Mental health effects of an online self-help intervention for university students during COVID-19: a non-randomized controlled pilot study (Preprint)

2021 ◽  
Author(s):  
Elodie Charbonnier ◽  
Bastien Trémolière ◽  
Louise Baussard ◽  
Aurelie Goncalves ◽  
Florence Lespiau ◽  
...  
Keyword(s):  
Mental Health ◽  
Pilot Study ◽  
University Students ◽  
Stress Management ◽  
Learned Helplessness ◽  
Intervention Group ◽  
Psychological State ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Help

BACKGROUND The COVID-19 pandemic and the resulting abrupt changes in daily life and ways of learning has had a significant impact on university students, especially on their mental health. However, little is known on how to prevent and/or reduce its impact to date. Prior to COVID, some studies have shown that online stress management programs were successful enough to improve students' mental health and stress adjustment strategies, suggesting that these interventions should be further developed during the pandemic. OBJECTIVE Our study explored the effects of an online self-help program which targeted stress management and learning. METHODS A non-randomized controlled study was initially conducted with 204 university students. Our final sample is composed of 67 participants distributed in two groups, the intervention group (participants who took part to the full program) and the control group (participants who did not take part in the program). The variables measured were: anxiety and depressive symptoms (HADS), academic burnout (MBI-SS), learned helplessness (LHQ), and coping strategies (Brief-COPE). Measurements were performed at the baseline (T0) and at 8 weeks (T1) after the baseline. RESULTS Means comparisons between T0 and T1 show in the intervention group a reduction in anxiety symptoms (d = .67), use of substance to cope with stress (d = .93) and learned helplessness (d = .53), which is not observed in the control group. CONCLUSIONS Our pilot study reports promising effects of our online self-help program combining stress and learning on students' psychological state. In the future, further research effort will be needed to confirm the beneficial effect of this type of program on university students.

scholarly journals A Mobile Health Intervention for Mental Health Promotion Among University Students: Randomized Controlled Trial

10.2196/17208 ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. e17208 ◽  
Author(s):  
Marcus Bendtsen ◽  
Ulrika Müssener ◽  
Catharina Linderoth ◽  
Kristin Thomas
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Controlled Trial ◽  
Intervention Group ◽  
Positive Mental Health ◽  
Control Group ◽  
Depression And Anxiety ◽  
Randomized Controlled

Background High positive mental health, including the ability to cope with the normal stresses of life, work productively, and be able to contribute to one’s community, has been associated with various health outcomes. The role of positive mental health is therefore increasingly recognized in national mental health promotion programs and policies. Mobile health (mHealth) interventions could be a cost-effective way to disseminate positive psychological interventions to the general population. Objective The aim of this study was to estimate the effect of a fully automated mHealth intervention on positive mental health, and anxiety and depression symptomology among Swedish university students using a randomized controlled trial design. Methods A 2-arm, single-blind (researchers), parallel-groups randomized controlled trial with an mHealth positive psychology program intervention group and a relevant online mental health information control group was employed to estimate the effect of the novel intervention. Participants were recruited using digital advertising through student health care centers in Sweden. Inclusion criteria were (1) university students, (2) able to read and understand Swedish, (3) and have access to a mobile phone. Exclusion criteria were high positive mental health, as assessed by the Mental Health Continuum Short Form (MHC-SF), or high depression and anxiety symptomology, as assessed by the Hospital Anxiety Depression Scale (HADS). The primary outcome was positive mental health (MHC-SF), and the secondary outcomes were depression and anxiety symptomatology (HADS). The subscales of MHC-SF were also analyzed as exploratory outcomes. Outcomes were measured 3 months after randomization through questionnaires completed on the participants’ mobile phones. Results A total of 654 participants (median age 25 years), including 510 (78.0%) identifying as female, were randomized to either the intervention (n=348) or control group (n=306). At follow-up, positive mental health was significantly higher in the intervention group compared with the control group (incidence rate ratio [IRR]=1.067, 95% CI 1.024-1.112, P=.002). For both depression and anxiety symptomatology, the intervention group showed significantly lower scores at follow-up compared with the control group (depression: IRR=0.820, 95% CI 0.714-0.942, P=.005; anxiety: IRR=0.899, 95% CI 0.840-0.962, P=.002). Follow-up rates were lower than expected (58.3% for primary outcomes and 52.3% for secondary outcomes); however, attrition analyses did not identify any systematic attrition with respect to baseline variables. Conclusions The mHealth intervention was estimated to be superior to usual care in increasing positive mental health among university students. A protective effect of the intervention was also found on depressive and anxiety symptoms. These findings demonstrate the feasibility of using an automated mobile phone format to enhance positive mental health, which offers promise for the use of mHealth solutions in public mental health promotion. Trial Registration International Standard Randomized Controlled Trial Registry ISRCTN54748632; http://www.isrctn.com/ISRCTN54748632

scholarly journals Efficacy of a web application for stress management among Iranian college students during COVID-19 outbreak: a study protocol for randomized controlled trials

