scholarly journals Compassion-Focused Intervention for Highly Self-Critical Individuals: Pilot Study

2018 ◽  
Vol 46 (5) ◽  
pp. 583-600 ◽  
Author(s):  
Alexandra Rose ◽  
Ruth McIntyre ◽  
Katharine A. Rimes
Keyword(s):  
Pilot Study ◽  
Treatment Approach ◽  
Controlled Trial ◽  
Self Esteem ◽  
Preliminary Evidence ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Weekly Treatment ◽  
Compassion Focused Therapy

Self-criticism is a transdiagnostic process associated with a range of psychological problems. This uncontrolled pilot study evaluated the feasibility and acceptability of a six-session intervention using methods from compassion-focused therapy to reduce self-criticism, as well as investigating changes in a range of outcome measures. Twenty-three university student participants with significant impaired functioning associated with high levels of self-criticism received six individual weekly treatment sessions and a 2-month follow-up appointment. Acceptability was assessed through participant feedback. The intervention appeared to be feasible in terms of recruitment and retention of participants, and participant feedback indicated that overall the intervention seemed acceptable. There were statistically significant improvements between pre- and post-intervention for self-criticism, functional impairment, mood, self-esteem and maladaptive perfectionism with medium to large effect sizes at both post-intervention and follow-up. Gains were maintained or increased between post-treatment and 2-month follow-up. The study showed preliminary evidence of effectiveness of a compassion-focused intervention for self-critical students which appeared to be a feasible and acceptable treatment approach. This intervention now requires investigation in a randomized controlled trial.

scholarly journals Aromatherapy with ylang ylang for anxiety and self-esteem: a pilot study

2014 ◽  
Vol 48 (3) ◽  
pp. 492-499 ◽  
Author(s):  
Juliana Rizzo Gnatta ◽  
Patricia Petrone Piason ◽  
Cristiane de Lion Botero Couto Lopes ◽  
Noemi Marisa Brunet Rogenski ◽  
Maria Júlia Paes da Silva
Keyword(s):  
Pilot Study ◽  
Essential Oil ◽  
Self Esteem ◽  
Physiological Parameters ◽  
Post Intervention ◽  
Temperature Method ◽  
Significant Difference ◽  
Perception Of Self ◽  
Cutaneous Application

Objective: To verify if the use of ylang ylang essential oil by cutaneous application or inhalation alters the anxiety and self-esteem perception and physiological parameters as blood pressure and temperature. Method : A pilot study with 34 professionals from a nursing group randomized in three groups: one received the ylang ylang essential oil by cutaneous application, the second received through inhalation and the third (placebo) received the ylang ylang essence through cutaneous application. The assessment was done by an Anxiety Inventory (IDATE) and the Dela Coleta self-esteem scale, applied on baseline, after 30, 60 and 90 days and after 15 days post-intervention (follow up). Results : In the pre and post-intervention intergroup analysis, there was a significant difference in self-esteem for the three groups (p values: G1=0.014; G2=0.016; G3=0.038). There were no differences in the analysis between groups for anxiety or for physiological parameters. Conclusion : It was found significant alterations only to the intergroup perception of self-esteem for the three groups.


scholarly journals Auricular acupressure for hot flashes in patients with prostate cancer: protocol for a pilot randomized controlled trial

2020 ◽  
Author(s):  
Jianfu Zhou ◽  
Rongwu Lin ◽  
Xuehua Liu ◽  
Liguo Lv ◽  
Shusheng Wang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Pilot Study ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Preliminary Evidence ◽  
Control Group ◽  
Random Allocation ◽  
Clinical Trial Registry ◽  
Auricular Acupressure

