scholarly journals A Pilot Randomized Controlled Trial of Dialectical Behavior Therapy (DBT) for Craving and Cessation in Marijuana Use Disorder Patients: Feasibility, Acceptability, and Appropriateness

2020 ◽  
Author(s):  
Mohammadreza davoudi ◽  
Zahra allame ◽  
Aliakbar Foroughi ◽  
Amir Abbas taheri
Keyword(s):  
Dialectical Behavior Therapy ◽  
Controlled Trial ◽  
Marijuana Use ◽  
Control Group ◽  
Control Groups ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Pilot Rct ◽  
Pilot Randomized Controlled Trial

Abstract Purpose: This study has investigated the feasibility and preliminary efficacy of DBT for Marijuana cessation and craving reduction as a pilot RCT.Methods: Sixty-one participants were randomly assigned to one of the DBT or psycho-education as active control-group with two-month follow-up. Patients completed measures at pre-interventions, post-interventions, and a two-month follow-up.Results: feasibility in DBT is significantly higher than the control group. In the DBT group 29/30 (96% retention) and in control group 24/31 (77% retention) completed all sessions (χ2= 4.95, p = 0.02). Moreover, 29/30 (96%) in the DBT group and 20/31 (64.5%) in the control group completed the two-month follow-up (χ2= 9.97, p = 0.002). For the acceptability of the intervention, results showed 16.57 (agree) in DBT and 9.6 (neither agree nor disagree) in control groups for p < 0.05. For appropriateness, results showed 17.03 (completely agree) in DBT and 10.7 (neither agree nor disagree) in control-groups for p < 0.05. for craving, results confirmed that there is no significant difference between groups (F = 3.52, p > 0.05); however, in “emotionality,” subscale DBT showed a significant reduction rather than the control group (F = 19.94, p < 0.05). For cessation rates, DBT was compared with the control group at the posttest (46% vs. 16%) and follow-up (40% vs. 9.5%), and results proved higher effectiveness in the DBT group for p < 0.05. Furthermore, among those who have lapsed, participation in the DBT group had fewer days than consume for p <0.05.Conclusions: DBT shows feasibility, acceptability, and promise in improving cessation rate in Marijuana use disorder and warrants further investigations.

scholarly journals A pilot Randomized Controlled Trial of Dialectical Behavior Therapy (DBT) for Craving and Cessation in Marijuana Use Disorder Patients: Feasibility, Acceptability, and Appropriateness

2020 ◽  
Author(s):  
mohammadreza davoudi ◽  
zahra allame ◽  
Aliakbar foroughi ◽  
Amir Abbas Taheri
Keyword(s):  
Dialectical Behavior Therapy ◽  
Controlled Trial ◽  
Marijuana Use ◽  
Control Group ◽  
Control Groups ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Pilot Rct ◽  
Pilot Randomized Controlled Trial

Abstract Purpose: This study has investigated the feasibility and preliminary efficacy of DBT for Marijuana cessation and craving reduction as a pilot RCT.Methods: sixty-one participants were randomly assigned to one of the DBT or psycho-education as active control-group with two-month follow-up. Patients completed measures at pre-interventions, post-interventions, and a two-month follow-up.Results: feasibility in DBT is significantly higher than the control group. In the DBT group 29/30 (96% retention) and in control group 24/31 (77% retention) completed all sessions (χ2= 4.95, p = 0.02). Moreover, 29/30 (96%) in the DBT group and 20/31 (64.5%) in the control group completed the two-month follow-up (χ2= 9.97, p = 0.002). For the acceptability of the intervention, results showed 16.57 (agree) in DBT and 9.6 (neither agree nor disagree) in control groups for p < 0.05. For appropriateness, results showed 17.03 (completely agree) in DBT and 10.7 (neither agree nor disagree) in control-groups for p < 0.05. for craving, results confirmed that there is no significant difference between groups (F = 3.52, p > 0.05); however, in “emotionality,” subscale DBT showed a significant reduction rather than the control group (F = 19.94, p < 0.05). For cessation rates, DBT was compared with the control group at the posttest (46% vs. 16%) and follow-up (40% vs. 9.5%), and results proved higher effectiveness in the DBT group for p < 0.05. Furthermore, among those who have lapsed, participation in the DBT group had fewer days than consume for p <0.05. Conclusions: DBT shows feasibility, acceptability, and promise in improving cessation rate in Marijuana use disorder and warrants further investigations.

