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. Author manuscript; available in PMC: 2019 Nov 1.
Published in final edited form as: Psychol Addict Behav. 2018 Oct 22;32(7):800–811. doi: 10.1037/adb0000398

Modified Cognitive Behavioral Therapy (M-CBT) for Cocaine Dependence: Development of Treatment for Cognitively Impaired Users and Results from a Stage 1 Trial

Efrat Aharonovich 1, Deborah S Hasin 2, Edward V Nunes 3, Malka Stohl 4, Daniela Cannizzaro 5, Aaron Sarvet 6, Karen Bolla 7, Kathleen M Carroll 8, Kamala Greene Genece 9
PMCID: PMC6242737  NIHMSID: NIHMS984028  PMID: 30346186

Abstract

Cognitive impairments are associated with poor outcomes when treating cocaine dependent patients, but behavioral interventions to mitigate this impact have not been developed. In this Stage 1A/1B treatment development study, several compensatory strategies (e.g. content repetition, daily logs, diaries, visual presentation) were combined to create a modified cognitive behavioral therapy (M-CBT) for treating cocaine dependence. Initially, a select group of therapists, neuropsychology experts, and patients were asked to provide input on early drafts of the treatment manual and companion patient workbook. After an uncontrolled small trial (N=15) and two rounds of manual development (Stage 1A), a pilot randomized clinical trial (N=102) of cocaine dependent outpatients with and without cognitive impairments was conducted (Stage 1B). Participants were randomized to M-CBT (N=52) or CBT (N=50). Both treatments were individually delivered over 12 weeks with assessments conducted at baseline, end-of-treatment, and 3-month follow-up. The primary outcome was frequency of cocaine use, measured by number of days used in the prior 7 days. Participants in the two treatment groups did not differ significantly on drug use reduction or retention in treatment. However, among participants who completed at least 9 weeks of treatment, those in M-CBT showed a trend towards greater reduction in cocaine use compared to those in the CBT group. M-CBT is feasible for impaired and non-impaired cocaine dependent participants. However, M-CBT treatment did not show significant superiority over standard CBT in the present sample.

Keywords: cognition, substance use disorders, cognitive-behavioral therapy, stage model

Introduction

Over 50% of patients entering drug and alcohol treatment suffer from cognitive deficits (Bates et al., 2004; Cannizzaro, Elliott, Stohl, Hasin, & Aharonovich, 2014; Fernandez-Calderon, Fernandez, Ruiz-Curado, Verdejo-Garcia, & Lozano, 2015; Fernandez-Serrano, Perez-Garcia, Schmidt Rio-Valle, & Verdejo-Garcia, 2010; Kalapatapu et al., 2013; Richardson-Vejlgaard, Dawes, Heaton, & Bell, 2009; Schrimsher, Parker, & Burke, 2007; Vik, Cellucci, Jarchow, & Hedt, 2004). Impairments are prominently found in areas relevant to successful treatment response, such as attention, memory, learning, and executive self-regulatory function. For example, delayed processing and response in participants with attention problems may interfere with the ability to quickly grasp complex tasks (Lezak, 2004; Zahn & Mirsky, 1999). Memory problems may impede recall of coping strategies and homework assigned between sessions. Deficits in executive functioning may compromise self-awareness and complicate the ability recognize antecedents of use, control impulsive responses (Alfonso, Caracuel, Delgado-Pastor, & Verdejo-Garcia, 2011; Bickel, Yi, Landes, Hill, & Baxter, 2011; de Wit, 2009; Field, Munafo, & Franken, 2009; Houben, Wiers, & Jansen, 2011; Rooke, Hine, & Thorsteinsson, 2008; Rupp, Kemmler, Kurz, Hinterhuber, & Fleischhacker, 2012), or develop insight related to the significance of substance abuse problems (Williams, Olfson, & Galanter, 2015).

Consistent with this hypothesis, we (Aharonovich et al., 2006; Aharonovich, Nunes, & Hasin, 2003) and others (Brewer, Worhunsky, Carroll, Rounsaville, & Potenza, 2008; Copersino et al., 2012; Horner, Harvey, & Denier, 1999; Teichner, Horner, & Harvey, 2001; Turner, LaRowe, Horner, Herron, & Malcolm, 2009; Verdejo-Garcia et al., 2012) showed that cognitive deficits predict poor treatment retention and outcome. In response, the development of treatments addressing cognitive impairments in substance users has been advocated (Leeman, Robinson, Waters, & Sofuoglu, 2014; Schulte et al., 2014; Sofuoglu, DeVito, Waters, & Carroll, 2013; Verdejo-Garcia, Lopez-Torrecillas, Gimenez, & Perez-Garcia, 2004; Vik et al., 2004; Vocci, 2008). However, little has been done to develop such treatments. Therefore, while chronic cocaine users often have cognitive deficits in multiple domains (Fernandez-Serrano, Perales, Moreno-Lopez, Perez-Garcia, & Verdejo-Garcia, 2012; Jovanovski, Erb, & Zakzanis, 2005; Robinson & Kolb, 1999; Soar, Mason, Potton, & Dawkins, 2012; Volkow et al., 1992; Vonmoos et al., 2014; Woicik et al., 2009), no behavioral treatments exist designed specifically to meet the needs of cognitively impaired cocaine users.

