Randomized controlled trial of online interventions for co-occurring depression and hazardous alcohol consumption: Primary outcome results

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).

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Computer-based interventions targeting hazardous alcohol consumption and depressiveness among medical care patients: Preliminary findings from a randomized controlled proof of concept trial

10.1055/s-0041-1732736 ◽

2021 ◽

Author(s):

C Meyer ◽

D Gürtler ◽

K Krause ◽

A Möhring ◽

J Freyer-Adam ◽

...

Keyword(s):

Alcohol Consumption ◽

Medical Care ◽

Proof Of Concept ◽

Randomized Controlled ◽

Hazardous Alcohol ◽

Computer Based ◽

Hazardous Alcohol Consumption

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Improvement of radiocephalic fistula maturation: rationale and design of the Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation (LIPMAT) study – a randomized controlled trial

The Journal of Vascular Access ◽

10.5301/jva.5000673 ◽

2017 ◽

Vol 18 (1_suppl) ◽

pp. S114-S117 ◽

Cited By ~ 5

Author(s):

Bram M. Voorzaat ◽

Jan van Schaik ◽

Koen E.A. van der Bogt ◽

Liffert Vogt ◽

Laurens Huisman ◽

...

Keyword(s):

Animal Model ◽

Randomized Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Arteriovenous Fistulas ◽

Randomized Controlled ◽

Hemodialysis Fistula ◽

Vein Diameter ◽

Double Blinded ◽

Fistula Maturation

Background Non-maturation is a frequent complication of radiocephalic arteriovenous fistulas (RCAVF). In an animal model, liposomal prednisolone improved maturation of experimental fistulas. The Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation (LIPMAT) study investigates if liposomal prednisolone improves RCAVF maturation. Methods and results The LIPMAT study is an investigator-initiated, multicenter, double-blinded, placebo-controlled randomized controlled trial with 1:1 randomization to liposomal prednisolone or placebo. Eighty patients receiving an RCAVF will be included. The primary outcome is the cephalic vein diameter six weeks after surgery, measured by ultrasound. The LIPMAT study started in May 2016. Enrollment is expected to be completed by the end of 2017. Conclusions The LIPMAT study is the first to evaluate the efficacy of liposomal prednisolone to enhance RCAVF maturation.

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An Internet-Based Cognitive Behavioral Therapy Program Adapted to Patients With Cardiovascular Disease and Depression: Randomized Controlled Trial

JMIR Mental Health ◽

10.2196/14648 ◽

2019 ◽

Vol 6 (10) ◽

pp. e14648 ◽

Cited By ~ 9

Author(s):

Peter Johansson ◽

Mats Westas ◽

Gerhard Andersson ◽

Urban Alehagen ◽

Anders Broström ◽

...

Keyword(s):

Cardiovascular Disease ◽

Randomized Controlled Trial ◽

Cognitive Behavioral Therapy ◽

Primary Outcome ◽

Behavioral Therapy ◽

Controlled Trial ◽

Cognitive Behavioral ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Eq Vas

Background Depression is a common cause of reduced well-being and prognosis in patients with cardiovascular disease (CVD). However, there is a lack of effective intervention strategies targeting depression. Objective The study aimed to evaluate the effects of a nurse-delivered and adapted internet-based cognitive behavioral therapy (iCBT) program aimed at reducing depression in patients with CVD. Methods A randomized controlled trial was conducted. A total of 144 patients with CVD with at least mild depression (Patient Health Questionnaire–9 [PHQ-9] score ≥5) were randomized 1:1 to a 9-week program of iCBT (n=72) or an active control participating in a Web-based discussion forum (online discussion forum [ODF], n=72). The iCBT program, which included 7 modules, was adapted to fit patients with CVD. Nurses with an experience of CVD care provided feedback and a short introduction to cognitive behavioral therapy. The primary outcome, depression, was measured using PHQ-9. Secondary outcomes were depression measured using the Montgomery-Åsberg Depression Rating Scale–self-rating version (MADRS-S), health-related quality of life (HRQoL) measured using Short Form 12 (SF-12) survey and EuroQol Visual Analogue Scale (EQ-VAS), and the level of adherence. An intention-to-treat analysis with multiple imputations was used. Between-group differences in the primary and secondary outcomes were determined by the analysis of covariance, and a sensitivity analysis was performed using mixed models. Results Compared with ODF, iCBT had a significant and moderate treatment effect on the primary outcome depression (ie, PHQ-9; mean group difference=−2.34 [95% CI −3.58 to −1.10], P<.001, Cohen d=0.62). In the secondary outcomes, compared with ODF, iCBT had a significant and large effect on depression (ie, MADRS-S; P<.001, Cohen d=0.86) and a significant and moderate effect on the mental component scale of the SF-12 (P<.001, Cohen d=0.66) and the EQ-VAS (P<.001, Cohen d=0.62). Overall, 60% (n=43) of the iCBT group completed all 7 modules, whereas 82% (n=59) completed at least half of the modules. No patients were discontinued from the study owing to a high risk of suicide or deterioration in depression. Conclusions Nurse-delivered iCBT can reduce depression and improve HRQoL in patients with CVD, enabling treatment for depression in their own homes and at their preferred time. Trial Registration ClinicalTrials.gov NCT02778074; https://clinicaltrials.gov/ct2/show/NCT02778074

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A randomized controlled trial of inhibitory control training for the reduction of alcohol consumption in problem drinkers.

Journal of Consulting and Clinical Psychology ◽

10.1037/ccp0000312 ◽

2018 ◽

Vol 86 (12) ◽

pp. 991-1004 ◽

Cited By ~ 16

Author(s):

Andrew Jones ◽

Elly McGrath ◽

Eric Robinson ◽

Katrijn Houben ◽

Chantal Nederkoorn ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Alcohol Consumption ◽

Inhibitory Control ◽

Controlled Trial ◽

Problem Drinkers ◽

Randomized Controlled

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Treatment of osteoarthritis with autologous, micro-fragmented adipose tissue: a study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05628-4 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Rasmus Kramer Mikkelsen ◽

Lars Blønd ◽

Lisbeth Rosenkrantz Hölmich ◽

Cecilie Mølgaard ◽

Anders Troelsen ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adipose Tissue ◽

Knee Injury ◽

Primary Outcome ◽

Morphological Changes ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Outcome Score ◽

Patient Reported

Abstract Background Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro-fragmented adipose tissue has been suggested to relieve symptoms. Methods/Design The study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grades 2–3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro-fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total, 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months; the Tegner activity score; treatment failure; and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis. Discussion This trial is the first to investigate the efficacy of autologous, micro-fragmented adipose tissue in a randomized controlled trial. The study uses the patient-reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient’s opinion about their knee and associated problems when suffering from osteoarthritis.

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