A Randomized Controlled Trial Evaluating Integrative Psychotherapeutic Group Treatment Compared to Self-Help Groups in Functional Vertigo/Dizziness

We tested the efficacy of an integrative psychotherapeutic group treatment (IPGT) in reducing vertigo/dizziness-related impairment along with depression, anxiety, and somatization by conducting a randomized controlled superiority trial comparing IPGT to self-help groups moderated by a clinical psychologist (SHG). Adult patients with functional vertigo and dizziness symptoms were randomly allocated to either the IPGT or SHG as active control group. Outcomes were assessed at baseline (t0), after treatment lasting 16 weeks (t1), and 12 months after treatment (t2). A total of 81 patients were assigned to IPGT and 78 patients were assigned to SHG. Vertigo-related impairment was reduced in both conditions (IPGT: t0–t1: d = 1.10, t0–t2: d = 1.06; SHG: t0–t1: d = 0.86, t0–t2: d = 1.29), showing the efficiency of both IPGT and SHG. Clinically relevant improvements were also obtained for depression in both groups. Linear mixed model analyses revealed no differences between groups for all outcomes (effect of group for the primary outcome: b = −1.15, SE = 2.13, t = −0.54, p = 0.59). Attrition rates were higher in SHG (52.6%) than in IPGT (28.4%). Both conditions improved primary and secondary outcomes while IPGT was better accepted by patients than SHG. Trial registration: ClinicalTrials.gov, Identifier: NCT02320851.

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

Otolaryngology ◽

10.1177/0194599821994742 ◽

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.

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Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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The Use of Telehealth Technology in Assessing the Accuracy of Self-Reported Weight and the Impact of a Daily Immediate-Feedback Intervention among Obese Employees

International Journal of Telemedicine and Applications ◽

10.1155/2011/909248 ◽

2011 ◽

Vol 2011 ◽

pp. 1-6 ◽

Cited By ~ 4

Author(s):

Nicolaas P. Pronk ◽

A. Lauren Crain ◽

Jeffrey J. VanWormer ◽

Brian C. Martinson ◽

Jackie L. Boucher ◽

...

Keyword(s):

Body Weight ◽

Mixed Model ◽

Linear Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Study Groups ◽

Outcome Variable ◽

Control Group ◽

Immediate Feedback ◽

The Impact

Objective.To determine the accuracy of self-reported body weight prior to and following a weight loss intervention including daily self-weighing among obese employees.Methods.As part of a 6-month randomized controlled trial including a no-treatment control group, an intervention group received a series of coaching calls, daily self-weighing, and interactive telemonitoring. The primary outcome variable was the absolute discrepancy between self-reported and measured body weight at baseline and at 6 months. We used general linear mixed model regression to estimate changes and differences between study groups over time.Results.At baseline, study participants underreported their weight by an average of 2.06 (se=0.33) lbs. The intervention group self-reported a smaller absolute body weight discrepancy at followup than the control group.Conclusions.The discrepancy between self-reported and measured body weight appears to be relatively small, may be improved through daily self-monitoring using immediate-feedback telehealth technology, and negligibly impacts change in body weight.

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A Randomized Clinical Trial of Snus Examining the Effect of Complete Versus Partial Cigarette Substitution on Smoking-Related Behaviors, and Biomarkers of Exposure

Nicotine & Tobacco Research ◽

10.1093/ntr/ntz055 ◽

2019 ◽

Vol 22 (4) ◽

pp. 473-481 ◽

Cited By ~ 1

Author(s):

Ellen Meier ◽

Bruce R Lindgren ◽

Amanda Anderson ◽

Sarah A Reisinger ◽

Kaila J Norton ◽

...