Cognitive Behavioral Therapy (CBT) is a widely-known treatment for cocaine dependence (Carroll, 1998). CBT for cocaine dependence is grounded in theories of social learning and operant conditioning. The main clinical features of this treatment include: (1) recognizing the antecedents and consequences of drug use behaviors, (2) identifying triggers and situations for which one is vulnerable to drug use, and (3) building skills to avoid high risk situations and to cope with drug cravings (Carroll, 1998). Randomized trials show that CBT is an effective treatment for cocaine dependence with long-term, lasting improvements (Carroll et al., 2004; Carroll & Onken, 2005; Irvin, Bowers, Dunn, & Wang, 1999). However, many patients drop out of CBT, limiting its efficacy (Carroll, 1997a, 1997b). CBT may be particularly challenging for cocaine patients with impaired cognitive functioning (Aharonovich et al., 2003). CBT can place considerable cognitive demands on patients, who are asked, for example, to attend to and retain content from 60-minute sessions, identify connections between behaviors and patterns in their day-to-day experience, relate these to abstract concepts introduced during sessions, and retain awareness of these connections between sessions. Our finding that impaired attention, memory, and abstract reasoning predict attrition in CBT for cocaine patients (Aharonovich et al., 2006; Aharonovich et al., 2003) led us to consider modifying CBT to compensate for cognitive deficits by presenting the therapeutic activities in a less cognitively demanding manner in order to be more engaging and effective. The current study was designed to develop and test whether such a modification of CBT would improve treatment outcomes among cocaine patients with cognitive impairments.

In this study, we followed the Stage Model of behavioral therapies research (Rounsaville, Carroll, & Onken, 2001). Stage 1A focuses on development of the therapy, manualization, development of fidelity assessment, and clinician training materials. In Stage 1B, the experimental therapy is tested in a randomized pilot trial. In this report, we describe Stage 1A activities and the Stage 1B randomized pilot trial conducted to evaluate whether M-CBT could improve treatment retention and substance use outcomes compared to CBT. We also explored whether differences in outcomes were specific to cognitively impaired patients or applicable to all patients. We hypothesized that M-CBT would be more effective than CBT in (1) reducing cocaine use and (2) retaining cocaine dependent patients in treatment, and further that the level of cognitive functioning would modify the effects of M-CBT, such that M-CBT effects would be stronger in cognitively impaired than in non-impaired patients.

Methods

Stage 1A

Treatment development.

In Stage 1A, our treatment development process included integrating evidence-based cognitive compensatory strategies, often used in treating patients with traumatic brain injuries (Rodakowski, Saghafi, Butters, & Skidmore, 2015; Twamley et al., 2015), psychotic disorders (Fabre et al., 2015; Hargreaves et al., 2015; McGurk et al., 2015); and other medical conditions such as cancer and strokes (Hughes et al., 2015; Sacks-Zimmerman, Duggal, & Liberta, 2015), into standard CBT sessions to improve learning and the retention of information. Specifically, our strategies targeted the following main cognitive domains: (1) Learning and Memory, (2) Executive functions. To compensate for recall and memory difficulties and facilitate learning, we shortened the standard length of a weekly CBT session from 60 minutes to 30 minutes. We also increased the frequency of the standard CBT session delivery from once to twice weekly during the first four weeks of treatment. These strategies (e.g., reduced session length and increased weekly frequency) were implemented during the first 4 weeks of treatment only as our previous data (Aharonovich et al., 2006) suggested that participants are most vulnerable to drop out during this period. Additionally, the didactic sessions were accompanied by an illustrated workbook covering the main topics discussed in each session. To compensate for executive function deficits, the workbook included to-do lists, explanations of key concepts, and visual illustrations of material covered in session, such as dealing with cravings and the stages of relapse.

During the treatment development phase for M-CBT, modifications and refinements of different versions of the treatment manual and patient workbook were made based on feedback from addiction and neuropsychology experts, counselors with clinical experience working with substance users, and informative work with participants.

Preliminary uncontrolled trial.

The final draft of the M-CBT treatment manual and patient workbook was tested in a small uncontrolled study (N=15). Participants were recruited from the same clinic where Stage 1B was later conducted (see below for detail). Participants provided verbal feedback to study staff at the end of each session on clarity of content and suggestions for improvement such as inclusion of session quizzes and weekly activities planners. Descriptive characteristics of the 15 participants enrolled in the Stage 1A trial can be found in Table 2.

Table 2.

