Given the high rate of comorbidity and functional interrelatedness, a treatment approach for opioid use disorder and pain that can address both problems simultaneously and utilize self-regulation techniques would be most efficient and potentially more effective that separate treatments. Clinically, these issues are usually addressed sequentially (OUD first, then pain) or do not address the pain at all due to a lack of training by addiction clinicians in pain or by pain clinicians in addiction. There are no empirical data supporting this treatment approach, and it may even hinder treatment for both disorders .
In the integrated format of STOP, co-morbid issues are treated simultaneously by the same mental health provider, who has training in both pain and OUD treatment, within a single treatment protocol with the goal of progressing toward resolution of both co-morbidities simultaneously . Using the common factors hypothesis of co-morbidities  integrated treatment focuses on mutual goals shared by each co-morbidity treatment. Specific treatments unique to a single issue are then added to the integrated treatment as needed. Based on other integrated treatment studies, this model provides the best opportunity to sustain recovery from OUD in the context of chronic pain [29, 30].
For instance, self-regulation is an effective tool to reduce pain reactivity as well as de-escalate pain-related emotional states and has been called many different things (i.e., relaxation , biofeedback , autogenic training , and imagery ). Meta-analyses indicate that self-regulation matches medication in pain reduction . Addiction research on self-regulation is limited, but it has been shown to effectively treat anxiety, cravings, psychopathology, and lead to a reduction in addiction behaviors [33, 35, 36]. Those using self-regulation after drug cue exposure or during treatment were more likely to successfully complete addiction treatment [37, 38]. A small study (N < 10) utilizing CBT and self-regulation showed promising outcomes in addiction treatment with improved opioid use and psychosocial measures .
In order to facilitate its eventual adoption, the STOP protocol had to: 1) meet the unique treatment needs of the patients, and 2) meet the needs of community addiction treatment centers who will be using the protocol. Therefore, STOP is based on psychophysiological research to identify and treat the unique needs of the COAP population using an integrated treatment protocol for both OUD and comorbid pain and seeks to increase pain tolerance, lessen drug use, and reduce drug cravings. In addition, STOP was designed to be community treatment friendly with a 12-week outpatient treatment format using rolling entry to allow individuals to join when they are ready and providing therapist training to allow addiction counselors to address both pain and OUD comorbidities while incorporating self-regulation treatment components.
STOP uses an innovative model of integrated treatment to treat co-morbid OUD and pain which blends CBT and self-regulation treatment (see Fig. 1). In an integrated model, co-morbid issues are treated simultaneously by the same provider within a single treatment protocol. Interactions between co-morbid issues are addressed with the goal of progressing toward resolution and stabilization of both co-morbidities simultaneously . As pain and OUD are intertwined and that a setback in one area may trigger a setback in the other, STOP addresses both areas simultaneously with a psychoeducation plan that teaches both therapists and participants how these two areas can affect each other to create setbacks or build-up of strengths.
Traditional research protocols for group therapy primarily use a closed group model . However, 84% of substance abuse psychotherapy treatment uses an open enrollment (rolling entry) format  to allow patients to enter treatment quickly and reduce relapse risk or death . The STOP protocol was conceptualized as a rolling entry community-friendly format because the quality of social interaction, commitment to the therapy process, and group alliance does not change based on group membership in rolling entry groups . Rolling entry format is both patient and provider friendly and should allow the final protocol to be seamlessly disseminated and incorporated into medication for opioid use disorder (MOUD) addiction programs, the final successful step to protocol development of dissemination and adoption of the protocol .
Pain management is not typically included in the training for drug and alcohol addiction counselors or master’s level therapists and most doctoral level substance use providers do not have training in pain management as part of their licensure . This lack of adequate training to substantively address pain leaves providers unable to treat patients entering substance abuse treatment with the comorbidity of pain. A critical component of a treatment protocol addressing COAP patients must include a therapist training protocol to address this gap in knowledge with basic pain management education. The current study included field testing of an innovative training protocol for addition therapists naïve to pain management treatment.
Using the information gathered on both patient and community treatment needs, we then developed and piloted a psychotherapy treatment approach to address the unique psychological and physiological needs of this population.
