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Substance abuse is a serious public health concern among veterans. Substance Use Disorders (SUDs) are associated with substantial psychosocial and health consequences as well as an increased likelihood of comorbidity with other psychiatric conditions [1,2]. The prevalence of SUDs and other mental health issues is higher among veterans compared to the general population [3-5]. This may, in part, be due to veterans consuming substances to cope with psychological responses linked to military experiences and engaging in greater risktaking behaviour [6-11].

In response to the needs of this high-risk population, the US Veterans Health Administration (VA) is focusing attention on increasing provision of effective treatment for SUDs [12]. Cognitive Behavior Therapy (CBT) is one of the most empirically validated psychotherapies for SUDs and is one such treatment being provided by the VA for substance abuse [13]. During CBT, patients explore how their thoughts, feelings, and behaviors are connected. By doing so, patients are able to discover the unhealthy thinking patterns and beliefs that result in negative behaviors and feelings. The therapist and patient then collaboratively work to promote positive ways of interpreting social stimuli and other external events that engender healthy behaviors and improved emotional wellbeing [14].

Additionally, there has been an increasing emphasis on brief interventions, an evidence-based approach for treating substance abuse [15]. For example, substantial attention has been focused on investigations of VA implementation and dissemination of Screening, Brief Intervention, and Referral to Treatment (SBIRT) [16]. Such initiatives have been fueled by the increasing need to efficiently and effectively treat veterans for SUD [12]. However, while four-session CBT has been shown to be effective in improving outcomes among chronic pain patients, investigations of brief CBT for the treatment of SUDs have been limited [17].

To meet the increasing need for brief, efficacious interventions to assist veterans in reducing substance abuse, the evidence-informed Four-Session Mind Freedom Plan (MFP) manualized treatment was developed [18]. MFP is an Integrative-CBT-based adjunctive individual therapy that functions as part of intensive group-based SUD treatment [18]. The MFP model is based on efficacious brief interventions, with format driven in part from patient feedback [18]. MFP incorporates traditional CBT and addresses spiritual factors when clinically indicated, similar to what was described by Reisweber 2011; in this way, MFP clinicians operate from a biopsychosocial-spiritual model [19]. The biopsychosocial-spiritual model acknowledges and utilizes the spiritual belief system a patient holds and incorporates it into the change process when possible [20]. MFP sessions focus on identifying and changing unhealthy thinking and behavioral patterns as core elements of CBT. It places an emphasis on problem-solving, coping skills, and goal-setting that allows the patient to better connect to others and a passionate pursuit that is in line with their moral compass [18]. At each session, structured worksheets are utilized, and homework is assigned to facilitate CBT-based skill building [18].

This internally-funded programmatic investigation aimed to collect preliminary evidence about whether SUD and other mental health outcomes improved more in veterans assigned to MFP therapy compared to veterans assigned to supportive solution-focused intervention and case management that includes elements of CBT and Motivational Enhancement Therapy (Treatment as Usual; TAU). This was conducted in an effort to help inform Mental Health Service programming decisions at our facility and related VA facilities. We hypothesized that, compared to TAU patients, participants of the MFP group would: 1)Have significantly improved depression, quality of life, treatment retention, and substance use outcomes at treatment conclusion compared to baseline assessment; and 2)Demonstrate improved problem-solving and reduced impulsivity at follow up.

Participants

Participants were N=35 non-legally involved (not court-ordered to complete treatment, on probation, or pending charges or court dates) veterans enrolled in the Substance Abuse Treatment Program (SATP) Intensive Outpatient Program (IOP) at the Hunter Holmes McGuire Veterans Administration Medical Center (RICVAMC) in Richmond, Virginia.