Baseline Samples Characteristics (Stages 1A and 1B)

Characteristics Sample 1A (N=15) Sample 1B: CBT (n=50) Sample 1B: M-CBT (n=52) Total (N=102) p
Demographic Characteristics
Sex (male), n (%) 10 (67.7) 30 (60.0) 34 (65.4) 64 (62.8) .57
Ethnicity, n (%)
 Hispanic 6 (40.0) 9 (18.0) 7 (13.5) 16 (15.7)
 Black 37 (74.0) 37 (71.1) 74 (72.5) .46
 Other 4 (8.0) 8 (15.4) 12 (11.8)
Education
 Less than HS Graduate, n (%) 11 (22.0) 11 (21.2) 22 (21.6)
 HS Grad/GED, n (%) 26 (52.0) 27 (51.9) 53 (52.0) .99
 Higher Degree, n (%) 13 (26.0) 14 (26.9) 27 (26.5)
 Years of education, M (SD) 11.2 (1.8)
Marital Status, n (%)
 Single 15 (67.7) 40 (80.0) 37 (71.2) 77 (75.5)
 Married or Living with Spouse 4 (8.0) 6 (11.5) 10 (9.8) .58
 Separated/Divorced/Widowed 6 (12.0) 9 (17.3) 15 (14.7)
Employment, n (%)
 Full-time or Part-time Work 5 (10.2) 11 (21.1) 16 (15.8)
 Unemployed, Disabled, Recipients of Public Assistance 7 (46.7) 34 (69.4) 29 (55.8) 63 (62.4) . 25
 Student, Retired or Other Status 10 (20.4) 12 (23.1) 22 (21.8)
HIV Status (positive), n (%)  6 (12.2)  10 (19.2)  16 (15.8)  .34
Age, M (SD) 42.7 (4.7) 45.8 (6.7) 45.9(6.1) 45.8 (6.3) .92
Baseline Cognitive Characteristicsa
NAB Total score, M (SD) 90.73 (10.9) 85.4 (13.2) 88.2 (15.2) 86.9 (14.3) .32
 Impaired (<85), n (%) 23 (46.0) 21 (40.4) 44 (43.1) .82
 Below Average (85-91), n (%) 14 (26.9) 14(28.0) 28 (27.5)
 Average (92-106), n (%) 9 (18.0) 10 (19.2) 19 (18.6)
 Above Average (>106), n (%) 4 (8.0) 7 (13.5) 11 (10.8)
Standardized WTAR IQ score, M (SD)b 86.7 (12.1) 87.8(9.4) 88.0 (8.2) 87.9 (9.4) .93
Drug Use Characteristics
Age of first use, M (SD) 20.8 (4.1) 21.5 (5.9) 21.5 (6.8) 21.5 (6.8) .62
Age of Dependence, M (SD) 23.8 (4.1) 26.7 (7.1) 27.5 (7.7) 27.1 (7.4) .59
Total Years Used, M (SD) 20.4 (4.8) 22.2 (8.4) 20.6 (7.3) 21.4 (7.8) .10
Number of days used cocaine per week in past 30 days, M (SD)c 3.8 (1.3) 4.4 (1.8) 4.5 (1.9) 4.5 (1.9) .92
Minimum $ spent per week, Median (IQR) 100 (40-200) 110 (50-200) 100 (50-200) .54
Maximum $ spent per week, Median (IQR) 200 (100-400) 300 (160-550) 288 (120-500) .12
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Note. IQR = Interquartile Range; p-values for categorical variables are from chi-square test; p-values for continuous variables are from t-tests for age and NAB scores, and from non-parametric Wilcoxon tests for drug use variables. Group comparisons were conducted on the Stage 1B sample only.

aNAB score missing for 1 participant in M-CBT treatment.

bAvailable for 49 CBT and 49 M-CBT participants

cData obtained from the Substance Use Inventory (SUI)

Stage 1B

Participants.

Participants were recruited from an outpatient substance abuse treatment clinic at a large city hospital in New York City through flyers and clinician referral. Participants were also recruited through advertisements in local papers that offered outpatient treatment at a substance abuse clinic in Washington Heights, Manhattan, New York.

Eligibility criteria included speaking English, being between age 18 and 55, and meeting DSM-IV criteria for current cocaine dependence. Individuals were excluded if they 1) met DSM-IV criteria for current dependence on another substance, with the exception of marijuana and alcohol, 2) had an Axis I psychiatric disorder including mood, ADHD, or psychotic disorder, 3) were unable to read English at the 6th grade level, 4) were not interested in receiving treatment, or 5) resided more than 2 hours away from the clinic.

Participants were prescreened over the phone to assess for cocaine use within the past 30 days. Those who reported four or more days of cocaine use were invited to the complete the inperson screening assessment. Participants were screened with the Psychiatric Research Interview for Substance and Mental Disorders for DSM-IV (PRISM-IV-Computerized Version) (Hasin et al., 2006) and, the Wide Range Achievement Test 4 (WRAT 4) (Wilkinson & Robertson, 2006) to assess reading level. The computerized PRISM-IV is an in-person interviewer administered assessment. Of the 267 individuals screened for the study, 122 were ineligible due to the following reasons: 1) no current DSM-IV cocaine dependence (n=51), 2) current DSM-IV Axis I psychiatric disorder or DSM-IV dependence on another substance (n=42), 3) inability read at 6th grade level (n=10), 4) other reasons including living too far away from the clinic to attend twice weekly visits, having a serious medical condition, and needing a referral to detox (n=19). Forty-three (16%) did not return to the clinic to complete screening and baseline procedures (see Figure 1 for more details). A total of 102 eligible individuals were randomized to receive either standard cognitive behavioral therapy (CBT, n=50) or modified cognitive behavioral therapy (M-CBT, n=52). Compared to those who were randomized, the 43 individuals who did not return to the clinic to complete screening did not differ in gender, ethnicity/race and education level, but did differ in age (Mean 42.3 vs 45.8; p=.01). Although those enrolled were statistically slightly older, both groups were in their 40s and we do not find these age differences clinically meaningful. Thus, failure to return to complete screening appears not to have influenced the final sample composition relative to the screened population.

