scholarly journals MINDFULNESS TRAINING FOR CAREGIVERS OF ALZHEIMER PATIENTS: PRELIMINARY RESULTS OF A RANDOMIZED CONTROLLED TRIAL

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S860-S860
Author(s):  
Miriam Hurtado Pomares ◽  
Daniel Mendialdua Canales ◽  
Paula Peral Gómez ◽  
Cristina Espinosa Sempere ◽  
Iris Juárez Leal ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Controlled Trial ◽  
Neuropsychiatric Symptoms ◽  
Depression Scale ◽  
Neuropsychiatric Disorders ◽  
Anxiety And Depression ◽  
Control Group ◽  
Depression Symptoms ◽  
Randomized Controlled

Abstract Mindfulness Based Health Care (MBHC) provides meditation techniques that may help to mitigate negative impact of dementia caregiving. We conducted a pilot randomized controlled trial with two parallel groups including 42 caregivers of Alzheimer patients (21 pairs). MBHC group learned the practice of mindfulness meditation once a week through 8 classes; control group did not receive any therapy. Anxiety and depression symptoms were the primary outcomes assessed in two occasions, i.e. at baseline and the end of the program, using the Hospital Anxiety and Depression scale respectively. Neuropsychiatric disorders of Alzheimer patients were also measured with Neuropsychiatric Inventory-Questionnaire. The details of the randomized controlled trial were described in clinicaltrial.gov NCT03858283. In this abstract, we presented the results of a pilot study conducted with 42 caregivers. Robust linear regression using MM-type estimator was performed to evaluate the changes in neuropsychiatric disorders in patients and anxiety and depression symptoms in caregivers adjusting for Score of Scale Global Deterioration. We observed that, compared to the control group, the MBHC group showed a tendency to a reduction in the total score Neuropsychiatric Inventor (β=-5.20; CI 95%: -10.47; 0.07) and the depression symptoms in the caregivers (β=-2.30; CI 95%: -5.43; 0.83). However, no changes were observed in the anxiety symptoms of the caregivers. In conclusion, the results of this pilot study suggested a positive effective on the reduction of neuropsychiatric symptoms in patents as well as on the depression in the caregivers. Nevertheless, these findings should be confirmed in a further complete study.

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.

scholarly journals Preventing depression in final year secondary students: School-based randomized controlled trial

2020 ◽  
Author(s):  
Y Perry ◽  
A Werner-Seidler ◽  
A Calear ◽  
A Mackinnon ◽  
C King ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Secondary Students ◽  
Controlled Trial ◽  
School Level ◽  
Control Group ◽  
Depression Symptoms ◽  
Randomized Controlled ◽  
Control Intervention ◽  
The Impact

Background: Depression often emerges for the first time during adolescence. There is accumulating evidence that universal depression prevention programs may have the capacity to reduce the impact of depression when delivered in the school environment. Objective: This trial investigated the effectiveness of SPARX-R, a gamified online cognitive behavior therapy intervention for the prevention of depression relative to an attention-matched control intervention delivered to students prior to facing a significant stressor-final secondary school exams. It was hypothesized that delivering a prevention intervention in advance of a stressor would reduce depressive symptoms relative to the control group. Methods: A cluster randomized controlled trial was conducted in 10 government schools in Sydney, Australia. Participants were 540 final year secondary students (mean 16.7 [SD 0.51] years), and clusters at the school level were randomly allocated to SPARX-R or the control intervention. Interventions were delivered weekly in 7 modules, each taking approximately 20 to 30 minutes to complete. The primary outcome was symptoms of depression as measured by the Major Depression Inventory. Intention-to-treat analyses were performed. Results: Compared to controls, participants in the SPARX-R condition (n=242) showed significantly reduced depression symptoms relative to the control (n=298) at post-intervention (Cohen d=0.29) and 6 months post-baseline (d=0.21) but not at 18 months post-baseline (d=0.33). Conclusions: This is the first trial to demonstrate a preventive effect on depressive symptoms prior to a significant and universal stressor in adolescents. It demonstrates that an online intervention delivered in advance of a stressful experience can reduce the impact of such an event on the potential development or exacerbation of depression.