Procedure

The study was reviewed and received ethical approval by the RICVAMC Institutional Review Board. Veterans slated for the fourweek SATP IOP were assigned to four weekly individual therapy sessions with either an MFP or a TAU practitioner. Our method of participant assignment to treatment arms was akin to a block randomization that accommodated the imperative to get each veteran individualized care as soon as a practitioner appointment slot was available. Veterans initially assigned to the participating subset of RICVAMC substance abuse IOP providers were further assigned to individual practitioners approximately weekly and randomly in the context of provider availability. Veterans were enrolled based on the date of their intake, and all veterans began treatment within 30 days of them seeking treatment. Once all slots with either MFP practitioners or all slots with TAU providers were completely full, veterans with the most recent date of seeking treatment were automatically assigned to open slots of the other treatment/providers until slots were full. Assignments were therefore not based on demographics, SUD severity, comorbidities, or other clinical characteristics. Veterans provided informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization, then completed a 20-minute baseline psychometric assessment battery (see below).

Veterans then participated in their treatment program and attended weekly individual MFP or TAU sessions (four total). At the conclusion of IOP, participants completed a 60-minute follow-up assessment with paper-and-pencil instruments, computerized impulsivity tasks, and the Delis-Kaplan Executive Function System (D-KEFS ) Tower Test. The order of administration of computerized tasks and the D-KEFS was randomized. Participants were given $20 for completing the baseline visit and $30 for completing the follow-up visit.

Assessments

Baseline: The assessments were selected based on commonality of use and acceptable or better test-retest reliability across an interval of several weeks. The Use subscale score of the 17-item Brief Addiction Monitor (BAM; test-retest reliability >0.50 for all but two items), was used to assess past 30 days substance use [21]. Total score on the 30- item Barratt Impulsiveness Scale (BIS-11; reliability=0.83) was used as a measure of trait impulsivity [22,23]. DSM-5 symptoms of Post- Traumatic Stress Disorder (PTSD) were measured using the total score of the 20-item PTSD Checklist-5 (PCL5 reliability=0.83) [24,25]. Anxiety levels were assessed using the total score of the 21-item Beck Anxiety Inventory (BAI; reliability=0.67) [26,27]. Depressive symptom severity was measured with the total score of the 21-item Beck Depression Inventory-II (BDI-II; reliability=0.73) [28,29]. Positive mental health, wellbeing, and happiness was measuring using the overall score of the 32-item Quality of Life Inventory (QoLI; total score; reliability=0.80) [30,31]. Lastly, demographics variables (age, gender, and race/ethnicity) were obtained from the electronic medical record.

Follow-up: We re-administered the BIS-11, QoLI, and BDI-II. Additionally, the following substance use and treatment measures were obtained from the electronic medical record: treatment retention (i.e., completed IOP); transition from IOP to a higher level of SUD care (residential treatment or inpatient detox); toxicology verified abstinence (proportion of positive urine drug screens [UDS]); and abstinence in the final week of IOP treatment.

Data analysis

Mixed-model analysis of variance (ANOVA) with repeated measures were used to determine the effect of MFP vs. TAU groups on BDI-II and QoLI scores as group X time interaction effects. IOP treatment outcome and substance use data were compared across the two treatment groups using chi-square analyses and independent ttests. All analyses were carried out using SPSS version 24. Items determined to be outliers (identified using the boxplot method) or with missing information were excluded from analyses involving that specific item. Follow-up measures completed greater than two weeks after the IOP completion date were excluded from analyses.

Patient characteristics

The sample was almost all male (94.3%), roughly half African American (54.3%) and half Caucasian (45.7%). Mean age was 56.40 years (SD =12.54). As shown in Table 1, those assigned to the MFP group had significantly higher BDI-II score at baseline compared to those in the TAU group (t (33)=2.30, p=0.03). No other significant differences were found between groups for baseline variables.

Table 1: Baseline comparisons of groups on demographic and patient description items (N=35).

