Clinical Trials Of Behavioral Interventions Research Articles

The Application of Cognitive Behavioral Therapy for Adolescent Patients With Endometriosis: A Topical Review

Recent advances and interest in nonpharmacological treatment approaches for various chronic pain conditions in adolescent patients have increased. Cognitive behavioral therapy (CBT) is widely regarded as the leading nonpharmacological treatment for chronic pain, encompassing gynecological conditions associated with chronic pelvic pain, such as endometriosis. Adolescents with endometriosis often present with different symptoms than adults and frequently report more comorbid psychiatric disorders than the general public. This review aims to (1) justify the application of CBT interventions in the context of adolescent patients with endometriosis; (2) integrate and analyze existing empirical evidence and reviews; (3) highlight the advantages, constraints, and future research directions in CBT for this demographic; and (4) introduce a novel biopsychosocial conceptual model. This model intricately considers the interplay of thoughts, emotions, behaviors, and physical symptoms specific to adolescents with endometriosis, providing a foundation for targeted CBT interventions. This holistic approach recognizes the multifaceted nature of their experience, paving the way for comprehensive and effective nonpharmacological therapeutic strategies. Given the nuanced and intricate nature of endometriosis in adolescents, there is a pressing need for innovative conceptual models and clinical trials of behavioral interventions explicitly designed for this demographic.

Prevalence of Gastrointestinal Symptoms and Irritable Bowel Syndrome Among Individuals With Symptomatic Posttraumatic Stress Disorder.

Our aim was to describe the prevalence of irritable bowel syndrome (IBS) and other gastrointestinal symptoms in a sample of veterans with posttraumatic stress disorder (PTSD) and to examine the relationship between gastrointestinal symptoms, PTSD severity, depression severity, and number of prior traumatic events reported. IBS and PTSD can co-occur; yet, little research has focused on describing the gastrointestinal symptoms and prevalence of IBS among veterans with PTSD. We examined baseline data from a randomized clinical trial of behavioral interventions for veterans with PTSD. Veterans completed questionnaires assessing gastrointestinal symptoms (Gastrointestinal Patient-Reported Outcome Measures Information Systems; PROMIS) and lifetime traumatic events. Multivariable regression analyses were performed to examine associations between gastrointestinal symptoms and the number of prior traumas reported PTSD severity, and depression symptom severity. One hundred eighty-four veterans with a diagnosis of PTSD were included. Twenty-five percent met the Rome III criteria for IBS. Veterans reported gastrointestinal symptoms including abdominal/belly pain (36%), diarrhea (21%), constipation (18%), and bloating/gas (17%). In multivariable analyses, greater PTSD severity was associated with worse constipation ( P =0.008), diarrhea ( P =0.005), and gas/bloating ( P =0.001) when controlling for age and sex. Higher levels of depressive symptoms severity were associated with greater abdominal/belly pain ( P =0.04). Among a sample of veterans with PTSD, rates of IBS and abdominal/belly pain are greater than general US population reference values. Although levels of constipation and bloating/gas are lower than general US population reference values, increased severity of PTSD was associated with increased gastrointestinal symptoms.

The yin and yang of pragmatic clinical trials of behavioral interventions for chronic pain: balancing design features to maximize impact.

Keefe, Francis J.a,*; Jensen, Mark P.b; Williams, Amanda C. de C.c; George, Steven Z.d Author Information

Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists.

Behavioral interventions involving electronic devices, financial incentives, gamification, and specially trained staff to encourage healthy behaviors are becoming increasingly prevalent and important in health innovation and improvement efforts. Although considerations of cost are key to their wider adoption, cost information is lacking because the resources required cannot be costed using standard administrative billing data. Pragmatic clinical trials that test behavioral interventions are potentially the best and often only source of cost information but rarely incorporate costing studies. This article provides a guide for researchers to help them collect and analyze, during the trial and with little additional effort, the information needed to inform potential adopters of the costs of adopting a behavioral intervention. A key challenge in using trial data is the separation of implementation costs, the costs an adopter would incur, from research costs. Based on experience with 3 randomized clinical trials of behavioral interventions, this article explains how to frame the costing problem, including how to think about costs associated with the control group, and describes methods for collecting data on individual costs: specifications for costing a technology platform that supports the specialized functions required, how to set up a time log to collect data on the time staff spend on implementation, and issues in getting data on device, overhead, and financial incentive costs.

