Trial Of Cognitive Behavioral Therapy Research Articles

Transitioning From In-Person to Remote Clinical Research on Depression and Traumatic Brain Injury During the COVID-19 Pandemic: Study Modifications and Preliminary Feasibility From a Randomized Controlled Pilot Study.

BackgroundTelehealth has provided many researchers, especially those conducting psychosocial research, with the tools necessary to transition from in-person to remote clinical trials during the COVID-19 pandemic. A growing body of research supports the effectiveness of telemental health for a variety of psychiatric conditions, but few studies have examined telemental health for individuals with comorbid medical diagnoses. Furthermore, little is known about the remote implementation of clinical trials examining telemental health interventions.ObjectiveThis paper outlines the procedural modifications used to facilitate conversion of an in-person randomized controlled trial of cognitive behavioral therapy (CBT) for depression in individuals with traumatic brain injury (TBI; CBT-TBI) to a telemental health study administered remotely.MethodsGiven the nature of remote implementation and specific challenges experienced by individuals with TBI, considerations related to treatment delivery, remote consent, data management, neuropsychological assessment, safety monitoring, and delivery of supportive material have been discussed. Feasibility, acceptability, and safety were evaluated by examining attendance and participant responses on self-report measures of treatment satisfaction and suicidal behavior.ResultsHigh rates of treatment attendance, assessment completion, study retention, and satisfaction with the intervention and modality were reported by participants who completed at least one telemental health CBT-TBI session.ConclusionsStudy modifications are necessary when conducting a study remotely, and special attention should be paid to comorbidities and population-specific challenges (eg, cognitive impairment). Preliminary data support the feasibility, acceptability, and safety of remotely conducting a randomized controlled trial of CBT-TBI.Trial RegistrationClinicalTrials.gov NCT03307070; https://clinicaltrials.gov/ct2/show/NCT03307070

Managing job stress among teachers of children with autism spectrum disorders: A randomized controlled trial of cognitive behavioral therapy with yoga.

Background:Job-related stress undermines occupational, personal, and organizational outcomes. Stress symptoms are common among teachers of children with autism spectrum disorders and affect the academic progress of the children. This study investigated the effectiveness of yoga-based cognitive behavioral therapy in reducing occupational stress among teachers of children with autism in Lagos states, Nigeria.Methods:The current study adopted a group-randomized waitlist control (WLC) trial design with pre-test, posttest, and follow-up assessments. Participants included 58 teachers of children with autism in public and private special schools in Lagos state. Participants were randomly assigned to combined cognitive behavioral therapy and yoga (Y-CBT) (N = 29) and WLC (N = 29) groups. The Y-CBT group participated in a 2 hours Y-CBT program weekly for 12 weeks. Three instruments – Demographic Questionnaire, Single-Item Stress Questionnaire, and Teachers’ Stress Inventory (TSI) were used to collect data. Data were collected at baseline; posttest and follow-up evaluations. Data were analyzed using means, standard deviations, t test statistics, repeated measures analysis of variance, and bar charts.Results:Results revealed that all dimensions of job stress (perception of stress sources, stress manifestation, and total TSI scores) reduced significantly at posttest and follow up assessments among the Y-CBT group, compared to the WLC.Conclusion:It was concluded that Y-CBT modalities could help to minimize the perception of stress sources and stress manifestation as well as total TSI scores among teachers of children with autism spectrum disorders.

Effect of cognitive behavioral therapy on anxiety and depression in patients with psoriasis: A protocol for systematic review and meta-analysis.

Background:Psoriasis can lead to higher social and psychological burden, and its occurrence is related to psychological disturbance. At present, there are many clinical trials on cognitive behavior therapy for depression and anxiety in patients with psoriasis. However, the results of studies vary greatly due to the different time and content of the intervention, and the curative effect is still controversial. Therefore, the purpose of this study was to explore the effect of cognitive behavior therapy on anxiety and depression in patients with psoriasis through meta-analysis.Methods:We searched Chinese and English databases to collect all randomized controlled trials of cognitive behavior therapy on anxiety and depression in patients with psoriasis until October 2021. Two researchers then independently screened articles, extracted data, and evaluated the quality of selected literatures. All data were processed by Stata 14.0.Results:The results will be published in peer-reviewed journals.Conclusion:Our study is expected to provide high-quality evidence-based medicine advice for the effects of cognitive behavior therapy on anxiety and depression in patients with psoriasis.Ethics and dissemination:Ethical approval was not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and shared on social media platforms. This review would be disseminated in a peer-reviewed journal or conference presentations.OSF REGISTRATION NUMBER:DOI 10.17605/OSF.IO/APKVG.