scholarly journals Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial

2020 ◽  
Vol 17 (7) ◽  
pp. 2465
Author(s):  
Alfonso Javier Ibáñez-Vera ◽  
Jerónimo Carmelo García-Romero ◽  
José Ramón Alvero-Cruz ◽  
Rafael Lomas-Vega
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Sham Group ◽  
Controlled Trial ◽  
Depression Scale ◽  
Physical Factor ◽  
Control Group ◽  
Local Pain ◽  
Randomized Controlled ◽  
Experimental Group

Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study’s goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 ± 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group (n = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy (n = 22); or a control group (n = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R2 = 0.46), total ICAF (R2 = 0.42) and ICAF physical factor scores (R2 = 0.38). Significant mean differences were found for the local pain (p = 0.025) and ICAF physical factor (p = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.

scholarly journals Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Naira Topooco ◽  
Sandra Byléhn ◽  
Ellen Dahlström Nysäter ◽  
Jenny Holmlund ◽  
Johanna Lindegaard ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adolescent Depression ◽  
Controlled Trial ◽  
National Level ◽  
Cognitive Behavioral ◽  
Controlled Study ◽  
Control Group ◽  
Depression Symptoms ◽  
Group Effect ◽  
Randomized Controlled

BACKGROUND Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed. OBJECTIVE The aim of this study was to determine the efficacy of an ICBT protocol blended with weekly real-time therapist sessions via chat; blended treatment, for adolescent depression, including major depressive episode (MDE). The protocol has previously been evaluated in a controlled study. METHODS In a two-arm randomized controlled trial, adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70) and allocated to either 8 weeks of treatment or to minimal attention control. Depression was assessed at baseline, at posttreatment, and at 12 months following treatment (in the intervention group). The primary outcome was self-reported depression level as measured with the Beck Depression Inventory II at posttreatment. The intervention was offered without the need for parental consent. RESULTS Over two weeks, 162 adolescents registered and completed the baseline screening. Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70). The average intervention completion was 74% (11.8 of 16 modules and sessions). Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (<italic>P</italic>&lt;.001), corresponding to a large between-group effect (intention-to-treat analysis: <italic>d</italic>=0.86, 95% CI 0.37-1.35; of completer analysis: <italic>d</italic>=0.99, 95% CI 0.48-1.51). A significant between-group effect was observed in the secondary depression outcome (<italic>P</italic>=.003); clinically significant improvement was found in 46% (16/35) of ICBT participants compared with 11% (4/35) in the control group (<italic>P</italic>=.001). CONCLUSIONS The results are in line with our previous study, further demonstrating that adolescents with depression can successfully be engaged in and experience significant improvement following ICBT blended with therapist chat sessions. Findings on participants’ age and baseline depression severity are of interest in relation to used study methods. CLINICALTRIAL ClinicalTrials.gov NCT02363205; https://clinicaltrials.gov/ct2/show/NCT02363205

scholarly journals Contributions of auriculotherapy in smoking cessation: a pilot study

2014 ◽  
Vol 48 (5) ◽  
pp. 883-890
Author(s):  
Roberta de Paiva Silva ◽  
Erika de Cássia Lopes Chaves ◽  
Sandra Cristina Pillon ◽  
Andréia Maria Silva ◽  
Denis da Silva Moreira ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Pilot Study ◽  
Controlled Trial ◽  
Control Group ◽  
Double Blind ◽  
Future Studies ◽  
Randomized Controlled ◽  
And Control ◽  
Experimental Group

Objective To evaluate the contribution of auriculotherapy in smoking cessation. Method Double-blind randomized controlled trial, conducted with 30 smokers allocated into two groups: Experimental Group (21 participants received 10 sessions of auriculotherapy at specific points for smoking) and Control Group (nine participants received auriculotherapy in points that have no effect on the focus of research). Results Auriculotherapy contributed in reducing the number of cigarettes smoked in 61.9% of participants (p=0.002), in reducing the difficult to abstain from smoking in places where it is forbidden by 38% (p=0.050) and in not smoking when ill 23.8% (p=0.025). Conclusion Given the efficacy only in terms of reducing the number of cigarettes smoked and other parameters, we suggest that future studies consider the use of auriculotherapy combined with other treatment methods, in order to achieve better results in cessation/abstinence.