Figure 1.

Figure 1.

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Flow of study participants in trial of Modified Cognitive Behavioral Therapy for cocaine dependence.

A flow chart containing participant recruitment, participation, and follow-up is provided in Figure 1. A computerized urn randomization was used to balance treatment groups with respect to categories assumed to affect treatment outcomes in this study: (1) baseline severity of cocaine use (high levels of cocaine use, defined as >4 days of use per week) (Raby et al., 2014; Schrimsher et al., 2007), (2) cognitive impairment (impairment was defined as NAB scores <85, or approximately 1 SD below the population mean of 100) (Stern & White, 2003). All participants provided informed consent. The study was approved by Institutional Review Boards at the New York State Psychiatric Institute and at the city hospital. Participants were compensated with $80 worth of gift cards for completing screening and baseline assessments, $40 worth of gift cards for completing end of study assessments (12 weeks after baseline), and $40 worth of gift cards for completing follow up assessments (3 months after the end of treatment). Participants were not compensated for attending twice weekly study visits throughout the duration of the 12-week study period, during which they received M-CBT or CBT sessions and provided a urine sample. Participants were provided with round trip transportation costs (subway cards) at each study visit.

Assessments.

Participants were assessed in an in-person screening at baseline before treatment initiation, bi-weekly during treatment, at the 12-week treatment termination point, and 3-months post termination. Participants met bi-weekly with an independent evaluator who collected urine specimens and monitored clinical symptoms.

Drug use.

The number of days and amount of cocaine and other substances (measured in U.S. dollars) used since the last clinic visit was assessed using the Substance Use Weekly Inventory (SUI) (Weiss, Hufford, Majavits, & Shaw, 1995). The SUI was administered by a study clinician during screening and at the beginning of each treatment session. The SUI is an in-person administered self-report measure similar to the Time-Line Follow-Back (Sobell & Sobell, 1995) and has been used in numerous studies to assess substance use patterns (Najavits, Weiss, Shaw, & Muenz, 1998; Reback, Larkins, & Shoptaw, 2004). At baseline, the SUI was used to assess drug use in the 30 days prior to randomization. Throughout the remainder of the 12 weeks of the study, the SUI was administered weekly to assess drug use in the past 7 days. All study clinicians had received training in the administration of the SUI and had at least three years of experience in administering assessments in clinical trials.

Participant self-reported cocaine use was verified through urine toxicology screens obtained at each study visit. Study visits and number of urine screens were balanced across groups. All participants were required to attend two study visits per week, during which urine samples were collected. All urine samples were sent to the laboratory to be analyzed for quantitative benzoylecgonine levels and scored as positive or negative using standard NIDA cutoffs. Of the total 627 urine samples collected, 526 (84%) were consistent with self-report, 56 (9%) were negative for cocaine although the participant reported recent cocaine use, and 45 (7%) were positive for cocaine in cases in which the participant had denied use. This high concordance rate is consistent with previous studies using cocaine dependent samples (Carroll et al., 2004), and is supportive of the accuracy and utility of SUI in assessing self-reported substance use (Carpenter, Smith, Aharonovich, & Nunes, 2008).

Craving

Participant self-rated experiences of cravings for cocaine were collected using a modification of the Cocaine Craving Visual Analogue Scale (Lee, 2002) at the beginning of each treatment session.

Cognitive functioning.

The Wechsler Test of Adult Reading (WTAR) was used to assess IQ level at treatment entry (Holdnack, 2001). Standardized WTAR scores are adjusted for age, ethnicity, and education (mean=100; SD= 15) (Spreen & Strauss, 1998). The WTAR was used as an efficient, reliable method of obtaining IQ estimates in this study. WTAR scores have been shown to correlate highly with subscales of the Wechsler Adult Intelligence Scale (WAIS) of verbal IQ (r = .75), verbal comprehension (r = .74), and full scale IQ (r = .73).

The Neurological Assessment Battery-Screening Module (NAB-SM) (Stern & White, 2003) was administered to determine patients’ level of cognitive functioning at baseline and at the end of treatment. The NAB-SM assesses five main areas of cognitive functioning: memory, attention, language, spatial reasoning, and executive functioning (Cannizzaro et al., 2014; Stern & White, 2003). The NAB-SM scores are corrected for age; gender and education level. It has been used in patients with moderate to severe traumatic brain injuries (Zgaljardic & Temple, 2010) and with substance using populations (Copersino et al., 2009; Grohman & Fals-Stewart, 2004). A total NAB score <85 is indicative of impairment and was used as the cut off level for stratification.

Working Alliance.

The Working Alliance Inventory-Short Form (WAI-S) (Tracey & Kokotovic, 1989) is a 12-item measure of working alliance between therapist and client. The reliability and validity of the WAI-S are comparable to the 36-item WAI (Busseri & Tyler, 2003). The WAI-S was administered at sessions 2, 5, and 10 to participants and therapists in both treatment groups. Items were scored on a 7-point scale, from 1 (poor) to 7 (good). Total WAI-S scores were calculated at each time point and represent the mean of all 12 items. High total WAI-S scores indicate a strong working alliance and low WAI scores indicate a weak working alliance.

