The opioid crisis is a serious public health concern and finding appropriate treatment modalities for opioid use disorder (OUD) has become a national priority. Evidence-based treatment recommendations from national organizations have indicated mixed results. In this article, we discuss the background knowledge and significance of the problem, and selected theoretical frameworks and review of the literature about several effective interventions, such as mindfulness, motivational interviewing, and cognitive behavioral therapy. However, there is a lack of a standardized behavioral intervention for OUD. In response to this gap, our team developed a manual-based treatment protocol for use in group settings of individuals with OUD who are also on medications. We describe the methods used to develop the manual, including detailed information about the 12 intervention sessions. The article concludes with discussion about implications and future directions for use of the manual.
Key Words: Opioid use disorder, substance use disorder, treatment protocol, manual, mental health, integrated behavioral health,; cognitive behavioral therapy, motivational interviewing, mindfulness meditation, relapse, recovery
The opioid crisis is a serious public health concern, particularly in rural areas...The opioid crisis is a serious public health concern, particularly in rural areas where access to substance use treatment is a desperate need (Alabama Department of Mental Health, 2019). Drug overdoses are the leading cause of accidental death in the United States, surpassing motor vehicle accidents and gun related deaths combined (Rudd et al., 2016). In fact, more people are dying today from drug overdoses than those who died during the height of the HIV/AIDS epidemic (Saloner & Barry, 2018).
Although many drugs contribute to these overdoses, the Centers for Disease Control and Prevention (CDC) posits that most overdose deaths are related to prescription opioids, heroin, and synthetic opiates, such as fentanyl (CDC, 2017). Therefore, opioid use disorders (OUD) are now considered a national crisis and epidemic, necessitating the development of treatment modalities that address both the disease of addiction as well as behavioral modifications that may have, in the first place contributed to the initiation of drug abuse.
Between 65 and 75% of individuals who overdose on opioids suffer from a comorbid psychiatric or mental health disorder...Between 65 and 75% of individuals who overdose on opioids suffer from a comorbid psychiatric or mental health disorder and thus are prone to relapse when engaged in treatment services (Bernard et al., 2018). Individuals with OUD further require comprehensive, evidence-based, and culturally sensitive treatments that are focused on long-term management, risk reduction, and proactive approaches related to behavioral modification and change (Saloner & Barry, 2018). This can be accomplished through the use of psychotherapies, such as cognitive behavioral therapy (CBT) and motivational interviewing (MI), and mindfulness strategies, such as mindfulness-based relapse prevention (MBPR) and mindfulness based stress reduction (MBSR; Mumba et al., 2018). The evidence is clear that integrated behavioral health that takes a holistic approach to recovery is important in ensuring sustained positive outcomes for this population (Mumba & Snow, 2017).
Background and Significance
Many factors have contributed to the opioid epidemic over the last decade.Many factors have contributed to the opioid epidemic over the last decade. These include overprescribing of opioids among individuals with chronic pain conditions - a situation that has been exacerbated by lobbying practices of pharmaceutical companies (Deiana & Giua, 2018). These companies have exerted aggressive marketing strategies that often leave providers under pressure to prescribe more than what is needed. In 2015 alone, enough prescription pills were filled to medicate every American around the clock for three weeks (Deiana & Giua, 2018). In 2018 (latest available data), Alabama hds the highest per capita prescription rate of 97.5 prescriptions per 100 persons; thus,in that year, there was an opioid prescription written for almost every man, woman, and child in Alabama (National Institute of Drug Abuse [NIDA], 2020). This is almost twofold the national average of 51.4 and interestingly a significant reduction from the estimated 121 prescription per 100 persons in 2017 (NIDA, 2020).
A combination of systems working in tandem has resulted in widespread addiction across the United States. According to Saloner and Barry (2018), prescription opioids significantly contributed to the opioid epidemic, however, it is intravenous heroin and other synthetic opioids such as fentanyl that are currently sustaining this crisis. Contributing to this crisis is the increase in the number of individuals with chronic pain conditions requiring long-term use of prescription opioids (Bernard et al., 2018).