The Efficacy of Traditional Cognitive Behavioural Therapy for Depressed Adults with Anhedonia: A Systematic Review

To date, the impact of traditional cognitive behavioural therapy (CBT) on anhedonia in major depressive disorder (MDD) has yet been systematically evaluated. This systematic review aims to examine the efficacy of traditional CBT for depressed adults with anhedonia. A literature search for randomised controlled trials of traditional CBT in adults with MDD from inception to July 2020 was conducted in 8 databases. The primary outcome was the levels of anhedonia. Ten studies with adults with MDD met the eligibility criteria. Our results indicate that traditional CBT is as effective as euthymic therapy, positive psychology therapy, self-system therapy,and medications for anhedonia in depression. Besides, our data provide further support for the development of augmented CBT to optimise treatment outcome for depressed adults with anhedonia. Received 11th June 2021; Revised 2nd September 2021; Accepted 20th September 2021

A Randomized Controlled Trial of Cognitive Behavior Therapy for Reducing Anxiety and Depressive Symptoms in Patients With Locally Recurrent Nasopharyngeal Carcinoma Receiving Reirradiation

<h3>Purpose/Objective(s)</h3> We hypothesized that the addition of cognitive behavioral therapy (CBT) to reirradiation significantly reduced depressive and anxiety symptoms in patients with locally recurrent nasopharyngeal carcinoma (NPC). The purpose of this randomized trial was to compare the efficacy of cognitive behavioral therapy versus treatment as usual (TAU) on anxiety and depression, and acute adverse events in patients with locally recurrent nasopharyngeal carcinoma receiving reirradiation. <h3>Materials/Methods</h3> A total of 150 patients with diagnosis of locally recurrent T3 to T4 NPC were randomly assigned to receive CBT plus reirradiation (CBT group, n = 75) or treatment as usual (TAU) plus reirradiation (TAU group, n = 75). All patients received reirradiation using Volume Modulated Arc Therapy (VMAT). The recurrent gross tumor volume of nasopharynx (PGTVnx) was irradiated at DT 60 Gy/30 Fx in 2.0 Gy per fraction. Patients in the CBT group received a series of six CBT sessions for 6 weeks during VMAT. Depression and anxiety were assessed using the Hospital Anxiety and Depression Scale (HADS) score at baseline, the completion of reirradiation, 1 and 3 months after reirradiation. Acute adverse events were also evaluated. <h3>Results</h3> Patients in the CBT group showed significantly less depression and anxiety than patients in the TAU group after the completion of CBT (<i>P</i> < 0.01). Compared with the TAU group, the CBT group showed a significantly lower incidence of acute adverse events including fatigue, insomnia, anemia, and weight losing (<i>P</i> < 0.05). <h3>Conclusion</h3> The addition of cognitive behavioral therapy to reirradiation significantly reduced depressive and anxiety symptoms. CBT combined with VMAT is associated with reduced incidence of acute toxic effects in patients with locally recurrent T3 to T4 nasopharyngeal carcinoma. This trial is registered with chictr.org.cn, number ChiCTR2000034701.

A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance.

