scholarly journals Adjunctive yoga v. health education for persistent major depression: a randomized controlled trial

2017 ◽  
Vol 47 (12) ◽  
pp. 2130-2142 ◽  
Author(s):  
L. A. Uebelacker ◽  
G. Tremont ◽  
L. T. Gillette ◽  
G. Epstein-Lubow ◽  
D. R. Strong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
General Health ◽  
Controlled Trial ◽  
Health Perceptions ◽  
Depression Symptoms ◽  
Role Functioning ◽  
Intervention Period ◽  
Randomized Controlled ◽  
Over Time

BackgroundThe objective of this study was to determine whether hatha yoga is an efficacious adjunctive intervention for individuals with continued depressive symptoms despite antidepressant treatment.MethodWe conducted a randomized controlled trial of weekly yoga classes (n = 63) v. health education classes (Healthy Living Workshop; HLW; n = 59) in individuals with elevated depression symptoms and antidepressant medication use. HLW served as an attention-control group. The intervention period was 10 weeks, with follow-up assessments 3 and 6 months afterwards. The primary outcome was depression symptom severity assessed by blind rater at 10 weeks. Secondary outcomes included depression symptoms over the entire intervention and follow-up periods, social and role functioning, general health perceptions, pain, and physical functioning.ResultsAt 10 weeks, we did not find a statistically significant difference between groups in depression symptoms (b = −0.82, s.e. = 0.88, p = 0.36). However, over the entire intervention and follow-up period, when controlling for baseline, yoga participants showed lower levels of depression than HLW participants (b = −1.38, s.e. = 0.57, p = 0.02). At 6-month follow-up, 51% of yoga participants demonstrated a response (⩾50% reduction in depression symptoms) compared with 31% of HLW participants (odds ratio = 2.31; p = 0.04). Yoga participants showed significantly better social and role functioning and general health perceptions over time.ConclusionsAlthough we did not see a difference in depression symptoms at the end of the intervention period, yoga participants showed fewer depression symptoms over the entire follow-up period. Benefits of yoga may accumulate over time.

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 P1070ONLINE HIGH-VOLUME HEMODIAFILTRATION REDUCES PRE-DIALYSIS LEVELS OF INDOXYL SULFATE COMPARED TO HIGH-FLUX HEMODIALYSIS: RESULTS FROM HDFIT MULTICENTRIC RANDOMIZED CONTROLLED TRIAL

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Jordana Lima ◽  
Murilo Guedes ◽  
Silvia Rodrigues ◽  
Ana Clara Flórido ◽  
Ana Beatriz Barra ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Plasma Levels ◽  
Controlled Trial ◽  
High Volume ◽  
Indoxyl Sulfate ◽  
High Flux ◽  
Randomized Controlled ◽  
Mean Differences ◽  
Over Time

Abstract Background and Aims Online High-Volume Hemodiafiltration (OL-HDF) combines convective and diffusive clearances and is associated with better outcomes compared to standard hemodialysis (HD). Although HDF has been shown to improve the clearance and pre-dialysis concentration of middle size uremic toxins, little is known about its effect on concentration of protein-bound uremic toxins (PBUT), particularly in comparison to high-flux HD. Here, we investigated whether high-volume post-dilution OL-HDF impacts pre-dialysis plasma levels of PBUT indoxyl sulfate (IxS), p-cresyl sulfate (pCS) and indole 3-acetic acid (IAA) compared to high-flux HD over time, since accumulation of these PBUT has been associated with increased overall mortality of CKD patients. Method This is post hoc analysis of the multicentric randomized controlled trial (RCT) studying the impact of post-dilution high-volume OL-HDF versus high-flux HD on measured physical activity (HDFit - clinicalTrials.gov: NCT02787161), which included clinically stable HD patients with a vintage >3 to <24 months. Total plasma levels of IxS, pCS and IAA were determined by high performance liquid chromatography (HPLC) with fluorescence detection at baseline, 3 and 6 months. The difference between HDF and HD in respect to changes in the PBUT concentrations during the follow up, analyzed using linear mixed effect models, was compared. Results are presented as mean differences between groups in the change from baseline along with 95% confidence intervals (CI). Results 193 patients (mean age 53 years old, 70% males and 60% white – no differences between groups) were analyzed. There were no differences between HD and OL-HDF groups regarding clinical and biochemical characteristics at the baseline. In the OL-HDF group, 99% of patients achieved a convective volume higher than 22 L and both groups had similar dialysis session duration and blood flows throughout the follow up. The mean differences (95% CI) in concentrations over time for PBUTs among HDF and HD groups are shown in Figure 1. HDF group presented a significantly lower trajectory of IxS levels and a lower trajectory of pCS levels than HD group. Trajectories of IAA levels were not different between groups. Conclusion OL-HDF reduced the pre-dialysis concentration of IxS and pCS through 6 months-period compared to high-flux HD.