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Fatemeh Khademian ◽  
Azam Aslani ◽  
Ramin Ravangard ◽  
Peivand Bastani ◽  
Mohammad Nami ◽  
...  
Keyword(s):  
Mental Health ◽  
College Students ◽  
Sleep Quality ◽  
Stress Management ◽  
Web Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
And Control

Abstract Background The prevalence of mental health disorders is increasing globally, and the prevalence of COVID-19 has made it worse. Evidence has indicated a major mental health burden and elevated anxiety associated with the new coronavirus outbreak in the general population. This study aims to evaluate an evidence-based web application (Naranj) for stress management among Iranian college students. Methods and design This study aims to present a protocol related to a randomized controlled trial among Iranian college students. The study will be conducted on 100 students from two colleges of Shiraz University of Medical Sciences in Iran. The participants will be randomly assigned to the intervention and control groups. The intervention group participants will be provided with a web application, whereas the control group ones will be provided with an app unrelated to stress management. The primary outcome for this study will be the Perceived Stress Scale, and the two groups will be compared with respect to stress level and sleep quality. Discussion A web application will be developed according to psychological theories and will be scientifically approved for managing college students’ stress and improving their sleep quality during the COVID-19 outbreak. Trial registration Iranian Registry of Clinical Trials IRCT20160427027647N2. Registered on 14 May 2020

The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study

2021 ◽  
pp. 1-8
Author(s):  
Sevde Aksu ◽  
Pelin Palas Karaca
Keyword(s):  
Pilot Study ◽  
Cesarean Section ◽  
Intervention Group ◽  
Control Group ◽  
Breast Pain ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Right ◽  
Documentation Tool ◽  
And Control

<b><i>Aim:</i></b> The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). <b><i>Methods:</i></b> A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (<i>n</i> = 30) and control groups (<i>n</i> = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. <b><i>Results:</i></b> Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (<i>p</i> &#x3c; 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (<i>p</i> &#x3e; 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (<i>p</i> &#x3c; 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (<i>p</i> &#x3c; 0.05). <b><i>Conclusions:</i></b> In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.

scholarly journals A Collaborative Deprescribing Intervention in a Subacute Medical Outpatient Clinic: A Pilot Randomized Controlled Trial

Metabolites ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. 204
Author(s):  
Anissa Aharaz ◽  
Jens Henning Rasmussen ◽  
Helle Bach Ølgaard McNulty ◽  
Arne Cyron ◽  
Pia Keinicke Fabricius ◽  
...  
Keyword(s):  
Pilot Study ◽  
Controlled Trial ◽  
Inappropriate Medication ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Patient Interviews ◽  
Number Of Patients ◽  
Multimorbid Patients ◽  
And Control

Medication deprescribing is essential to prevent inappropriate medication use in multimorbid patients. However, experience of deprescribing in Danish Subacute Medical Outpatient Clinics (SMOCs) is limited. The objective of our pilot study was to evaluate the feasibility and sustainability of a collaborative deprescribing intervention by a pharmacist and a physician to multimorbid patients in a SMOC. A randomized controlled pilot study was conducted, with phone follow-up at 30 and 365+ days. A senior pharmacist performed a systematic deprescribing intervention using the Screening Tool of Older Persons’ potentially inappropriate Prescriptions (STOPP) criteria, the Danish deprescribing list, and patient interviews. A senior physician received the proposed recommendations and decided which should be implemented. The main outcome was the number of patients having ≥1 medication where deprescribing status was sustained 30 days after inclusion. Out of 76 eligible patients, 72 (95%) were included and 67 (93%) completed the study (57% male; mean age 73 years; mean number of 10 prescribed medications). Nineteen patients (56%) in the intervention group and four (12%) in the control group had ≥1 medication where deprescribing status was sustained 30 days after inclusion (p = 0.015). In total, 37 medications were deprescribed in the intervention group and five in the control group. At 365+ days after inclusion, 97% and 100% of the deprescribed medications were sustained in the intervention and control groups, respectively. The three most frequently deprescribed medication groups were analgesics, cardiovascular, and gastrointestinal medications. In conclusion, a collaborative deprescribing intervention for multimorbid patients was feasible and resulted in sustainable deprescribing of medication in a SMOC.