Effect of buddy-style intervention on exercise adherence in community-dwelling disabled older adults: A pilot randomized controlled trial

2021 ◽  
pp. 026921552110411
Author(s):  
Hiromichi Takeda ◽  
Katsuhiko Takatori
Keyword(s):  
Older Adults ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Adherence ◽  
Control Group ◽  
Adult Day Care ◽  
Control Groups ◽  
Randomized Controlled ◽  
And Control ◽  
Pilot Randomized Controlled Trial

Objective To assess the preliminary effects of a buddy-style intervention to improve exercise adherence. Design A parallel-group, open-label, pilot randomized controlled trial. Setting Adult day-care centers. Participants Sixty-five disabled older adults. Interventions All participants underwent a 12-week home exercise program, and the intervention group received a 5–10 min buddy-style intervention between older adults in the intervention group once weekly at an adult day-care center. Main measures Based on the exercise log calendar, the number of days of exercise was assessed for each of the three phases: 1–4 weeks, 5–8 weeks, and 9–12 weeks. Short physical performance battery was measured at baseline and after 12 weeks. Results Of the 590 screened older adults, 65 were recruited and 33 were assigned to the intervention group. One participant in each group withdrew before the program began, and four and five patients in the intervention and control groups, respectively, dropped out by the 12-week assessment. Analysis of covariance of the 28 and 26 patients in the intervention and control groups, respectively, for whom exercise log calendars could be retrieved, showed that the intervention group (24.4/28 days) exercised significantly more days than the control group (20.6/28 days) at 9–12 weeks ( P = 0.009). In the between-group effect of the intention-to-treat analysis of short physical performance battery, walking and standing test ( P = 0.790, P = 0.829) were not significantly different, and balance test ( P = 0.049) was significantly better in the control group. Conclusions There was a preliminary effect of the buddy-style intervention to improve exercise adherence.

scholarly journals Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3246
Author(s):  
Juan P. Sanabria-Mazo ◽  
Jesus Montero-Marin ◽  
Albert Feliu-Soler ◽  
Virginia Gasión ◽  
Mayte Navarro-Gil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Control Group ◽  
Active Control Group ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.

scholarly journals Acupuncture to Treat Primary Dysmenorrhea in Women: A Randomized Controlled Trial

2011 ◽  
Vol 2011 ◽  
pp. 1-11 ◽  
Author(s):  
Caroline A. Smith ◽  
Caroline A. Crowther ◽  
Oswald Petrucco ◽  
Justin Beilby ◽  
Hannah Dent
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Effect ◽  
Controlled Trial ◽  
Acupuncture Group ◽  
Control Group ◽  
Primary Dysmenorrhea ◽  
Menstrual Pain ◽  
Randomized Controlled ◽  
Significant Difference

We examined the effectiveness of acupuncture to reduce the severity and intensity of primary dysmenorrhea. A randomized controlled trial compared acupuncture with control acupuncture using a placebo needle. Eligible women were aged 14–25 years with a diagnosis of primary dysmenorrhea. Women received nine sessions of the study treatment over 3 months. The primary outcomes were menstrual pain intensity and duration, overall improvement in dysmenorrhea symptoms and reduced need for additional analgesia, measured at 3, 6 and 12 months from trial entry. A total of 92 women were randomly assigned to the intervention (acupuncture and control ). At 3 months although pain outcomes were lower for women in the acupuncture group compared with the control group, there was no significant difference between groups. Women receiving acupuncture reported a small reduction in mood changes compared with the control group, relative risk (RR) 0.72, 95% confidence interval (CI) 0.53–1.00, . Follow-up at 6 months found a significant reduction in the duration of menstrual pain in the acupuncture group compared with the control group, mean difference –9.6, 95% CI –18.9 to –0.3, , and the need for additional analgesia was significantly lower in the acupuncture group compared with the control group, RR 0.69, 95% CI 0.49–0.96, , but the follow-up at 12 months found lack of treatment effect. To conclude, although acupuncture improved menstrual mood symptoms in women with primary dysmenorrhea during the treatment phase, the trend in the improvement of symptoms during the active phase of treatment, and at 6 and 12 months was non-significant, indicating that a small treatment effect from acupuncture on dysmenorrhea may exist. In the study, acupuncture was acceptable and safe, but further appropriately powered trials are needed before recommendations for clinical practice can be made.

scholarly journals Effects of a novel dye containing toothpaste versus regular fluoridated toothpaste for supragingival biofilm reduction in patients with chronic gingivitis: A Randomized Controlled Trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Avita Rath ◽  
Chong Junning ◽  
Priyadarshini HR ◽  
Brandon Nicholas Teo ◽  
Naik Hsian Zhen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Image Analysis ◽  
Controlled Trial ◽  
Control Group ◽  
Dental Biofilm ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Tooth Surfaces ◽  
The Mean