This study examines the impact of cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) therapy for comorbid insomnia and sleep apnea on nocturnal sleep and daytime functioning. A partial factorial design was used to examine treatment pathways with CBT-I and PAP and the relative benefits of each treatment. One hundred eighteen individuals with comorbid insomnia and sleep apnea were randomized to receive CBT-I followed by PAP, self-monitoring followed by CBT-I concurrent with PAP, or self-monitoring followed by PAP only. Participants were assessed at baseline, PAP titration, and 30 and 90 days after PAP initiation. Outcome measures included sleep diary- and actigraphy-measured sleep, Flinders Fatigue Scale, Epworth Sleepiness Scale, Functional Outcome of Sleep Questionnaire, and cognitive emotional measures. A main effect of time was found on diary-measured sleep parameters (decreased sleep onset latency and wake after sleep onset; increased total sleep time and sleep efficiency) and actigraphy-measured sleep parameters (decreased wake after sleep onset; increased sleep efficiency) and daytime functioning (reduced Epworth Sleepiness Scale, Flinders Fatigue Scale; increased Functional Outcome of Sleep Questionnaire) across all arms (all P < .05). Significant interactions and planned contrast comparisons revealed that CBT-I was superior to PAP and self-monitoring on reducing diary-measured sleep onset latency and wake after sleep onset and increasing sleep efficiency, as well as improving Functional Outcome of Sleep Questionnaire and Flinders Fatigue Scale compared to self-monitoring. Improvements in sleep and daytime functioning were found with PAP alone or concomitant with CBT-I. However, more rapid effects were observed on self-reported sleep and daytime performance when receiving CBT-I regardless of when it was initiated. Therefore, concomitant treatment appears to be a favorable approach to accelerate treatment outcomes. Registry: ClinicalTrials.gov; Name: Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea (MATRICS); URL: https://clinicaltrials.gov/ct2/show/NCT01785303; Identifier: NCT01785303. Tu AY, Crawford MR, Dawson SC, etal. A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance. J Clin Sleep Med. 2022;18(3):789-800.

Persistent posttraumatic headaches and functioning in veterans: Injury type can matter.

To characterize the relationship between head trauma types (blast injury, blunt injury, combined blast+blunt injury) with subsequent headache presentations and functioning. Posttraumatic headaches (PTHs), the most common sequelae of traumatic brain injury (TBI), are painful and disabling. More than 400,000 veterans report having experienced a TBI, and understanding the predictors of PTHs may guide treatment developments. This study used a nested-cohort design analyzing baseline data from a randomized clinical trial of cognitive behavioral therapy for PTH (N=190). Participants had PTH (from blast and/or blunt head trauma) and symptoms of posttraumatic stress disorder (PTSD). The Structured Diagnostic Interview for Headache-Revised and Ohio State University Traumatic Brain Injury Identification Method were used to phenotype headaches and head injury histories, respectively. Individuals with persistent PTHs after a combined blast and blunt head trauma were more likely (OR=3.45; 95% CI [1.41, 8.4]) to experience chronic (vs. episodic) PTHs compared with the blunt trauma only group (23/33, 70% vs. 26/65, 40%, respectively); and they were more likely (OR=2.51; 95% CI [1.07, 5.9]) to experience chronic PTH compared with the blast trauma only group (44/92, 48%). There were no differences between head injury type on headache-related disability, depression symptoms, or severity of PTSD symptoms. The combination of blast and blunt injuries was associated with headache chronicity, but not headache disability. Considering the refractory nature of chronic headaches, the potential added and synergistic effects of distinct head injuries warrant further study.

Mediation of outcomes for cognitive behavioral therapy targeted to parents of children with Functional Abdominal Pain Disorders

ObjectiveThere is a large body of evidence for the efficacy of Cognitive Behavioral Therapy (CBT) in treating Functional Abdominal Pain Disorders (FAPD) in children. In most CBT interventions for FAPD, parents participate together with their children. However, only one study to date has examined targeting parents alone for treatment. The aim of the current study was to examine mediators of a parent-only CBT treatment incorporating social learning (SLCBT) for FAPD in children. MethodsWe examined mediators of child outcomes in an existing randomized controlled trial (n = 316) of parent-only social learning CBT compared to an education condition. Hypothesized mediators (parental protectiveness, perceived threat of pain, catastrophizing) were assessed at 3 months post-treatment, and outcomes (parent ratings of disability, quality of life, school absences, and health care visits) were assessed at 6 months post-treatment. Mediation analyses were performed using Hayes' PROCESS macro. ResultsPain catastrophizing significantly mediated treatment effects for all outcomes (B ranged from −1.65 to 2.22). Reduction in pain threat was a significant mediator for all outcomes (B ranged from −1.84 to 3.13) except school absences and health care visits. Decrease in parental protectiveness mediated effects on disability and missed school (B ranged from −1.47 to 1.34). Mediation effects did not differ by in-person or remote delivery of SLCBT. ConclusionChanges in maladaptive parental thoughts and behaviors following parent-only SLCBT intervention appeared to mediate the effects of the intervention. Parental catastrophizing appears to be a particularly important target given that decreases in that variable mediated all outcomes.

