A randomized controlled trial of cognitive behavioral therapy compared with diabetes education for diabetic peripheral neuropathic pain

2020 ◽  
pp. 135910532096226
Author(s):  
Diana M Higgins ◽  
Alicia A Heapy ◽  
Eugenia Buta ◽  
Kathryn M LaChappelle ◽  
Kristin L Serowik ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Pain Intensity ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Diabetes Education ◽  
Peripheral Neuropathic Pain ◽  
Mental Health Functioning ◽  
Randomized Controlled ◽  
Health Functioning

A randomized controlled trial compared cognitive behavioral therapy (CBT) and diabetes education (ED) as an adjunctive treatment for diabetic peripheral neuropathic pain (DPNP). We examined change from baseline to 12- and 36-week follow-up in overall pain intensity (NRS), neuropathic pain intensity/quality, pain interference, and mental health functioning, among others. Although CBT participants demonstrated improvement in pain intensity NRS, there were no between-condition differences at either follow-up. CBT reduced neuropathic pain intensity at 12-weeks more than ED. At 36-weeks, CBT was superior to ED for improving pain interference and mental health functioning. Results provide evidence of benefit of CBT for DPNP. ClinicalTrials.gov Identifier: NCT00830011

scholarly journals Fulranumab for treatment of diabetic peripheral neuropathic pain: A randomized controlled trial

Neurology ◽  
2014 ◽  
Vol 83 (7) ◽  
pp. 628-637 ◽  
Author(s):  
H. Wang ◽  
G. Romano ◽  
M. E. Frustaci ◽  
N. Bohidar ◽  
H. Ma ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Neuropathic Pain ◽  
Controlled Trial ◽  
Peripheral Neuropathic Pain ◽  
Randomized Controlled

scholarly journals Mindfulness-based cognitive therapy and cognitive behavioral therapy for chronic pain in multiple sclerosis: a randomized controlled trial protocol

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Dawn M. Ehde ◽  
Kevin N. Alschuler ◽  
Melissa A. Day ◽  
Marcia A. Ciol ◽  
Makena L. Kaylor ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Usual Care ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Average Pain Intensity ◽  
Average Pain ◽  
Pre Treatment ◽  
Management Approaches

Abstract Background Chronic pain is one of the most prevalent and disabling symptoms associated with multiple sclerosis (MS). Individuals with MS are interested in nonpharmacologic pain management approaches. Cognitive-behavioral therapy (CBT) is efficacious in improving MS-related pain outcomes. Mindfulness-based cognitive therapy (MBCT) is a promising, alternative approach. Little is known about moderators of these treatments’ outcomes, however. This article describes the study protocol for the first randomized controlled trial comparing MBCT, CBT, and usual care and examining treatment effect moderators in individuals with chronic pain and MS. Methods We will conduct a single-center, randomized, single blind, parallel-group trial comparing MBCT, CBT, and usual care in adults with MS and chronic pain. Both interventions will be delivered via eight group sessions using videoconferencing technology. Primary (average pain intensity) and secondary outcomes (including pain interference, depressive symptoms, fatigue, and sleep) will be assessed pre-treatment, mid-treatment, post-treatment, and at 6-month follow up. Potential treatment moderators will be assessed pre-treatment. We hypothesize that participants randomly assigned to MBCT or CBT will report significantly greater reductions in average pain intensity than participants assigned to usual care at post-treatment (primary study endpoint) and 6-month follow up. We also hypothesize that mindfulness, pain catastrophizing, and behavioral activation pre-treatment will moderate response to both active treatments, but not response to usual care. Discussion Findings will provide important new information about the efficacy and moderators of two nonpharmacologic pain management approaches delivered using technology to overcome common barriers to treatment access. The knowledge gained may lead to better patient-treatment matching and, ultimately, better pain treatment outcomes in MS. Trial registration ClinicalTrials.gov, NCT03782246. Registered on 20 December 2018.