Abstract BackgroundHot flashes, characterized by intense heat sensation and diaphoresis, are common side effects resulted from hormonotherapy in patients with prostate cancer. Cumulated studies have revealed beneficial role of acupuncture as complementary and alternative recipe for the management of hot flashes. However, little is known about the auricular acupressure (AA), a micro-acupuncture technique whose therapeutic purpose is similar with conventional acupuncture. Therefore, this current study aims to explore the effects and determine the feasibility of AA for hot flashes in patients with prostate cancer.Methods/DesignThis proposed pilot study is a two-arm parallel, single-blinded, randomized sham-controlled trial. A total of 72 participants of prostate cancer suffered with hot flashes will be recruited and randomly allocated into two groups in a 1:1 ratio. Equal randomization is conducted using a computer-generated random allocation sequence. Sheng Zhi Qi (TF2), Nei Fen Mi (CO18), Shen Men (TF4), Shen (CO10) and Pi Zhi Xia (AT4) are selected as experimental acupressure points, and five helix points (HX 8-12) are used as sham control acupressure points. Participants in the experimental group and control group will receive AA and sham-AA treatment, respectively. The duration of the treatment is 6 weeks with two sessions per week, and the follow-up period is 12 weeks. The primary outcome is Hot Flash Score (HFS). The secondary outcomes include Quality of Life (QoL), Pittsburgh Sleep Quality Index (PSQI) and Hamilton Anxiety Scale (HAS). All outcomes measurement will be conducted before and through treatment period as well as follow-up period. Safety assessment will be carried out through treatment and follow-up period.DiscussionThis pilot study will for the first time advance our knowledge on feasibility of AA in alleviating hot flashes in patients of prostate cancer and provide preliminary evidence for a further full-scale trial.Trial registrationChinese Clinical Trial Registry, ChiCTR1900026694. Registered on 19 October 2019.

Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial

2020 ◽  
Vol 47 (4) ◽  
pp. 451-462
Author(s):  
Júlia Caetano Martins ◽  
Sylvie Nadeau ◽  
Larissa Tavares Aguiar ◽  
Aline Alvim Scianni ◽  
Luci Fuscaldi Teixeira-Salmela ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Experimental Group

BACKGROUND: Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels. OBJECTIVE: To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke. METHODS: A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up. RESULTS: No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02). CONCLUSION: TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.

Promoting Forgiveness at a Christian College: A Comparison of the REACH Forgiveness and Forgive for Good Methods

2020 ◽  
Vol 48 (2) ◽  
pp. 154-165
Author(s):  
Loren L. Toussaint ◽  
Brandon J. Griffin ◽  
Everett L. Worthington ◽  
Mitchell Zoelzer ◽  
Frederic Luskin
Keyword(s):  
Randomized Controlled Trial ◽  
Community Intervention ◽  
Controlled Trial ◽  
Christian College ◽  
Combined Effects ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Forgiveness Intervention ◽  
Luther College

The present study is the first randomized, controlled trial comparing REACH Forgiveness and Forgive for Good, two of the most commonly used approaches to promote forgiveness. Additionally, the combined effects of psychoeducation and a community forgiveness intervention were examined. Psychoeducation participants were 99 Luther College students randomly assigned to six hours of one of two types of forgiveness training led by undergraduate facilitators or a control condition. The community forgiveness intervention involved campus-wide modifications to the environment that were difficult for most students to not notice. Unforgiveness and forgiveness were measured at pre-, post-intervention, and two-month follow-up. Both forgiveness groups reported decreased unforgiveness and increased forgiveness pre- to post-intervention, and these gains were maintained at follow-up. Both methods were found to be equally effective, can be taught by undergraduates, and were effective in tandem with a community intervention.

Bayesian methods for pilot studies

2020 ◽  
Vol 17 (4) ◽  
pp. 414-419 ◽  
Author(s):  
Andrew R Willan ◽  
Lehana Thabane
Keyword(s):  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Bayesian Methods ◽  
Controlled Trial ◽  
Recruitment Strategies ◽  
Pilot Studies ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Study Results

