scholarly journals Effects of Illness Management and Recovery: A Multicenter Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Bert-Jan Roosenschoon ◽  
Jaap van Weeghel ◽  
Mathijs L. Deen ◽  
Emmie W. van Esveld ◽  
Astrid M. Kamperman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Esteem ◽  
Group Differences ◽  
Illness Management ◽  
Personal Recovery ◽  
Illness Management And Recovery ◽  
Randomized Controlled ◽  
The Impact

There have been inconsistent findings in the literature with respect to the efficacy of Illness Management and Recovery (IMR) in the psychosocial treatment of people with schizophrenia or other severe mental illnesses. This study aimed to comprehensively investigate the effectiveness of IMR, including the impact of completion and fidelity. In this randomized controlled trial (RCT), 187 outpatients received either IMR plus care as usual (CAU) or only CAU. Multilevel modeling was implemented to investigate group differences over an 18-month period, comprising 12 months of treatment and six months of follow-up. The primary outcome was overall illness management, which was assessed using the client version of the IMR scale. Secondary outcomes included measures regarding illness management, clinical, personal, and functional recovery, and hospitalizations. The interviewers were blinded to group allocation. This clinical trial was registered with the Netherlands Trial Register (NL4931, NTR5033). Patients who received IMR showed statistically significant improvement in self-reported overall illness management (the primary outcome). Moreover, they showed an improvement in self-esteem, which is a component of personal recovery. There were no effects within the other questionnaires. There were also no statistically significant between-group differences in terms of hospitalizations. Patients in both groups showed statistically significant improvement in clinician-rated overall illness management, social support, clinical and functional recovery, and self-stigma over time. IMR completion was associated with stronger effects. High IMR fidelity was associated with self-esteem. This study confirms the efficacy of IMR in overall illness self-management. To our knowledge, this is the first RCT on IMR to explore the impact of fidelity on treatment efficacy. Future studies should further establish efficacy in personal recovery. To improve efficacy, it appears important to promote IMR completion and fidelity.

scholarly journals A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lara Bücker ◽  
Josefine Gehlenborg ◽  
Steffen Moritz ◽  
Stefan Westermann
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Group Differences ◽  
Control Group ◽  
Gambling Problems ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

scholarly journals Effect of medically lowering intraocular pressure in glaucoma suspects with high myopia (GSHM study): study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Feng Bin Lin ◽  
◽  
Shi Da Chen ◽  
Yun He Song ◽  
Wei Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intraocular Pressure ◽  
High Myopia ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Rank Test ◽  
Inner Plexiform Layer ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Currently, whether and when intraocular pressure (IOP)-lowering medication should be used in glaucoma suspects with high myopia (GSHM) remains unknown. Glaucoma suspects are visual field (VF) defects that cannot be explained by myopic macular changes or other retinal and neurologic conditions. Glaucoma progression is defined by VF deterioration. Here we describe the rationale, design, and methodology of a randomized controlled trial (RCT) designed to evaluate the effects of medically lowering IOP in GSHM (GSHM study). Methods The GSHM study is an open-label, single-center, RCT for GSHM. Overall, 264 newly diagnosed participants, aged 35 to 65 years, will be recruited at the Zhongshan Ophthalmic Center, Sun Yat-sen University, between 2020 and 2021. Participants will be randomly divided into two arms at a 1:1 ratio. Participants in the intervention arm will receive IOP-lowering medication, while participants in the control arm will be followed up without treatment for 36 months or until they reach the end point. Only one eye per participant will be eligible for the study. If both eyes are eligible, the eye with the worse VF will be recruited. The primary outcome is the incidence of glaucoma suspect progression by VF testing over 36 months. The secondary outcomes include the incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer, and retinal ganglion cell-inner plexiform layer loss, progression of myopic maculopathy, visual function loss, and change in the quality of life. Statistical analyses will include baseline characteristics comparison between the intervention and control groups using a two-sample t-test and Wilcoxon rank sum test; generalized linear models with Poisson regression for the primary outcome; Kaplan-Meier curve and log-rank test for the incidence of the secondary outcome; and longitudinal analyses to assess trends in outcomes across time. Discussion To the best of our knowledge, the GSHM study is the first RCT to investigate the impact of medically lowering IOP in GSHM. The results will have implications for the clinical management of GSHM. Trial registration ClinicalTrials.gov NCT04296916. Registered on 4 March 2020

scholarly journals Exercise to Reduce Mobility Disability and Prevent Falls After Fall-Related Leg or Pelvic Fracture: RESTORE Randomized Controlled Trial