AIM:To compare the effects of a plaque disclosing toothpaste with a regular fluoridated toothpaste for supragingival biofilm reduction in patients with chronic gingivitis.MATERIALS AND METHODS:This study was a randomized controlled trial with a parallel design. Forty patients, both males and females aged 18-25 years with chronic generalized gingivitis (N=40) were randomly allocated to two groups of twenty each (n=20), using lottery method. Participants in the experimental group brushed with a plaque disclosing toothpaste, while participants in the control group brushed with regular fluoridated toothpaste. Clinically, biofilm was measured using Silness & Loe Plaque Index, both at baseline and at follow up visits by two assessors who were blinded to group allocation. Adjunctly, intraoral photographs were taken for Digital Plaque Image Analysis of the remaining dental biofilm in the upper and lower anterior labial tooth surfaces, and calculated based on the area of stained pixels. Data was analyzed using SPSS version 22. Mean plaque scores between the groups were compared using independent sample t-test and p<0.05 was considered significant.RESULTS:Data of all the 40 participants were analyzed as they were no drop outs. No significant differences were found in the mean plaque scores between the two groups (p=0.059) at the end of the study. Similarly, Digital Plaque Image Analysis showed no significant difference in the mean plaque scores between the groups (p= 0.93).CONCLUSION:This study showed that there are no additional benefits of using a plaque disclosing toothpaste, in enhancing the removal of the supragingival dental biofilm during routine oral hygiene maintenance.   

Enhancing adoptive parenting: A randomized controlled trial

2010 ◽  
Vol 15 (4) ◽  
pp. 529-542 ◽  
Author(s):  
Alan Rushton ◽  
Elizabeth Monck ◽  
Morven Leese ◽  
Paul McCrone ◽  
Jessica Sharac
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Adoptive Parents ◽  
Control Group ◽  
Parenting Interventions ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Significant Difference

The aim was to conduct a pragmatic randomized controlled trial (RCT) to evaluate two parenting programmes designed for adopters of children late placed from care. Adoptive parents, with children between 3 and 8 years who were screened to have serious behavioural problems early in the placement, participated in home-based, manualized, parenting programmes delivered by trained and supervised family social workers. The adopters who agreed to join the study were randomly allocated to one of two parenting interventions or to a “services as usual” group. Baseline, immediate post-intervention and six-month follow-ups were assessed using questionnaires and adopter interviews. No cases were lost to follow-up at any point and satisfaction was high with both parenting interventions. At the six-month follow-up, a significant difference ( p < 0.007) was found for “satisfaction with parenting” in favour of the intervention group (Effect Size d = 0.7). Negative parenting approaches were reduced in the intervention group. However, no significant differences in child problems were found between the intervention groups and control group, adjusting for baseline scores. Costs analysis showed that a relatively modest investment in post-adoption support would be well spent in improving adopters’ satisfaction with parenting in the intervention group compared to the routine service group.

scholarly journals A pilot randomized controlled trial of exercise to improve cognitive performance in patients with stable glioma: a proof of concept

2019 ◽  
Vol 22 (1) ◽  
pp. 103-115 ◽  
Author(s):  
Karin Gehring ◽  
Martijn M Stuiver ◽  
Eva Visser ◽  
Corelien Kloek ◽  
Martin van den Bent ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Performance ◽  
Cognitive Deficits ◽  
Controlled Trial ◽  
Exercise Group ◽  
Control Group ◽  
Proof Of Concept ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background Patients with glioma often suffer from cognitive deficits. Physical exercise has been effective in ameliorating cognitive deficits in older adults and neurological patients. This pilot randomized controlled trial (RCT) explored the possible impact of an exercise intervention, designed to improve cognitive functioning in glioma patients, regarding cognitive test performance and patient-reported outcomes (PROs). Methods Thirty-four clinically stable patients with World Health Organization grades II/III glioma were randomized to a home-based remotely coached exercise group or an active control group. Patients exercised 3 times per week for 20–45 minutes, with moderate to vigorous intensity, during 6 months. At baseline and immediate follow-up, cognitive performance and PROs were assessed with neuropsychological tests and questionnaires, respectively. Linear regression analyses were used to estimate effect sizes of potential between-group differences in cognitive performance and PROs at 6 months. Results The exercise group (n = 21) had small- to medium-sized better follow-up scores than the control group (n = 11) on several measures of attention and information processing speed, verbal memory, and executive function, whereas the control group showed a slightly better score on a measure of sustained selective attention. The exercise group also demonstrated small- to medium-sized better outcomes on measures of self-reported cognitive symptoms, fatigue, sleep, mood, and mental health–related quality of life. Conclusions This small exploratory RCT in glioma patients provides a proof of concept with respect to improvement of cognitive functioning and PROs after aerobic exercise, and warrants larger exercise trials in brain tumor patients.

scholarly journals Effects of geriatric interdisciplinary home rehabilitation on complications and readmissions after hip fracture: a randomized controlled trial