Background/aims: The use of pilot studies to help inform the design of randomized controlled trials has increased significantly over the last couple of decades. A pilot study can provide estimates of feasibility parameters, such as the recruitment, compliance and follow-up probabilities. The use of frequentist confidence intervals of these estimates fails to provide a meaningful measure of the uncertainty as it pertains to the design of the associated randomized controlled trial. The objective of this article is to introduce Bayesian methods for the analysis of pilot studies for determining the feasibility of an associated randomized controlled trial. Methods: An example from the literature is used to illustrate the advantages of a Bayesian approach for accounting for the uncertainty in pilot study results when assessing the feasibility of an associated randomized controlled trial. Vague beta distribution priors for the feasibility parameters are used. Based on the results from a feasibility study, simulation methods are used to determine the expected power of specified recruitment strategies for an associated randomized controlled trial. Results: The vague priors used for the feasibility parameters are demonstrated to be considerably robust. Beta distribution posteriors for the feasibility parameters lead to beta-binomial predictive distributions for an associated randomized controlled trial regarding the number of patients randomized, the number of patients who are compliant and the number of patients who complete follow-up. Ignoring the uncertainty in pilot study results can lead to inadequate power for an associated randomized controlled trial. Conclusion: Applying Bayesian methods to pilot studies’ results provides direct inference about the feasibility parameters and quantifies the uncertainty regarding the feasibility of an associated randomized controlled trial in an intuitive and meaningful way. Furthermore, Bayesian methods can identify recruitment strategies that yield the desired power for an associated randomized controlled trial.

The impact of an empowerment intervention on people with schizophrenia: Results of a randomized controlled trial

2017 ◽  
Vol 63 (3) ◽  
pp. 212-223 ◽  
Author(s):  
Abdalhadi Hasan ◽  
Mahmoud Musleh
Keyword(s):  
Randomized Controlled Trial ◽  
Psychiatric Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Post Intervention ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
The Impact

Aims: The aim of the study was to assess what empowerment intervention has on people with schizophrenia. Methods: A randomized controlled trial was carried out between November 2015 and May 2016 involving 112 participants who had been diagnosed with schizophrenia. Patients, who were 18 years and above diagnosed with Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V) schizophrenia or schizoaffective disorder from the outpatient mental health clinics in Jordan, were randomly assigned to take part in an intervention that consisted of receiving 6 weeks’ worth of information booklets, with face to face discussions, while receiving their usual medication or allocated treatment as usual. The participants were assessed at baseline, immediately after the intervention and at 3-month follow-up. The primary outcome was a change in the helplessness score. Secondary outcomes were psychiatric symptoms, recovery rate, empowerment and quality of life. Results: This study showed that people with schizophrenia in the intervention group showed more improvement in the helplessness score immediately post-intervention ( F = 74.53, p < .001) and at 3-month follow-up ( F = 75.56, p < .001), they reported significant improvements in all secondary outcomes. Conclusion: This study indicated that the empowering intervention was an effective intervention when integrated with treatment as usual.

scholarly journals Add-On Effect of Postural Instructions to Abdominopelvic Exercise on Urinary Symptoms and Quality of Life in Climacteric Women with Stress Urinary Incontinence. A Pilot Randomized Controlled Trial

2021 ◽  
Vol 18 (3) ◽  
pp. 928
Author(s):  
Laura Fuentes-Aparicio ◽  
Mercè Balasch-Bernat ◽  
Laura López-Bueno
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Controlled Trial ◽  
Exercise Program ◽  
Post Intervention ◽  
Patient’S Satisfaction ◽  
Randomized Controlled

The aim of this study was to investigate the add-on effect of postural instructions to an abdominopelvic exercise program on incontinence urinary symptoms (UI symptoms) and quality of life (QoL) in climacteric women with stress urinary incontinence (SUI). A randomized controlled trial was performed with a total of 40 climacteric women with SUI aged between 46 and 75 years old. Participants were randomly assigned to two groups: a group performing an abdominopelvic exercise program (AEP) (n = 20) and a group performing abdominopelvic exercise with the addition of postural instructions (AEPPI) (n = 20). Primary outcome measures were UI symptoms, UI impact and QoL related to UI (UI-QoL), measured by 48 h Pad Test and International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF), which were assessed at baseline, post-intervention and 3 months follow-up. Secondary outcome was patient’s satisfaction measured by the 100-point Visual Analogic Scale (VAS) only after the intervention. Between-groups differences were observed in terms of UI-QoL immediately after intervention. Within-groups differences were observed between baseline to 3 months follow-up and between post-intervention to 3 months follow-up in AEPPI group (p < 0.05) for UI-QoL and UI impact. UI symptoms were improved in both groups between baseline to 3-months follow-up (p < 0.05). Patient’s satisfaction was higher in the AEPPI group (p < 0.05). The addition of postural instructions to an abdominopelvic exercise program improves UI impact to QoL and patients’ satisfaction in women with SUI.