Trajectory of treatment response in the child and adolescent migraine prevention (CHAMP) study: A randomized clinical trial.

Identify preventive medication treatment response trajectories among youth participating in the Childhood and Adolescent Migraine Prevention study. Data were evaluated from 328 youth (ages 8-17). Childhood and Adolescent Migraine Prevention study participants completed headache diaries during a 28-day baseline period and a 168-day active treatment period during which youth took amitriptyline, topiramate, or placebo. Daily headache occurrence trajectories were established across baseline and active treatment periods using longitudinal hierarchical linear modeling. We tested potential treatment group differences. We also compared final models to trajectory findings from a clinical trial of cognitive behavioral therapy plus amitriptyline for youth with chronic migraine to test for reproducibility. Daily headache occurrence showed stability across baseline. Active treatment models revealed decreases in headache frequency that were most notable early in the trial period. Baseline and active treatment models did not differ by treatment group and replicated trajectory cognitive behavioral therapy plus amitriptyline trial findings. Replicating headache frequency trajectories across clinical trials provides strong evidence that youth can improve quickly. Given no effect for medication, we need to better understand what drives this clinically meaningful improvement. Results also suggest an expected trajectory of treatment response for use in designing and determining endpoints for future clinical trials.Trial Registration. ClinicalTrials.gov Identifier: NCT01581281.

Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women

BackgroundInsomnia and sleep disturbances are common in pregnancy and have potentially significant consequences for both maternal and infant health. There is limited research examining the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) during pregnancy. With increased distress and limited access to services during the COVID-19 pandemic, there is also an unprecedented need for telehealth delivery of treatment programs for pregnant women. The aims of this trial are to evaluate the impact of the Sleeping for Two adaptation of CBT-I in pregnancy (in-person or telehealth) versus treatment as usual (TAU) in reducing symptoms of insomnia (primary outcome), as well as increasing gestational length and reducing symptoms of depression (secondary outcomes).MethodsA two-arm, single-blinded, parallel group randomized controlled trial (RCT) design with repeated measures will be used to evaluate the impact of CBT-I compared to TAU among a sample of 62 pregnant women, enrolled between 12 and 28 weeks of gestation, who self-identify as experiencing insomnia. Five weekly individual sessions of CBT-I will be delivered in person or via telehealth depending on physical distancing guidelines. Assessment of insomnia diagnosis by structured interview, self-reported insomnia symptom severity and sleep problems, and sleep quantity and quality as measured by a daily diary and actigraphy will occur at 12–28 weeks of pregnancy (T1), 1 week post-treatment (T2), and 6 months postpartum (T3).DiscussionCBT-I delivered in pregnancy has the potential to reduce symptoms of insomnia and depression and could lead to reduced risk of preterm birth, all of which can minimize risk of negative maternal and child health and developmental consequences in the short (e.g., infant death) and long terms (e.g., developmental delays). This RCT builds on a successful open pilot trial conducted by our team and will provide further evaluation of a novel evidence-based treatment for pregnancy-related insomnia, which can be widely disseminated and used to treat individuals that are most in need of intervention. Findings will enhance understanding of pregnancy-related sleep problems, as well as means by which to improve the health and sleep of mothers and their children.Trial registrationClinicalTrials.gov NCT03918057. Registered on 17 April 2019.