2018 ◽  
Vol 33 (1) ◽  
pp. 64-73 ◽  
Author(s):  
Monica Berggren ◽  
Åsa Karlsson ◽  
Nina Lindelöf ◽  
Undis Englund ◽  
Birgitta Olofsson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hip Fracture ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Geriatric Care ◽  
Control Group ◽  
Older Individuals ◽  
Randomized Controlled ◽  
Significant Difference

Objective: This pre-planned secondary analysis of geriatric interdisciplinary home rehabilitation, which was initially found to shorten the postoperative length of stay in hospital for older individuals following hip fracture, investigated whether such rehabilitation reduced the numbers of complications, readmissions, and total days spent in hospital after discharge during a 12-month follow-up period compared with conventional geriatric care and rehabilitation. Design: Randomized controlled trial. Setting: Geriatric department, participants’ residential care facilities, and ordinary housing. Subjects: Individuals aged ⩾70 years with acute hip fracture ( n = 205) were included. Intervention: Geriatric interdisciplinary home rehabilitation was individually designed and aimed at early discharge with the intention to prevent, detect, and treat complications after discharge. Main measures: Complications, readmissions, and days spent in hospital were registered from patients’ digital records and interviews conducted during hospitalization and at 3- and 12-month follow-up visits. Results: No significant difference in outcomes was observed. Between discharge and the 12-month follow-up, among participants in the geriatric interdisciplinary home rehabilitation group ( n = 106) and control group ( n = 93), 57 (53.8%) and 44 (47.3%) had complications ( P = 0.443), 46 (43.4%) and 38 (40.9%) fell ( P = 0.828), and 38 (35.8%) and 27 (29.0%) were readmitted to hospital ( P = 0.383); the median total days spent in hospital were 11.5 and 11.0 ( P = 0.353), respectively. Conclusion: Geriatric interdisciplinary home rehabilitation for older individuals following hip fracture resulted in similar proportions of complications, readmissions, and total days spent in hospital after discharge compared with conventional geriatric care and rehabilitation.

scholarly journals Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence

10.2196/17571 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e17571
Author(s):  
Emilio Goldenhersch ◽  
Johannes Thrul ◽  
Joaquín Ungaretti ◽  
Nicolas Rosencovich ◽  
Cristian Waitman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Virtual Reality ◽  
Tobacco Cessation ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Digital Interventions ◽  
Pilot Randomized Controlled Trial

Background Obstacles to current tobacco cessation programs include limited access and adherence to effective interventions. Digital interventions offer a great opportunity to overcome these difficulties, yet virtual reality has not been used as a remote and self-administered tool to help increase adherence and effectiveness of digital interventions for tobacco cessation. Objective This study aimed to evaluate participant adherence and smoking cessation outcomes in a pilot randomized controlled trial of the digital intervention Mindcotine (MindCotine Inc) using a self-administered treatment of virtual reality combined with mindfulness. Methods A sample of 120 participants was recruited in the city of Buenos Aires, Argentina (mean age 43.20 years, SD 9.50; 57/120, 47.5% female). Participants were randomly assigned to a treatment group (TG), which received a self-assisted 21-day program based on virtual reality mindful exposure therapy (VR-MET) sessions, daily surveys, and online peer-to-peer support moderated by psychologists, or a control group (CG), which received the online version of the smoking cessation manual from the Argentine Ministry of Health. Follow-up assessments were conducted by online surveys at postintervention and 90-day follow-up. The primary outcome was self-reported abstinence at postintervention, with missing data assumed as still smoking. Secondary outcomes included sustained abstinence at 90-day follow-up, adherence to the program, and readiness to quit. Results Follow-up rates at day 1 were 93% (56/60) for the TG and 100% (60/60) for the CG. At postintervention, the TG reported 23% (14/60) abstinence on that day compared with 5% (3/60) in the CG. This difference was statistically significant (χ21=8.3; P=.004). The TG reported sustained abstinence of 33% (20/60) at 90 days. Since only 20% (12/60) of participants in the CG completed the 90-day follow-up, we did not conduct a statistical comparison between groups at this follow-up time point. Among participants still smoking at postintervention, the TG was significantly more ready to quit compared to the CG (TG: mean 7.71, SD 0.13; CG: mean 7.16, SD 0.13; P=.005). A total of 41% (23/56) of participants completed the treatment in the time frame recommended by the program. Conclusions Results provide initial support for participant adherence to and efficacy of Mindcotine and warrant testing the intervention in a fully powered randomized trial. However, feasibility of trial follow-up assessment procedures for control group participants needs to be improved. Further research is needed on the impact of VR-MET on long-term outcomes. Trial Registration ISRCTN Registry ISRCTN50586181; http://www.isrctn.com/ISRCTN50586181

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