Depression and quality of life

There was a significant group X time interaction effect on BDI-II score (F (1,28) =12.17, p=0.002), where MFP-assigned patients showed statistically significant reductions in BDI-II over time, with minimal reduction in the TAU group. There was no significant difference between MFP and TAU groups for post-treatment endorsement of suicidal ideation on the BDI-II (7.7% vs. 23.5%; p=0.25). The treatment group X time effect on QoLI scores did not reach significance, (F (1, 28) =3.60, p=0.068).

Substance use and treatment engagement

As shown in Table 2, patients in the MFP group were twice as likely as those in the TAU group to complete IOP treatment (100% vs. 50%; p=0.002). Additionally, TAU showed a trend to be more likely to transition to a higher level of SUD care compared to MFP participants (22.7% vs. 0%; p=0.06).

Table 2: Substance use and treatment variables by treatment group.

The proportion of UDS-positive urines in the MFP group (M=.25, SD=0.38) was half that of those in the TAU group (M=0.51, SD=0.46), t (32) =-1.70, p=0.10. Patients in the MFP group were over twice as likely as those in the TAU group to be abstinent in the final week of IOP (84.6% vs. 40.9%; p=0.012).

Principal findings

This was a demonstration project of Four Session Mind Freedom Plan (MFP), a brief Integrative-CBT-based adjunctive individual therapy for group-based intensive SUD treatment. Consistent with our primary hypothesis, those in the MFP group were more likely to complete IOP treatment and be abstinent in the final week of IOP compared to TAU patients. Additionally, we found MFP-assigned patients showed significant reductions in depression over time, with minimal decreases in IOP TAU patients whose adjunctive weekly individualized therapy sessions were composed of supportive solutionfocused intervention and case management that includes elements of CBT and Motivational Enhancement Therapy. However, contrary to our secondary hypothesis, we did not find any treatment group differences for neurocognitive measures. These results potentially support the continued application of MFP individual therapy compared to TAU as part of IOP treatment in RICVAMC veteran. The results may also provide support for investigation of MFP individual treatment effectiveness in other settings.

Compared to TAU patients, those in the MFP group were more likely to complete IOP treatment and be abstinent in the final week of IOP. These results are particularly meaningful given that treatment retention has been linked with reductions in substance use and 12- month post-treatment abstinence [32-35]. Additionally, our results are consistent with previous findings that behavioral approaches are associated with substance abuse treatment retention (e.g., behavioral couples therapy) [36].

Whereas MFP patients showed significant reductions in depression over time, TAU patients demonstrated minimal reduction. There was also a trend toward an improvement in QoLI scores in MFP patients but not TAU patients. This reflects how CBT is a long-standing evidence-based treatment for depression and, more recently, brief CBT-based interventions have been found to be effective in addressing depressive symptoms [37,38].

While Baker et al. (2012) found that CBT-based interventions were linked to significant decreases in alcohol use and depressive symptoms, others have not found significant reductions in depression [39-43]. Those studies that found collateral improvement in depression may have featured precise interventions that better reduced drinking itself, to result in a more robust downstream effect on reducing depression. More focused research that disentangles these possibilities using longitudinal collection of brain and neurobehavioral biomarkers is of great interest.

The integrative-CBT-based MFP individual therapy was likely effective for a variety of reasons. It is hard to parse out what aspects of MFP had the greatest impact. The theorists who developed the protocol hypothesized that it was the integrative nature of the CBT and the fact that it utilized a biopsychosocial-spiritual model. As part of the MFP manual, therapists were instructed to view their patients as having a need to seek meaning. For many patients, this appeared to be a powerful process that may have had the effect of improving their retention in treatment. At times, this led to discussions of spiritual beliefs, when brought up by the patient. The positive impact of discussing spirituality when clinically indicated is consistent with the findings of Martinez et al. where patients appreciated these discussions [44]. Therapists of the MFP arm were also encouraged to process their patients’ hot cognitions as they arose. In doing so, some patients could identify and change the thinking and behavior patterns that were impacting their ability to connect to others and transcend themselves. This was reported by some patients to result in a goal that motivated them to not use drugs or alcohol during difficult times.

