design and 
sample characteristics. Contemp Clin Trials, 2013. 34(2): p. 270-81.