Evaluating Seeking Safety for Women in Prison: A Randomized Controlled Trial

2017 ◽  
Vol 29 (3) ◽  
pp. 281-290 ◽  
Author(s):  
Stephen J. Tripodi ◽  
Annelise M. Mennicke ◽  
Susan A. McCarter ◽  
Katie Ropes
Keyword(s):  
Randomized Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Post Traumatic Stress ◽  
Treatment As Usual ◽  
Seeking Safety ◽  
Randomized Controlled

Objective: This study assessed the effectiveness of Seeking Safety on depression and post-traumatic stress disorder (PTSD) with incarcerated women. Method: A randomized controlled trial ( N = 40) was used to analyze Seeking Safety’s effectiveness compared to a treatment-as-usual control group. Analyses of covariance were used to assess differences at posttest ( n = 33) and 4-month follow-up ( n = 29) while repeated measures analysis of variance was used to assess the influence of the intervention on changes over time ( n = 29). The researchers also analyzed individual participants’ scores from pretest to 4-month follow-up ( n = 29). Results: Both groups decreased their scores on the Center for Epidemiology Studies–Depression Scale and the PTSD Checklist, although improvement was greater for treatment group participants except for depression at 4-month follow-up. Conclusion: Results support the continued use of Seeking Safety as a helpful corrections-based intervention for women, but more research with larger sample sizes is needed to consider it an effective intervention.

scholarly journals Effects of a psychological nursing intervention on prevention of anxiety and depression in the postpartum period: a randomized controlled trial

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Hongling Liu ◽  
Yang Yang
Keyword(s):  
Postpartum Depression ◽  
Controlled Trial ◽  
Intervention Group ◽  
Depression Scale ◽  
Behavior Intervention ◽  
Anxiety And Depression ◽  
Control Group ◽  
Cognitive Behavior ◽  
Randomized Controlled ◽  
Primiparous Women

Abstract Background Anxiety and postpartum depression are the most common psychological problems in women after delivery. Cognitive behavior intervention has been reported to have an effect in the therapy of postpartum depression. This research aimed to investigate whether cognitive behavior intervention could prevent the pathogenesis of postpartum depression in primiparous women. Methods In this randomized controlled trial, primiparous women who were prone to postpartum depression were recruited. Participates in the control group received routine postpartum care and those in the intervention group received both routine postpartum care and cognitive behavior intervention. Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), Edinburgh Postpartum Depression Scale (EPDS) and Pittsburgh Sleep Quality Index (PSQI) were evaluated before and after the intervention. Results In the intervention group, the post-intervention scores of HAMA, HAMD, EPDS and PSQI were all significantly lower than the baseline scores (p = 0.034, p = 0.038, p = 0.004, p = 0.014, respectively). The proportion of participants with postpartum depression in the intervention group (11.5%) was significantly lower than the control group (24.3%) after the 6-week intervention. Participants in the intervention group were significantly more satisfied with the care than those in the control group (p = 0.032). Conclusion This research provided evidence that cognitive behavioral intervention in postpartum period could alleviate anxiety and depression in primiparous women, and inhibit the pathogenesis of postpartum depression. Trial registry This clinical trial was registered in the Chinese Clinical Trial Registry (ChiCTR2000040076).

scholarly journals Effect of acupuncture on insomnia in menopausal women: A Study protocol for a Randomized Controlled Trial

2018 ◽  
Author(s):  
Shanshan Li ◽  
Ping Yin ◽  
Xuan Yin ◽  
Anna Bogachko ◽  
Tingting Liang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Depression Scale ◽  
Menopausal Transition ◽  
Syndrome Differentiation ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Rating ◽  
Menopausal Women

Abstract Background: China today has high occurrences of insomnia in perimenopausal women. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia related to depression and stroke. Although there are some programs supporting insomnia during the menopausal transition, there are few randomized controlled trials to provide evidence regarding their effectiveness. We design a randomized controlled trial of suitable sample size to verify the effectiveness of acupuncture in patients with insomnia during the menopausal transition and to form an optimized acupuncture treatment protocol. Method/Design: In this randomized, single-site, single-blind, placebo-controlled trial, 84 eligible patients will be recruited and randomly assigned to either the acupuncture group (n = 42) or the sham control group (n = 42) in a 1:1 ratio. Participants will receive a total of 18 sessions of treatment for eight consecutive weeks. Treatments will be given three times per week in the first four weeks, twice a week for the next two weeks and finally treatment once weekly for the final two weeks. Treatment will utilize eight main acupoints (GV20, GV24, GV29, RN6, RN4, SP6, HT7, EX-HN22), and extra two acupoints based on syndrome differentiation. The primary outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will be measured by sleep parameters recorded in the Actigraphy (SE, TST, SA), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Menopause Quality of Life (Men-QOL). The primary outcomes will be assessed at baseline, week four, week eight, and first and the third month following the end of treatment. Discussion: If the results confirm that acupuncture is effective and safe for the treatment on insomnia in menopausal women, this positive outcome could provide evidence for clinical application.

