Therapy session frequency and abstinence outcomes in opioid use disorder
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Cognitive Behavior Therapy and Opioid Use Disorder
Abstract
Opioid use disorders (OUD) have become prevalent among adults over the past two decades. The treatment of these disorders has become a major issue in the public health sector. The purpose of the study is to establish whether more therapy sessions generate better patient outcomes in terms of abstinence from the illicit use of opioids and sustained remission in adult patients diagnosed with OUD. A sample of 278 patients enrolled at Opioid Rehabilitation Center was selected to participate in this study and divided into a control group and a treatment group. The control group underwent only one therapy session within a 12-week period while the treatment group was subjected to at least two therapy sessions on a monthly basis for 12 weeks. Baseline (pretest) data was collected prior to administering the treatment intervention and posttest data was collected at the end of the 12-week period. The study found the treatment group has better abstinence rates and sustained remission in comparison to the control group.
Key terms: therapy sessions, opioid use disorder, cognitive behavior therapy, adult patients, opioid treatment center, abstinence rates, sustained remission, treatment.
Overview
Opioid use disorders have increased at a rapid rate in the past two decades, particularly among adolescents and emerging adults aged 18-25 years. The increase in the rate of these disorders is attributable to an increase in the illicit use of prescription opioids. The situation has exacerbated among older adults who use opioids for the management of chronic pain. Many older adults who visit physician offices for acute or chronic pain related diagnoses or non-cancer pain symptoms receive an opioid prescription. However, the illicit use of prescription opioids has become a major issue, especially among patients enrolled in an outpatient treatment center with primary opioid use disorder diagnosis and co-occurring mental illness.
As a result, the treatment of this disorder is increasingly critical to help enhance the health and outcomes of these patients. While cognitive behavior therapy is one of the approaches used in the treatment of opioid use disorder, the frequency of therapy sessions that increases chances of abstinence from illicit opioid use remains unknown. There is a gap in the literature on how many therapy sessions that patients with primary opioid use disorder and co-occurring mental illness should undertake to increase abstinence from illicit use of opioids. This project seeks to examine whether two or more therapy sessions in a month enhances the likelihood of patients with primary opioid use disorder to abstain from illicit opioid use in comparison to one therapy session within a 12 week period.
Background of the Study
According to Dowell, Haegerich & Chou (2016), opioids are medications that are commonly prescribed for pain. It is estimated that 20% of patients who visit physician offices with acute or chronic pain or non-cancer pain symptoms receive opioid prescription. Even though the rates of opioid prescriptions vary greatly across states, they increase more for general practice, family practice and internal medicine unlike other healthcare specialties. The rates of opioid prescriptions per capita increased by 7.3% between 2007 and 2012 (Dowell, Haegerich & Chou, 2016). In 2012, healthcare providers in the United States wrote more than 259 million opioid prescriptions for pain management. These prescriptions were adequate for every adult in the country to have a bottle of pills.
While opioids are commonly prescribed for pain, their use is associated with some serious risks such as opioid use disorder and overdose. It is estimated that over 165,000 people died from opioid-related overdose in the United States between 1999 and 2014. Over the past few years, the public health sector in the country has witnessed a significant increase in the number of patients diagnosed with opioid use disorder and co-occurring mental illnesses. Schuman-Olivier, Greene, Bergman & Kelly (2014) contend that the rates of opioid use disorder have increased dramatically in the past 15 years, particularly among adults aged between 18 and 25 years. The dramatic increase in the rates of this disorder is attributable to increased opioid misuse and dependence rates. Over the past two decades, more young adults and older adults are seeking treatment for opioid use disorders and co-occurring mental illnesses. Sharma, Bruner, Barnett & Fishman (2016) contend that opioid use and addition in young adults is a serious and rising health problem of epidemic proportions.
Given these factors and trends, treatment for opioid use disorders has become increasingly critical in the modern public health sector. Treatment for opioid use disorder is considered vital toward enhancing the health and outcomes of these patients while enhancing their likelihood of abstinence from illicit opioid use. Numerous treatment approaches have been developed and are utilized for opioid use disorder and co-occurring mental illnesses. Maglione et al. (2018) contends that opioid use disorder is treated using medication assisted treatment (MAT) in combination with patient monitoring, counseling, and other behavioral therapies. However, the effectiveness of these treatment approaches remain unknown since illicit opioid use and addiction remains a major public health problem, especially among adolescents and young adults (Sharma, Bruner, Barnett & Fishman, 2016).