scholarly journals Cognitive–behavioural therapy in medication-treated adults with attention-deficit/hyperactivity disorder and co-morbid psychopathology: a randomized controlled trial using multi-level analysis

2015 ◽  
Vol 45 (13) ◽  
pp. 2793-2804 ◽  
Author(s):  
S. Young ◽  
M. Khondoker ◽  
B. Emilsson ◽  
J. F. Sigurdsson ◽  
F. Philipp-Wiegmann ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Adhd Symptoms ◽  
Hyperactivity Disorder ◽  
Randomized Controlled ◽  
Cognitive Behavioural ◽  
End Of Treatment ◽  
Over Time

BackgroundAttention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by high rates of co-morbid psychopathology. Randomized controlled trials of multimodal interventions, combining pharmacological and psychological treatments, have shown a robust treatment effect for ADHD symptoms but outcomes for co-morbid symptoms have been mixed. This may be accounted for by the type of intervention selected and/or by methodological problems including lack of follow-up and low power. The current study addressed these limitations in a parallel-group randomized controlled trial conducted in Iceland.MethodA total of 95 adult ADHD patients who were already being treated with medication (MED) were randomly assigned to receive treatment as usual (TAU/MED) or 15 sessions of cognitive–behavioural therapy (CBT/MED) using theR&R2ADHDintervention which employs both group and individual modalities. Primary measures of ADHD symptoms and severity of illness, and secondary measures of anxiety, depression and quality of life were given at baseline, end of treatment and 3-month follow-up. Primary outcomes were rated by clinicians blind to treatment condition assignment.ResultsCBT/MED showed overall (combined outcome at end of treatment and 3-month follow-up) significantly greater reduction in primary outcomes for clinician-rated and self-rated ADHD symptoms. Treatment effect of primary outcomes was maintained at follow-up, which suggests robust and lasting findings. In contrast to the primary outcomes, the secondary outcomes showed significant improvement over time.ConclusionsThe study provides evidence for the effectiveness ofR&R2ADHDand demonstrates that there are differential effects over time for ADHD symptomsversusco-morbid problems, the latter taking longer to show positive effects.

Effect on Overall Health Status With Weightbearing at 2 Weeks vs 6 Weeks After Open Reduction and Internal Fixation of Ankle Fractures

2020 ◽  
Vol 41 (6) ◽  
pp. 658-665
Author(s):  
Jonathon Schubert ◽  
Kaj T. A. Lambers ◽  
Cheryl Kimber ◽  
Katharina Denk ◽  
Matthew Cho ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Health Status ◽  
General Health ◽  
Controlled Trial ◽  
Ankle Fractures ◽  
General Health Status ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Vas Scores

Background: Ongoing controversy exists on postoperative weightbearing status after open reduction and internal fixation of an ankle fracture. This prospective randomized controlled trial aimed to compare patient-based and physician-based outcomes after early weightbearing at 2 vs 6 weeks postoperatively. Methods: Fifty patients with unstable rotational-type ankle fractures were treated operatively with subsequent immobilization in a below-the-knee cast for 2 weeks and were then randomly allocated to 2 groups. The first group had early weightbearing at 2 weeks postoperation and the second group at 6 weeks postoperation. Follow-up included subjective and objective evaluations performed at 2, 6, 12, and 26 weeks postoperatively. The primary outcome was the patient-based general health status as measured with the EuroQol-5D (EQ-5D) scoring system. Secondary outcome was the Olerud and Molander ankle score. Power analysis revealed a study group of 50 patients was needed to show a clinically relevant effect size of 10 points in both EQ-5D visual analog scale (VAS) score and Olerud and Molander score. Results: Patients in the early weightbearing group had higher mean EQ-5D VAS scores at a 6-week follow-up ( P = .014) of 77 ± 14 compared to 66 ± 15 for late mobilization. No difference was found at other follow-up points or between groups for physician-based outcome measures. At 26 weeks postoperatively, mean Olerud and Molander ankle scores were similar at 84 ± 16 and 81 ± 17 for mobilization at 2 and 6 weeks postoperation, respectively. Conclusion: Early weightbearing after operative fixation of rotational-type ankle fractures had a clinically relevant and statistically significant benefit in patient-based general health status, as quantified with EQ-5D VAS scores, at 6 weeks postoperation. These results contribute to our understanding of early weightbearing and may encourage consideration of weightbearing at 2 weeks postoperatively in standard protocols. Level of Evidence: Therapeutic Level I, prospective randomized controlled trial.