...exclusive pharmacotherapy may be inadequate as it does not address comorbid mental health and psychiatric conditions among those with OUD Despite the immense need for treatment, many counties in the Deep South are classified as mental health professional shortage areas (Health Services and Resources Administration [HRSA], 2020). Therefore, individuals with a substance use disorder (SUD) such as OUD cannot access the treatment they need, although finding appropriate treatment modalities for OUD has become a national priority (Connery, 2015). Much progress has been achieved in the development of medications to assist with recovery and pharmacotherapy has recently become the gold standard for the treatment of OUD (Bonnie et al., 2017). However, exclusive pharmacotherapy may be inadequate as it does not address comorbid mental health and psychiatric conditions among those with OUD (Bonnie et al., 2017) which, if left unaddressed, can complicate the recovery process for many individuals and in fact, increase the risk for relapse.
Researchers recommend a combination of psychosocial support and pharmacotherapies (Fogger & Lehmann, 2017). However, non-significant findings have resulted from studies that have utilized counseling in addition to medication therapy (Weiss et al., 2011). Identified limitations from these studies included (a) counseling provided by individuals who do not have significant addiction expertise, (b) counseling based on manuals or protocols that only address addictions in general without incorporating an integrated behavioral health approach, (c) manuals that are outdated, and (c) outcomes that have exclusively relied on self-report measures that are not supported by other biological outcomes.
Researchers recommend a combination of psychosocial support and pharmacotherapiesTo address these identified gaps in the literature and practice, our multidisciplinary investigative team developed a manual for the treatment of individuals with OUD in group settings. The manual includes evidence-based protocols and information from the Substance Use and Mental Health Services Administration (SAMHSA), NIDA, and the CDC, and incorporates tenets from CBT, MI, and mindfulness based strategies. The purpose of this article is to describe the process of developing and organizing the novel behavioral manual-based treatment protocol for use among individuals with OUD and co-occurring mental health needs who also take medication for opioid use disorders (MOUD).
Theoretical Frameworks and Review of Literature
The development and organization of the manual-based treatment protocol primarily drew from two theoretical frameworks: Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (Beck, 1995; 1997; Miller & Rollnick, 2013). In a review of 16 meta-analyses, a seminal and important work in the field of addiction counseling by Butler et al. (2006) showed that CBT is effective in the treatment of a wide range of conditions, including depression and anxiety. Recent studies have further shown CBT to be an effective intervention among those with OUD (Moore et al., 2016; Whitten & Stanik-Hutt, 2013).
Mindfulness meditation has been utilized in the treatment of many conditions...Mindfulness meditation (MM) is a mind-body modality that involves the practice of attending to present-moment experiences in a self-directed and non-judgmental manner that promotes non-reactive affect management and self-regulation skills (Grant et al., 2017). Mindfulness meditation has been utilized in the treatment of many conditions, including: depression, anxiety, and many types of addictive disorders (Garland & Howard, 2018). Mindfulness meditation has also been shown to reduce cravings, which are significant risk factors for relapse in many addictive disorders (Garland & Howard, 2018). Therefore, MM can allow individuals with SUD, including those with OUD, to experience reduced cravings and improved overall psychosocial well-being. This ultimately contributes to positive outcomes in this population.
Motivational interviewing (MI), which is a conversational person-centered method of communication, helps people identify their ability, readiness, and willingness to change, while at the same time targeting ambivalence to change (Hamera, 2014; Hattema, Steel, & Miller, 2005). Motivational interviewing has many benefits, including reductions in depressive symptoms and prescription drug misuse; it also increases self-efficacy, and increases motivation to change (Chang et al., 2015). Based on the transtheoretical model of change that posits that change in behavior is an intentional process, MI is associated with better treatment outcomes in substance abuse rehabilitation and treatment (Prochaska et al., 1992; May et al., 2015). The transtheoretical model of change also involves six different stages: pre-contemplation, contemplation, preparation, action, maintenance, and termination (Prochaska et al., 1992).
