scholarly journals Evaluation of the online-based self-help programme “Selfapy” in patients with unipolar depression: study protocol for a randomized, blinded parallel group dismantling study

2020 ◽  
Author(s):  
Krämer Rico ◽  
Stephan Köhler
Keyword(s):  
Controlled Trial ◽  
Depression Scale ◽  
Unipolar Depression ◽  
Drop Out ◽  
Control Group ◽  
Hamilton Depression Scale ◽  
Self Help ◽  
Parallel Group ◽  
Blinded Study ◽  
The Impact

Abstract Background: This study aims to evaluate the online-based self-help programme “Selfapy” on a sample of depressive subjects and, furthermore, the impact of an unaccompanied version vs. a therapeutic accompanied version. Subjects are randomly assigned to the unaccompanied course (without weekly calls from a psychologist), an accompanied course (with weekly calls from a psychologist), or the control group. Various secondary parameters related to online self-help programmes, such as life satisfaction, therapeutic relationship, social activation, self-esteem, attitude towards Internet interventions and drop-out rates, are also recorded.Methods: A sample size of 400 subjects will be included. Subjects must have at least a mild to moderate depressive episode (BDI-II and Hamilton Depression Scale) and then will be randomly assigned into one of three groups: (a) immediate access to the unaccompanied depression course of “Selfapy”, (b) immediate access to the accompanied depression course of “Selfapy”, or (c) access to “Selfapy” after a 24-week delay (waiting list). The intervention period will last for a period of 12 weeks. Diagnostic assessments will take place at four different points in time: T1 (at baseline before the treatment), T2 (6 weeks after the start of the intervention), T3 (12 weeks after the start of the intervention; end of program) and T4 (3 months after completion of the treatment follow-up).Conclusion: The effectiveness of the online self-help program "Selfapy" for depression, is to be investigated in a randomized, controlled, blinded study. Additionally, this study will utilize a “dismantled” approach to enable the comparison of the accompanied andTrial registration: Current Controlled Trial DRKS00017191Date of registration: 14.06.2019

scholarly journals Evaluation of the online-based self-help programme “Selfapy” in patients with unipolar depression: study protocol for a randomized, blinded parallel group dismantling study

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rico Krämer ◽  
Stephan Köhler
Keyword(s):  
Depressive Symptoms ◽  
Depression Scale ◽  
Drop Out ◽  
Control Group ◽  
Hamilton Depression Scale ◽  
Online Interventions ◽  
Phone Calls ◽  
Self Help ◽  
Low Threshold ◽  
The Impact

Abstract Background Patients with mild to moderate depressive symptoms can have limited access to regular treatment; to ensure appropriate care, low-threshold treatment is needed. Effective online interventions could increase the supply of low-threshold treatment. Further research is needed to evaluate the effectiveness of online interventions. This study aims to evaluate the online-based self-help programme “Selfapy” on a sample of depressive subjects and compares the impact of the programme’s unaccompanied version with its therapeutic accompanied version. Methods A sample of 400 subjects that have a mild to severe depressive episode (Becks Depression Inventory - II and Hamilton Depression Scale) will be used. Subjects are randomly assigned to immediate access to an unaccompanied course (no support from psychologist via weekly phone calls), immediate access to an accompanied course (support from a psychologist via weekly phone calls) or a waiting list control group (access to the intervention after 24 weeks). The intervention will last for a period of 12 weeks. Depressive symptoms as a primary parameter, as well as various secondary parameters, such as life satisfaction, therapeutic relationships, social activation, self-esteem, attitudes towards Internet interventions and drop-out rates, are recorded at four different points in time: at baseline (T1), 6 weeks after the start of the intervention (T2), 12 weeks after the start of the intervention (T3) and 3 months after completion of the treatment follow-up (T4). Conclusion This randomized and controlled, blinded study will make use of a “dismantled” approach to adequately compare the accompanied and unaccompanied versions of the intervention. Positive and meaningful results are expected that could influence the acceptance and implementation of online interventions. Trial registration German Clinical Trials Register DRKS00017191. Registered on 14 June 2019