Parenthetically, we also conducted a series of exploratory assessments of impulsivity at follow-up, and found no differences between treatment groups in either devaluation of delayed rewards in the delay-discounting task, commission error rates in the emotionalface go-no-go task, scores on the Barratt Impulsiveness Scale (BIS), or scores of the Delis-Kaplan Executive Function System (D-KEFS ) Tower Test (data not shown) [45-47]. This suggested that MFP-group improvements were not likely mediated by substantial reductions in myopic decision-making or improvements in executive functions.

There are several limitations to the present study. First, the sample was restricted to veterans, and results may not generalize to the broader population of individuals with SUDs. Nonetheless, this is an important and particularly vulnerable subgroup, which has been linked with increased substance use and problems [3]. Second, for unknown reasons, patients assigned to MFP had higher depression at baseline, despite how patients were assigned akin to block randomization to MFP versus TAU in the context of transient fluctuations in MFP and TAU provider availability. While this afforded the MFP group more room for improvement, their more severe baseline depression likely “stacked the deck” against SUD treatment motivation and retention generally and made their retention all the more remarkable [48,49]. We surmise that this baseline difference was likely a chance consequence of the small sample size of a pilot program evaluation project. Third, since each practitioner administered only one treatment approach (MFP vs TAU), treatment approach was confounded by practitioner. Fourth, due to cost and logistical constraints of a program evaluation, neurocognition was only assessed at follow-up, and self-reported substance use was only assessed using a standardized measure (BAM) at baseline. However, key substance use measures (UDS results and self-reported substance use) were nevertheless available in the medical chart. Finally, our sample size was likely too small to reveal potential significant differences between treatment groups for some variables (e.g., QoLI score). However, our sample was determined to be suitable for an initial evaluation of the MFP at our facility.

Because the current study only provides preliminary evidence of the potential efficacy of MFP for addressing SUD and depressive symptoms in a small sample of veterans, a more formal randomized controlled trial of MFP with more sophisticated symptom-matching randomization (e.g. urn randomization) and random assignment of practitioners to treatment arms may be warranted. A larger sample size could provide sufficient power for subgroup analyses (e.g., comparing outcomes based on type of SUD, SUD severity level, and comorbidity). Additionally, to assess generalizability and variation in effectiveness attributable to practitioners, future trials could include implementation at multiple sites, and in the context of other treatment programs. Lastly, given the recent National Institute of Mental Health focus on understanding mechanisms of intervention effects, further investigation is needed into the relationship between SUD, neurocognitive function, and MFP treatment [50].

Our investigation examined

• Whether veterans assigned to MFP therapy had improvements in SUD and other mental health outcomes post-treatment compared to TAU veterans; and

• Treatment was linked to neurocognitive function (problem solving, decision making, and impulsivity).

Key findings were that those in the MFP group had greater treatment retention, improved depression over time, and reduced substance use compared to TAU patients. Additionally, TAU patients showed a trend to be more likely to transition to a higher level of SUD care compared to MFP participants. Conversely, groups did not differ in neurocognitive performance after treatment, suggesting that clinical improvements were not related to or mediated by improvements in cognition. Our results provide preliminary evidence supporting the potential efficacy of MFP individual therapy for those with SUDs in intensive group-based treatment, and so provide grist for continued investigation of MFP for the treatment of SUDs.

This project was supported by grant from the VA Mid-Atlantic Mental Illness Research, Education and Clinical Center (VISN 6 MIRECC) of the Department of Veterans Affairs Office of Mental Health Services, the VA Mid-Atlantic Healthcare Network (VISN 6). We would like to thank the staff of the Hunter Holmes McGuire Veterans Administration Medical Center (RICVAMC) Substance Abuse Treatment Program (SATP) who contributed to the outcome of this study and manuscript.