A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder

Abstract

Background and aims: Post-traumatic stress disorder (PTSD) is common among people with substance use disorders, and the comorbidity is associated with negative outcomes. We report on a randomized controlled trial comparing the effect of integrated cognitive-behavioral therapy (ICBT) plus standard care, individual addiction counseling plus standard care and standard care alone on substance use and PTSD symptoms.

Design: Three-group, multi-site randomized controlled trial.

Setting: Seven addiction treatment programs in Vermont and New Hampshire, USA.

Participants/cases: Recruitment took place between December 2010 and January 2013. In this single-blind study, 221 participants were randomized to one of three conditions: ICBT plus standard care (SC) (n = 73), individual addiction counseling (IAC) plus SC (n = 75) or SC only (n = 73). One hundred and seventy-two patients were assessed at 6-month follow-up (58 ICBT; 61 IAC; 53 SC). Intervention and comparators: ICBT is a manual-guided therapy focused on PTSD and substance use symptom reduction with three main components: patient education, mindful relaxation and flexible thinking. IAC is a manual-guided therapy focused exclusively on substance use and recovery with modules organized in a stage-based approach: treatment initiation, early abstinence, maintaining abstinence and recovery. SC are intensive out-patient program services that include 9-12 hours of face-to-face contact per week over 2-4 days of group and individual therapies plus medication management.

Measurements: Primary outcomes were PTSD severity and substance use severity at 6 months. Secondary outcomes were therapy retention.

Findings: PTSD symptoms reduced in all conditions with no difference between them. In analyses of covariance, ICBT produced more favorable outcomes on toxicology than IAC or SC [comparison with IAC, parameter estimate: 1.10; confidence interval (CI) = 0.17-2.04; comparison with SC, parameter estimate: 1.13; CI = 0.18-2.08] and had a greater reduction in reported drug use than SC (parameter estimate: -9.92; CI = -18.14 to -1.70). ICBT patients had better therapy continuation versus IAC (P<0.001). There were no unexpected or study-related adverse events.

Conclusions: Integrated cognitive behavioral therapy may improve drug-related outcomes in post-traumatic stress disorder sufferers with substance use disorder more than drug-focused counseling, but probably not by reducing post-traumatic stress disorder symptoms to a greater extent.

Trial registration: ClinicalTrials.gov NCT01457391.

Keywords: Co-occurring disorders; PTSD; evidence-based treatment; integrated cognitive behavioral therapy (ICBT); integrated treatments; substance use.

Conflict of interest statement

Declarations of interest: This research was supported by the National Institute on Drug Abuse (NIDA) R01DA027650 (PI: McGovern). The authors report no conflicts of interest. Clinical trials registration NCT01457391

© 2015 Society for the Study of Addiction.

Figures

Figure 1

CONSORT of RCT of treatments for co-occurring substance use disorders and PTSD

Figure 2. Intent-to-treat analyses of primary outcomes by treatment type (n=221)

*p<.05 wald chi-square test for overall group difference ancova both baseline and covariates severity site xmlns:xlink="http://www.w3.org/1999/xlink" position="float" orientation="portrait" xlink:href="nihms679789u1.jpg">

Figure 3. Study therapy continuation: ICBT and IAC session attendance (ICBT n=61, IAC n=56)

Chi-square test for therapy differences in attendance rates: *p≤.05; **p≤.01; ***p≤.001