Client Satisfaction.

The Client Satisfaction Questionnaire (CSQ-8) (Attkisson, 1987), a widely used 8-item scale, was used to assess participants’ general satisfaction with treatment. We added two items to the standard measure to assess satisfaction with treatment-specific components included in M-CBT. Items were scored on a 5-point Likert scale. Total scores were calculated for each participant by summing the scores of all items. High total scores indicate high levels of satisfaction and low scores indicate the opposite.

Treatment.

Cognitive Behavioral Therapy.

CBT included 12 individual sessions of 60-minute duration (a total of 12 hours over 12 weeks). The session content followed Carroll’s (1998) manualized treatment for cocaine dependent patients. The treatment’s main focus was abstinence from cocaine and other substances. Therapists used motivational enhancement techniques to elicit commitment and behavioral analysis techniques to examine cravings and patterns of use. Therapists also taught participants to recognize internal and external antecedents of cocaine use, and develop effective coping skills for these through skill training and role playing. Skill development included role playing and rehearsing drug refusal, strengthening problem-solving abilities, and developing emergency coping plans. Participants were given standard CBT homework assignments to complete between sessions.

Modified-Cognitive Behavioral Therapy.

M-CBT included 8 individual sessions of 30-minute duration during the first four weeks of treatment and 8 individual sessions of 60-minute duration during the final eight weeks of treatment (a total of 12 hours over 12 weeks). In other words, compared to standard CBT, M-CBT sessions during the first four weeks of treatment were shorter in length (i.e., 30 minutes rather than 60 minutes) and occurred more frequently (i.e., twice per week rather than once per week). The session content of M-CBT paralleled many of the same modules as standard CBT (i.e. coping with cravings; shoring up motivation and commitment; refusal skills), but it also incorporated several key modifications to help individuals with cognitive impairments solidify the understanding and retention of important concepts. See Table 1 for a detailed description of M-CBT’s key modifications to standard CBT. These modifications were conceptualized and tested as described earlier during Stage 1 A. Treatment completion for both M-CBT and CBT was defined as attending at least 75% of the core sessions, or attending sessions for at least 9 of the 12 week treatment period.

Table 1.

Key Structure and Module Modifications in M-CBT

M-CBT Key Modifications Standard CBT for cocaine dependence (Carroll, 1998)
Structure

  • Shorten session length to 30 minutes

  • Increase session frequency to 2x/week

  • 60 minute sessions

  • 1×/week sessions
Modules

  • Short simplified communication

  • Concrete and visual presentation of content: handouts, graphic-cartoon drawings, graphs to facilitate logical abilities

  • Workbook of self-guided tasks, daily and weekly activity plans, coping plans

  • “Teach-backs”

  • Repetition until mastery of concept occurs

  • Use of mnemonic and external memory aids

  • Short quizzes of each module

  • Didactic verbal presentation of content

  • Self-guided tasks (e.g, “homework”) promoting coping skills acquisition
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Treatment delivery and adherence.

Treatments were delivered by three doctoral-level therapists experienced in delivering standard CBT to substance users. They were trained in delivering M-CBT by (a) reading the respective treatment manual and workbook, and (b) rehearsing the in-session workbook exercises and conducting role plays with the first author (EA). Therapists delivered both treatments and were randomly assigned to participants. To promote adherence to the manual guidelines, therapists completed a session checklist at the end of each session, which outlined key components of each respective treatment. All treatment sessions were audio recorded for later review. Each therapist’s first 5 session recordings were reviewed to assure adherence and 10% of all subsequent session recordings were randomly chosen and reviewed, and used for supervision purposes. Weekly group and individual supervision were conducted with a focus on adherence to treatment, enhancing competent delivery of the interventions, concerns about specific participants, and preparation for subsequent sessions.

Main outcome measures.

Primary outcome.

The primary outcome was frequency of cocaine use measured by number of days used per week as reported on the Substance Use Inventory (SUI).

Secondary outcomes.

Secondary outcomes included level of abstinence indicated by the proportion of urine tests that were negative for cocaine out of the total number of urine tests completed; and cocaine craving calculated as the number of days per week participants craved cocaine.

Retention in treatment was also examined as a secondary outcome. Completion of treatment was defined as attending >75% of the treatment sessions, allowing for mixed compliance that is common in substance abuse treatment (Aharonovich, Amrhein, Bisaga, Nunes, & Hasin, 2008; Carroll, 1998). Participation in treatment was measured by the percent of total therapy sessions attended out of a total of 12 sessions for CBT and a total of 16 sessions for M-CBT.

Data analysis.

Baseline characteristics, including demographics, neuropsychological test scores (NAB-SM scores), and current drug use were examined descriptively. Continuous variables were described by means and standard deviations, and differences between treatment groups were tested using t-tests for variables that were normally distributed, and non-parametric Wilcoxon tests for variables that did not have a normal distribution. Categorical variables were described by frequencies and percentages. Differences between treatment groups were examined using Chi-square tests.