A telehealth approach to improving clinical trial access for infants with tuberous sclerosis complex

BackgroundResearch in rare genetic syndromes associated with ASD is often hampered by the wide geographic distribution of families and the presence of medical comorbidities, such as epilepsy, that may preclude travel to clinical sites. These challenges can limit the sample size and generalizability of the cohorts included in both natural history studies and clinical trials. Tuberous sclerosis complex (TSC) is a rare genetic syndrome that confers an elevated risk for autism spectrum disorder (ASD), with social communication delays identified in this population as early as 12 months of age. Early identification of risk necessitates parallel testing of early intervention, prompting the first randomized controlled clinical trial of behavioral intervention for infants with TSC (NCT03422367). However, considerable early recruitment challenges have mandated the systematic identification of enrollment barriers followed by modification of the study design to address these barriers.MethodsCaregivers were interviewed regarding barriers to enrollment (phase 1). Adaptations to the intervention were made to address these barriers (phase 2). Outcomes based on this modification to the study design were defined by enrollment rate and participant demographics.ResultsQualitative reports from caregivers indicated that distance and time were the primary barriers to clinical trial enrollment. The intervention was then modified to a remote model, with at-home, parent-delivered intervention, and weekly video conferencing with interventionists at the study sites. Enrollment increased 10-fold (from 3 to 30 participants) within 1 year and included a more diverse and clinically representative cohort of infants.ConclusionThe design and implementation of more scalable methods to disseminate research remotely can substantially improve access to clinical trials in rare neurodevelopmental disorders. The lessons learned from this trial can serve as a model for future studies not only in rare conditions, but in other populations that lack adequate access, such as families with limited financial or clinical resources. Continued efforts will further refine delivery methods to enhance efficiency and ease of these delivery systems for families.

Psychosocial mechanisms of a behavioral treatment for urinary incontinence of prostate cancer survivors

Purpose: We examined underlying psychosocial processes of a behavioral treatment for urinary incontinence (UI) of prostate cancer survivors.Design: Secondary analysis of data collected from a clinical trial.Sample: Two hundred forty-four prostate cancer survivors who participated in a clinical trial of behavioral intervention to UI as intervention or control subjects.Methods: The participants had a 3-month behavioral intervention or usual care and were followed up for an additional 3 months. They were assessed at baseline, 3, and 6 months. Latent growth curve models were performed to examine trajectories of each study variable and relationships among the variables.Findings: Increasing self-efficacy and social support were significantly and independently associated with more reduction of urinary leakage frequency over time.Implications for psychosocial oncology: Providing problem-solving skills and social support, including peer support, are essential for empowering patients to reduce UI.

A yoga & exercise randomized controlled trial for vasomotor symptoms: Effects on heart rate variability

ObjectivesHeart rate variability (HRV) reflects the integration of the parasympathetic nervous system with the rest of the body. Studies on the effects of yoga and exercise on HRV have been mixed but suggest that exercise increases HRV. We conducted a secondary analysis of the effect of yoga and exercise on HRV based on a randomized clinical trial of treatments for vasomotor symptoms in peri/post-menopausal women. DesignRandomized clinical trial of behavioral interventions in women with vasomotor symptoms (n=335), 40–62 years old from three clinical study sites. Interventions12-weeks of a yoga program, designed specifically for mid-life women, or a supervised aerobic exercise-training program with specific intensity and energy expenditure goals, compared to a usual activity group. Main outcome measuresTime and frequency domain HRV measured at baseline and at 12 weeks for 15min using Holter monitors. ResultsWomen had a median of 7.6 vasomotor symptoms per 24h. Time and frequency domain HRV measures did not change significantly in either of the intervention groups compared to the change in the usual activity group. HRV results did not differ when the analyses were restricted to post-menopausal women. ConclusionsAlthough yoga and exercise have been shown to increase parasympathetic-mediated HRV in other populations, neither intervention increased HRV in middle-aged women with vasomotor symptoms. Mixed results in previous research may be due to sample differences. Yoga and exercise likely improve short-term health in middle-aged women through mechanisms other than HRV.

Variations in Delivery and Exercise Content of Physical Therapy Rehabilitation Following Total Knee Replacement Surgery: A Cross-Sectional Observation Study.