scholarly journals Impact of Intensive Gait Training With and Without Electromechanical Assistance in the Chronic Phase After Stroke–A Multi-Arm Randomized Controlled Trial With a 6 and 12 Months Follow Up

2021 ◽  
Vol 15 ◽  
Author(s):  
Susanne Palmcrantz ◽  
Anneli Wall ◽  
Katarina Skough Vreede ◽  
Påvel Lindberg ◽  
Anna Danielsson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Gait Training ◽  
Conventional Group ◽  
Control Group ◽  
Walk Test ◽  
Post Intervention ◽  
Randomized Controlled

Introduction: Movement related impairments and limitations in walking are common long-term after stroke. This multi-arm randomized controlled trial explored the impact of training with an electromechanically assisted gait training (EAGT) system, i.e., the Hybrid Assistive Limb® (HAL), when integrated with conventional rehabilitation focused on gait and mobility.Material and Methods: Participants, aged 18–70 years with lower extremity paresis but able to walk with manual support or supervision 1–10 years after stroke, were randomized to (A) HAL-training on a treadmill, combined with conventional rehabilitation interventions (HAL-group), or (B) conventional rehabilitation interventions only (Conventional group), 3 days/week for 6 weeks, or (C) no intervention (Control group). Participants in the Control group were interviewed weekly regarding their scheduled training. Primary outcome was endurance in walking quantified by the 6 Minute Walk Test (6MWT). A rater blinded to treatment allocation performed assessments pre- and post-intervention and at follow-ups at 6 and 12 months. Baseline assessment included the National Institute of Health Stroke Scale (NIHSS) and the Modified Ranking Scale (MRS). Secondary outcomes included the Fugl Meyer Assessment- Lower Extremity, 10 Meter Walk Test, Berg Balance Scale (BBS), Barthel Index (BI) and perceived mobility with the Stroke Impact Scale.Results: A total of 48 participants completed the intervention period. The HAL-group walked twice as far as the Conventional group during the intervention. Post-intervention, both groups exhibited improved 6 MWT results, while the Control group had declined. A significant improvement was only found in the Conventional group and when compared to the Control group (Tukey HSD p = 0.022), and not between the HAL group and Conventional group (Tukey HSD p = 0.258) or the HAL- group and the Control group (Tukey HSD p = 0.447). There was also a significant decline in the Conventional group from post-intervention to 6 months follow up (p = 0.043). The best fitting model to predict outcome included initial balance (BBS), followed by stroke severity (NIHSS), and dependence in activity and participation (BI and MRS).Conclusion: Intensive conventional gait training induced significant improvements long-term after stroke while integrating treadmill based EAGT had no additional value in this study sample. The results may support cost effective evidence-based interventions for gait training long-term after stroke and further development of EAGT.Trial registration: Published on clinicaltrials.gov (NCT02545088) August 24, 2015.

scholarly journals Rehabilitation of executive function in chronic paediatric brain injury: a randomized controlled trial