Keyword(s):

New York ◽

Mixed Model ◽

Linear Mixed Model ◽

Controlled Trial ◽

Partial Substitution ◽

Randomized Controlled ◽

Biomarkers Of Exposure ◽

Wilcoxon Rank Sum Test ◽

Volatile Organic ◽

Subsequent Exposure

Abstract Introduction This 8-week multisite, randomized controlled trial of snus examined the differential effects of instructions on (1) snus use, (2) smoking and smoking-related measures, and (3) exposure to tobacco-related constituents. Method US adult daily cigarette smokers (n = 150; 43.3% female; Medianage = 43.5) were recruited from Minneapolis, Minnesota; Columbus and Coshocton, Ohio; and Buffalo, New York. Following a 1-week sampling phase of snus, participants who used at least 7 pouches were randomized to either (1) partial substitution (PS; “use snus as you like with your cigarettes”), (2) complete substitution (CS; “avoid cigarettes”), or (3) usual brand cigarettes (UB). Analyses included between-group analyses (eg, PS vs. CS) using Wilcoxon rank sum test of cigarettes per day and snus pouches per day, and a linear mixed model (biomarkers). Results Compared to the PS and UB groups, smokers assigned to CS reported greater reductions in cigarettes per day (ps < .001), using more snus pouches per day (p = .02), and more smoke-free days (CS median = 14.5, PS and UB medians = 0, p < .001). In addition, results demonstrated reductions in carbon monoxide (p < .001), total nicotine equivalents (p = .02), and four out of five measured volatile organic compounds (ps < .01) over time among the CS group. Exposure to N′-nitrosonornicotine increased by trial end only among the PS group (p < .04). Phenanthrene tetraol increased among all groups by trial end (p = .02) with no difference between groups. Conclusions Instructions to completely switch from cigarettes to snus resulted in the greatest reduction in cigarettes and exposure to harmful constituents. Implications Directly instructing smokers to switch completely to snus, rather than using ad libitum (with no instructions to avoid cigarettes), is necessary for reductions in smoking and subsequent exposure to harmful constituents.

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The effect of written information and counselling by an advanced practice nurse on resilience in women with vulvar neoplasia during six months after surgical treatment and the influence of social support, recurrence, and age: A secondary analysis of a multicenter randomized controlled trial, WOMAN-PRO-II

10.21203/rs.2.16848/v2 ◽

2020 ◽

Author(s):

Sabine Kofler ◽

Andrea Kobleder ◽

Stefan Ott ◽

Beate Senn

Keyword(s):

Randomized Controlled Trial ◽

Surgical Treatment ◽

Mixed Model ◽

Linear Mixed Model ◽

Practice Nurse ◽

Controlled Trial ◽

Advanced Practice ◽

Advanced Practice Nurse ◽

Randomized Controlled ◽

Written Information

Abstract Background: Women with vulvar neoplasia often complain about physical and psychological distress after surgical treatment. Lack of information and support can influence resilience. Whether an information-related intervention through an advanced practice nurse supports resilience and which other factors affect resilience in women with vulvar neoplasia has never been investigated. Methods: The aims of this study were (a) to analyse whether counselling based on the WOMAN-PRO II program causes a significant improvement in the resilience scores of women with vulvar neoplasia compared to written information and (b) to identify the potential predictors of resilience. A randomized controlled trial was conducted in women with vulvar neoplasia (n = 49) six months after surgical treatment in four Swiss hospitals and one Austrian hospital. Analyses of resilience and its predictors were performed using a linear mixed model. Results: Thirty-six women (intervention I, n = 8; intervention II, n = 28) completed the randomized controlled trial. In total, 13 women (26.5%) dropped out of the trial. The resilience score did not differ significantly between the two interventions three and six months after randomisation (p = 0.759). Age (b = .04, p = 0.001), social support (b = .28, p = 0.009), counselling time (b = .03, p = 0.018) and local recurrence (b = −.56, p = 0.009) were identified as significant predictors of resilience in the linear mixed model analyses. Conclusion: The results indicate that the WOMAN-PRO II program as single intervention does not cause a significant change in the resilience scores of women with vulvar neoplasia six months after surgery. Predictors that promote or minimise resilience have been identified and should be considered when developing resilience programs for women with vulvar neoplasia. A repetition of the study with a larger sample size is recommended.