A Randomized Clinical Trial of Cognitive-Behavioral Therapy for Insomnia to Augment Posttraumatic Stress Disorder Treatment in Survivors of Interpersonal Violence

Introduction: Individuals exposed to interpersonal violence (IPV) commonly develop posttraumatic stress disorder (PTSD) with co-occurring depression and insomnia. Standard PTSD interventions such as cognitive processing therapy (CPT) do not typically lead to remission or improved insomnia. Cognitive behavioral therapy for insomnia (CBTi) improves insomnia in individuals with PTSD, but PTSD severity remains elevated. Objective: To determine whether sequential treatment of insomnia and PTSD is superior to treatment of only PTSD. Methods: In a 20-week trial, 110 participants exposed to IPV who had PTSD, depression and insomnia were randomized to CBTi followed by CPT or to attention control followed by CPT. Primary outcomes following CBTi (or control) were the 6-week change in score on the Insomnia Severity Index (ISI), the Clinician-Administered PTSD Scale (CAPS), and the Hamilton Rating Scale for Depression (HAM-D). Primary outcomes following CPT were the 20-week change in scores. Results: At 6 weeks, the CBTi condition had greater reductions in ISI, HAM-D, and CAPS scores than the attention control condition. At 20 weeks, participants in the CBTi+CPT condition had greater reductions in ISI, HAM-D, and CAPS scores compared to control+CPT. Effects were larger for insomnia and for depression than for PTSD. Similar patterns were observed with respect to clinical response and remission. A tipping point sensitivity analyses supported the plausibility of the findings. Conclusions: The sequential delivery of CBTi and CPT had plausible, significant effects on insomnia, depression, and PTSD compared to CPT alone. The effects for PTSD symptoms were moderate and clinically meaningful.

Bleuler revisited: on persecutory delusions and their resistance to therapy

Bleuler revisited: on persecutory delusions and their resistance to therapy

A Crossover Design for Comparative Efficacy: A 28 Days-Randomized Clinical Trial of Cognitive Behavioral Therapy for Chronic Pain of Degenerative Conditions

In physiotherapy practice, a number of patients are known to suffer from chronic pain which results in reduced activity levels, interference in sleep, enjoyment of life, mood, and relations with others. Cognitive behavioral therapy, in this aspect will provide a holistic approach to the available treatment. Cognitive behavioral therapy has also been shown to target cognitive distortions such as pain catastrophizing, fear avoidance, overgeneralizing and others, all the while improving physical health, activity levels and quality of life. This study assessed the efficacy of cognitive behavioral therapy in the management of patients with chronic pain at the University Teaching Hospitals in Zambia. A randomized clinical trial utilizing a crossover design was utilized for the study. A random sample of 32 participants was used in the study after fulfilling the study criteria. Data was analyzed using ANCOVA with alpha of 0.05. The study recorded small effects in the reduction of pain intensity in both phase one and two. In phase one, it also recorded small effects in general work interference, sleep interference and enjoyment of life interference but recorded medium effects in normal work interference and mood interference. Phase two of the study recorded small effect size in reduction of general work interference, normal work interference, mood interference, relations with others interference, sleep interference and Enjoyment of Life interference. Cognitive behavioral therapy ensures the management of chronic pain addresses areas in which an individual is affected by pain and which in turn exacerbate the chronic pain. Physiotherapy provides a more holistic approach when used in conjunction with cognitive behavioral therapy.

Internet Cognitive-Behavioral Therapy for Painful Chronic Pancreatitis: A Pilot Feasibility Randomized Controlled Trial.

INTRODUCTION:Severe abdominal pain is a cardinal symptom of chronic pancreatitis (CP) associated with a high economic and societal burden. In other chronic pain conditions, cognitive-behavioral therapy (CBT) has demonstrated efficacy in improving patient outcomes (e.g., pain-related disability and depression). However, CBT has not yet been evaluated in adult patients with painful CP. We aimed to (i) evaluate the feasibility and acceptability of an adapted Internet CBT program for CP and (ii) generate pilot data regarding the effects of treatment on patient pain outcomes.METHODS:Thirty adults (mean age = 49.8 years, SD = 12.5; 80% women) with suspected or definite CP were randomized to Internet CBT (Pancreatitis Pain Course) versus control. The Pancreatitis Pain Course has 5 CBT lessons (e.g., thought challenging, relaxation, and activity pacing) delivered over 8 weeks. Pain interference, pain intensity, and quality of life were assessed at pretreatment, posttreatment, and the 3-month follow-up. Qualitative interviews were conducted at posttreatment with a subset of participants.RESULTS:Eighty percent of participants rated the program as highly acceptable; 64.3% completed all 5 lessons. Qualitative data revealed positive perceptions of program features, relevancy, and skills. Patients randomized to Internet CBT demonstrated moderate to large effects in reducing pain intensity and pain interference from baseline to 3 months. The proportion of treatment responders (>30% improvement) was significantly greater in the Internet-CBT group than in the control group (50% vs 13%, Fisher exact t test P = 0.04).DISCUSSION:In this first trial of CBT pain self-management in CP, feasibility, acceptability, and preliminary efficacy for reducing pain and disability were demonstrated. Future definitive trials of CBT are needed.