Cognitive behavior therapy (CBT) is one of the approaches used in treatment of opioid use disorder and associated co-occurring mental illnesses. According to Moore et al. (2016), cognitive behavior therapy has been found effective in treatment of substances of abuse and a series of psychiatric disorders. These researchers contend that pharmacological management with adjunct CBT is associated with greater opioid abstinence than pharmacological treatment alone among prescription opioid use disorder patients (Moore et al., 2016). Based on existing evidence-based practice, CBT increases drug abstinence of illicit opioids by nearly 10% among adults diagnosed with primary opioid use disorder. However, the effectiveness of this treatment approach depends on the number of therapy sessions undertaken by the patient. Existing literature is yet to establish the number of therapy sessions that generate greater improvements in treatment of opioid use disorder and abstinence from illicit opioid use.
Significance of the Study
This study will play a critical role to understanding the effectiveness of cognitive behavior therapy in treatment of opioid use disorder and co-occurring mental illnesses as well as enhancing abstinence from illicit opioid use. The study will help address the existing gap in literature on the number of therapy sessions that contribute to improved outcomes among adult patients with primary opioid use disorder within a three month period. The study’s findings will help enhance treatment for primary opioid use disorder and co-occurring mental illnesses. Through improving treatment, the findings of this study will also help address one of the major serious and growing public health problems among adults i.e. opioid abuse and addiction. As shown in existing literature, opioid abuse and addiction is a major public health issue of epidemic proportions. Therefore, effective treatment of opioid use disorder and enhanced abstinence from illicit opioid use would help address this public health issue and its associated complications and impacts.
Purpose of the Study
The purpose of this study is to examine the effectiveness of cognitive behavior therapy in treatment of primary opioid use disorder among adults enrolled in an outpatient opioid treatment center. The study seeks to establish the extent with which therapy sessions for this condition enhances likelihood of abstinence from illicit opioid use. In this regard, the study will focus on determining whether two or more therapy sessions in a month increases abstinence from illicit opioid use and sustain remission among adult patients in comparison to one therapy session within a 12 week period. The project seeks to answer the following PICOT question:
Among 20 to 55-year-old adult patients enrolled in an outpatient opioid treatment center with primary opioid use disorder diagnosis and co-occurring mental illness, do those who receive 2 or more therapy sessions in a month more likely to ABSTAIN FROM ILLICIT OPIOID USE and sustain remission compared to those who receive only one therapy session within a 12 week period?
Data
The achievement of the purpose of the study and its objectives requires collection of relevant data from a suitable representative sample. The data collection process entails identifying the target population, determining a representative sample using an appropriate sampling strategy, identifying a suitable data collection instrument, and determining the data collection process. A suitable research design is also identified and acts as the premise for the data collection process and analysis.
Population
As shown in the study’s PICOT question, the target population for this research is adults aged between 20 and 55 years. This is an appropriate target population because opioid usage is common among them. Individuals aged between 18 and 25 years are regarded as emerging adults who have high rates of chronic prescription opioid usage as shown in existing studies (Schuman-Olivier, Greene, Bergman & Kelly, 2014). Over the past 15 years, opioid use has dramatically increased in individuals aged between 18-25 years at 7.4 per 1,000 in comparison to 5.0 per 1,000 in those aged 26-34 years and 4.0 per 1,000 in those aged between 39-49 years (Schuman-Olivier, Greene, Bergman & Kelly, 2014). On the other hand, opioids are prescribed for individuals aged 50-55 years to help in treatment of chronic pain. Older adults use opioids for treatment of acute or chronic pain and non-cancer symptoms of pain. Given these statistics, individuals aged between 20 and 55 years are a suitable target population because they use opioids more than other populations.
Sample
For this study, a sample of 278 patients enrolled at Opioid Rehabilitation Center were selected to participate. The Center provides outpatient services to patients with primary opioid use disorder diagnosis and co-occurring mental illnesses. These outpatient healthcare services include the use medication assisted treatment and behavioral therapies like cognitive behavior therapy in treatment of opioid use disorder. The facility was selected because of its proximity to the researcher and the fact that outpatient facilities account for a huge percentage of treatment modalities for opioid use disorder (Strashny, 2014).
