scholarly journals Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition: Results of the �Fitter na kanker� Randomized Controlled Trial (Preprint)

2016 ◽  
Author(s):  
Fieke Z. Bruggeman-Everts ◽  
Marije D. J. Wolvers ◽  
Rens van de Schoot ◽  
Miriam M. R. Vollenbroek-Hutten ◽  
Marije L. Van der Lee
Keyword(s):  
Randomized Controlled Trial ◽  
Active Control ◽  
Controlled Trial ◽  
Depression Scale ◽  
Secondary Outcome ◽  
Web Based ◽  
Technical Problems ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Fatigue Severity

BACKGROUND Approximately one third of all patients who have been successfully treated for cancer suffer from chronic cancer-related fatigue (CCRF). Effective and easily accessible interventions are needed for these patients. OBJECTIVE The current paper reports on the results of a 3-armed randomized controlled trial investigating the clinical effectiveness of two different guided Web-based interventions for reducing CCRF compared to an active control condition. METHODS Severely fatigued cancer survivors were recruited via online and offline channels, and self-registered on an open-access website. After eligibility checks, 167 participants were randomized via an embedded automated randomization function into: (1) physiotherapist-guided Ambulant Activity Feedback (AAF) therapy encompassing the use of an accelerometer (n=62); (2) psychologist-guided Web-based mindfulness-based cognitive therapy (eMBCT; n=55); or (3) an unguided active control condition receiving psycho-educational emails (n=50). All interventions lasted nine weeks. Fatigue severity was self-assessed using the Checklist Individual Strength - Fatigue Severity subscale (primary outcome) six times from baseline (T0b) to six months (T2). Mental health was self-assessed three times using the Hospital Anxiety and Depression Scale and Positive and Negative Affect Schedule (secondary outcome). Treatment dropout was investigated. RESULTS Multiple group latent growth curve analysis, corrected for individual time between assessments, showed that fatigue severity decreased significantly more in the AAF and eMBCT groups compared to the psycho-educational group. The analyses were checked by a researcher who was blind to allocation. Clinically relevant changes in fatigue severity were observed in 66% (41/62) of patients in AAF, 49% (27/55) of patients in eMBCT, and 12% (6/50) of patients in psycho-education. Dropout was 18% (11/62) in AAF, mainly due to technical problems and poor usability of the accelerometer, and 38% (21/55) in eMBCT, mainly due to the perceived high intensity of the program. CONCLUSIONS Both the AAF and eMBCT interventions are effective for managing fatigue severity compared to receiving psycho-educational emails. CLINICALTRIAL Trialregister.nl NTR3483; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3483 (Archived by WebCite at http://www.webcitation.org/6NWZqon3o)

Feasibility and effectiveness of activity-scheduling as a guided self-help intervention for the prevention of depression and anxiety in residents in homes for the elderly: a pragmatic randomized controlled trial

2011 ◽  
Vol 23 (6) ◽  
pp. 969-978 ◽  
Author(s):  
Els Dozeman ◽  
Digna J. F. van Schaik ◽  
Harm W. J. van Marwijk ◽  
Max L. Stek ◽  
Aartjan T. F. Beekman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Depression Scale ◽  
Secondary Outcome ◽  
Depression And Anxiety ◽  
Residential Homes ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Self Help

ABSTRACTBackground: Elderly people living in residential homes are at high risk for developing major depressive and anxiety disorders, and therefore deserve attention in terms of preventive interventions. We evaluated the feasibility and effectiveness of a guided self-help intervention for the prevention of depression and anxiety in these residents.Methods: We conducted a pragmatic randomized controlled trial in two parallel groups comparing the intervention with usual care in 14 residential homes in and surrounding the city of Amsterdam in the Netherlands. A total of 129 residents with a score of 8 or more on the Centre for Epidemiologic Studies Depression Scale (CES-D) screening instrument, who did not meet the full diagnostic criteria for disorders, and were not suffering from cognitive impairment were recruited between April 2007 and December 2008. Participants were randomized to a guided self-help intervention (n = 67) or to usual care (n = 62). The main outcome measures were improvement in the level of symptoms of depression and anxiety. The secondary outcome was improvement in participation in organized activities in the residential homes. The study is registered in de Dutch Cochrane Centre, under number ISRCTN27540731.Results: Only 21% of the participants (mean age 84.0 years (SD 6.7), 72.1% suffering from two or more chronic illnesses) completed the intervention. Although we found some large positive effect sizes on the CES-D, none of these effects was statistically significant.Conclusion: Although guided self-help may be promising in the prevention of depression and anxiety, it proved to be difficult to apply in this very old and vulnerable group of people living in residential homes.

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

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

Auricular Vagus Nerve Acupressure for Patients with Emotional Distress under the COVID-19 Pandemic: A Smartphone-based, Randomized，Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Peijing Rong ◽  
Lei Wang ◽  
Lingling Yu ◽  
Junying Wang ◽  
Yan Ma ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Vagus Nerve ◽  
Emotional Distress ◽  
Response Rate ◽  
Controlled Trial ◽  
Depression Scale ◽  
Randomized Controlled ◽  
Falling Asleep ◽  
Global Spread ◽  
Study Sites

BACKGROUND The global spread of the 2019 coronavirus diseases (COVID-19) has caused emotional distress. However, whether auricular vagus nerve acupressure (AVNA) is effective in improving emotional distress under the COVID-19 has not been well-documented. OBJECTIVE To confirm whether AVNA is effective in improving emotional distress under the COVID-19 pandemic. METHODS A smartphone-based online, randomized, controlled trial was designed in four study sites, including Wuhan, Beijing, Shenyang, and Guangzhou of China, from 26 February 2020 to 28 April 2020. Participants were randomly assigned to three times of AVNA (n = 191) or usual care (UC, n = 215) for 14 days. The primary outcome was the response rate, which was the proportion of participants whose Hospital Anxiety and Depression Scale (HADS) score reduced from baseline by ≥ 50%. The assessment was conducted at baseline, 3 days, and 14 days. RESULTS The AVNA group had a markedly higher response rate than the UC group at 3 days (35.6% vs. 24.9%, P = 0.02) and at 14 days (70.7% vs. 60.6%, P = 0.02). The AVNA group showed significantly greater reduction in score of HADS at the two measurement points and BAI at 3 days (P ≤ 0.03), with average respective effect size of 0.217 and 0.195. Participants with AVNA spent less time falling asleep and rated their sleep quality being remarkably higher than those with UC at endpoint. CONCLUSIONS AVNA can be recommended for patients with emotional distress under the current COVID-19 pandemic and other emergent events. CLINICALTRIAL www.chictr.org.cn Identifier: ChiCTR2000030078.

The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

2021 ◽  
Author(s):  
Ronnie L. Shammas ◽  
Caitlin E. Marks ◽  
Gloria Broadwater ◽  
Elliot Le ◽  
Adam D. Glener ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Lavender Oil ◽  
Entire Cohort ◽  
Randomized Controlled ◽  
Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

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