A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain

Neurology ◽  
2006 ◽  
Vol 67 (8) ◽  
pp. 1411-1420 ◽  
Author(s):  
J. F. Wernicke ◽  
Y. L. Pritchett ◽  
D. N. D'Souza ◽  
A. Waninger ◽  
P. Tran ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Neuropathic Pain ◽  
Controlled Trial ◽  
Peripheral Neuropathic Pain ◽  
Randomized Controlled

scholarly journals Results of the first randomized controlled trial of integrated cognitive-behavioral therapy for eating disorders and posttraumatic stress disorder

2021 ◽  
pp. 1-10
Author(s):  
Kathryn Trottier ◽  
Candice M. Monson ◽  
Stephen A. Wonderlich ◽  
Ross D. Crosby
Keyword(s):  
Posttraumatic Stress Disorder ◽  
Eating Disorders ◽  
Randomized Controlled Trial ◽  
Posttraumatic Stress ◽  
Stress Disorder ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Ptsd Symptoms ◽  
Randomized Controlled

Abstract Background Eating disorders (EDs) and posttraumatic stress disorder (PTSD) frequently co-occur and can share a functional relationship. The primary aim of this initial randomized controlled trial was to determine whether integrated cognitive-behavioral therapy (CBT) for co-occurring ED-PTSD was superior to standard CBT for ED in improving PTSD symptoms. Intervention safety and desirability, as well as the relative efficacy of the treatments in improving anxiety, depression, and ED symptomatology, were also examined. Methods Following a course of intensive ED treatment, individuals with ED-PTSD were recruited to participate and randomized to integrated CBT for ED-PTSD or standard CBT for ED. The sample consisted of 42 individuals with a range of ED diagnoses. Outcomes were assessed at end-of-treatment, 3-, and 6-month follow-up using interview and self-report measures. Results Mixed models revealed significant interactions of time and therapy condition on clinician-rated and self-reported PTSD symptom severity favoring Integrated CBT for ED-PTSD. Both treatments were associated with statistically significant improvements in PTSD, anxiety, and depression. Improvements were maintained at 3- and 6-month follow-up. There was good safety with both interventions, and satisfaction with both treatments was high. However, there was a stronger preference for integrated treatment. Conclusions Integrating CBTs for PTSD and ED following intensive ED treatment is safe, desirable, and efficacious for improving PTSD symptoms. Future studies with larger sample sizes are needed to determine whether Integrated CBT for ED-PTSD provides benefits over standard CBT for ED with respect to ED outcomes.

scholarly journals A Self-Administered Multicomponent Web-Based Mental Health Intervention for the Mexican Population During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Alejandro Dominguez-Rodriguez ◽  
Anabel De La Rosa-Gómez ◽  
M Jesús Hernández Jiménez ◽  
Paulina Arenas-Landgrave ◽  
Sofía Cristina Martínez-Luna ◽  
...  
Keyword(s):  
Mental Health ◽  
Positive Psychology ◽  
Behavioral Activation ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Well Being ◽  
Web Based ◽  
Significance Level ◽  
Randomized Controlled

BACKGROUND The COVID-19 pandemic has become a public health emergency of international concern; it has not only threatened people's physical health but has also affected their mental health and psychological well-being. It is necessary to develop and offer strategies to reduce the psychological impact of the outbreak and promote adaptive coping. OBJECTIVE This study protocol aims to describe a self-administered web-based intervention (Mental Health COVID-19) based on the principles of positive psychology supported by elements of cognitive behavioral therapy and behavioral activation therapy to reduce the symptoms of anxiety and depression and increase positive emotions and sleep quality during and after the COVID-19 outbreak through a telepsychology system. METHODS A randomized controlled clinical superiority trial with two independent groups will be performed, with intrasubject measures at four evaluation periods: pretest, posttest, 3-month follow-up, and 6-month follow-up. Participants will be randomly assigned to one of two groups: self-administered intervention with assistance via chat or self-administered intervention without assistance via chat. The total required sample size will be 166 participants (83 per group). RESULTS The clinical trial is ongoing. This protocol was approved by the Research Ethics Board of the Free School of Psychology-University of Behavioral Sciences (Escuela libre de Psicología-Universidad de Ciencias del Comportamiento). The aim is to publish the preliminary results in December 2020. A conservative approach will be adopted, and the size effect will be estimated using the Cohen <i>d</i> index with a significance level (α) of .05 (95% reliability) and a conventional 80% power statistic. CONCLUSIONS The central mechanism of action will be to investigate the effectiveness of an intervention based on positive psychology through a web platform that can be delivered through computers and tablets, with content that has been rigorously contextualized to the Mexican culture to provide functional strategies to help the target users cope with the COVID-19 pandemic. CLINICALTRIAL ClinicalTrials.gov NCT04468893; https://clinicaltrials.gov/ct2/show/NCT04468893 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/23117

scholarly journals Comparing Internet-Based Cognitive Behavioral Therapy With Standard Care for Women With Fear of Birth: Randomized Controlled Trial

