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.

scholarly journals Randomized controlled trial on the effect of Internet-based Cognitive Behavioral Therapy with Real-Time Therapist Support Via a Video Conference for patients with chronic pain: A study protocol

2020 ◽  
Author(s):  
Kayoko Taguchi ◽  
Noriko Numata ◽  
Kana Kutsuzawa ◽  
Kensuke Yoshimura ◽  
Eiji Shimizu
Keyword(s):  
Chronic Pain ◽  
Cognitive Behavioral Therapy ◽  
Usual Care ◽  
Real Time ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Video Conference ◽  
Randomized Controlled ◽  
Therapist Support

Abstract Background: Chronic pain, which persists for at least 12 weeks, is a serious medical condition that not only causes numerous physical and mental conditions, but also affects a person's entire life. Previous studies concerning cognitive behavioral therapy for patients with chronic pain have shown low to intermediate effectiveness. This paper describes the study protocol for a randomized controlled trial (RCT) to evaluate the effectiveness of our newly developed Internet-based Cognitive Behavioral Therapy with Real-Time Therapist Support Via a Video Conference (vCBT) as an adjunct to usual care compared with only usual care for chronic pain. Methods: The RCT comprises two parallel groups (vCBT + usual care and usual care alone) of 20 participants each (n=40) who were diagnosed with chronic pain. We aim to evaluate the effectiveness of the intervention over 16 weeks. The primary outcome is pain intensity, which will be assessed by the Numerical Rating Scale (NRS) at week 16. Secondary outcomes are pain catastrophic perception and daily life impairment degree, each assessed by the Pain Catastrophizing Scale (PCS) and Pain Disability Assessment Scale (PADS). In addition, anxiety, depression, and quality of life will be assessed. All measures will be assessed at weeks 1 (baseline), 8 (middle), and 16 (post). Discussion: This study aims to demonstrate the effectiveness of Internet-based CBT with Real-Time Therapist Support Via a Video Conference for patients with chronic pain. The findings of this study will show a feasibility and safety of online CBT for chronic pain, valuable addition to the treatment options for these patients. And we expect that many therapists will be able to universally provide CBT of comparable quality in the treatment of chronic pain by using the CBT protocol which we have developed.

scholarly journals Randomized controlled trial on the effect of Internet-based Cognitive Behavioral Therapy with Real-Time Therapist Support Via a Video Conference for patients with chronic pain: A study protocol

2020 ◽  
Author(s):  
Kayoko Taguchi ◽  
Noriko Numata ◽  
Kana Kutsuzawa ◽  
Kensuke Yoshimura ◽  
Eiji Shimizu
Keyword(s):  
Chronic Pain ◽  
Cognitive Behavioral Therapy ◽  
Usual Care ◽  
Real Time ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Video Conference ◽  
Randomized Controlled ◽  
Therapist Support

Abstract Background: Chronic pain, which persists for at least 12 weeks, is a serious medical condition that not only causes numerous physical and mental conditions, but also affects a person's entire life. Previous studies concerning cognitive behavioral therapy for patients with chronic pain have shown low to intermediate effectiveness. This paper describes the study protocol for a randomized controlled trial (RCT) to evaluate the effectiveness of our newly developed Internet-based Cognitive Behavioral Therapy with Real-Time Therapist Support Via a Video Conference (vCBT) as an adjunct to usual care compared with only usual care for chronic pain. Methods: The RCT comprises two parallel groups (vCBT + usual care and usual care alone) of 20 participants each (n=40) who were diagnosed with chronic pain. We aim to evaluate the effectiveness of the intervention over 16 weeks. The primary outcome is pain intensity, which will be assessed by the Numerical Rating Scale (NRS) at week 16. Secondary outcomes are pain catastrophic perception and daily life impairment degree, each assessed by the Pain Catastrophizing Scale (PCS) and Pain Disability Assessment Scale (PADS). In addition, anxiety, depression, and quality of life will be assessed. All measures will be assessed at weeks 1 (baseline), 8 (middle), and 16 (post). Discussion: This study aims to demonstrate the effectiveness of Internet-based CBT with Real-Time Therapist Support Via a Video Conference for patients with chronic pain. The findings of this study will show a feasibility and safety of online CBT for chronic pain, valuable addition to the treatment options for these patients. And we expect that many therapists will be able to universally provide CBT of comparable quality in the treatment of chronic pain by using the CBT protocol which we have developed. Trial registration: UMIN000031124 ; Open public recruiting