Initial therapy manual development
The initial STOP manual was developed based on interviews with our community addiction treatment partners about the needs in their treatment population. We selected empirically validated pain treatments and substance use treatments, such as pain education, pain CBT, OUD CBT, relapse prevention, sleep hygiene, and self-regulation therapies, based on previously identified needs from the psycho-physiological studies [19, 25, 26]. Treatments were modified to address the specific needs of the patient population and coalesced into a 90-min, 12-week, rolling entry group therapy treatment called STOP. Sessions used visual images in addition to auditory descriptions for participants who are visual learners, as well as activities to help participants practice the skills from the group. These skills were reinforced with take home worksheets to continue the use of the skills outside of session.
We taught a single relaxation technique that was repeated every session. Participants were asked to practice this relaxation technique daily at home so that they would be extremely familiar with one specific strategy. This method was designed to give participants a known “go-to” and effective tool when they were in the midst of the stress surrounding a drug craving or pain flare. In order to reinforce the use of this relaxation strategy, participants were given Biodots  to enhance at home practice. These are small heat sensitive stickers that change color based on the temperature of the participant’s skin (generally a fingertip), similar to “mood rings” that were popular in fashion during the 1970s and 1990s . Biodots provide a cheap form of at home biofeedback during relaxation practice, providing a visual aid for participants to understand the tension and stress in their bodies and to help them reduce it, thereby reducing pain as well. Participants can observe the color of the biodot both at the outset of their relaxation practice, and any changes during their relaxation practice, the Biodot becoming lighter indicating increased heat and blood flow to the fingertip and less muscle tension . This reinforces the physical and mental changes that occur during the relaxation practice taught in session. Biodots are less than 2 cents per dot, have a quick reaction time, and are easy for participants to interpret . Therefore, biodots could be easily incorporated into the therapy process, easily replaced if lost, and do not require any other special equipment to allow participants to engage in effective at-home biofeedback practice.
Each session was group-based and 90 min long. Each session includes: a therapist manual, visual images of key components for each section (for display), participant handouts, and participant homework. Ssessions contained a mixture of didactic, participant practice (e.g., role plays, demonstrations, examples), and interactive problem solving. Visual images and in session skills practice were emphasized to maintain participant engagement, particularly for individuals who may not have strengths in traditional academic skills of verbal and written learning.
The materials were reviewed by experts in the field and revised based on their feedback. We completed an acceptability and beta test of the intervention with a group of five individuals struggling with COAP who were recruited from our community addiction treatment partners. Individuals represented different ages, genders, ethnicities, and phases of treatment. We conducted post-treatment interviews with participants to identify areas that required a final revision. We revised the protocol once again to result in STOP (Self-regulation Therapy for Opioid use and Pain).
Study therapists were selected for STOP training and providing STOP therapy in the study based on four primary criteria: 1) interest in learning STOP for comorbid pain and OUD, 2) having a master’s degree in a mental health field (psychology, counseling, or social work), 3) experience as a therapist, and 4) willing to work with the study for at least 1 year. Therapists were also required to complete all necessary research ethics trainings.
Pain management is not a standard component of training for addiction counselors . However, due to the high rate of co-morbidity and the need to develop an addiction treatment community-friendly intervention, a portion of the therapy manual was dedicated to therapist education in pain management to ensure that therapists are able to engage patients with this complex comorbidity and feel comfortable addressing both aspects of comorbid pain and OUD. The STOP therapist training manual provided basic behavioral pain management education to therapists on the topics of basic pain physiology, the interaction between the biology and the psychology of pain, the impact of behavioral pain treatment, and the goal of the pain strategies included in the treatment. The training consisted of a mix of didactic information outlining the rationale and purpose of each of the session topics, applying that information in role plays, and ongoing supervision of therapy sessions through audio recordings. Previous research that trained addiction counselors to treat comorbid disorders indicated that with didactics and supervision, therapists can develop the skills needed to deliver a CBT-based protocol for comorbid addiction and mental health issues . Two master’s level certified addiction counselors received the training for the study. Both therapists were female with 4–5 years of full-time practice.
Therapists received one full day of training on: basic pain physiology, the influence of mood states on pain and cravings, self-regulation and CBT for pain and OUD, influence of sleep on pain, linkages between OUD and pain, and individual skills to increase pain self-efficacy. Formal training contained lectures, demonstrations/modeling, and experiential experiences in small group and 1-on-1 formats. To balance periods of lectures with hands-on training, we provided a lecture introducing a skill or concept, then therapists used this skill in a mock therapy session to allow the trainer to observe their initial grasp of the concept and provide corrections or further skill development as needed. At the end of the didactic training, each therapist had led mock sessions of the key components for STOP. After the completion of the training, including successfully completing the mock sessions under the supervision of a licensed psychologist (AW), the therapist was determined to be competent to provide the therapy.