10.2196/10420 ◽  
2018 ◽  
Vol 5 (3) ◽  
pp. e10420 ◽  
Author(s):  
Elisabet Rondung ◽  
Elin Ternström ◽  
Ingegerd Hildingsson ◽  
Helen M Haines ◽  
Örjan Sundin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Pregnant Women ◽  
Standard Care ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Over Time

Background Although many pregnant women report fear related to the approaching birth, no consensus exists on how fear of birth should be handled in clinical care. Objective This randomized controlled trial aimed to compare the efficacy of a guided internet-based self-help program based on cognitive behavioral therapy (guided ICBT) with standard care on the levels of fear of birth in a sample of pregnant women reporting fear of birth. Methods This nonblinded, multicenter randomized controlled trial with a parallel design was conducted at three study centers (hospitals) in Sweden. Recruitment commenced at the ultrasound screening examination during gestational weeks 17-20. The therapist-guided ICBT intervention was inspired by the Unified protocol for transdiagnostic treatment of emotional disorders and consisted of 8 treatment modules and 1 module for postpartum follow-up. The aim was to help participants observe and understand their fear of birth and find new ways of coping with difficult thoughts and emotions. Standard care was offered in the three different study regions. The primary outcome was self-assessed levels of fear of birth, measured using the Fear of Birth Scale. Results We included 258 pregnant women reporting clinically significant levels of fear of birth (guided ICBT group, 127; standard care group, 131). Of the 127 women randomized to the guided ICBT group, 103 (81%) commenced treatment, 60 (47%) moved on to the second module, and only 13 (10%) finished ≥4 modules. The levels of fear of birth did not differ between the intervention groups postintervention. At 1-year postpartum follow-up, participants in the guided ICBT group exhibited significantly lower levels of fear of birth (U=3674.00, z=−1.97, P=.049, Cohen d=0.28, 95% CI –0.01 to 0.57). Using the linear mixed models analysis, an overall decrease in the levels of fear of birth over time was found (P≤ .001), along with a significant interaction between time and intervention, showing a larger reduction in fear of birth in the guided ICBT group over time (F1,192.538=4.96, P=.03). Conclusions Fear of birth decreased over time in both intervention groups; while the decrease was slightly larger in the guided ICBT group, the main effect of time alone, regardless of treatment allocation, was most evident. Poor treatment adherence to guided ICBT implies low feasibility and acceptance of this treatment. Trial Registration ClinicalTrials.gov NCT02306434; https://clinicaltrials.gov/ct2/show/NCT02306434 (Archived by WebCite at http://www.webcitation.org/70sj83qat)

scholarly journals A randomized controlled comparison of integrative cognitive-affective therapy (ICAT) and enhanced cognitive-behavioral therapy (CBT-E) for bulimia nervosa

2013 ◽  
Vol 44 (3) ◽  
pp. 543-553 ◽  
Author(s):  
S. A. Wonderlich ◽  
C. B. Peterson ◽  
R. D. Crosby ◽  
T. L. Smith ◽  
M. H. Klein ◽  
...  
Keyword(s):  
Eating Disorder ◽  
Cognitive Behavioral Therapy ◽  
Bulimia Nervosa ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Bulimic Symptoms ◽  
Intent To Treat

BackgroundThe purpose of this investigation was to compare a new psychotherapy for bulimia nervosa (BN), integrative cognitive-affective therapy (ICAT), with an established treatment, ‘enhanced’ cognitive-behavioral therapy (CBT-E).MethodEighty adults with symptoms of BN were randomized to ICAT or CBT-E for 21 sessions over 19 weeks. Bulimic symptoms, measured by the Eating Disorder Examination (EDE), were assessed at baseline, at the end of treatment (EOT) and at the 4-month follow-up. Treatment outcome, measured by binge eating frequency, purging frequency, global eating disorder severity, emotion regulation, self-oriented cognition, depression, anxiety and self-esteem, was determined using generalized estimating equations (GEEs), logistic regression and a general linear model (intent-to-treat).ResultsBoth treatments were associated with significant improvement in bulimic symptoms and in all measures of outcome, and no statistically significant differences were observed between the two conditions at EOT or follow-up. Intent-to-treat abstinence rates for ICAT (37.5% at EOT, 32.5% at follow-up) and CBT-E (22.5% at both EOT and follow-up) were not significantly different.ConclusionsICAT was associated with significant improvements in bulimic and associated symptoms that did not differ from those obtained with CBT-E. This initial randomized controlled trial of a new individual psychotherapy for BN suggests that targeting emotion and self-oriented cognition in the context of nutritional rehabilitation may be efficacious and worthy of further study.

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