scholarly journals Efficacy and Safety of Chuanxiong Qingnao Granule in Patients with Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Yi-Fan Li ◽  
Hui-Min Hu ◽  
Bo-Ning Wang ◽  
Yi Zhang ◽  
Xing Liu ◽  
...  
Keyword(s):  
Treatment Group ◽  
Migraine Attack ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Hamilton Depression Scale ◽  
Efficacy And Safety ◽  
Attack Frequency ◽  
Double Blind ◽  
Double Blind Placebo

Objective. To evaluate the efficacy and safety of Chuanxiong Qingnao Granule (CQG) to treat migraine. Method. This study was a randomized, double-blind, placebo-controlled trial. All migraineurs were recruited and randomly assigned into a treatment group treated with CQG and a control group treated with a placebo. The whole research process included a 4-week baseline, 12-week intervention, and 12-week follow-up. The primary outcome was responder rate, defined as the percentage of migraineurs with 50% or more reduction in the frequency of migraine attack during treatment and posttreatment period compared with the baseline. The secondary outcomes were the number of migraine days, migraine attack frequency, visual analogue scale (VAS), Fatigue Severity Scale (FSS), Hamilton Depression Scale (HAMD), and Migraine Disability Assessment (MIDAS). Results. A total of 346 migraineurs completed the research and were included in the intention-treatment analyses. The response rates differed significantly between the treatment group and the control group (71.5% vs. 12.1% at week 12 and 83.1% vs. 3.4% at week 24). Attack frequency, days of headache attack, VAS, FSS, HAMD, and MIDAS decreased at week 12 in both groups with more reduction in the treatment group ( P < 0.001 ). No severe adverse events were observed in this trial. Conclusion. Chuanxiong Qingnao Granule can significantly improve headache symptoms in patients with migraine while improving disability, fatigue, and depression with a good safety profile.

scholarly journals A Randomised Controlled Trial of Pharmacist Medication Histories and Supplementary Prescribing on Medication Errors in Postoperative Medications

2011 ◽  
Vol 39 (6) ◽  
pp. 1064-1070 ◽  
Author(s):  
S. B. Marotti ◽  
R. K. Kerridge ◽  
M. D. Grimer
Keyword(s):  
Hospital Stay ◽  
Controlled Trial ◽  
Control Group ◽  
History Taking ◽  
Medication History ◽  
Parallel Group ◽  
Supplementary Prescribing ◽  
Randomised Controlled ◽  
The Impact ◽  
Parallel Group Trial

Errors in the management of regular medications at the time of hospital admission are common. This randomised controlled three-arm parallel-group trial examined the impact of pharmacist medication history taking and pharmacist supplementary prescribing on unintentional omissions of postoperative medications in a large perioperative service. Participants included elective surgical patients taking regular medications with a postoperative hospital stay of one night or more. Patients were randomly assigned, on admission, to usual care (n=120), a pharmacist medication history only (n=120) or pharmacist medication history and supplementary prescribing (n=120). A medication history involved the pharmacist interviewing the patient preoperatively and documenting a medication history in the medical record. In the supplementary prescribing group the patients’ regular medicines were also prescribed on the inpatient medication chart by the pharmacist, so that dosing could proceed as soon as possible after surgery without the need to wait for medical review. The estimate marginal mean number of missed doses during a patients hospital stay was 1.07 in the pharmacist supplementary prescribing group, which was significantly less than both the pharmacist history group (3.30) and the control group (3.21) (P <0.001). The number of medications charted at an incorrect dose or frequency was significantly reduced in the pharmacist history group and further reduced in the prescribing group (P <0.001). We conclude that many patients miss doses of regular medication during their hospital stay and preoperative medication history taking and supplementary prescribing by a pharmacist can reduce this.

scholarly journals Effects of Virtual Reality-Based Physical And Psychological Exercise On Depression In Stroke Patients : A Meta-Analysis