Ongoing supervision and training
Study therapists attended weekly group supervision throughout the training and implementation period. Supervision was provided by a licensed clinical psychologist who is a pain and OUD specialist (AW/EE). During these meetings, participant progress (including weekly quantitative and toxicology data), the supervisor’s findings from the audio recordings of previous sessions including adherence and competence, and next week’s session were reviewed.
During weekly supervision, therapists reviewed the next week’s STOP therapy session and provided a practice session presentation during group supervision to allow the supervisor to ensure that therapists fully understood the concepts presented in the session and were prepared to lead the therapy group. Once the therapists displayed basic competency at delivering the manualized treatment sessions as determined by a licensed psychologist (AW/EE), an additional 1-day “booster” training was provided to address more complex issues that may arise in this patient population (e.g., relapse on opioids due to pain flare). Modifications to the therapist training protocol were made based on the clinical experience of the therapists, adherence and competency ratings, subject response, and therapist content knowledge.
All STOP sessions were audio recorded. These recordings were used to assess therapy fidelity using a Therapist Integrity Measure developed for this study. A Therapy Integrity Measure was devised for the current study to assess the therapist’s proficiency and fidelity at delivering the STOP treatment after receiving the STOP training. For each session, 10 specific prescribed interventions or therapist behaviors in the manual were listed (e.g., in session 1, “Therapist was well-prepared with all the materials needed for the session.” “Therapist explained the gate control theory of pain with visual displays.” “Therapist completed the body scan relaxation exercise in a slow, calming manner.”) on a Likert scale of 0 (not at all), 1 (poor skill), 2 (limited skill), 3 (acceptable skill), 4 (considerable skill), 5 (extensive skill). Raters were trained to follow a detailed scoring rubric operationalizing each of the scores 0–5.
This therapy integrity measure allowed us to derive a score for adherence to prescribed interventions in the manual; we tallied dichotomous no or yes delivery score for each intervention in the session (each of 10 items is scored 0 (“no”, not delivered) or 1 (“yes” if rater endorsed 1, 2, 3, 4, or 5) for a total possible adherence score per session of 10, and total possible adherence score of 120 for the entire 12-session protocol. We were also able to derive a session score for quality/level of skill (from poor skill  to extensive skill  for all of the delivered (i.e., “non 0”) interventions, for a possible mean therapist skill score of 1 to 5 per session or per the entire 12-session protocol.
The first and third authors, both licensed clinical psychologists, independently reviewed audiotapes of STOP therapy sessions for each therapist. Satisfactory fidelity was defined as 90% or greater of delivering the components of the intervention with a competency rating of 4/5 for each item. Once a therapist met both criteria for each session, he or she was identified as proficient for that session. Once full proficiency on STOP was achieved, ongoing ratings of proficiency were made on 30% of randomly selected treatment sessions. Inter-rater reliability for rating the first 12 sessions was 93% for individual items (the discrepant ratings were all within 1 point), and 100% for a dichotomous “pass/fail” decision.
For the groups administered to the 14 pilot participants, the overall adherence score for individual sessions was M = 10, SD = 0, and the overall skill score was M = 4.2, SD = 0.37. Upon completion of the study, we were able to examine overall manual adherence and skill of administration, as well as the broader domains of treatment such as coping with pain and integrative domains such as self-regulation for tolerance of both pain and opioid cravings.
Participants were recruited from community addiction treatment centers. Inclusion criteria were English fluency, age 18 to 65 (inclusive), in active treatment for OUD on MOUD, a diagnosed chronic pain condition, and currently stable on their MOUD dose (e.g., not actively titrating up or down). Exclusion criteria were an unstable/untreated psychiatric disorder, recent psychiatric hospitalization (< 3 months ago), or unstable cardiac condition in the past 3 months. Thirty-four participants were initially screened for the current Stage 1a study. Twelve of those screened were ineligible: 10 did not have a chronic pain diagnosis or had a primary substance of abuse other than opioids, and two were not stable on their methadone or buprenorphine dose. Eight individuals were deemed eligible but never appeared for the baseline intake appointments, did not complete informed consent, and did not respond to follow-up contact attempts. There were 14 individuals who were screened, deemed eligible, arrived for their baseline appointment where they provided informed consent for the full study, and completed the baseline assessment.