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Self-Help for Social Anxiety: Randomized Controlled Trial Comparing a Mindfulness and Acceptance-Based Approach With a Control Group

Behavior Therapy ◽

10.1016/j.beth.2018.10.007 ◽

2019 ◽

Vol 50 (4) ◽

pp. 696-709 ◽

Cited By ~ 3

Author(s):

Nancy L. Kocovski ◽

Jan E. Fleming ◽

Rebecca A. Blackie ◽

Meagan B. MacKenzie ◽

Alison L. Rose

Keyword(s):

Randomized Controlled Trial ◽

Social Anxiety ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Self Help

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A randomized controlled trial of the use of self-help materials in addition to standard general practice treatment of depression compared to standard treatment alone

Psychological Medicine ◽

10.1017/s0033291705006422 ◽

2005 ◽

Vol 36 (3) ◽

pp. 325-333 ◽

Cited By ~ 15

Author(s):

PAUL SALKOVSKIS ◽

KATHARINE RIMES ◽

DEBORAH STEPHENSON ◽

GERALD SACKS ◽

JAN SCOTT

Keyword(s):

Primary Care ◽

Randomized Controlled Trial ◽

Social Adjustment ◽

Standard Treatment ◽

Controlled Trial ◽

Control Group ◽

Global Functioning ◽

Randomized Controlled ◽

Self Help ◽

Treatment Of Depression

Background. The purpose of the study was to examine whether the addition of a brief individual self-help package to standard primary-care treatment of depression with antidepressants is associated with any additional improvements in clinical outcome.Method. Individuals with major depressive disorder who were prescribed an antidepressant were recruited through their general practitioner (GP) and allocated randomly to standard treatment alone or standard treatment plus self-help. Assessments of symptoms, social adjustment, global functioning, satisfaction with treatment and knowledge about the management of the disorder were completed at three time points over 26 weeks.Results. One hundred and twelve individuals agreed to participate and 96 met criteria for inclusion in the randomized controlled trial. Subjects in both treatment conditions improved substantially over the study period; the mean Beck Depression Inventory (BDI) score fell from 27·3 to 13·9 in the intention-to-treat analysis. There were no between group differences in outcome on any of the primary outcome measures, nor did these approach even marginal significance. Patients and GPs were highly satisfied with the self-help programme, and the intervention as compared to the control group reported significantly greater improvements in knowledge about depression and satisfaction with information received about depression.Conclusions. An individualized self-help package improved perceived knowledge about depression but did not have identifiable effects on outcome when offered to patients treated in primary care. The study was sufficiently well powered to detect relatively small effects.

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Effects of momentary self-monitoring on empowerment in a randomized controlled trial in patients with depression

European Psychiatry ◽

10.1016/j.eurpsy.2015.09.004 ◽

2015 ◽

Vol 30 (8) ◽

pp. 900-906 ◽

Cited By ~ 16

Author(s):