ObjectivePrevalence of total knee replacement (TKR) is large and growing but functional outcomes are variable. Physical therapy (PT) is integral to functional recovery following TKR but little is known about the quantity or content of PT delivered. Purposes of this study were to describe the amount and exercise content of PT provided in the terminal episode of PT care following TKR and to examine factors associated with utilization and content.MethodsSubjects included participants in a clinical trial of behavioral interventions for patients undergoing primary unilateral TKR who had completed the 6-month study evaluation. PT records were requested from 142 consecutive participants who had completed their post-TKR rehabilitation, 102 in/out patient care, and 40 in homecare. Information on utilization and exercises was extracted from a retrospective review of the PT records.ResultsWe received 90 (88%) outpatient and 27 (68%) homecare PT records. Records showed variability in timing, amount and content of PT. Patients receiving outpatient PT had more visits and remained in PT longer (p<0.001). Exercises known in the TKR literature were utilized more frequently in the outpatient setting (p=0.001) than in home care. Records from both settings had limited documentation of strengthening progression.ConclusionsThe study reveals considerable variability in timing, utilization and exercise content of PT following TKR and suggests sub-optimal exercise for strengthening. While methods we employed document variability, improved systematic PT documentation and in-depth research are needed to identify optimal timing, utilization and content of PT following TKR.

Preference, Expectation, and Satisfaction in a Clinical Trial of Behavioral Interventions for Acute and Sub-Acute Low Back Pain

Preference, Expectation, and Satisfaction in a Clinical Trial of Behavioral Interventions for Acute and Sub-Acute Low Back Pain

Preference, Expectation, and Satisfaction in a Clinical Trial of Behavioral Interventions for Acute and Sub-Acute Low Back Pain

The equivalency of behavioral interventions has led to the consideration of whether patient-related factors influence clinical trial outcomes. The primary purpose of this secondary analysis was to determine if treatment preference and patient expectation were predictors of trial outcomes and if selected patient-satisfaction items were appropriate as outcome measures. Perceived effectiveness, treatment preference, and patient expectation were assessed before random assignment, and patient satisfaction was assessed 6 months later. Patient preference was associated with perceived effectiveness for those with no treatment preference and those preferring graded exposure. Higher patient expectation was associated with higher perceived effectiveness ratings for all treatments in the clinical trial. Patients with no strong treatment preferences had larger 6-month improvements in pain intensity and disability, while patients with higher expectations had lower disability at baseline, 4 weeks, and 6 months. Patient satisfaction rates did not differ based on treatment received. Patient satisfaction was highest with treatment delivery and much lower with treatment effect. Patient satisfaction was uniformly associated with expectations being met, but only satisfaction with treatment effect was associated with lower pain and disability scores. These data support assessment of treatment preference and patient expectation as predictors and patient satisfaction as an outcome measure in low back pain (LBP) clinical trials. These data indicate treatment preference potentially impacts rate of improvement for patients with low back pain. Patient expectation did not impact rate of improvement, but those with higher expectations had lower pain and disability scores throughout the trial. Optimal assessment of patient satisfaction should include items that separately consider treatment delivery and effect.

Psychosocial interventions in breast cancer

A broad literature supports the importance of lifestyle, stress, and other psychosocial variables as independent risk factors for cancer and other diseases, whereas positive psychological well being is associated with reduced mortality. The evidence is sufficiently strong to motivate clinical research to evaluate the potential that intervening on these factors would alter the trajectory of these diseases. In their provocatively titled article, Stefanek and colleagues criticize the design and interpretation of results from a recently published clinical trial of psychological interventions for breast cancer patients. Although they raise valid criticisms related to its design and analysis, their recommendation that clinical trials of this nature be suspended until putative mechanisms of action are understood better is inconsistent with the general history of clinical trials in medicine. Moreover, the trial conducted by Andersen et al stands as a considerable accomplishment that deserves a closer look in a broader context. Two major trends have influenced the design and conduct of clinical trials of behavioral interventions. One is a widely held belief that behavioral interventions must be theory-based, reflecting psychological mechanisms of behavior change on 1 hand and addressing biologic mechanisms of disease causality on the other. The effect of these 2 principles on the design of clinical trials has been to include the collection of extensive secondary outcomes that might identify potential moderators and mediators of the intervention as well as biobehavioral mechanisms that might be affected if the intervention shows promise. The trial by Andersen et al is an excellent case in point. The intervention was designed carefully to address all of the biobehavioral pathways that are believed to influence the course of illness and to monitor progress on each. The investigators collected extensive data on stress and depression, health habits, adherence to medical care and indicators of immune function, devising composite indices that included many of these variables. The various measures and methods were detailed in a series of articles that reflect the enormous amount of careful effort expended to design and

Randomized Clinical Trial of Behavioral Intervention and Nutrition Education to Improve Caloric Intake and Weight in Children With Cystic Fibrosis

