scholarly journals Nocebo-Hypothesis Cognitive Behavioral Therapy (NH-CBT) for Persons With Functional Neurological Symptoms (Motor Type): Design and Implementation of a Randomized Active-Controlled Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Matt Richardson ◽  
Maria Kleinstäuber ◽  
Dana Wong

Introduction: Functional Neurological Symptom Disorders (FNSD) are associated with high levels of disability and immense direct and indirect health costs. An innovative interdisciplinary rehabilitation approach for individuals with functional neurological symptoms of motor type–Nocebo-Hypothesis Cognitive Behavioral Therapy (NH-CBT)—combines CBT and movement retraining with video feedback embedded in a comprehensive explanatory model of the etiology of FNSD.Methods: This protocol describes the development and implementation of a phase II, parallel group, randomized controlled trial with blinded outcome assessors to compare the efficacy of NH-CBT with an active control condition (supportive counseling and movement retraining). Individuals meeting diagnostic criteria of an FNSD or psychogenic movement disorder will be randomly assigned to one of the 8-week interventions. Self-report scales of motor and other physical symptoms, symptom-related psychological variables, and assessor ratings of participants' mobility will be administered at baseline, and at 8- and 16-week follow-up. Adverse events will be monitored across all sessions and therapeutic alliance will be measured at the end of therapy. The primary statistical analysis will test the hypothesis that NH-CBT is more effective than the control intervention at the 8-week follow-up.Discussion: The therapeutic strategies of NH-CBT are theory-driven by assumptions of the predictive coding model of the etiology of FNSD. Strengths and limitations of this trial will be discussed.Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR; identifier: ACTRN12620000550909).

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Laura Dellazizzo ◽  
Stéphane Potvin ◽  
Kingsada Phraxayavong ◽  
Alexandre Dumais

AbstractThe gold-standard cognitive–behavioral therapy (CBT) for psychosis offers at best modest effects. With advances in technology, virtual reality (VR) therapies for auditory verbal hallucinations (AVH), such as AVATAR therapy (AT) and VR-assisted therapy (VRT), are amid a new wave of relational approaches that may heighten effects. Prior trials have shown greater effects of these therapies on AVH up to a 24-week follow-up. However, no trial has compared them to a recommended active treatment with a 1-year follow-up. We performed a pilot randomized comparative trial evaluating the short- and long-term efficacy of VRT over CBT for patients with treatment-resistant schizophrenia. Patients were randomized to VRT (n = 37) or CBT (n = 37). Clinical assessments were administered before and after each intervention and at follow-up periods up to 12 months. Between and within-group changes in psychiatric symptoms were assessed using linear mixed-effects models. Short-term findings showed that both interventions produced significant improvements in AVH severity and depressive symptoms. Although results did not show a statistically significant superiority of VRT over CBT for AVH, VRT did achieve larger effects particularly on overall AVH (d = 1.080 for VRT and d = 0.555 for CBT). Furthermore, results suggested a superiority of VRT over CBT on affective symptoms. VRT also showed significant results on persecutory beliefs and quality of life. Effects were maintained up to the 1-year follow-up. VRT highlights the future of patient-tailored approaches that may show benefits over generic CBT for voices. A fully powered single-blind randomized controlled trial comparing VRT to CBT is underway.


2007 ◽  
Vol 37 (6) ◽  
pp. 849-862 ◽  
Author(s):  
HENK JAN CONRADI ◽  
PETER de JONGE ◽  
HERMAN KLUITER ◽  
ANNET SMIT ◽  
KLAAS van der MEER ◽  
...  

Background. The long-term outcome of major depression is often unfavorable, and because most cases of depression are managed by general practitioners (GPs), this places stress on the need to improve treatment in primary care. This study evaluated the long-term effects of enhancing the GP's usual care (UC) with three experimental interventions.Method. A randomized controlled trial was conducted from 1998 to 2003. The main inclusion criterion was receiving GP treatment for a depressive episode. We compared: (1) UC (n=72) with UC enhanced with: (2) a psycho-educational prevention (PEP) program (n=112); (3) psychiatrist-enhanced PEP (n=37); and (4) brief cognitive behavioral therapy followed by PEP (CBT-enhanced PEP) (n=44). We assessed depression status quarterly during a 3-year follow-up.Results. Pooled across groups, depressive disorder-free and symptom-free times during follow-up were 83% and 17% respectively. Almost 64% of the patients had a relapse or recurrence, the median time to recurrence was 96 weeks, and the mean Beck Depression Inventory (BDI) score over 12 follow-up assessments was 9·6. Unexpectedly, PEP patients had no better outcomes than UC patients. However, psychiatrist-enhanced PEP and CBT-enhanced PEP patients reported lower BDI severity during follow-up than UC patients [mean difference 2·07 (95% confidence interval (CI) 1·13–3·00) and 1·62 (95% CI 0·70–2·55) respectively] and PEP patients [2·37 (95% CI 1·35–3·39) and 1·93 (95% CI 0·92–2·94) respectively].Conclusions. The PEP program had no extra benefit compared to UC and may even worsen outcome in severely depressed patients. Enhancing treatment of depression in primary care with psychiatric consultation or brief CBT seems to improve the long-term outcome, but findings need replication as the interventions were combined with the ineffective PEP program.