...combining mindfulness with evidence-based interventions such as CBT and MI are effective strategies to target specific conditions Extant research indicates that combining mindfulness with evidence-based interventions such as CBT and MI are effective strategies to target specific conditions (Fjorback et al., 2011). For example, Zgierska et al. (2016), in a randomized controlled trial of mindfulness and CBT found that these modalities were effective among individuals with OUD and chronic pain. In addition to CBT and MM, additional resources, including tenets of Acceptance and Commitment Therapy (ACT) and the Co-occurring Disorders Treatment Workbook were utilized when developing the manual-based treatment protocol described in this article (Hayes et al., 2006; DMHLP, 2002). The core principles of ACT include concepts such as acceptance, cognitive defusion, the now, self, values, and the committed action, which focus on the combination of acceptance and mindfulness as well as commitment and behavior change (Hayes et al., 2013). All of these tenets were incorporated into the manual-based treatment protocol to produce a comprehensive and holistic manual-based approach to OUD treatment.
Process of Developing the Manual
A comprehensive review of the literature was conducted to examine availability of manual-based treatment protocols for SUD, and particularly OUD for individuals who have comorbid mental health problems. Specific organizations, including SAMHSA, CDC, and NIDA were reviewed for up-to-date recommendations about how to treat OUD. Using recommendations from these sources, and incorporating CBT, MI, and MM tenets and exercises, we embarked on developing the manual-based treatment protocol (hereafter known as the manual) for OUD as a framework for use by licensed professional counselors in group therapy settings.
After the comprehensive review of the literature and selection of materials and information to be incorporated into the manual, investigators reviewed counseling literature to determine the appropriate number of sessions for the protocol. Recommendations were mixed; they varied based on setting. From personal clinical practice, the investigators determined that 10 to 12 sessions were appropriate to produce the desired behavioral change. Additionally, this ensured that the licensed counselors and clients have enough time to build rapport with all group members prior to transitioning into sensitive topics related to substance use and misuse in a group setting. Based on this review and discussion, we settled on 12 sessions.
...the investigators determined that 10 to 12 sessions were appropriate to produce the desired behavioral changeNext, we had to determine the most important topics to cover in the sessions. Session content was based on recommendations from SAMHSA, NIDA, and CDC, as well as from clinical practice experiences. Initially, the investigators divided the 12 sessions into four overarching themes: introduction and goal setting; psychoeducation; treatment; and maintenance and relapse prevention. These topics were identified as core components of any substance use treatment protocol. The breakdown of the sessions was: A) Introduction and Goal Setting (1 session); (B) Psycho education (3 sessions); B) Treatment (5 Sessions); C) Maintenance/ Relapse Prevention (3 Session). Each session was between 60 to 75 minutes.
We then had to develop specific content to cover in each session, including any interactive exercises and related homework (assignments) that clients would be required to complete in between sessions. Group sessions were to be held on a weekly basis.
Description of the Manual Protocol
Cognitive behavioral therapy and MI were selected as the core intervention frameworks...Cognitive behavioral therapy and MI were selected as the core intervention frameworks based on extant research indicating that combining mindfulness with evidence-based interventions, such as CBT and MI, are effective strategies to target specific conditions including OUD (Fjorback et al., 2011; Zgierska et al., 2016). Treatment largely followed the framework that MI was utilized to keep participants engaged and enhances their readiness to change, while CBT actively involves clients in changing behaviors (Kertes et al., 2011). Group sessions were structured with didactic and experiential elements in the process. Generally, CBT supplemented MI by "providing action-based interventions to help clients learn to modify their thoughts and behaviors" (Iarussi et al., 2016, pg 4). Below is a summary of the group counseling sessions including general objectives, MI and MM exercises, and other resources utilized.