scholarly journals Computerised cognitive–behavioural therapy for depression in adolescents: 12-month outcomes of a UK randomised controlled trial pilot study

BJPsych Open ◽  
2019 ◽  
Vol 6 (1) ◽  
Author(s):  
Barry Wright ◽  
Lucy Tindall ◽  
Rebecca Hargate ◽  
Victoria Allgar ◽  
Dominic Trépel ◽  
...  
Keyword(s):  
Mental Health ◽  
Cost Effectiveness ◽  
Pilot Study ◽  
Cognitive Behavioural Therapy ◽  
Care Pathway ◽  
Intervention Group ◽  
Behavioural Therapy ◽  
Self Help ◽  
Cognitive Behavioural ◽  
Randomised Controlled

Background Computerised cognitive–behavioural therapy (CCBT) in the care pathway has the potential to improve access to psychological therapies and reduce waiting lists within Child and Adolescent Mental Health Services, however, more randomised controlled trials (RCTs) are needed to assess this. Aims This single-centre RCT pilot study compared a CCBT program (Stressbusters) with an attention control (self-help websites) for adolescent depression at referral to evaluate the clinical and cost-effectiveness of CCBT (trial registration: ISRCTN31219579). Method The trial ran within community and clinical settings. Adolescents (aged 12–18) presenting to their primary mental health worker service for low mood/depression support were assessed for eligibility at their initial appointment, 139 met inclusion criteria (a 33-item Mood and Feelings Questionnaire score of ≥20) and were randomised to Stressbusters (n = 70) or self-help websites (n = 69) using remote computerised single allocation. Participants completed mood, quality of life (QoL) and resource-use measures at intervention completion, and 4 and 12 months post-intervention. Changes in self-reported measures and completion rates were assessed by group. Results There was no significant difference between CCBT and the website group at 12 months. Both showed improvements on all measures. QoL measures in the intervention group showed earlier improvement compared with the website group. Costs were lower in the intervention group but the difference was not statistically significant. The cost-effectiveness analysis found just over a 65% chance of Stressbusters being cost-effective compared with websites. The 4-month follow-up results from the initial feasibility study are reported separately. Conclusions CCBT and self-help websites may both have a place in the care pathway for adolescents with depression.

scholarly journals 4016 Combined Eating Disorder and Weight-Loss Online Guided-Self Help Intervention: Updated Results from an Ongoing Pilot Study

2020 ◽  
Vol 4 (s1) ◽  
pp. 54-54
Author(s):  
Grace Elise Monterubio ◽  
Ellen E. Fitzsimmons-Craft ◽  
Denise E. Wilfley
Keyword(s):  
Eating Disorder ◽  
Pilot Study ◽  
Mixed Model ◽  
Intervention Group ◽  
Baseline Survey ◽  
Control Group ◽  
Student Health Services ◽  
Eating Disorder Examination ◽  
Self Help ◽  
Study Population

OBJECTIVES/GOALS: Aims 1&2: Develop (1) and implement (2) online, guided self-help intervention for ED psychopathology and weight reduction. Aim 3: Follow-up to track remission of ED psychopathology and symptoms and WL maintenance at end of treatment and 6-months. METHODS/STUDY POPULATION: N = 60 college students meeting criteria (clinical/sub-clinical binge-type ED with BMI > 25) will complete a baseline survey and then will be randomized into a condition. Students in the intervention group (n = 30) will be offered 8 weeks of an online, guided self-help intervention for ED and WL. Students in the control group (n = 30) will receive an email message to seek support from Student Health Services. All participants will receive follow-ups 9 weeks and 6 months after baseline. Data analysis will compare Eating Disorder Examination Questionnaire (EDE-Q) scores and WL (change in BMI) at all three time-points. Group comparisons will be assessed via two-way mixed-model ANOVA. RESULTS/ANTICIPATED RESULTS: Recruitment is still ongoing. Data collected by the time of the conference will be presented on the poster. DISCUSSION/SIGNIFICANCE OF IMPACT: Online, guided self-help interventions have been used for WL, as well as for treatment of EDs separately, but no program exists to manage these commonly comorbid conditions concurrently. Thus, this pilot study will examine the effectiveness of combined programs to breach this treatment gap.