A stratified sampling technique was employed in selecting the representative sample in order to ensure representation of all ages within the target population. Using this sampling technique, the researcher approached all patients enrolled at Opioid Rehabilitation Center within the past 6 months. Of those approached (n = 322), 24 declined to participate, 7 withdrew before the data collection process commenced. Individuals with unclear opioid use disorder assessments (n = 9) and those in some form of remission (n = 4) were excluded, which resulted in a representative sample size of 278 opioid use disorder patients. As shown in Table 1, these participants provided information regarding their age, gender, employment and student status, race and ethnicity, and educational attainment as part of enrollment in the outpatient opioid treatment center. 65.1% of these patients reported illicit opioid use in the 90 days prior to enrolment at Opioid Rehabilitation Center while the rest had an opioid addiction. The study’s findings from this sample can be generalized because they represent a huge portion of the target population and provide rich descriptions of the phenomenon under investigation.
Instrumentation
The data collection instruments employed in this study included the Structured Clinical Interview for DSM-IV-TR (SCID). This is a semi-structured interview that is administered by trained personnel at baseline to evaluate opioid use disorder and co-occurring mental illnesses based on the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), Axis I (First et al., 2002). This instrument was used because of its effectiveness in establishing an opioid dependence diagnosis as well as primary opioid use disorder and co-occurring mental illnesses (Schuman-Olivier, Greene, Bergman & Kelly, 2014). A self-made questionnaire was also used to collect data after administering the treatments to help determine the effectiveness of the therapy sessions. The questionnaire was designed based on the specific goals of the study and included questions relating to the study variables. The use of the self-made questionnaire was attributable to the researcher’s inability to find an appropriate post-test data collection instrument that would fit the study in relation to its goals, purpose and objectives. To ensure internal validity of this data collection instrument, the questionnaire was reviewed by two doctorate level professors and two experienced primary care physicians at Opioid Rehabilitation Center. The researcher made some changes to the questions based on the input of these professionals.
Data Collection
At the beginning of the study, the researcher worked with a trained personnel at Opioid Rehabilitation Center to administer the Structured Clinical Interview for DSM-IV-TR (SCID). This semi-structured questionnaire was administered to the sample size of 278 patients diagnosed with primary opioid use disorder. It established diagnosis for this disorder among the selected sample size. SCID showed that 65.1% of these patients (n = 181) engaged in illicit opioid use in the 90 days before enrolment at the facility or prior to commencement of the data collection process. These patients reported illicit use of opioid because of their addiction and dependence on the drug for their day-to-day functioning. These patients had received opioid prescription for pain management at the facility, but engaged in illicit. This data collection instrument also showed that the remaining 34.9% (n = 97) had opioid dependence based on the diagnostic criteria established in DSM-IV. While these individuals had not engaged in illicit opioid use within 90 days prior to the data collection process, they showed signs and symptoms of primary opioid use disorder.
Following establishment of opioid use disorder using SCID, study participants were randomly divided into two groups i.e. treatment group (n = 167) and a control group (n = 111). The control group has similar items to the treatment group i.e. diagnosis of primary opioid use disorder, co-occurring mental illnesses, and illicit use of opioids. Once the representative sample was divided into two, baseline data was collected using SCID. Baseline (pre-test) data was collected on illicit use of opioids and remission prior to the treatment.
The control group then received one cognitive behavior therapy session within a 12 week period while the treatment group received at least two cognitive behavior therapy sessions on a monthly basis within a 12 week period. Physician Management with Cognitive Behavior Therapy (PM-CBT) sessions lasted for approximately 30 minutes and was provided by primary care physicians. For the treatment group, the physician reviewed the patient’s attendance at self-help groups and recent drug use during each therapy session. The physician also provided brief advice and support on techniques the patient can use to achieve or maintain abstinence from illicit opioid use and how to sustain remission. For the control group, the primary care physician provided advice and support once during the therapy session and did not conduct any reviews or follow-up on the patient until after 12 weeks. The therapy sessions for both groups included a 50-minute manual-guided session.
In collaboration with the primary care physicians, the researcher administered the self-made questionnaire at the end of 12 weeks. The questionnaire was administered to both the control and treatment group to collect post-test data on abstinence from illicit use of opioids and sustained remission. However, some patients in the treatment group were withdrawn from the study at this stage and were not requested to complete the questionnaire. Participants in the treatment group (n = 21) were withdrawn from the study for mission more than 3 Physician Management with Cognitive Behavior Therapy (PM-CBT) sessions. The researcher defined completion of the research as remaining and participating in all the therapy sessions. Failure to participate in all sessions could have had substantial impacts on the study’s results and contributed to incorrect findings and conclusions. As a result, participants who missed at least three therapy sessions were withdrawn from the study. Therefore, the final sample who completed the research was 257 i.e. treatment group (n = 146) and control group (n = 111).