All primary analyses of treatment effects used an intent-to-treat approach based on treatment assignments, and were conducted using SAS version 9.3 (SAS-Institute, 2013). To assess change over time in the outcomes, and how these changes related to treatment assignment, we used generalized linear mixed models. Parameters were estimated using restricted maximum likelihood estimation for continuous outcomes and residual pseudo-likelihood estimation for binary outcomes (PROC GLIMMIX). Random intercepts and slopes were added when these were demonstrated to enhance model fit. Time was log-transformed in order to represent the greater slope anticipated in the early weeks of treatment. Baseline frequency of cocaine use (operationalized as the total number of days of cocaine use in the 30 days before randomization) was used as a covariate for these analyses. If significant interaction was found between treatment group and impairment status, we planned to conduct all primary analyses separately on the cognitively impaired (n=44 patients) and non-impaired patients (n=58).

In addition to the principal analyses conducted on the 102 participants randomized to study treatment, a secondary set of analyses was conducted to determine treatment effects for the 36 patients who completed treatment. Differences in retention rates between the treatment groups and between cognitively impaired and non-impaired subgroups were analyzed using non-parametric Kruskall Wallis tests and log-normal regressions.

Results

Participant characteristics

Of the 102 participants randomized to treatment, 63% were male, 72% were African American, and 18% were Hispanic. Most (92%) were single or divorced, and 69% were unemployed, disabled or on public assistance. The mean age of the participants was 45.8 years. Participants reported using cocaine a mean of 18.0 days in the previous 30 days. The mean amount spent per week on cocaine was $194. All participants met DSM-IV criteria for a current diagnosis of cocaine dependence. The overall standard WTAR IQ score was 87.9, suggesting a somewhat lower than average IQ (mean=100; SD=15) in this sample. There were no statistically significant differences by treatment condition on any of the characteristics reported in Table 2.

All M-CBT and CBT therapy sessions were audio recorded for supervision and assessment of fidelity to their respective manual guidelines. To evaluate the potential effect of the therapist on findings reported in the following subsections, we conducted an ANOVA on treatment retention, self-reported cocaine use and urine test results by therapist (three in total). No significant therapist effects were found for any of these variables, (all p> 0.15).

Effects of Treatments in Cognitively Impaired and Non-Impaired Subgroups

Of the 102 individuals initiating treatment, 43% were cognitively impaired as indicated by NAB-SM scores below 85. To determine whether a differential effect of treatment on cocaine use existed between the impaired and non-impaired groups, we first tested a three-way interaction between weeks in treatment, treatment type, and impairment status, with the outcome defined as days used cocaine in the past 7 days as obtained from the SUI. This interaction was not significant, (t=−0.49, df =413, p =0.69). Therefore, planned stratified analyses within each group (impaired, non-impaired) were not warranted.

Participation and Retention by Treatment Condition and Cognitive Functioning

Overall, participants completed 34% of clinic visits, attended 42% of therapy sessions, and remained in the study an average of 5.9 weeks (Table 3). There were no differences in retention between the two treatment groups for either percent of total visits attended (p =.87), percent of therapy sessions attended (p =.65), or number weeks completed (p =.90) using the non-parametric Wilcoxon-Mann-Whitney test. Similarly, there were no differences in retention by baseline cognitive impairment status for percent of total visits attended (p =.73), percent therapy sessions (p =.82) or weeks completed (p =.86). Further testing using log-normal regression models controlling for baseline cocaine use did not indicate any difference in retention rates when examining: (1) the main effect of treatment, (2) the main effect of cognitive impairment status or (3) their interaction.

Table 3.

Retention Rates by Treatment Group and Impairment Status.

Total Sample Treatment Group Impairment Status
CBT (n=50) M-CBT (n=52) p Impaired (n=44) Non-impaired (n=58) p
Number of Weeks Completed, M (SD) 5.9 (4.6) 5.7 (4.4) 6.1 (4.8) .90b 5.8 6.0 .86b
 Completed 4 weeks, n (%) 51.0% (52) 50% (25) 51.9% (27) .85a 50% 51.7% .86a
 Completed 9 weeks, n (%) 35.3 (36) 32 % (16) 38.5 % (20) .49a 34.1% 36.2 % .82a
 Completed 12 weeks, n (%) 30.4 (31) 28% (14) 32.7 % (17) .61a 29.6% 31.0% .87a
Percentage of Study Visits Attended, M (SD) 34.2 (27.7) 32.8 (26.8) 35.5 (28.7) .87b 32.7 35.4 .73b
Percentage of Therapy Sessions Attended, M (SD) 42.0 (31.2) 40.3 (31.3) 43.5 (31.3) .65b 41.3 42.4 .82b
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a

Chi-squared p-value

b

Wilcoxon p-value

Overall Effect of Condition on Cocaine Use

Generalized linear mixed models evaluating the effects of treatment condition (i.e., CBT or M-CBT) on the number of days used cocaine per week are presented in Figure 2a. The overall effect for time was significant, indicating a general reduction in the frequency of cocaine use over time (t=−6.24, df=76; P=<.001). Although Figure 2 shows a slight advantage for participants in M-CBT during the final 10-12 weeks, overall, participants in M-CBT did not demonstrate a significant reduction in frequency of cocaine use compared to those in CBT (treatment x time, t = −0.56, df =413; p =0.57). However, among those who completed treatment (at least 9 weeks of therapy; n=36), participants in M-CBT showed a trend towards a greater frequency in reduction of use than those in CBT (treatment x time, t= −1.91, df = 345, p =.057). Specifically, this advantage occurred during weeks 10-12 (Figure 2b).