2020 ◽  
Vol 35 (10) ◽  
pp. 2907-2916 ◽  
Author(s):  
Catherine Sherrington ◽  
Nicola Fairhall ◽  
Catherine Kirkham ◽  
Lindy Clemson ◽  
Anne Tiedemann ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Pelvic Fracture ◽  
Lower Limb ◽  
Fall Risk ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Group Differences ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Disability and falls are common following fall-related lower limb and pelvic fractures. Objective To evaluate the impact of an exercise self-management intervention on mobility-related disability and falls after lower limb or pelvic fracture. Design Randomized controlled trial. Participants Three hundred thirty-six community dwellers aged 60+ years within 2 years of lower limb or pelvic fracture recruited from hospitals and community advertising. Interventions RESTORE (Recovery Exercises and STepping On afteR fracturE) intervention (individualized, physiotherapist-prescribed home program of weight-bearing balance and strength exercises, fall prevention advice) versus usual care. Main Measures Primary outcomes were mobility-related disability and rate of falls. Key Results Primary outcomes were available for 80% of randomized participants. There were no significant between-group differences in mobility-related disability at 12 months measured by (a) Short Physical Performance Battery (continuous version, baseline-adjusted between-group difference 0.08, 95% CI − 0.01 to 0.17, p = 0.08, n = 273); (b) Activity Measure Post Acute Care score (0.18, 95% CI − 2.89 to 3.26, p = 0.91, n = 270); (c) Late Life Disability Instrument (1.37, 95% CI − 2.56 to 5.32, p = 0.49, n = 273); or in rate of falls over the 12-month study period (incidence rate ratio 0.96, 95% CI 0.69 to 1.34, n = 336, p = 0.83). Between-group differences favoring the intervention group were evident in some secondary outcomes: balance and mobility, fall risk (Physiological Profile Assessment tool), physical activity, mood, health and community outings, but these should be interpreted with caution due to risk of chance findings from multiple analyses. Conclusions No statistically significant intervention impacts on mobility-related disability and falls were detected, but benefits were seen for secondary measures of balance and mobility, fall risk, physical activity, mood, health, and community outings. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12610000805077

Randomized Controlled Trial of Illness Management and Recovery in Multiple-Unit Supportive Housing

2009 ◽  
Vol 60 (12) ◽  
pp. 1629-1636 ◽  
Author(s):  
Aaron J. Levitt ◽  
Kim T. Mueser ◽  
Joe DeGenova ◽  
Julie Lorenzo ◽  
Dawn Bradford-Watt ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Supportive Housing ◽  
Illness Management ◽  
Illness Management And Recovery ◽  
Randomized Controlled ◽  
Multiple Unit

scholarly journals Effects of an Eight Week Online intervention for Depression, Anxiety and Stress in a university sample; randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Paul Ritvo ◽  
Farah Ahmad ◽  
Christo El Morr ◽  
Meysam Pirbaglou ◽  
Rahim Moineddin
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Psychological Characteristics ◽  
Secondary Outcome ◽  
Group Differences ◽  
Web Based ◽  
Randomized Controlled ◽  
The Impact ◽  
Labor Strike

BACKGROUND University students are experiencing higher levels of distress and mental health disorder. In addressing mental health needs, web-based interventions have shown increasing promise to overcome geographic distances and high student-to-counselor ratios, with a potential for widespread implementation. The Mindfulness Virtual Community (MVC) program, a web based program, guided by mindfulness and cognitive behavioural therapy principles, is among such efforts to effectively and efficiently reduce symptoms of depression, anxiety, and stress in students. OBJECTIVE To evaluate the efficacy of an 8-week MVC program in a 2 arm randomized controlled trial (RCT) in reducing depression, anxiety, and stress (primary outcomes), and improving mindfulness (secondary outcome) in undergraduate students at a Canadian university. Guided by two prior RCTs that each demonstrated efficacy when administered during regular university operations, the current study coincided with a university-wide labor strike. Given widespread closures as a result of COVID-19, student response to online mental health programming on a disrupted campus can provide useful information for anticipating the impact of COVID-19 related disruptions METHODS In this parallel arm RCT, 154 students were randomly allocated to the 8-week MVC intervention (n= 76) or a waitlist control (WLC) condition (n= 78). The intervention included (1) educational and mindfulness video modules, (2) anonymous peer-peer discussions, and (3) anonymous, group-based, professionally guided, videoconferences. Study outcomes were evaluated at baseline and at 8-week follow-up using: Patient Health Questionnaire-9 (PHQ-9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Generalized estimation equations with an AR(1) covariance structure were used to evaluate the impact of intervention, with outcome evaluations performed on both an intention to treat (ITT) and per protocol (PP) basis. RESULTS Participants (n= 154) were 35 males and 117 females with a mean age of 23.1 years. There were no statistically significant differences at baseline between MVC and WLC on demographics and psychological characteristics, indicating similar demographic-psychological characteristics across the MVC-WLC groups. Results under both ITT and PP approaches indicated significant between group differences for PSS (ITT: β= -2.31, P= .03; PP: β= -2.38, P= .03), but no significant between group differences in PHQ-9 (ITT: β= -0.44, P= 0.64; PP: β= -0.62, P= .053), BAI (ITT: β= -2.06, P= .31; PP: β= -2.32, P= .27), and FFMQ-SF (ITT: β= 1.33, P= .43; PP: β= 1.44, P= .41) (compared to WLC). CONCLUSIONS Under university labor strike conditions, the MVC program led to statistically significant reductions in PSS compared to WLC, but no other significant between group differences. Comparisons are made with previous study waves, undertaken during non-disrupted university conditions, where efficacy was demonstrated across depression, anxiety and mindfulness outcomes, are discussed. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275

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