C.J.P. Simons ◽

J.A. Hartmann ◽

I. Kramer ◽

C. Menne-Lothmann ◽

P. Höhn ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Group Treatment ◽

Antidepressant Treatment ◽

Controlled Trial ◽

Self Report ◽

Control Group ◽

Self Monitoring ◽

Randomized Controlled ◽

Experimental Group ◽

Reliable Increase

AbstractBackgroundInterventions based on the experience sampling method (ESM) are ideally suited to provide insight into personal, contextualized affective patterns in the flow of daily life. Recently, we showed that an ESM-intervention focusing on positive affect was associated with a decrease in symptoms in patients with depression. The aim of the present study was to examine whether ESM-intervention increased patient empowerment.MethodsDepressed out-patients (n = 102) receiving psychopharmacological treatment who had participated in a randomized controlled trial with three arms: (i) an experimental group receiving six weeks of ESM self-monitoring combined with weekly feedback sessions, (ii) a pseudo-experimental group participating in six weeks of ESM self-monitoring without feedback, and (iii) a control group (treatment as usual only). Patients were recruited in the Netherlands between January 2010 and February 2012. Self-report empowerment scores were obtained pre- and post-intervention.ResultsThere was an effect of group × assessment period, indicating that the experimental (B = 7.26, P = 0.061, d = 0.44, statistically imprecise) and pseudo-experimental group (B = 11.19, P = 0.003, d = 0.76) increased more in reported empowerment compared to the control group. In the pseudo-experimental group, 29% of the participants showed a statistically reliable increase in empowerment score and 0% reliable decrease compared to 17% reliable increase and 21% reliable decrease in the control group. The experimental group showed 19% reliable increase and 4% reliable decrease.ConclusionsThese findings tentatively suggest that self-monitoring to complement standard antidepressant treatment may increase patients’ feelings of empowerment. Further research is necessary to investigate long-term empowering effects of self-monitoring in combination with person-tailored feedback.

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The Contribution of Pro-Vitamin A Biofortified Cassava to Vitamin A Intake in Nigerian Pre-school Children

British Journal Of Nutrition ◽

10.1017/s0007114521000039 ◽

2021 ◽

pp. 1-26

Author(s):

Ibukun Afolami ◽

Folake Samuel ◽

Karin Borgonjen-van den Berg ◽

Martin Mwangi ◽

Olatundun Kalejaiye ◽

...

Keyword(s):

Vitamin A ◽

Dietary Intake ◽

Mixed Model ◽

Linear Mixed Model ◽

Vitamin A Deficiency ◽

Controlled Trial ◽

Potential Contribution ◽

Randomized Controlled ◽

Habitual Diet ◽

To Receive

ABSTRACT Background: Biofortified yellow cassava has been developed to alleviate vitamin A deficiency. We examined the potential contribution of yellow cassava to total Retinol Activity Equivalent (RAE) intake if replacing white by yellow cassava among pre-school Nigerian children. Methods: Dietary intake was assessed as part of a randomized controlled trial. Preschool children (n=176) were randomly assigned to receive either white cassava (WC) or yellow cassava (YC) for 17 weeks. Dietary intake assessments were conducted during the intervention and one month after, when children had resumed their habitual diet. Differences in RAE intake between groups and time points were compared using a linear mixed model regression analysis. Results: During intervention, median RAE intake was 536 µg/day in the YC group and 301 µg/day in the WC group (p<0.0001). YC contributed ˜40% to total RAE intake. Nine percent of children in the YC versus 29% in the WC groups had RAE intake below the Estimated Average Requirement. After intervention, median RAE intake was 300 µg/day and did not differ between intervention groups (p=0.5). The interaction effect of group and time showed a 37% decrease in RAE intake in the YC group after the intervention (Exp(β) = 0.63 [95% CI 0.56, 0.72]). If WC was replaced by YC after intervention, the potential contribution of YC to total RAE intake was estimated to be ˜32%. Conclusions: Yellow cassava increased total RAE intake and showed a substantially lower inadequacy of intake. It is therefore recommended as a good source of provitamin A in cassava-consuming regions.

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Effectiveness of self-help workbook intervention on quality of life in cancer patients receiving chemotherapy: results of a randomized controlled trial

10.21203/rs.3.rs-19471/v1 ◽

2020 ◽

Author(s):

Toshimi Takano ◽

Ayako Matsuda ◽

Noriko Ishizuka ◽

Yukinori Ozaki ◽

Koichi Suyama ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Cancer Patients ◽

Emotional Functioning ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Self Help

Abstract Background: A self-help workbook is expected to support cancer patients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. Methods: From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). Results: No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continued cytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. Conclusions: Self-help workbook intervention was feasible in cancer patients receiving chemotherapy. Although the effect of the intervention was limited, the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy.Trial registration: UMIN Clinical Trials Registry, UMIN000012842. Registered 14 January 2014, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015002

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