Variables
The data collection process will include the use of different variables, which will help in answering the research questions. One of the variables that will be used in the study is treatment process variables. These variables are critical because the data collection process will take place during the treatment process for the patient’s primary diagnosis of opioid use disorder and co-occurring mental illnesses. Treatment process variables include the number of physician visits, number of therapy sessions, and the length on the CBT session. These treatment process variables will provide information relating to the patient’s progress and outcomes during treatment. Their incorporation in the study is crucial because they help determine the effectiveness of the number of therapy sessions in enhancing abstinence from illicit opioid use and sustain remission in adult patients diagnosed with opioid use disorder and co-occurring mental illnesses.
The second set of variables that will be used in this study is retention variables, which primarily refers to the study completion. As previously indicated, study completion for this research is defined as participating in all PM-CBT therapy sessions for the 12-week period. Retention variables i.e. remaining in the study and participating in all therapy sessions are critical toward determining the overall effectiveness of the therapy sessions in treatment of opioid use disorder. These variables help to indicate whether there are differences in patients’ outcomes in relation to abstinence from illicit opioid use and sustain remission. The use of these variable is important to ensure that valid and credible results are generated and relevant conclusions drawn. Project Design
As shown in the data collection process, the design of this project is a quantitative experimental pretest-posttest research. According to Dimitrov & Rumrill Jr. (2003), pretest-posttest research designs are commonly used in behavioral research. The primary objective of using this research design is to compare groups and/or measure change emerging from experimental treatments. The evaluation of intervention programs or treatments usually require the use of two waves of data i.e. pretest and posttest data (Alessandri, Zuffiano & Perinelli, 2017). However, when a treatment intervention is involved the researcher needs these two waves of data from two different groups in order to generate credible findings and draw relevant conclusions. The two waves of data from the two groups have significant impacts on the researcher’s choice regarding probable statistical analyses techniques.
The nature of the research (PICOT) question for this study implies that two waves of data are required from two different groups. In this case, the researcher needs data regarding the impact of one therapy session within a 12 week period as well as effect of at least two therapy sessions on a monthly basis. To effectively measure this, the two different therapy sessions need to be administered to two different groups from the sample. Therefore, a quantitative experimental research involving pretest and posttest data is suitable toward achieving the purpose of the study. The intervention used in this study as the premise for collecting pretest and posttest data is Physician Management with Cognitive Behavior Therapy (PM-CBT). This intervention was utilized on the premise that cognitive behavior therapy has been found to be an effective treatment approach opioid use disorder (Moore et al., 2016). This intervention was administered to the two groups, but in different frequencies to help determine the number of CBT sessions that are effective in enhancing abstinence from opioid use disorder and sustain remission in outpatient opioid use disorder patients.
Results
The study generated significant insights on the issue of effectiveness of CBT therapy sessions in improving abstinence from illicit opioid use and sustained remission among adult patients with primary opioid use disorder and co-occurring mental illnesses as follows:
Data Analysis
Alessandri, Zuffiano & Perinelli (2017) contend that pretest and posttest data significantly impacts the researcher’s choice regarding probable statistical analyses to be carried out. Since this study is a quantitative research involving the collection of quantitative pretest and posttest data, data was analyzed using statistical analyses techniques. The researcher performed statistical analyses on pretest and posttest data from the control group and treatment group to help answer the research question and achieve the purpose of the study.
To compare the differences between the control group and treatment group in terms of the number of therapy sessions received and their impact on abstinence and sustained remission, the researcher utilized ANOVA and Chi-square tests. Chi-square tests for categorical variables were used for univariate comparisons of opioid use disorder patients. In addition, t-tests were utilized to compare the two groups of patients for interval and continuous variables. The researcher also conducted Analysis of Variance (ANOVA) tests for treatment process/outcome variables. ANOVA tests for treatment process variables were controlled for assigned therapy sessions. In this regard, ANOVA tests were used to evaluate the number of therapy sessions for each group, changes in abstinence from illicit use of opioids, and sustained remission in relation to primary opioid use disorder and co-occurring mental illnesses.