scholarly journals Determining the effects of exercise after smoking cessation therapy completion on continuous abstinence from smoking: Japanese study protocol

2019 ◽  
Author(s):  
Yuka Ozaki ◽  
Maki Komiyama ◽  
Kenji Ueshima ◽  
Hiroyasu Iso ◽  
Satoko Sakata ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Intervention Group ◽  
Developed Countries ◽  
Abstinence Rate ◽  
Psychological State ◽  
Control Group ◽  
Randomized Controlled ◽  
Continuous Abstinence ◽  
Therapy Completion ◽  
Smoking Cessation Therapy

Abstract Background: Despite a steady world-wide decline over recent decades, the smoking rates remain high in developed countries. In Japan, the smoking rate is 30% for men and 10% for women. Based on these rates, Japan's smoking population is estimated to be 18.8 million (14.06 million for men and 4.74 million for women). The rate of success for smoking cessation has recently improved due to the widespread availability of drug therapy; however, the success rate for quitting smoking one year after beginning therapy is only around 50%. Previous studies have demonstrated that exercise can relieve mental stress during continuous abstinence from smoking and curb smoking resumption. To date, no large-scale randomized controlled trials have examined the effects of exercise on smoking cessation. The present study aims to determine the effects of implementing an intervention in the form of exercise instruction after smoking cessation therapy completion on continuous abstinence from smoking. Methods: This is a multicenter, prospective, parallel-group, randomized controlled trial in Japan.We will enroll 300 individuals visiting a smoking cessation clinic (over three months) who have abstained from smoking in the second month after their initial visit as potential participants. Participants will not habitually exercise and will consent to participate. Participants will be randomly assigned to the exercise intervention group or control group. The intervention group will receive instruction on exercises that can be incorporated into their daily lives. The control group will be followed during the standard smoking cessation support program. The primary endpoint will be the continuous abstinence rate, and secondary endpoints will be weight, blood pressure, exhaled carbon monoxide concentration, psychological state, and blood test results. These indices will be compared between the intervention and control groups, with follow-up periods of nine months for both groups. Discussion: By examining the effects of exercise instruction after completion of a 12-week smoking cessation therapy, this study should yield quality information that can be used to develop protocols to improve the continuous abstinence rate and inhibit weight gain after smoking cessation therapy.

scholarly journals Impact of Remote Titration Combined With Telemonitoring on the Optimization of Guideline-Directed Medical Therapy for Patients With Heart Failure: Internal Pilot of a Randomized Controlled Trial

JMIR Cardio ◽  
10.2196/21962 ◽  
2020 ◽  
Vol 4 (1) ◽  
pp. e21962
Author(s):  
Veronica Artanian ◽  
Heather J Ross ◽  
Valeria E Rac ◽  
Mary O'Sullivan ◽  
Darshan H Brahmbhatt ◽  
...  
Keyword(s):  
Heart Failure ◽  
Pilot Study ◽  
Medical Therapy ◽  
Intervention Group ◽  
Dose Optimization ◽  
Control Group ◽  
Internal Pilot ◽  
Randomized Controlled ◽  
Patients With Heart Failure ◽  
Clinic Visits

Background To improve health outcomes in patients with heart failure, guideline-directed medical therapy (GDMT) should be optimized to target doses. However, GDMT remains underutilized, with less than 25% of patients receiving target doses in clinical practice. Telemonitoring could provide reliable and real-time physiological data for clinical decision support to facilitate remote GDMT titration. Objective This paper aims to present findings from an internal pilot study regarding the effectiveness of remote titration facilitated by telemonitoring. Methods A 2-arm randomized controlled pilot trial comparing remote titration versus standard care in a heart function clinic was conducted. Patients were randomized to undergo remote medication titration facilitated by data from a smartphone-based telemonitoring system or standard titration performed during clinic visits. Results A total of 42 patients with new-onset (10/42, 24%) and existing (32/42, 76%) heart failure and a mean age of 55.29 (SD 11.28) years were randomized between January and June 2019. Within 6 months of enrollment, 86% (18/21) of patients in the intervention group achieved optimal doses versus 48% (10/21) of patients in the control group. The median time to dose optimization was 11.0 weeks for the intervention group versus 18.8 weeks for the control group. The number of in-person visits in the intervention group was 54.5% lower than in the control group. Conclusions The results of this pilot study suggest that remote titration facilitated by telemonitoring has the potential to increase the proportion of patients who achieve optimal GDMT doses, decrease time to dose optimization, and reduce the number of clinic visits. Remote titration may facilitate optimal and efficient titration of patients with heart failure while reducing the burden for patients to attend in-person clinic visits. Trial Registration ClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513 International Registered Report Identifier (IRRID) RR2-10.2196/preprints.19705

scholarly journals Primary Care and Physical Literacy: A Non-Randomized Controlled Pilot Study to Combat the High Prevalence of Physically Inactive Adults in Austria