2021 ◽  
Author(s):  
Hebing Liu ◽  
Zhaohua Cheng ◽  
Shuo Wang ◽  
Yong Jia ◽  
Chen Li
Keyword(s):  
Virtual Reality ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Depression Scale ◽  
Control Group ◽  
Stroke Patients ◽  
Depth Study ◽  
Health Related ◽  
Mean Differences ◽  
The Impact

Abstract Background: Virtual Reality (VR) has been widely used in health-related fields. The aim of this study was to assess the effectiveness of virtual reality-based physical and psychological exercise on depression.Methods: A total of 752 patients with stroke from 11 randomized controlled trial (RCT) studies were included in this meta-analysis and the studies derived from 6 electronic databases searched from database inception to August 2021. For continuous results, the standardized mean differences (SMDs) and 95% confidence intervals (CIs) were calculated to synthesize the effects.Results: The meta-analysis showed that compared with control group, VR-based interventions significantly decreased the depression scale score (SMD = −0.71, 95% CI: −1.32, −0.10) in the subjects. The results showed that the the patient age and total intervention time had a significant impact on the outcome of depression. The smaller the age and longer the intervention duration, the greater the impact on the outcome of depression.Conclusions: The current meta-analysis indicated the virtual reality-based physical and psychological exercise has a significant effect on depression in stroke patients compared to controls. The study showed an outstanding reduction in depression for aged under 60 participants and intervention longer than 8 weeks. At the same time, clinical studies of different ages and different intervention time also need further in-depth study.

scholarly journals 572Randomized Controlled Trial Investigating the Effect of an Educational Intervention on Paternal Postpartum Depression Risk

2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Yuichi Ichinose ◽  
Kevin Urayama ◽  
Makoto Okamura ◽  
Naomi Sugiura ◽  
Maiko Suto ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Educational Intervention ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Intervention Group ◽  
Significant Risk ◽  
Depression Scale ◽  
Control Group ◽  
Parallel Group ◽  
And Control

Abstract Background Postpartum paternal depression (PPPD) is under-acknowledged worldwide compared to maternal depression, despite PPPD prevalence being reported to be just as high. Although PPPD has clear health consequences, even on other family members, preventive methods have been under-studied. We investigated the association between an educational intervention and risk of PPPD. Methods We performed a parallel-group, randomized controlled trial in an obstetrics clinic in Japan that included expecting fathers and their pregnant partners at 28-32 weeks gestation. The intervention comprised an educational booklet created for fathers that was distributed during pregnancy. For the primary outcome, Edinburg Postnatal Depression Scale (EPDS) was administered at one and three months post-delivery, and EPDS of 8 or greater was considered at risk for depression. Results In total, the intervention and control groups comprised 286 and 282 couples, respectively. At follow-up, depressive symptoms were observed in 7.2% of fathers in the intervention group and 9.8% in the control group (odds ratio [OR] = 0.71, 95% confidence interval [CI] = 0.36-1.36). Logistic regression in an adjusted analysis showed a reduced, but non-significant risk of PPPD (odds ratio=0.61, 95% confidence interval=0.31-1.20). Conclusions In the first PPPD intervention study of its kind in Japan, our study suggests that distributing the educational booklet to fathers may be helpful in general, but may not be enough to significantly influence the risk of a major condition like PPPD. Key messages A more personalized preventive approach beyond the simple administration of a booklet may be necessary to significantly impact PPPD occurrences.

Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: a parallel-group randomized controlled trial

2021 ◽  
pp. 1-15
Author(s):  
Christian S. Chan ◽  
Christy Y. F. Wong ◽  
Branda Y. M. Yu ◽  
Victoria K. Y. Hui ◽  
Fiona Y. Y. Ho ◽  
...  
Keyword(s):  
Major Depression ◽  
Cognitive Behavioral Therapy ◽  
Sleep Quality ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Depression Scale ◽  
Self Help ◽  
Parallel Group ◽  
Insomnia Severity

Abstract Background Despite its efficacy in treating comorbid insomnia and depression, cognitive behavioral therapy for insomnia (CBT-I) is limited in its accessibility and, in many countries, cultural compatibility. Smartphone-based treatment is a low-cost, convenient alternative modality. This study evaluated a self-help smartphone-based CBT-I in alleviating major depression and insomnia. Methods A parallel-group randomized, waitlist-controlled trial was conducted with 320 adults with major depression and insomnia. Participants were randomized to receive either a 6-week CBT-I via a smartphone application, proACT-S, or waitlist condition. The primary outcomes included depression severity, insomnia severity, and sleep quality. The secondary outcomes included anxiety severity, subjective health, and acceptability of treatment. Assessments were administered at baseline, post-intervention (week 6) follow-up, and week 12 follow-up. The waitlist group received treatment after the week 6 follow-up. Results Intention to treat analysis was conducted with multilevel modeling. In all but one model, the interaction between treatment condition and time at week 6 follow-up was significant. Compared with the waitlist group, the treatment group had lower levels of depression [Center for Epidemiologic Studies Depression Scale (CES-D): Cohen's d = 0.86, 95% CI (−10.11 to −5.37)], insomnia [Insomnia Severity Index (ISI): Cohen's d = 1.00, 95% CI (−5.93 to −3.53)], and anxiety [Hospital Anxiety and Depression Scale – Anxiety subscale (HADS-A): Cohen's d = 0.83, 95% CI (−3.75 to −1.96)]. They also had better sleep quality [Pittsburgh Sleep Quality Index (PSQI): Cohen's d = 0.91, 95% CI (−3.34 to −1.83)]. No differences across any measures were found at week 12, after the waitlist control group received the treatment. Conclusion proACT-S is an efficacious sleep-focused self-help treatment for major depression and insomnia. Trial registration ClinicalTrials.gov, NCT04228146. Retrospectively registered on 14 January 2020. https://clinicaltrials.gov/ct2/show/NCT04228146

Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

2020 ◽  
Vol 20 (2) ◽  
pp. 101-120
Author(s):  
Ayça Aktaç Gürbüz ◽  
Orçun YORULMAZ ◽  
Gülşah DURNA
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Intervention Program ◽  
Controlled Trial ◽  
Community Sample ◽  
Case Vignette ◽  
Control Group ◽  
Obsessive Compulsive ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

Impact of an Amaranth-Sorghum Grains Product on Nutrient Intake of Children Aged 6-23 Months in Kiandutu Slums, Thika, Kenya

10.37512/700 ◽  
2020 ◽  
Keyword(s):  
Nutrition Education ◽  
Nutrient Intake ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Composite Flour ◽  
Monthly Basis ◽  
Sorghum Flour ◽  
Baseline Characteristics ◽  
The Impact

Poor quality complementary foods contribute to undernutrition in children aged 6-23 months. Therefore, there is need to explore foods that will provide adequate nutrients for this age group. This study aimed at determining the impact of a sorghum-amaranth composite flour porridge on nutrient intake of children aged 6-23 months. A randomized controlled trial was conducted at Kiandutu slum, Thika, Kenya. Children in the control group (CG), received a maize-sorghum flour while those in the treatment group (TG) received an amaranth-sorghum flour. The sample size per study group was 73 mother-child pairs. The children in the TG received Kcal 1000 worth of porridge/day while those in the CG received Kcal 266.8/day. Mothers of children in both groups were given nutrition education at baseline, and monthly, for six months. Food intake data was taken at baseline, then monthly for six months. Descriptive statistics were used to describe nutrient intake. Chi square and Mann Whitney U test were was used to compare the baseline characteristics of the two groups and their nutrient intake, respectively. At baseline characteristics of the two groups were similar. On a monthly basis, nutrient intake in the TG was significantly higher for a majority of the nutrients than in the CG. The product can contribute to preventing under-nutrition in children aged 6-23 months.

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.

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.

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