To address issues of missing or abnormal data in the study, the researcher evaluated retention variables using Cox Regression survival analysis. This analysis was conducted weeks into the treatment intervention and used to exclude participants who did not engage in all therapy sessions. In essence, missing or abnormal data was addressed through excluding participants who missed at least three Physician Management with Cognitive Behavior Therapy (PM-CBT) sessions. The withdrawal of these participants from completing the posttest questionnaire was carried out after evaluation through Cox Regression survival analysis. This analysis technique is commonly employed in quantitative studies to test for variations in survival times of two or more groups in a study while adjusting the covariates of interest. For this study, Cox Regression survival analysis was carried out on the treatment group only. This is primarily because the treatment group was required to participate in more than one therapy session unlike the control group. Therefore, retention or survival times or rates affected the treatment group rather than the control group.
Findings
Table 2 provides the baseline demographic, clinical and treatment process variables for the control and treatment groups of patients with primary opioid use disorder and co-occurring mental illnesses. The table shows that these two groups had no variations in terms of gender, age, race, employment or student status or education with respect to their present condition. In essence, these groups were similar on all demographic characteristics. The two groups also had similar characteristics in terms of the length or duration of therapy sessions, which lasted for approximately 30 minutes each. However, these groups differed in treatment variables in terms of number of physician visits and number of therapy sessions. Since the treatment group received at least two therapy sessions on a monthly basis, they had more numbers of physician visits and therapy sessions in comparison to the control group.
Table 3 presents treatment outcomes and retention variables by the treatment group and the control group. As shown in this table, the two groups had significant differences in treatment outcomes and retention variables. The control group presented significantly higher levels of opioid dependence and addiction than the treatment group after the treatment intervention (p < 0.01). On the contrary, the treatment group presented significantly higher levels of self-efficacy than the control group after the intervention was administered (p < 0.01). The control group presented significantly lower abstinence rates than the treatment group (p < 0.05) as evidenced in the number of urines negative for all opioids and substance use calendar. Compared with the control group, the treatment group presented significantly higher levels of sustained remission (p < 0.05).
The two groups did not differ significantly in terms of rates of completion of the treatment and other retention variables. While some patients in the treatment group (n = 21) were withdrawn from the study for missing at least three therapy sessions, the overall completion rates of the treatment did not differ significantly between the two groups. For the treatment group, the completion rate as evaluated using Cox Regression was 87.43% while completion rate for the control group was 100%.
Discussion
The current study examined whether outpatients diagnosed with primary opioid use disorder and co-occurring mental illnesses report improved abstinence from illicit opioid use and sustain remission after undergoing at least two therapy sessions monthly or one therapy session within a 12 week period. The study’s results/findings have provided significant insights regarding the role cognitive behavior therapy plays in treatment of opioid use disorder and its associated mental illnesses.
The study’s findings demonstrate that cognitive behavior therapy leads to better abstinence outcomes in patients who undergo at least two week therapy sessions on a monthly basis. The research has demonstrated that patients report better outcomes in terms of improved abstinence from illicit opioid use after undergoing more therapy sessions. In essence, the more the number of therapy sessions, the better the abstinence rates among patients with primary opioid disorder and co-occurring mental illnesses. These findings are consistent with Moore et al. (2016) who found that cognitive behavior therapy is associated with greater opioid abstinence among prescription opioid use disorder patients within a 24-week period. The impact of more therapy sessions on improved abstinence rates in comparison to one therapy session within a 12-week period occurred with an effect size in the small to medium range (Cohen’s d = .35).
Secondly, the study also demonstrated that more therapy sessions are linked to significantly higher levels of sustained remission among patients diagnosed with primary opioid use disorder and co-occurring mental illnesses. Patients who received one therapy session within a 12-week period demonstrated limited sustained remission in comparison to those who received at least two therapy sessions every month. The improved sustained remission is attributable to the fact that more CBT sessions enhanced key recovery attitudes and skills among primary opioid use disorder patients. Participants in the treatment group demonstrated improved self-efficacy, decrease in opioid dependence and better coping skills unlike those in the control group. These factors in turn influenced the participants’ ability to sustain remission from illicit opioid use resulting in better outcomes.
The study demonstrated that opioid use and dependence did not vary across age, gender, educational attainment, employment, and race unlike previous studies have established (Moore et al., 2016).
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