2021 ◽  
Vol 18 (16) ◽  
pp. 8593
Author(s):  
Peter Holler ◽  
Johannes Jaunig ◽  
Othmar Moser ◽  
Silvia Tuttner ◽  
Helmut Simi ◽  
...  
Keyword(s):  
Physical Activity ◽  
Pilot Study ◽  
Self Efficacy ◽  
Intervention Group ◽  
Physical Activity Behavior ◽  
Controlled Study ◽  
Control Group ◽  
Physical Literacy ◽  
Randomized Controlled ◽  
Activity Behavior

The multidimensional concept of physical literacy is fundamental for lifelong physical activity engagement. However, physical literacy-based interventions are in their infancy, especially among adults. Therefore, the purpose of this pilot study was to assess the association of a physical literacy-based intervention with changes in self-reported physical literacy among inactive adults. A non-randomized controlled study (2 × 2 design) was conducted, comparing pre- vs. postintervention. Twenty-eight inactive healthy participants in the intervention group (89% female, 53 ± 10 years) entered a physical literacy-based intervention once weekly for 14 weeks. The non-treated control group consisted of 22 inactive adults (96% female, 50 ± 11 years). Physical literacy was evaluated with a questionnaire encompassing five domains: physical activity behavior, attitude/understanding, motivation, knowledge, and self-efficacy/confidence. ANOVA models were applied to evaluate changes by time and condition. Following the intervention, significant improvements were seen for overall physical literacy and in four out of five physical literacy domains, including physical activity behavior, attitude/understanding, knowledge, and self-efficacy/confidence (all p < 0.01, Cohen’s d = 0.38–0.83). No changes by time x condition were found for motivation. The physical literacy-based intervention applied in this study may be a promising approach to help inactive adults to adopt an active lifestyle.

scholarly journals Effects of an attachment-based parent intervention on mothers of children with autism spectrum disorder: preliminary findings from a non-randomized controlled trial

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Nobuyo Kubo ◽  
Megumi Kitagawa ◽  
Sayaka Iwamoto ◽  
Toshifumi Kishimoto
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Children With Autism ◽  
Autism Spectrum ◽  
Control Group ◽  
Randomized Controlled ◽  
Children With Asd

Abstract Background Caregivers of children with autism spectrum disorders (ASD) often experience difficulties in responding appropriately to the needs of those children, who typically express attachment in distinct and nonconventional ways. This highlights the need for an attachment-based approach targeted at caregivers of children with ASD. Circle of Security Parenting (COSP), an attachment-based parenting program, is designed to increase caregivers’ sensitivity to children’s attachment needs. The aim of this study was to provide verification of the effectiveness of COSP in mothers of children with ASD. Methods This study was a non-randomized controlled trial. Sixty mothers of children with ASD aged 4–12 were recruited. Twenty mothers received the COSP intervention, while 40 did not. The characteristics of children in the control group were matched with those of the intervention group. To evaluate the outcomes of the intervention, changes in parental self-efficacy and mental health were assessed using the Tool to Measure Parenting Self-Efficacy (TOPSE) and the General Health Questionnaire-30 (GHQ-30). The children’s improvement in emotional and behavioral problems was assessed from the mothers’ perspective using the Child Behavior Checklist (CBCL). Both groups completed the assessments in parallel. Evaluations were compared between baseline (T1) and 6-month follow-up (T2). Results Scores for self-efficacy and mental health of mothers and behavior of children were significantly improved from T1 to T2 in the intervention group, but not in the control group. Participants’ mental health was markedly worsened in the control group. Conclusion This study demonstrated that the COSP program for mothers of children with ASD improved their parental self-efficacy and mental health, and reduced their subjective sense of difficulties related to their children’s behaviors. Our findings support the effectiveness of the attachment-based program for mothers of children with ASD, providing the groundwork for further studies of the attachment-based intervention for children with ASD and their families. Future studies with larger samples and randomization are also needed for direct evaluation of the improvement of children's attachment security, and for exploration of the synergistic relationship between various family support strategies and COSP. Trial Registration This trial was registered with the University Hospital Medical Information Network Clinical Trial Registry (No. UMIN000039574)

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