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Anne E. Brandt ◽  
Torun G. Finnanger ◽  
Ruth E. Hypher ◽  
Torstein B. Rø ◽  
Eva Skovlund ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Executive Function ◽  
Brain Injury ◽  
Daily Life ◽  
Controlled Trial ◽  
Executive Dysfunction ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background Impaired executive functions (EFs, i.e., purposeful, goal-directed behaviour) cause significant disability after paediatric acquired brain injury (pABI) warranting efficient interventions. Goal Management Training (GMT) is a metacognitive protocol proven effective for executive dysfunction in adults. This pre-registered, blinded, parallel-randomized controlled trial evaluated efficacy of a paediatric adaptation (pGMT) compared to a psychoeducative control (paediatric Brain Health Workshop, pBHW) to improve EF. Methods Children aged 10 to 17 years with pABI (e.g., traumatic brain injury, brain tumour), ≥ 1 year post-onset or ended treatment, with parent-reported EF complaints were eligible. Participants were randomized (computer-algorithm) to either group-based pGMT (n = 38) or pBHW (n = 38). The active control was tailored to keep non-specific factors constant. Thus, both treatments comprised of 7 sessions at hospitals over 3 consecutive weeks, followed by 4 weeks of telephone counselling of participants, parents, and teachers. Parent-reported daily life EF, assessed by the questionnaire Behavior Rating Inventory of Executive Function (BRIEF; Behavioral Regulation Index (BRI) and Metacognition Index (MI)), were co-primary outcomes 6 months post-intervention. Secondary outcomes included neuropsychological tests and a complex naturalistic task (Children’s Cooking Task). Results Seventy-three participants (96%) completed allocated interventions and 71 (93%) attended the 6-month follow-up. The results demonstrated no significant difference in effectiveness for the two interventions on parent-reported EF: For BRIEFBRI, mean (SD) raw score for pGMT was 42.7 (8.8) and 38.3 (9.3) for pBHW. Estimated difference was − 2.3 (95% CI − 5.1 to 0.6). For BRIEFMI, the corresponding results were 80.9 (20.4) for GMT and 75.5 (19.3) for pBHW. Estimated difference was − 1.4 (95% CI −8.5 to 5.8). In performance-based tests, pGMT was associated with improved inhibition and executive attention, while pBHW was associated with fewer errors in the naturalistic task. Conclusions In pABI, metacognitive training (pGMT) did not demonstrate additional effectiveness on parent-reported daily life EF at 6-month follow-up, when compared to a psychoeducative control. Both interventions were well-tolerated and demonstrated distinct improvements at different EF assessment levels. To conclude on pGMT efficacy, larger studies are needed, including further investigation of appropriate assessment levels and possible differences in effect related to treatment duration, developmental factors, and injury characteristics. Trial registration ClinicalTrials.gov, NCT0321534211, 11 July 2017

scholarly journals The Short- and Long-term Effectiveness of the WhyDairy? School-based Nutrition Education Intervention: A Randomized Controlled Trial

2019 ◽  
Vol 13 (1) ◽  
pp. 16-26
Author(s):  
Megan Racey ◽  
Andrew McKenney ◽  
David Wosnick ◽  
Emma Sypes ◽  
William Albabish ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Dairy Products ◽  
Controlled Trial ◽  
Dietary Behaviour ◽  
Post Intervention ◽  
Web Based ◽  
School Based Intervention ◽  
Randomized Controlled ◽  
School Based

Background:Despite the known health benefits of dairy products, their daily consumption continues to decline in many populations, particularly in pre-adolescents and adolescents.Objective:The primary objective of the cluster randomized controlled trial was to assess whether a school-based intervention enhanced with a web-based component, known as WhyDairy? was more effective than a standardized dairy education program at changing: (i) knowledge of dairy products, (ii) intentions to consume dairy products, and (iii) dietary intake of dairy products.Methods:Grade 7 students (n=175) in 10 Southwestern Ontario schools were randomized by the school, into intervention or control. Intervention schools received the WhyDairy? intervention with a website component while control schools received a DFO education program. Intervention schools were further randomized to receive follow-up contact, through monthly emails, or no follow-up contact. A questionnaire, consisting of three surveys (knowledge, FFQ, and intention), was delivered at baseline, post-intervention, and follow-up.Results:All groups significantly increased their knowledge post-intervention but only intervention schools with follow-up email contact maintained this positive change in knowledge. No groups saw significant changes in dietary behaviour. The email campaign was successful in reaching parents but did not result in high engagement or changes in student outcomes.Conclusion:The results of this study demonstrate the effectiveness of a school-based intervention enhanced with a web-based component in changing student knowledge regarding dairy products and the engagement of the website during the intervention period. Future work should consider longer durations to see changes in dietary behaviour and more targeted approaches during follow-up periods.

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