Figure 2.

Figure 2.

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Days used cocaine per week by treatment group in Completers and Non-Completers.

Note: The graphs illustrated in Figures 2a and 2b represent model-estimated values for the intent-to-treat sample (N=102 for Figure 2a, N=36 for Figure 2b).

For the urine toxicology screen results, we found no overall significant effect of time in the entire sample (t=−1.2, df=77, p=.23) or among those who completed treatment (t=−0.23, df=35, p=.82). However, similar to the results for the SUI, we found a marginally significant effect of treatment by time among treatment completers, among whom those in M-CBT showed a trend towards greater reduction in use than those in CBT (treatment x time, t=−1.88, df=285, p=.062).

Results for cocaine cravings were similar to findings of cocaine use. The overall effect for time was significant (t =−5.32, df =76, p =<.001) indicating a general reduction in cravings; however, those assigned to M-CBT did not differ significantly compared to those assigned to CBT (treatment x time, t =−0.33, df=413, p =0.19). Among completers of at least 9 weeks of treatment, those assigned to M-CBT showed a trend towards fewer craving days than those in CBT (treatment x time, t= −1.82, df = 345, p =.069).

Working alliance.

Across the three time points that the WAI-S was administered (i.e., weeks 2, 5, and 10), the mean participant WAI-S score ranged from 5.2 (SD=.6) to 6 (SD=.6) in CBT and from 5.5 (SD=1.0) to 6.0 (SD=.7) in MCBT participants. The mean therapist WAI-S score ranged from 5.2 (SD=5) to 5.3 (SD=4) in CBT and 5.4 (SD=5) to 5.5 (SD=5) in MCBT therapists. There was no significant difference in participant or therapist mean WAI-S scores between the two treatment groups at any time point. Further analyses on the subset of 9-week completers did not indicate differences between the treatment groups. Overall, these results suggest a moderate to strong working alliance between all participants and therapists throughout the study.

Client satisfaction.

Participants reported high levels of satisfaction with the treatment they received during the study. The mean CSQ total score was 41.4 (SD =9.3), with scores ranging from 18 to 50. There was no difference in mean CSQ scores between MCBT (43.0, SD =8.2) when compared to CBT (39.9, SD =10.1), F(1,57)=1.5, p =0.28. However, further analyses showed that among the 9-week completers, mean CSQ scores differed significantly between participants in MCBT (46.5, SD =5.2) and CBT (37.9, SD =10.0), F(1,29)=9.5, p =0.004. This finding indicated that among the 9-week completers, treatment satisfaction was significantly higher among those in the MCBT group.

Discussion

The current study reports on the development and evaluation of M-CBT, a CBT intervention modified to address cognitive impairments in cocaine dependent individuals. The plan of research was guided by the NIH Stage Model of Treatment Development (Rounsaville et al., 2001).

In Stage 1A, we modified CBT to produce M-CBT, and demonstrated its feasibility in a small single-arm pilot test. In Stage IB, we compared the efficacy of M-CBT against standard CBT in a pilot, 2-arm randomized trial among participants with cocaine dependence. Results of the randomized pilot study provided limited support for the efficacy of M-CBT compared to CBT. Results showed a significant effect for time in treatment, but did not show a significant treatment by time interaction, indicating a lack of difference overall between M-CBT and CBT. However, among participants who completed treatment, we found a trend towards a significant difference that favored M-CBT in reducing cocaine use and cocaine cravings, particularly in the final three weeks of treatment. There were no significant differences in retention in treatment outcomes between M-CBT and CBT, and cognitively impaired and non-impaired participants did not differ in their treatment retention or cocaine use reductions.

Note that baseline cognitive assessments indicated an overall highly impaired sample, as the mean WTAR standard IQ score was 87.9, with 36 participants (36.3%) scoring at 85 or less, which is at least 1 SD below the population mean of 100. Compared to other studies of CBT for substance using patients, these IQ scores are lower, for example, in Carroll and colleagues’ (2011) sample of 77 substance users, the Shipley mean estimated age-adjusted IQ was 99.87 (SD=12.98). Furthermore, 43% of our sample (n=44) had moderate to severe cognitive impairments as indicated by total NAB-SM scores <85. The poor retention in this study may have been due to the fact that even with the modifications resulting in M-CBT, CBT delivery in a largely traditional, verbal format may not have been sufficiently different from standard CBT to be adequate for this sample.

To explore this issue, we examined whether IQ scores were related to treatment retention. There were no significant differences in WTAR scores between those who completed 9 weeks of treatment (M=91.1, SD=11.1, n=34) and those who dropped out before reaching week 9 (M=86.7, SD=7.0, n=61, p=.10). However, we did find that when retention was defined as 12 weeks of treatment (completed all weeks), those who completed treatment showed a trend towards higher WTAR scores (M=90.7, SD=11.3, n=30) than those who dropped out before reaching week 12 (M=86.6, SD=7, n=65, p=.08). This supports the possibility that even the modifications in M-CBT were insufficient to address the cognitive needs of many of the study participants. Future studies should consider adding components of cognitive remediation therapy (CRT), that demonstrated efficacy in sample of substance using veterans with high rates of more severe cognitive impairments (Bell, Laws, & Petrakis, 2017) combined with the computer-delivered format utilized by Carroll and colleagues (2011), as a computer’s ‘patience and neutrality’ may better allow for needed repetitions and absorption of the content at the participant’s own pace and level of cognitive comprehension.

