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.

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.

scholarly journals Does a tailored intervention to promote adherence in patients with chronic lung disease affect exacerbations? A randomized controlled trial

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Claudia Gregoriano ◽  
Thomas Dieterle ◽  
Anna-Lisa Breitenstein ◽  
Selina Dürr ◽  
Amanda Baum ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ambulatory Setting ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Copd Patients ◽  
The Impact ◽  
Inhaled Medication

Abstract Background Poor medication-adherence is common in chronic lung patients, resulting in reduced health-outcomes and increased healthcare-costs. This study aimed to investigate the impact of an acoustic reminder and support calls on adherence to inhaled therapy in asthma and COPD patients and to determine their effect on exacerbations. Methods This single-blinded randomized controlled trial investigated asthma and COPD patients during 6 months in an ambulatory setting. The intervention consisted of daily alarm clock and support phone calls, whenever use of rescue medication doubled or inhaled medication was not taken as prescribed. Primary outcome was time to next exacerbation. Frequency of exacerbations, adherence to inhaled medication and quality of life scores were secondary outcomes. Cox and Poisson regression were used to determine intervention effect on time to exacerbation and frequency of exacerbations, respectively. Results Seventy-five participants were assigned to the intervention group and 74 to usual follow-up care. During a median follow-up of 6.2 months, 22 and 28% in the intervention and control groups respectively, experienced at least one exacerbation. Intervention had no effect on time to first exacerbation (HR 0.65, 95% CI 0.21 to 2.07, P = .24), but showed a trend toward a 39% decreased frequency of exacerbations (RR = 0.61, 95% CI 0.35 to 1.03, P = .070) for the adjusted models, respectively. The intervention group had significantly more days with 80–100% taking adherence regarding puff inhalers (82 ± 14% vs. 60 ± 30%, P < .001) and dry powder capsules (90 ± .10% vs. 80 ± 21%, P = .01). Timing adherence in participants using puff inhalers was higher in the intervention group (69 ± 25% vs. 51 ± 33%, P < .001). No significant differences in QoL were found between the two groups. Conclusion Participants assigned to the intervention group had significantly better taking and timing adherence of inhaled medication resulting in a trend towards a decreased frequency of exacerbations. However, no effect on time to next exacerbation was observed. Trial registration ClinicalTrials.gov: NCT02386722, Registered 14 February 2014.

scholarly journals Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Angela A T Schuurmans ◽  
Karin S Nijhof ◽  
Ron Scholte ◽  
Arne Popma ◽  
Roy Otten
Keyword(s):  
Randomized Controlled Trial ◽  
Posttraumatic Stress ◽  
Controlled Trial ◽  
Self Report ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Posttraumatic Symptoms ◽  
Secondary Outcomes ◽  
Anxiety Depression

BACKGROUND Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents’ intrinsic motivation. The neurofeedback element reinforces relaxation abilities. OBJECTIVE This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care. METHODS This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters. RESULTS The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021. CONCLUSIONS Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents. CLINICALTRIAL Netherlands Trial Register NL6689 (NTR6859); https://www.trialregister.nl/trial/6689 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19881

scholarly journals Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized Controlled Trial

10.2196/19881 ◽  
2020 ◽  
Vol 9 (9) ◽  
pp. e19881 ◽  
Author(s):  
Angela A T Schuurmans ◽  
Karin S Nijhof ◽  
Ron Scholte ◽  
Arne Popma ◽  
Roy Otten
Keyword(s):  
Randomized Controlled Trial ◽  
Posttraumatic Stress ◽  
Controlled Trial ◽  
Self Report ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Posttraumatic Symptoms ◽  
Secondary Outcomes ◽  
Anxiety Depression

Background Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents’ intrinsic motivation. The neurofeedback element reinforces relaxation abilities. Objective This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care. Methods This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters. Results The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021. Conclusions Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents. Trial Registration Netherlands Trial Register NL6689 (NTR6859); https://www.trialregister.nl/trial/6689 International Registered Report Identifier (IRRID) DERR1-10.2196/19881

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 The effect of eggs on early child growth in rural Malawi: the Mazira Project randomized controlled trial

2019 ◽  
Vol 110 (4) ◽  
pp. 1026-1033 ◽  
Author(s):  
Christine P Stewart ◽  
Bess Caswell ◽  
Lora Iannotti ◽  
Chessa Lutter ◽  
Charles D Arnold ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Head Circumference ◽  
Controlled Trial ◽  
Intervention Group ◽  
Child Growth ◽  
Control Group ◽  
Z Score ◽  
Randomized Controlled ◽  
The Impact

ABSTRACT Background Stunted growth is a significant public health problem in many low-income countries. Objective The aim of this study was to evaluate the impact of 1 egg per day on child growth in rural Malawi. Design We conducted an individually randomized controlled trial in which 660 children aged 6–9 mo were equally allocated into an intervention (1 egg/d) or control group. Eggs were provided during twice-weekly home visits for 6 mo. Control households were visited at the same frequency. Assessors blinded to intervention group measured length, weight, head circumference, and midupper arm circumference at baseline and the 6-mo follow-up visit. To assess adherence, multipass 24-h dietary recalls were administered at baseline, 3-mo, and 6-mo visits. Results Between February and July 2018, 660 children were randomly assigned into the intervention (n = 331) and control (n = 329) groups. Losses to follow-up totaled 10%. In the intervention group, egg consumption increased from 3.9% at baseline to 84.5% and 70.3% at the 3-mo and 6-mo visits, whereas in the control group, it remained below 8% at all study visits. The baseline prevalence of stunting was 14%, underweight was 8%, and wasting was 1% and did not differ by group. There was no intervention effect on length-for-age, weight-for-age, or weight-for-length z scores. There was a significantly higher head circumference for age z score of 0.18 (95% CI: 0.01, 0.34) in the egg group compared with the control group. There was a significant interaction with maternal education (P = 0.024), with an effect on length-for-age z score only among children whose mothers had higher education. Conclusions The provision of 1 egg per day to children in rural Malawi had no overall effect on linear growth. A background diet rich in animal source foods and low prevalence of stunting at baseline may have limited the potential impact. This trial was registered at clinicaltrials.gov as NCT03385252.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

scholarly journals Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

2021 ◽  
Vol 18 (14) ◽  
pp. 7510
Author(s):  
Guillermo García Pérez de Sevilla ◽  
Olga Barceló Guido ◽  
María de la Paz De la Cruz ◽  
Ascensión Blanco Fernández ◽  
Lidia B. Alejo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Effect Size ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Nutrition Intervention ◽  
Sitting Time ◽  
Post Intervention ◽  
University Employees ◽  
Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

scholarly journals Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

2021 ◽  
Vol 27 (1) ◽  
pp. 146045822199640
Author(s):  
Faranak Kazemi Majd ◽  
Vahideh Zarea Gavgani ◽  
Ali Golmohammadi ◽  
Ali Jafari-Khounigh
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Readmission ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

Sign in / Sign up

Export Citation Format

Share Document