Randomized pilot trial of cognitive-behavioral therapy and acceptance-based behavioral therapy in the treatment of Spanish-speaking Latino primary care patients with generalized anxiety disorder.

The evidence base supporting the usefulness of traditional cognitive-behavioral therapy (CBT) and newer acceptance-based CBT treatments for generalized anxiety disorder (GAD) has grown over the past decades. GAD is prevalent among several Latino subgroups, particularly Puerto Ricans. However, there remains uncertainty regarding the appropriateness of these interventions for Spanish-speaking Latinos since they have been routinely excluded in both efficacy and effectiveness studies. As an initial step to bridge this gap, this pilot study examined the potential efficacy of two CBT interventions for GAD, traditional CBT and acceptance-based behavioral therapy (ABBT), in a sample of Spanish-speaking Latinos. Ninety primary care patients with GAD were randomly assigned to receive CBT (n=30), ABBT (n=30), or treatment as usual (TAU) (n=30). Excessive worry, the core feature of GAD, was assessed with the Penn State Worry Questionnaire (PSWQ), which is considered the gold standard measure of GAD-related worry. At follow-up, PSWQ scores for participants in the CBT and ABBT groups were statistically lower than those of the TAU group and statistically comparable to each other. CBT and ABBT reduced worry level to a greater degree than usual care by follow-up. Our findings provide preliminary, yet crucial data, which support the potential of both interventions targeting GAD symptoms among Spanish-speaking Latino primary care patients.

A randomized controlled trial of cognitive behavior therapy for reducing anxiety and depressive symptoms in patients with locoregional advanced nasopharyngeal carcinoma.

12121 Background: The purpose of this randomized trial was to compare the efficacy of cognitive behavioral therapy (CBT) versus treatment as usual (TAU) on anxiety and depression, response rates and acute adverse events in patients with locoregional advanced nasopharyngeal carcinoma (NPC) receiving chemoradiotherapy. To the best of our knowledge, this is the first randomized trial evaluating the effect of CBT for depression and anxiety in patients with locoregional advanced NPC treated with chemoradiotherapy. Methods: A total of 202 patients with diagnosis of stage III-IVa (8th AJCC) NPC were randomly assigned to receive CBT plus chemoradiotherapy (CBT group, n = 101) or treatment as usual (TAU) plus chemoradiotherapy (TAU group, n = 101). Patients in the CBT group received a series of six CBT sessions for 6 weeks during concurrent chemoradiotherapy. Depression and anxiety were assessed using the Hospital Anxiety and Depression Scale (HADS) score at baseline, the completion of chemoradiotherapy, 1 and 3 months after chemoradiotherapy. Response rates and adverse events were also evaluated. This trial is registered with chictr.org.cn, number ChiCTR2000034701. Results: Patients in the CBT group showed significantly less depression and anxiety than patients in the TAU group after the completion of CBT (P &lt; 0.01). Complete response (CR) rate was significantly higher in CBT group than in TAU group (100% vs. 93.1%，P = 0.014). Compared with the TAU group, the CBT group showed a significantly lower incidence of acute adverse events including anemia, fatigue, mucositis, insomnia and weight losing (P &lt; 0.05). Conclusions: The addition of CBT to chemoradiotherapy significantly reduced depressive and anxiety symptoms. CBT combined with chemoradiotherapy is associated with improved response rates, with reduced incidence of acute toxic effects in patients with locoregional advanced nasopharyngeal carcinoma. Clinical trial information: ChiCTR2000034701.

Brief relaxation training effects on long-term endocrine therapy adherence among women with breast cancer.