Personalized attention control therapy for PTSD: effectiveness and moderators of outcome in a randomized controlled trial

2020 ◽  
pp. 1-11
Author(s):  
Adva Segal ◽  
Daniel S. Pine ◽  
Yair Bar-Haim
Keyword(s):  
Treatment Outcome ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Post Treatment ◽  
Attention Control ◽  
Randomized Controlled ◽  
Control Therapy ◽  
Pre Treatment ◽  
Attentional Interference

Abstract Background Previous randomized controlled trials (RCTs) suggest that attention control therapy (ACT), targeting aberrant fluctuations of attention toward and away from threats in patients with PTSD, may be effective in reducing symptoms. The current RCT examined whether the use of personalized-trauma stimuli enhances ACT efficacy in patients with PTSD. Additional moderators of treatment outcome were tested on an exploratory basis. Methods Sixty patients with PTSD were randomly assigned to either personalized ACT, non-personalized ACT, or a control condition. Changes in symptoms were examined across pre-treatment, post-treatment, and a 3-month follow-up. Attentional interference was examined pre- and post-treatment. Baseline clinical and cognitive indices as well as the time elapsed since the trauma were tested as potential moderators of treatment outcome. Results A significant reduction in clinical symptoms was noted for all three conditions with no between-group differences. Attention bias variability decreased following ACT treatment. Personalized ACT was more effective relative to the control condition when less time had elapsed since the trauma. Baseline clinical and cognitive indices did not moderate treatment outcome. Conclusions In this RCT of patients with PTSD, ACT was no more effective in reducing PTSD symptoms than a control condition. The data also suggest a potential benefit of personalized ACT for patients who experienced their trauma more recently.

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 Polysomnographic Predictors of Treatment Response to Cognitive Behavioral Therapy for Insomnia in Participants With Co-morbid Insomnia and Sleep Apnea: Secondary Analysis of a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Alexander Sweetman ◽  
Bastien Lechat ◽  
Peter G. Catcheside ◽  
Simon Smith ◽  
Nick A. Antic ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Apnea ◽  
Cognitive Behavioral Therapy ◽  
Sleep Disturbance ◽  
Treatment Response ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Pre Treatment

ObjectiveCo-morbid insomnia and sleep apnea (COMISA) is a common and debilitating condition that is more difficult to treat compared to insomnia or sleep apnea-alone. Emerging evidence suggests that cognitive behavioral therapy for insomnia (CBTi) is effective in patients with COMISA, however, those with more severe sleep apnea and evidence of greater objective sleep disturbance may be less responsive to CBTi. Polysomnographic sleep study data has been used to predict treatment response to CBTi in patients with insomnia-alone, but not in patients with COMISA. We used randomized controlled trial data to investigate polysomnographic predictors of insomnia improvement following CBTi, versus control in participants with COMISA.MethodsOne hundred and forty five participants with insomnia (ICSD-3) and sleep apnea [apnea-hypopnea index (AHI) ≥ 15] were randomized to CBTi (n = 72) or no-treatment control (n = 73). Mixed models were used to investigate the effect of pre-treatment AHI, sleep duration, and other traditional (AASM sleep macrostructure), and novel [quantitative electroencephalography (qEEG)] polysomnographic predictors of between-group changes in Insomnia Severity Index (ISI) scores from pre-treatment to post-treatment.ResultsCompared to control, CBTi was associated with greater ISI improvement among participants with; higher AHI (interaction p = 0.011), less wake after sleep onset (interaction p = 0.045), and less N3 sleep (interaction p = 0.005). No quantitative electroencephalographic, or other traditional polysomnographic variables predicted between-group ISI change (all p > 0.09).DiscussionAmong participants with COMISA, higher OSA severity predicted a greater treatment-response to CBTi, versus control. People with COMISA should be treated with CBTi, which is effective even in the presence of severe OSA and objective sleep disturbance.

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