Group sessions were structured with didactic and experiential elements in the processIntroduction and Goal Setting (1 session). Acknowledging that the counselor and client relationship (or therapeutic alliance) is one of the strongest predictors of outcome during therapy, one of the major objectives in session one is starting to build the alliance with participants. The objectives of the session include: (a) establishing a working atmosphere, (b) building alliance, (c) building motivation for change and (d) raising expectations/setting an intention. During the first session the therapist introduces him/herself, and spends time getting to know the clients. Clients are given time to provide their history, especially in relation to substance use, offering as much as they feel comfortable sharing during the first meeting. The therapist also tries to ascertain the level of motivation of the clients and why they are currently seeking treatment. Equally important is addressing confidentiality and laying group rules for subsequent sessions. During all sessions, the counselor is encouraged to use motivational interviewing strategies recommended by Miller and colleagues (2013) to enhance motivation and avoid resistance. Examples of these strategies are empathetic listening, rolling with resistance, pointing out discrepancies, and eliciting self-motivation statements.
Another important objective for this session is to set treatment goalsAnother important objective for this session is to set treatment goals. The focusing agenda map/agenda setting map by Naar-King & Safren (2017) is provided to participants on the first day to help them set treatment goals. The counselor is cognizant that, while treatment may be generally geared toward abstinence from opioid use, clients often have other coexisting problems and concerns, some of which may not be related to substance use. Thus, while the primary focus of treatment should be recovery from opioid abuse and misuse, it is important that the counselor recognizes additional challenges and assists clients to navigate through other presenting problems/issues. These additional concerns, if unaddressed, may stymie progression through recovery.
Psychoeducation (3 sessions). The goal of the psychoeducation sessions is to assist clients to better understand issues surrounding OUD with the goal of enhancing their ability to manage the addiction. In these sessions, the counselor expounds on addiction as a mental health disorder. Some topics covered in the psychoeducation sessions include motivation and consequences of opioid use; connection between opioid use and mental health issues; and various types of stigma toward mental health conditions, including OUD. Given that cravings are a difficult problem for so many individuals suffering from OUD, this topic is introduced very early in treatment and is covered throughout the remaining sessions.
...participants learn how CBT works and how it is applicable to their own lives In addition to issues of opioid use/abuse, participants learn how CBT works and how it is applicable to their own lives. Some of the MI exercises that are incorporated in psychoeducation sessions are decision balance risk factors, and protective factors for substance use problems. In these sessions, participants are introduced to mindfulness-based exercises, such as SOBER (Stop, Observe, Breathe, Expand, Respond) breathing and body scan. Participants are also strongly encouraged to practice these exercises at home between the sessions.
Treatment (5 Sessions). The treatment sessions deal with a variety of issues, including stages of change, dealing with cravings; identifying and coping with thoughts related to opioid use, stigma associated with opioid and mental health issues, ambivalence to quitting drug use; and attitudes and values as they relate to substance abuse and mental health issues. Regarding stigma, the treatment sessions focus of discussions of structural stigma in substance abuse settings that may adversely impact outcomes of individuals with OUD.
During these sessions that focus on treatment, the counselor utilizes and elicits change talk (Miller & Rollnick, 2013; Rosengren, 2009). Various exercises, including the confidence and readiness rulers (Miller & Rollnick, 2013), are utilized to assess participant readiness and confidence to make changes. Other exercises include the decision balance and worksheet for monitoring of thoughts. This is very important as it relates to reducing cravings for substances. The manual-based treatment protocol incorporates exercises to ensure that participants are actively engaging in their recovery journey and that they are taking ownership of their personal recovery journey.
The manual-based treatment protocol incorporates exercises to ensure that participants are actively engaging in their recovery journey...After a comprehensive discussion on healthy coping, participants are encouraged to identify, record, and utilize different coping skills. Lastly, additional mindfulness exercises are introduced, such as loving-kindness meditation. Again, participants are encouraged to utilize the newly learned knowledge, skills, and exercises from group therapy between the sessions to ensure ownership of recovery process.