12061 Background: Despite life-saving potential, many women struggle to adhere to adjuvant endocrine therapy (AET) for their early-stage, hormone receptor-positive breast cancer. Prior research has demonstrated that emotional distress is a barrier to AET adherence. The current study aimed to test the long-term effects of two 5-week post-surgical group-based stress management interventions, cognitive behavioral therapy (CBT) and relaxation training (RT), versus an attention-matched health education (HE) control on AET adherence at long-term follow-up. Methods: We conducted long-term follow-up (median = 8 years, range = 7-11 years) of a cohort of women who enrolled in a randomized controlled trial of CBT vs. RT vs. HE shortly after surgery for stage 0-3 breast cancer.We measuredadherence with the Endocrine Therapy Medication Usage Questionnaire (ETMUQ) given at long-term follow-up. First, we established adherence factors on the ETMUQ via confirmatory factor analysis. We then used structural equation modeling to regress these factors on study arm, controlling for patient age, stage of disease, and treatments received (chemotherapy/radiation). Results: The sample was predominately middle-aged ( M= 54.81, SD= 10.19), White (41.5%) and Hispanic (42.2%), partnered (62.2%) with stage 1 (57.0%) or stage 2 (25.9%) disease. Of the women who completed long-term follow-up (N = 59, 44.7% of original sample); more than half (n = 30; 50.8%) reported having at least some problems with adherence. There was an effect of intervention group on adherence, such that women receiving RT (n = 15) had significantly better adherence than those receiving CBT (n = 20) on the factor measuring Forgetfulness/Inconsistency ( B(SE) =.57 (.34), p=.001), and marginally better adherence than those receiving CBT on the factor measuring Intentional Nonadherence ( B(SE) =.60 (.33), p =.062). There was no such effect when comparing RT or CBT to HE (n = 24). Conclusions: Women receiving RT were less likely to forget to take their AET and marginally less likely to intentionally miss doses of AET in the long-term compared to women receiving CBT. Future research could investigate the mechanism by which RT may improve adherence. For example, RT may reduce somatic symptoms related to AET or improve a patients’ self-efficacy to cope with these symptoms thereby reducing intentional non-adherence. In addition, RT may improve patients’ attention and awareness leading to less forgetfulness. Clinical trial information: NCT02103387.

Heart rate and heart rate variability as outcomes and longitudinal moderators of treatment for pain across follow-up in Veterans with Gulf War illness

AimsAccumulating evidence suggests Gulf War illness (GWI) is characterised by autonomic nervous system dysfunction (higher heart rate [HR], lower heart rate variability [HRV]). Yoga – an ancient mind-body practice combining mindfulness, breathwork, and physical postures – is proposed to improve autonomic dysfunction yet this remains untested in GWI. We aimed to determine (i) whether HR and HRV improve among Veterans with GWI receiving either yoga or cognitive behavioural therapy (CBT) for pain; and (ii) whether baseline autonomic functioning predicts treatment-related pain outcomes across follow-up. Main methodsWe present secondary analyses of 24-hour ambulatory cardiac data (mean HR, square root of the mean squared differences between successive R-R intervals [RMSSD], high frequency power [HF-HFV], and low-to-high frequency ratio [LF/HF] extracted from a 5-min window during the first hour of sleep) from our randomised controlled trial of yoga versus CBT for pain among Veterans with GWI (ClinicalTrials.govNCT02378025; N = 75). Key findingsVeterans who received CBT tended towards higher mean HR at end-of-treatment. Better autonomic function (lower mean HR, higher RMSSD/HF-HRV) at baseline predicted greater reductions in pain across follow-up, regardless of treatment group. Better baseline autonomic function (mid-range-to-high RMSSD/HF-HRV) also predicted greater pain reductions with yoga, while worse baseline autonomic function (higher mean HR, lower RMSSD/HF-HRV) predicted greater pain reductions with CBT. SignificanceTo our knowledge, this is the first study to suggest that among Veterans with GWI, HR may increase with CBT yet remain stable with yoga. Furthermore, HR and HRV moderated pain outcome across follow-up for yoga and CBT.