10.2196/10420 ◽  
2018 ◽  
Vol 5 (3) ◽  
pp. e10420 ◽  
Author(s):  
Elisabet Rondung ◽  
Elin Ternström ◽  
Ingegerd Hildingsson ◽  
Helen M Haines ◽  
Örjan Sundin ◽  
...  

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)


2013 ◽  
Vol 44 (3) ◽  
pp. 543-553 ◽  
Author(s):  
S. A. Wonderlich ◽  
C. B. Peterson ◽  
R. D. Crosby ◽  
T. L. Smith ◽  
M. H. Klein ◽  
...  

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.


Author(s):  
Zeinab Khairkhah ◽  
Ahmad Borjali ◽  
Faramarz Sohrabi

The present research was done with the aim of determining the effectiveness of group Cognitive – Behavioral therapy on reducing depression and its subscales (emotional symptoms, cognitive symptoms and physical symptoms) among the wives of the martyrs in the city of Tehran. First, 200 wives of the martyrs were randomly selected from among the wives of the martyrs who had referred to the counseling center of the Foundation of Martyrs and the questionnaire of depression was administered on them. The subjects whose level of depression was higher than the average level were determined and from among them 60 people were randomly chosen and later they were divided into two equal groups and from these two groups, by drawing one group was selected as the experimental and the other was selected as the control group. In the pretest stage, the questionnaire was administered on the subjects and the experimental group was placed under training, i.e. group cognitive-behavioral therapy, while the control group received no such therapy. In the posttest stage, the questionnaire of depression was carried out on both groups and one month later, the follow up stage was administered. Findings revealed that training group cognitive-behavioral therapy was effective on decreasing depression on the wives of the martyrs in Tehran. Findings also indicated depression among the experimental group and in the follow up stage they enjoyed necessary constancy. It is concluded that the group cognitive-behavioral therapy has considerably diminished depression among the wives.


2021 ◽  
Author(s):  
Christian Shaunlyn Chan ◽  
Christy Wong ◽  
Branda Y. M. Yu ◽  
Victoria Ka-Ying Hui ◽  
Fiona Y. Y. Ho ◽  
...  

Background: Despite its efficacy in treating comorbid insomnia and depression, cognitive behavioral therapy for insomnia (CBT-I) is limited in its accessibility and, in many regions, cultural compatibility. Smartphone-based treatments is a low-cost, convenient alternative modality. This study evaluated a self-help smartphone-based CBT-I in alleviating major depression and insomnia.Methods: A parallel-group randomized, waitlist-controlled trial was conducted with 322 adults with major depression and insomnia. Participants were randomized to receive either a 6-week CBT-I via a smartphone application, proACT-S, or waitlist condition. The primary outcomes included depression severity, insomnia severity, and sleep quality. The secondary outcomes included anxiety severity, subjective health, and acceptability of treatment. Assessments were administered at baseline, post-intervention follow up (Week 6), and Week 12 follow-up. The waitlist group received treatment after the first follow-up.Results: Intention to treat analysis was conducted with multilevel modeling. In all but one models, the interaction between treatment condition and the time point at Week 6 follow-up was significant. Compared with the waitlist group, the treatment group had lower levels of depression (CES-D: treatment difference = 0.83, 95% CI [0.58, 1.09]), insomnia (ISI: treatment difference = 0.89, 95% CI [0.64, 1.16]), and anxiety (HADS-A: treatment difference = 0.80, 95% CI [0.55, 1.06]). They also had better sleep quality (PSQI: treatment difference = 0.84, 95% CI [0.58, 1.10]). No differences across any measures were found at Week 12, after the waitlist control group received the treatment. Conclusion: proACT-S is an efficacious sleep-focused self-help treatment for major depression and insomnia.


2018 ◽  
Author(s):  
Elisabet Rondung ◽  
Elin Ternström ◽  
Ingegerd Hildingsson ◽  
Helen M Haines ◽  
Örjan Sundin ◽  
...  

BACKGROUND Although many pregnant women report fear related to the approaching birth, no consensus exists on how fear of birth (FOB) should be handled in clinical care. OBJECTIVE This randomized controlled trial (RCT) aimed to compare the efficacy of a guided internet-based self-help program based on cognitive behavioral therapy (guided ICBT) with standard care (SC) on the levels of FOB in a sample of pregnant women reporting FOB. METHODS This nonblinded, multicenter RCT 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 (UP) and consisted of 8 treatment modules and 1 module for postpartum follow-up. The aim was to help participants observe and understand their FOB and find new ways of coping with difficult thoughts and emotions. SC was offered in the three different study regions. The primary outcome was self-assessed levels of FOB, measured using the Fear of Birth Scale (FOBS). RESULTS We included 258 pregnant women reporting clinically significant levels of FOB (guided ICBT group, 127; SC 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 FOB 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 FOB (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 FOB over time was found (P=<.001), along with a significant interaction between time and intervention, showing a larger reduction in FOB in the guided ICBT group over time (F1,192.538=4.96, P=.03). CONCLUSIONS FOB 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. CLINICALTRIAL ClinicalTrials.gov NCT02306434; https://clinicaltrials.gov/ct2/show/NCT02306434 (Archived by WebCite at http://www.webcitation.org/70sj83qat)


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