Maintenance/Relapse Prevention (3 Session). The objectives of these sessions include (a) re-affirming the progress made in treatment, (b) introducing and practicing problem solving skills, (c) preparing and planning for high risk-situation by developing a personalized coping plan, and (d) reviewing available resources in the community. For example, counselors provide participants with a pamphlet that has SAMHSA and CDC hotlines for suicide prevention, detox facilities within the 50-mile radius of the treatment centers, homeless shelters, and even resources for employment support.
An important component of this session is to help clients identify the most common high-risk situations...An important component of these sessions is to help clients identify the most common high-risk situations for substance abuse and mental health issues, and their personal triggers of relapse. These sessions further focus on assisting participants to identify early warning signs for relapse and development of a personalized relapse prevention plan. This is done by utilizing the high-risk situations worksheet (Daley & Marlatt, 2006). The worksheets are provided to the clients prior to the session in which they are utilized, and the counselor works with clients through the worksheet during the session. Soliciting group feedback on the personalized treatment plan is also welcomed to foster peer support while at the same time promoting accountability and personal responsibility for maintaining sobriety after the 12 group sessions are completed.
Soliciting Feedback from Experts
The completed draft manual was sent to experts in the field for input. Specifically, the completed manual was sent to five experts comprising of researchers/educators (n=3), and clinicians (n=2). The experts resided within the West Alabama region and had experience (either through work or research activities) with individuals with OUD. The experts were asked to review the manual and provide input on (a) content coverage, (b) the exercises and whether they matched the content, (c) ease of utilization of the manual by the licensed counselor, and (d) any additional comments. Overall, the experts indicated that this was a timely manual. They recommended that the group therapy sessions in which this manual would be used should be a closed group (i.e., the same participants in each group throughout the duration). The experts suggested that this would increase participant engagement with the content and exercises by providing a safe and secure environment and consistent interaction with the same peers.
They indicated that it can be quite difficult to keep this population focused on a single task for a long time...The experts recommended that the licensed counselor should ensure that sessions do not last longer than 90 minutes so as not to deter participation and full engagement with the process. They indicated that it can be quite difficult to keep this population focused on a single task for a long time; therefore, lengthy sessions could deter willingness to participate. One of the experts also recommended than an additional mindfulness exercise be added to the relapse prevention sessions and the decision balance exercise should be revisited in the relapse prevention sessions. The last recommendation was that exercises should not be so long and stringent that participants would not look forward to them. This same recommendation had been provided concerning homework exercises. We incorporated recommendations before the protocol was piloted for feasibility and acceptability via focus groups of individuals with OUD and comorbid mental health problems. Results of the focus group study for feasibility and acceptability of the manual-based treatment protocol are detailed in a separate manuscript (Mumba et al., 2020).
This manual was developed to be utilized as an intervention in OUD treatment in response to gaps that were identified in the literature and the mixed results from studies that employed psychotherapy in addition to medications. This manual-based protocol is currently being pilot tested for efficacy compared to treatment as usual in improving adherence to MOUD in a randomized controlled clinical trial of individuals with OUD and comorbid mental health problems. It is noteworthy to mention that the intervention is not intended to work with serious mental illnesses, such as schizophrenia, but rather it is intended for those with anxiety, stress, and depressive symptoms, which are not only commonly associated with OUD but have been shown to increase the risk of OUD and double the risk of relapse among those undergoing treatment.
...we intended to capitalize on gains attributable to each modality and safely achieve additive effects By combining CBT, MI, and MM in the treatment manual we intended to capitalize on gains attributable to each modality and safely achieve additive effects (Veehof et al., 2011). Emotions such as self-stigma, failure, vulnerability, and guilt, which are associated with substance use including OUD, are managed, or addressed when CBT is combined with MI. The treatment manual incorporates useful tools such as self-reflection and introspection for handling such emotions, and a specific session in treatment is dedicated to addressing these factors. This is very important because if these issues are not properly managed, they can precipitate relapse and drug misuse. Additionally, mindfulness interventions have been consistently shown to decrease cravings, which are significant risk factors for relapse and even fatal overdoses (Witkiewitz & Bowen, 2010).