Furthermore, this population is difficult to engage. Of the 66 participants who dropped out before 9 weeks, 3 were incarcerated, 2 became uninterested in treatment, 7 had worsening drug use and were referred to detoxification, 3 became homeless, 6 moved out of state or got a job whose hours that did not permit continued participation, and 45 were lost to contact despite all outreach efforts (i.e., phone calls, letters, calls to participants’ back-up contacts). Given this, these results suggest the need for a more synthesized hybrid modification of CBT, which could be achieved by adding components of other interventions that have previously shown to improve retention in substance using populations such as contingency management (CM) (Higgins et al., 2003; Stitzer & Vandrey, 2008). Participant engagement and retention could also be improved by migrating the entire intervention to a technology-enhanced platform in which visual images can be used to avoid difficulties with verbal comprehension and other cognitive impairments (Aharonovich, Stohl, Cannizzaro, & Hasin, 2017). Based on our previous experience, use of an electronic tablet or smartphone with colorful still, animated, or video images would almost certainly be livelier and more engaging. In our other studies examining much briefer interventions for substance users, we found very high engagement rates in smartphone-delivered treatment that incorporated such images, a video counselor and considerable positive reinforcement for continued participation (Aharonovich, 2016; Hasin, Aharonovich, & Greenstein, 2014). These results suggest that adaption of M-CBT to a more engaging electronic platform could hold considerable promise for patient participation and efficacy.

Study limitations are noted. A larger sample would have facilitated more fine-grained analyses. A more varied group of patients would have enhanced generalizeability. Using evidenced-based CBT for cocaine dependence as the control condition was a highly stringent test of M-CBT. A treatment as usual (TAU) condition would have been a less stringent option. However, since the research question was whether M-CBT would improve CBT, the present test was most likely the appropriate one. Addressing M-CBT among patients dependent on substances other than cocaine would also have enhanced generalizability. Also, while recent neuroimaging studies suggest a role of neurocognition as a biomarker for addiction or as a mechanism of behavior change (Garrison & Potenza, 2014; Moeller, Bederson, Alia-Klein, & Goldstein, 2016; Zilverstand, Parvaz, Moeller, & Goldstein, 2016) neuroimaging of the present sample of patients was not conducted. Further, exploration of mechanisms of change in CBT, e.g., the role of coping skills acquisition or homework completions in treatment outcomes (Kazantzis et al., 2016; Kiluk et al., 2017; Longabaugh, 2010) were not explored in this study. This was beyond the scope of the current paper, but we plan to address it and report on it in a subsequent report.

In conclusion, M-CBT as designed in the present study was not found to be a superior treatment for cognitively impaired cocaine dependent participants than CBT, as was hypothesized during the conceptualization stage of this project. While M-CBT demonstrated significantly higher treatment satisfaction than CBT in the sub-group of the 9-week completers, overall, M-CBT demonstrated only marginal evidence for efficacy over standard CBT. However, the results of the randomized trial, in conjunction with findings from more recent studies, offer important clues that point toward considerable benefits of technology-enhanced behavioral interventions.

The work of ourselves (Aharonovich et al., 2017) and others (Acosta, Marsch, Xie, Guarino, & Aponte-Melendez, 2012; Carroll et al., 2011) examining technological platforms to deliver interventions provides further encouragement for ongoing efforts to develop improved and more engaging interventions. Future research should investigate the use of such platforms to deliver components of M-CBT, enabling participants to engage with treatment briefly yet more frequently, at their own cognitive pace and ability. Providing appealing and interactive content may produce more successful outcomes.

Acknowledgments

This research was funded by grant R01DA020647 from the National Institute on Drug Abuse (PI: Efrat Aharonovich). Interpretations of the data discussed in this paper were presented in posters at the 2013 Research Society on Alcoholism Annual Conference and the 2013 College for Problems on Drug Dependence Annual Conference, and as a Grand Rounds presentation at Jacobi Medical Center in 2014. The abstracts for the posters are shared on Research Gate.

Contributor Information

Efrat Aharonovich, Department of Psychiatry, Columbia University Medical Center.

Deborah S. Hasin, Department of Psychiatry, Columbia University Medical Center, and Department of Epidemiology, Mailman School of Public Health, Columbia University

Edward V. Nunes, Department of Psychiatry, Columbia University Medical Center

Malka Stohl, New York State Psychiatric Institute.

Daniela Cannizzaro, New York State Psychiatric Institute.

Aaron Sarvet, New York State Psychiatric Institute.

Karen Bolla, Department of Neurology, Johns Hopkins University Bayview Medical Center.

Kathleen M. Carroll, Department of Psychiatry, Yale University School of Medicine

Kamala Greene Genece, Division of Substance Abuse, Montefiore Medical Center.

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