Maintenance of Wellness in Patients With Obsessive-Compulsive Disorder Who Discontinue Medication After Exposure/Response Prevention Augmentation: A Randomized Clinical Trial.

IMPORTANCE: Serotonin reuptake inhibitors (SRIs) are the only medications approved for obsessive-compulsive disorder (OCD), yet most patients taking SRIs exhibit significant symptoms. Adding exposure/response prevention (EX/RP) therapy improves symptoms, but it is unknown whether patients maintain wellness after discontinuing SRIs. OBJECTIVE: To assess whether patients with OCD who are taking SRIs and have attained wellness after EX/RP augmentation can discontinue their SRI with noninferior outcomes compared with those who continue their SRI therapy. DESIGN, SETTING, AND PARTICIPANTS: A 24-week, double-blind, randomized clinical trial was performed from May 3, 2013, to June 25, 2018. The trial took place at US academic medical centers. Participants included 137 adults with a principal diagnosis of OCD (≥1 year) who were taking an SRI (≥12 weeks), had at least moderate symptoms (defined as Yale-Brown Obsessive-Compulsive Scale [Y-BOCS] score ≥18 points), and received as many as 25 sessions of EX/RP therapy. Those who attained wellness (Y-BOCS score ≤14 points; 103 patients [75.2%]) were study eligible. Data were analyzed from June 29, 2019, to October 2, 2021. INTERVENTION: Participants were randomly assigned either to receive taper to placebo (taper group) or to continue their SRI (continuation group) and monitored for 24 weeks. MAIN OUTCOME AND MEASURES: The Y-BOCS score (range, 0-40 points) was the primary outcome; the Hamilton Depression Rating Scale (HDRS; range, 0-52 points) and the Quality-of-Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF; range, 0%-100%) scores were secondary outcomes. Outcomes were assessed at 8 time points by independent evaluators who were blinded to randomization. The taper regimen was hypothesized to be noninferior to continuation at 24 weeks using a 1-sided α value of .05. RESULTS: A total of 101 patients (mean [SD] age, 31.0 [11.2] years; 55 women [54.5%]) participated in the trial: 51 patients (50.5%) in the taper group and 50 patients (49.5%) in the continuation group. At 24 weeks, patients in the taper group had noninferior results compared with patients in the continuation group (mean [SD] Y-BOCS score: taper group, 11.47 [6.56] points; continuation group: 11.51 [5.97] points; difference, -0.04 points; 1-sided 95% CI, -∞ to 2.09 points [below the noninferiority margin of 3.0 points]; mean [SD] HDRS score: taper group, 5.69 [3.84] points; continuation group, 4.61 [3.46] points; difference, 1.08 points; 1-sided 95% CI, -∞ to 2.28 points [below the noninferiority margin of 2.5 points]; mean [SD] Q-LES-Q-SF score: taper group, 68.01% [15.28%]; continuation group, 70.01% [15.59%]; difference, 2.00%; 1-sided 95% CI, -∞ to 6.83 [below the noninferiority margin of 7.75]). However, the taper group had higher rates of clinical worsening (23 of 51 [45%] vs 12 of 50 [24%]; P = .04). CONCLUSIONS AND RELEVANCE: Results of this randomized clinical trial show that patients with OCD who achieve wellness after EX/RP therapy could, on average, discontinue their SRI with noninferior outcomes compared with those who continued their SRI. Those who tapered the SRI had higher clinical worsening rates. Future research should evaluate if SRI half-life alters these rates. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01686087.

Maximizing remission from cognitive-behavioral therapy in medicated adults with obsessive-compulsive disorder.