...the licensed counselor utilizing [the manual] it must have significant expertise in the substance use treatment arena...It is important for the group leader—in this case the licensed counselor—to create a safe atmosphere to build trust. Based on the feedback from our experts, for this manual-based treatment protocol to be effective, the licensed counselor utilizing it must have significant expertise in the substance use treatment arena; otherwise participants may not feel adequately supported throughout the program and this can contribute to attrition. Other important qualities required to effectively lead these counseling sessions include genuineness, caring demeanor, openness, self-awareness, active listening, confronting, supporting, and role modeling (Corey & Corey, 2006; Furr & Barret, 2000). This perspective is consistent with the viewpoint of counselors that client-counselor relationship, and by extension clients' feelings that the counselor understands them, are significant predictors of treatment outcomes (Bordin, 1979, 1994; Kim et al., 2005; Lustig et al, 2002).
Our intended goals for this manual-based treatment protocol was utilization in substance use treatment settings to 1) improve adherence to medications for OUD, self-efficacy, and quality of life, and 2) foster reductions in anxiety, stress, and depressive symptoms. It was developed for use in a group therapy setting. The protocol contains 12 sessions, divided into introduction and goal setting; psychoeducation; treatments; and maintenance and relapse prevention. Each weekly session lasts approximately 75 minutes but no more than 90 minutes. The manual-based treatment protocol is supported by theoretical frameworks from CBT, MI, and MM.
We believe that the synergistic effect of combining these modalities promises better outcomes for individuals with OUD and comorbid mental health conditionsWe developed the manual as a response to the lack of standardized treatment that we have noticed within the substance use treatment community. We believe that the synergistic effect of combining these modalities promises better outcomes for individuals with OUD and comorbid mental health conditions. The interactive and experiential group exercises and homework are designed to foster peer support and promote personal ownership of the recovery process. We are hopeful that the findings of our ongoing clinical trial may provide much-needed evidence to support this treatment modality for use in a variety of substance use treatment centers.
Mercy Ngosa Mumba, PhD, RN
University of Alabama, Capstone College of Nursing
Dr. Mumba is an Associate Professor in the Capstone College of Nursing. Her research focuses on treatment, prevention, and management of substance use problems, particularly opioid use disorders.
George Tongi Mugoya, PhD
University of Alabama, Department of Educational Studies in Psychology, Research Methodology and Counseling
Dr. Mugoya is an Associate Professor in the Department of Educational Studies in Psychology. His research areas of interest include treatment of substance use disorders and training of substance use counselors.
Natalia Langner Smith, MS, PhD(c)
University of Alabama, School of Social Work
Ms. Smith is a PhD Candidate in the School of Social Work. She works as a graduate research assistant in Dr. Mumba’s research lab.
Andrea Glenn, PhD
University of Alabama, Center for Youth Development and Intervention, Department of Psychology
Dr. Glenn is an Associate Professor in the Department of Psychology. She studies disruptive behaviors problems and reducing inequality through mental health interventions.
Courtney Potts, MA
University of Alabama, Department of Educational Studies in Psychology, Research Methodology and Counseling
Ms. Potts is a graduate research assistant in Dr. Mugoya research lab. She is currently pursuing her master’s in educational counseling.
Madelyn Hope Campbell
University of Alabama, Capstone College of Nursing
Ms. Campbell is an undergraduate research assistant in Dr. Mumba’s research lab. She is currently pursuing a Bachelor of science in biology.
University of Alabama, Capstone College of Nursing
Ms. Kirwan is an undergraduate research assistant in Dr. Mumba’s research lab. She is currently a pre-med major at the University of Alabama.
Austin Butler, MBA, MPA
University of Alabama, Capstone College of Nursing
Ms. Butler is the program manager at the Capstone College of Nursing. She manages all research conducted in Dr. Mumba’s research lab.
Lori Davis, MD
Tuscaloosa VA Medical Center
Dr. Davis is the Associate Chief of Staff for Research at the Tuscaloosa VA Medical Center. Her research focuses on mental health and substance use treatment needs of veterans.
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