381 Evening Chronotype Predicts Subjective Sleep Symptom Severity in Pregnant Women with Insomnia Disorder

Abstract Introduction Evening chronotype is associated with greater reports of insufficient sleep and sleep-related distress. Little research has examined this relationship within the context of pregnancy. This study investigated whether eveningness predicts insomnia severity, sleep effort, dysfunctional sleep beliefs, and sleep reactivity to stress in pregnant women with insomnia disorder. Methods Pregnant women with insomnia disorder who spoke English or Spanish enrolled in a clinical trial of cognitive behavioral therapy for insomnia (N = 178; M age = 32.6 years). Before beginning treatment, participants completed the Composite Scale of Morningness (CSM), Insomnia Severity Index (ISI), Glasgow Sleep Effort Scale (GSS), Dysfunctional Beliefs and Attitudes about Stress Scale (DBAS), and Ford Insomnia Response to Stress Test (FIRST). Participants were categorized into evening, intermediate, or morning chronotypes (bottom 25%, middle 50%, or top 25% of CSM scores, respectively). MANCOVA examined whether chronotype predicted higher baseline ISI, GSS, DBAS, and FIRST scores after adjusting for age, gestational week of pregnancy, and language. Results Sleep measures collectively differed by chronotype, F(8, 336) = 4.05, p &amp;lt; .001; Wilk’s Λ = .83, partial η-sqd = .09. Follow-up ANOVAs testing individual dependent variables were all significant (partial η-sqd = .04 – .10, p &amp;lt; .05). Pairwise comparisons (Bonferroni-adjusted; p &amp;lt; .05) found that evening types had higher ISI scores than intermediate (M difference = 2.21) and morning types (M difference = 2.30), and higher DBAS scores than morning types (M difference = .95). Morning types had lower FIRST scores than evening (M difference = 5.44) and intermediate types (M difference = 3.89). Conclusion Evening chronotype was associated with greater insomnia severity and maladaptive sleep-related cognition than other chronotypes among pregnant women with insomnia disorder. Future research may examine whether differences in chronotype have implications for insomnia treatment outcome during pregnancy, and whether greater morningness confers protection against sleep challenges during the early postpartum period. Support (if any) NIH R01 NR013662

664 Characteristics of respondents to a virtual trial of a digital behavioral treatment for insomnia during the COVID-19 pandemic

IntroductionRates of sleep disturbance and sleep medication use have increased during the COVID-19 pandemic, at a time when face-to-face delivery of behavioral insomnia treatments is severely limited. To support research during the pandemic, the FDA released guidelines promoting the use of “alternative methods” to conduct trials in a virtual or decentralized manner. Currently, few data exist regarding the impact of virtual trial enrollment during a pandemic. This abstract presents data from a decentralized, open-label, single-arm real-world clinical trial of the Somryst prescription digital therapeutic for insomnia, which provides insight on who seeks care for insomnia using virtual research methods.MethodsIn alignment with FDA guidance, the DREAM trial began enrolling patients in March, 2020 with an expected final sample size of 350 adults (Clinical Trial # NCT04325464). This abstract presents data from participants seeking enrollment into the trial via an online screening. Demographic and sleep variables were collected to confirm eligibility.ResultsOf 1,063 respondents, the majority were female (62%) and the most common age brackets were ages 30–39 (22%); 40–49 (20%); and 50–59 (20%). Most respondents (63.8%) did not report being under the care of a healthcare provider for their insomnia. Respondents reported sleep problems for an average of 12.9 years; sleep problems 5 nights/week; and sleeping an average of 5.4 hours/night. Geographic diversity was high with respondents from 45 states and Washington DC. Of those passing initial screening (N=270), 5.5% reported having another diagnosed sleep disorder, 14.4% reported a comorbid psychological condition, 58.9% reported taking a medication for insomnia, and 30.7% reported taking a medication for depression. Using the Insomnia Severity Index, 16.7% had subthreshold/mild insomnia (score 8–14), 60.0% had moderate insomnia (score 15–21), and 23.7% had severe insomnia (score > 21).ConclusionRespondents to this decentralized trial reported moderate-severe, long-lasting insomnia with high rates of medication use for sleep and depression. Results demonstrate that virtual trials can quickly draw a highly geographically diverse research population, overcoming logistical challenges inherent in a pandemic and resulting in recruiting appropriate, but more geographically diverse, samples than those typically observed in randomized trials of cognitive behavioral therapy for insomnia (CBT-I).Support (if any):