Fourteen participants (50% female; 50% male) were included in the Stage 1a feasibility and acceptability study of STOP. Participants on average were 43.9 years old (SD = 10.36), with a diagnosed current chronic pain condition (50% had a muscular-skeletal pain source with 50% experiencing mixed neuropathic/muscular skeletal pain, 0% experienced only neuropathic pain). Their mean pain level at baseline was at a 6.1 (SD = 2.90) out of 10 and their mean craving level was 3.9 (SD = 2.52) out of 10. The study sample was 72% Caucasian; 50% on buprenorphine MOUD (Mdose = 9.5 mg, SD = 3.0) and 50% on methadone MOUD (Mdose = 71.3 mg, SD = 48.55); 50% had some college or higher education level. Ten participants had a diagnosis of Major Depressive Disorder (MDD) and 7 participants had a diagnosis of Generalized Anxiety Disorder (GAD). Two participants were employed, three were seeking work, and nine were on Social Security Disability Insurance. All participants had multiple previous relapses (M = 3.3, SD 2.48) and had been in their current treatment a median of 5 months (including medical withdrawal management). While not required for the study, it should be noted that all the participants had previously dropped out or relapsed from addiction treatment at least once in their history, which suggests that our participant population reflects the typical patient population in a community OUD treatment program.
Participants completed a brief screener to ensure eligibility prior to enrolling into the study. STOP group therapy was provided to participants in their current community addiction treatment center setting, and in collaboration with our community partners, it was offered as a group treatment option in lieu of one of the other mandatory groups they were required to attend to stay in the program and receive methadone or buprenorphine. Throughout the sessions of the study, participants remained stable on a dose of methadone maintenance treatment (MMT) or buprenorphine/naloxone. All procedures were approved by the University of Massachusetts Medical School IRB and the Colorado Multiple IRB (COMIRB) commission.
Participants could enter at any point in the 12 sessions once they had completed medical withdrawal management and medication induction phases of their treatment (See Table 1). There were periodic points of brief review or introduction of the techniques throughout STOP to ensure that everyone had some awareness of the terminology and practices in the protocol regardless of when they entered. If participants missed a session, a brief review of the session would occur by phone or in person prior to the next week’s session.
Baseline, within treatment, and follow-up assessment
In addition to three major assessments during the study: baseline, post-treatment, and 3-month follow-up, participants completed brief weekly assessments of mood, craving, drug use, pain, and a urine toxicology.
Numeric Rating Scale on 0–100 scale was used to rate current and previous week’s pain levels and opioid craving levels . This scale measured week-to-week change, facilitated rapid response by the treatment team if there were any potential negative effects of treatment and allowed participants to track relationship between treatment engagement, home practice, and improvement in pain and craving levels over time. Timeline Follow Back reports were used to collect daily drug use data over the previous week. As a validation of self-report, participants took a 14-panel urine toxicology screen for amphetamine, barbiturates, benzodiazepines, buprenorphine, cocaine, MDMA, methamphetamine, methadone, opiates, oxycodone, PCP, PPX, tricyclic antidepressants, and THC at all assessment points, including weekly .
At each of the three major assessment, participants completed urine toxicology, a functional assessment, and an assessment battery. The assessment battery included self-report surveys on craving, distress tolerance, mood, pain levels, pain attitudes, and behaviors, including the Multi-dimensional Pain Inventory , a 52-item survey divided into 12 sub-scales. The inventory captures the chronic pain experience across three dimensions including negative life impact, perception of social support, and ability to engage in daily activities.
During the major assessments, participants also did a cold pressor task during which several psychophysiological measures were taken including: heart rate, peripheral temperature (oC), frontalis electromyography, and galvanic skin response, in three stages: a 5-min resting baseline, cold pressor task, and a 5-min recovery period. For the cold pressor task, the research asked each participant to place their non-dominant hand up to the wrist in a 2 °C cold water bath. Participants reported when they first experience pain, and remove their hand when, “it becomes too painful.” After the cold pressor task, participants were debriefed using a relaxation exercise and completed a follow-up survey.
At the follow-up assessment points only, participants were administered qualitative interviews related to usage, comfort, and preferences related to the strategies presented in the sessions, the activities, and homework assignments. Participants were compensated for their travel in the form of a one-day bus pass, a one-day medical center parking pass, or a five-dollar gas gift card for each appointment (therapeutic or non-therapeutic) attended, and $20 for each non-therapeutic (e.g., assessment) session at the pre-, post-, and three-month follow-ups.
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