scholarly journals Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial

10.2196/13393 ◽  
2019 ◽  
Vol 21 (11) ◽  
pp. e13393 ◽  
Author(s):  
Naira Topooco ◽  
Sandra Byléhn ◽  
Ellen Dahlström Nysäter ◽  
Jenny Holmlund ◽  
Johanna Lindegaard ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adolescent Depression ◽  
Controlled Trial ◽  
National Level ◽  
Cognitive Behavioral ◽  
Controlled Study ◽  
Control Group ◽  
Depression Symptoms ◽  
Group Effect ◽  
Randomized Controlled

Background Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed. Objective The aim of this study was to determine the efficacy of an ICBT protocol blended with weekly real-time therapist sessions via chat; blended treatment, for adolescent depression, including major depressive episode (MDE). The protocol has previously been evaluated in a controlled study. Methods In a two-arm randomized controlled trial, adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70) and allocated to either 8 weeks of treatment or to minimal attention control. Depression was assessed at baseline, at posttreatment, and at 12 months following treatment (in the intervention group). The primary outcome was self-reported depression level as measured with the Beck Depression Inventory II at posttreatment. The intervention was offered without the need for parental consent. Results Over two weeks, 162 adolescents registered and completed the baseline screening. Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70). The average intervention completion was 74% (11.8 of 16 modules and sessions). Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (P<.001), corresponding to a large between-group effect (intention-to-treat analysis: d=0.86, 95% CI 0.37-1.35; of completer analysis: d=0.99, 95% CI 0.48-1.51). A significant between-group effect was observed in the secondary depression outcome (P=.003); clinically significant improvement was found in 46% (16/35) of ICBT participants compared with 11% (4/35) in the control group (P=.001). Conclusions The results are in line with our previous study, further demonstrating that adolescents with depression can successfully be engaged in and experience significant improvement following ICBT blended with therapist chat sessions. Findings on participants’ age and baseline depression severity are of interest in relation to used study methods. Trial Registration ClinicalTrials.gov NCT02363205; https://clinicaltrials.gov/ct2/show/NCT02363205

scholarly journals Preventing depression in final year secondary students: School-based randomized controlled trial

2020 ◽  
Author(s):  
Y Perry ◽  
A Werner-Seidler ◽  
A Calear ◽  
A Mackinnon ◽  
C King ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Secondary Students ◽  
Controlled Trial ◽  
School Level ◽  
Control Group ◽  
Depression Symptoms ◽  
Randomized Controlled ◽  
Control Intervention ◽  
The Impact

Background: Depression often emerges for the first time during adolescence. There is accumulating evidence that universal depression prevention programs may have the capacity to reduce the impact of depression when delivered in the school environment. Objective: This trial investigated the effectiveness of SPARX-R, a gamified online cognitive behavior therapy intervention for the prevention of depression relative to an attention-matched control intervention delivered to students prior to facing a significant stressor-final secondary school exams. It was hypothesized that delivering a prevention intervention in advance of a stressor would reduce depressive symptoms relative to the control group. Methods: A cluster randomized controlled trial was conducted in 10 government schools in Sydney, Australia. Participants were 540 final year secondary students (mean 16.7 [SD 0.51] years), and clusters at the school level were randomly allocated to SPARX-R or the control intervention. Interventions were delivered weekly in 7 modules, each taking approximately 20 to 30 minutes to complete. The primary outcome was symptoms of depression as measured by the Major Depression Inventory. Intention-to-treat analyses were performed. Results: Compared to controls, participants in the SPARX-R condition (n=242) showed significantly reduced depression symptoms relative to the control (n=298) at post-intervention (Cohen d=0.29) and 6 months post-baseline (d=0.21) but not at 18 months post-baseline (d=0.33). Conclusions: This is the first trial to demonstrate a preventive effect on depressive symptoms prior to a significant and universal stressor in adolescents. It demonstrates that an online intervention delivered in advance of a stressful experience can reduce the impact of such an event on the potential development or exacerbation of depression.

Sign in / Sign up

Export Citation Format

Share Document