Practice guidelines for adults with obsessive-compulsive disorder (OCD) recommend augmenting serotonin reuptake inhibitors (SRIs) with exposure and ritual prevention (EX/RP). However, fewer than half of patients remit after a standard 17-session EX/RP course. We studied whether extending the course increased overall remission rates and which patient factors predicted remission. Participants were 137 adults with clinically significant OCD (Yale-Brown Obsessive Compulsive Scale [Y-BOCS] score ≥18) despite an adequate SRI trial (≥12 weeks). Continuing their SRI, patients received 17 sessions of twice-weekly EX/RP (standard course). Patients who did not remit (Y-BOCS ≤12) received up to 8 additional sessions (extended course). Of 137 entrants, 123 completed treatment: 49 (35.8%) remitted with the standard course and another 46 (33.6%) with the extended course. Poorer patient homework adherence, more Obsessive-Compulsive Personality Disorder (OCPD) traits, and the Brain-Derived Neurotrophic Factor (BDNF) Val66MET genotype were associated with lower odds of standard course remission. Only homework adherence differentiated non-remitters from extended course remitters. Extending the EX/RP course from 17 to 25 sessions enabled many (69.3%) OCD patients on SRIs to achieve remission. Although behavioral (patient homework adherence), psychological (OCPD traits), and biological (BDNF genotype) factors influenced odds of EX/RP remission, homework adherence was the most potent patient factor overall.

The Association between Insomnia and Anxiety Symptoms in a Naturalistic Anxiety Treatment Setting.

Objective/Background: Few studies have examined the relationship between insomnia and anxiety treatment outcomes in naturalistic settings. Furthermore, prior studies typically examine insomnia within a single anxiety diagnosis without accounting for the high overlap between disorders. Here we investigate the association between insomnia and multiple anxiety disorders over a course of cognitive behavioral treatment (CBT) in a naturalistic treatment setting. Participants: Insomnia was assessed in 326 patients seeking treatment at a clinic specializing in CBT for anxiety. Methods: Multilevel modeling was used to investigate whether insomnia moderated reductions in anxiety symptoms. A cross-lagged analysis tested for bidirectional effects between insomnia and anxiety. Multiple regression was used to investigate the relationship between insomnia and anxiety while controlling for the other anxiety disorders and depression. Results: While there was a significant reduction in insomnia during treatment in all anxiety disorders, the majority of the most severe patients remained in the clinical range at post-treatment. Baseline insomnia did not significantly moderate anxiety outcomes, suggesting that patients with high or low levels of insomnia will do equally well in CBT for anxiety. The bidirectional effect between insomnia and anxiety did not reach significance. Additionally, posttraumatic stress disorder, generalized anxiety disorder, and panic disorder were associated with the greatest endorsement of insomnia, after controlling for the overlap between disorders. Conclusions: Sleep problems may persist after anxiety treatment, suggesting that CBT for insomnia may be warranted during or after a course of CBT for anxiety. Importantly, baseline insomnia does not impede anxiety reduction during CBT.

Beyond the Constraints of an RCT: Naturalistic Treatment Outcomes for Anxiety-Related Disorders.

Despite considerable data from randomized controlled trials supporting use of behavioral therapies for anxiety disorders and anxiety-related disorders, there is a relative scarcity of data demonstrating that such findings are generalizable to patients in nonresearch settings, and a lack of standardized repeated outcome measurement in such settings. Using one of the largest examinations of naturalistic outcomes of behavioral therapies in treatment-seeking patients (N = 489), we examined the clinical characteristics and treatment outcomes of patients seeking treatment for anxiety and anxiety-related disorders in the past 3 years. Patients seeking treatment at a clinic specializing in cognitive-behavioral therapy (CBT) completed self-report questionnaires via an electronic data capture system and diagnostic interview at baseline, and were reassessed at mid- and posttreatment. Patients with anxiety and related disorders were assessed for changes in symptom severity and secondary outcomes (impairment/functioning, quality of life, and depression) over the course of therapy. Patients showed clinically significant and statistically reliable improvement in anxiety symptom severity scores over treatment (p < .001), after controlling for number of sessions received. Patients also showed significant improvement in depression, quality of life, and functioning (p values ≤ .001). We also found significant improvement in disorder-specific symptoms, including obsessive-compulsive disorder, posttraumatic stress disorder, generalized anxiety disorder, and social anxiety disorder (p values ≤ .001). Importance of, and ways to facilitate, integration of more routine assessment of a broader range of symptoms via online assessment systems and methods to better determine the effectiveness of CBT in naturalistic clinics are discussed.