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

2018 ◽  
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 (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)

Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial

2018 ◽  
Vol 47 (2) ◽  
pp. 347-354 ◽  
Author(s):  
Alessandro Di Martino ◽  
Berardo Di Matteo ◽  
Tiziana Papio ◽  
Francesco Tentoni ◽  
Filippo Selleri ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hyaluronic Acid ◽  
Functional Status ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Symptomatic Relief ◽  
Randomized Controlled ◽  
Over Time

Background: Platelet-rich plasma (PRP) injections have been proposed as a new conservative option for knee degeneration to provide symptomatic relief and delay surgical intervention. Although the current literature provides some evidence on the benefits of this technique compared with viscosupplementation, no studies have been performed to compare their long-term effects. Purpose: To compare the long-term clinical outcomes provided by intra-articular injections of either PRP or hyaluronic acid (HA) to treat knee degenerative disease. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients with a history of chronic symptomatic knee degenerative changes and osteoarthritis (Kellgren-Lawrence grade 0-3) were enrolled: 192 patients were randomized to undergo 3 blinded weekly intra-articular injections of either PRP or HA. Patients were prospectively evaluated before the injection and then at 2, 6, 12, and 24 months and a mean of 64.3 months (SD, 7.8 months) of follow-up. Evaluation was based on International Knee Documentation Committee (IKDC) subjective (main outcome), EuroQol visual analog scale, and Tegner scores; 167 patients reached the final evaluation. Results: Both treatments were effective in improving knee functional status and symptoms over time: Mean ± SD IKDC subjective score improved significantly for both PRP and HA groups ( P < .0005) and remained stable over time up to 24 months (from 53.3 ± 14.3 to 67.3 ± 18.1 and from 50.3 ± 13.2 to 62.1 ± 20.8 for PRP and HA groups, respectively). At final evaluation, a significant IKDC reduction was observed in both treatment groups, with the PRP group still presenting significantly higher values compared with baseline: PRP 60.5 ± 19.0 ( P < .001 vs baseline), HA 55.7 ± 18.8 (not significant vs baseline). A comparative analysis showed no significant intergroup difference in any of the clinical scores at any follow-up point. The median duration of patient subjective perception of symptomatic relief was 9 months for HA and 12 months for PRP (not significant). The only significant difference was observed in the rate of reintervention at 24 months, which was significantly lower in the PRP group (22.6% vs 37.1%, P = .036). Conclusion: Both treatments were effective in improving knee functional status and symptoms over time. PRP did not provide an overall superior clinical improvement compared with HA in terms of either symptomatic-functional improvement at different follow-up points or effect duration. Registration: NCT01670578 (ClinicalTrials.gov identifier).

Preventing depression using a smartphone app: a randomized controlled trial

2020 ◽  
pp. 1-10 ◽  
Author(s):  
Mark Deady ◽  
Nicholas Glozier ◽  
Rafael Calvo ◽  
David Johnston ◽  
Andrew Mackinnon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Intervention Group ◽  
Smartphone App ◽  
Control Group ◽  
Depression Symptoms ◽  
Randomized Controlled ◽  
Small Effect Size

Abstract Background There is evidence that depression can be prevented; however, traditional approaches face significant scalability issues. Digital technologies provide a potential solution, although this has not been adequately tested. The aim of this study was to evaluate the effectiveness of a new smartphone app designed to reduce depression symptoms and subsequent incident depression amongst a large group of Australian workers. Methods A randomized controlled trial was conducted with follow-up assessments at 5 weeks and 3 and 12 months post-baseline. Participants were employed Australians reporting no clinically significant depression. The intervention group (N = 1128) was allocated to use HeadGear, a smartphone app which included a 30-day behavioural activation and mindfulness intervention. The attention-control group (N = 1143) used an app which included a 30-day mood monitoring component. The primary outcome was the level of depressive symptomatology (PHQ-9) at 3-month follow-up. Analyses were conducted within an intention-to-treat framework using mixed modelling. Results Those assigned to the HeadGear arm had fewer depressive symptoms over the course of the trial compared to those assigned to the control (F3,734.7 = 2.98, p = 0.031). Prevalence of depression over the 12-month period was 8.0% and 3.5% for controls and HeadGear recipients, respectively, with odds of depression caseness amongst the intervention group of 0.43 (p = 0.001, 95% CI 0.26–0.70). Conclusions This trial demonstrates that a smartphone app can reduce depression symptoms and potentially prevent incident depression caseness and such interventions may have a role in improving working population mental health. Some caution in interpretation is needed regarding the clinical significance due to small effect size and trial attrition. Trial Registration Australian and New Zealand Clinical Trials Registry (www.anzctr.org.au/) ACTRN12617000548336

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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