To evaluate the efficacy of a behavioral plus nutrition education intervention, Be In CHARGE!, compared with that of a nutrition education intervention alone on caloric intake and weight gain in children with cystic fibrosis and pancreatic insufficiency. Randomized controlled trial. Cystic fibrosis centers in the eastern, midwestern, and southern United States. Seventy-nine children aged 4 to 12 years below the 40th percentile for weight for age were recruited. Sixty-seven completed the intervention and 59 completed a 24-month follow-up assessment. Comparison of a behavioral plus nutrition education intervention with a nutrition education intervention alone. Primary outcomes were changes from pretreatment to posttreatment in caloric intake and weight gain. Secondary outcomes were changes from pretreatment to posttreatment in percentage of the estimated energy requirement and body mass index z score. These outcomes were also examined 24 months posttreatment. After treatment, the behavioral plus nutrition education intervention as compared with the nutrition education intervention alone had a statistically greater average increase on the primary and secondary outcomes of caloric intake (mean, 872 vs 489 cal/d, respectively), percentage of the estimated energy requirement (mean, 148% vs 127%, respectively), weight gain (mean, 1.47 vs 0.92 kg, respectively), and body mass index z score (0.38 vs 0.18, respectively). At the 24-month follow-up, children in both conditions maintained an estimated energy requirement of around 120% and did not significantly differ on any outcomes. A behavioral plus nutrition education intervention was more effective than a nutrition education intervention alone at increasing dietary intake and weight over a 9-week period. However, across the 24-month follow-up, both treatments achieved similar outcomes. Trial Registration clinicaltrials.gov Identifier: NCT00006169.

Standard care quality determines treatment outcomes in control groups of HAART-adherence intervention studies: Implications for the interpretation and comparison of intervention effects.

Clinical trials of behavioral interventions seek to enhance evidence-based health care. However, in case the quality of standard care provided to control conditions varies between studies and affects outcomes, intervention effects cannot be directly interpreted or compared. The objective of the present study was to examine whether standard care quality (SCQ) could be reliably assessed, varies between studies of highly active antiretroviral HIV-adherence interventions, and is related to the proportion of patients achieving an undetectable viral load ("success rate"). Databases were searched for relevant articles. Authors of selected studies retrospectively completed a checklist with standard care activities, which were coded to compute SCQ scores. The relationship between SCQ and the success rates was examined using meta-regression. Cronbach's alpha, variability in SCQ, and relation between SCQ and success rate. Reliability of the SCQ instrument was high (Cronbach's alpha = .91). SCQ scores ranged from 3.7 to 27.8 (total range = 0-30) and were highly predictive of success rate (p = .002). Variation in SCQ provided to control groups may substantially influence effect sizes of behavior change interventions. Future trials should therefore assess and report SCQ, and meta-analyses should control for variability in SCQ, thereby producing more accurate estimates of the effectiveness of behavior change interventions.

Design of Control‐Group Conditions in Clinical Trials of Behavioral Interventions

To review considerations in the design of placebo (attention) control conditions for community-based clinical trials of health behavior change interventions and to provide practical strategies for the design of control conditions. A well-designed control condition is an essential component of a clinical trial to foster the unambiguous interpretation of study findings. Pitfalls in the design of control conditions in clinical trials of behavioral interventions are identified and strategies to address them are offered. Types of control conditions that have been used in fall prevention trials are described, along with their strengths and weaknesses. The control condition used in the recent fall evaluation and prevention program (FEPP) was designed to overcome limitations of previous trial designs; it is provided to illustrate how to apply specific design principles. Pitfalls in the design of behavioral intervention studies may be avoided with the application of sound design principles. The FEPP active control condition can be used as a model in the design of future studies.

The fallibility of diagnostic tests for sexually transmitted diseases: the impact of behavioral and epidemiologic studies.

Analysis of sexually transmitted disease (STD) data to identify specific behaviors and risk factors often fails to take into account the misclassification of disease by a less than perfect diagnostic test. The authors consider here how a diagnostic test's performance profile can introduce misclassification and thereby bias measures of association. The authors used hypothetical data relating to diagnostic tests for Chlamydia trachomatis infections and oral contraceptive use to determine odds ratio estimates given a range of sensitivity, specificity, prevalence of infection, and sample size. Lower specificity in a diagnostic test can result in an underestimation of a risk factor's association with an infection. This bias is particularly severe in low prevalence populations. Use of a diagnostic test with low specificity also will increase the sample size needed to demonstrate the association and, thus, the cost of such surveys. Diagnostics tests for sexually transmitted diseases have less than perfect sensitivity and specificity, which affects the validity of analyses of factors associated with sexually transmitted diseases. Analyses done using low prevalence populations and/or small sample sizes may underestimate the magnitude of effect in retrospective studies and clinical trials of behavioral interventions aimed at reducing sexually transmitted disease risk.