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

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

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Mental Health Promotion Among University Students Using Text Messaging: Protocol for a Randomized Controlled Trial of a Mobile Phone–Based Intervention (Preprint)

10.2196/preprints.12396 ◽

2018 ◽

Author(s):

Kristin Thomas ◽

Marcus Bendtsen

Keyword(s):

Mental Health ◽

Mental Illness ◽

Randomized Controlled Trial ◽

University Students ◽

Mobile Phone ◽

Controlled Trial ◽

Well Being ◽

Positive Mental Health ◽

Control Group ◽

Randomized Controlled

BACKGROUND There is a growing understanding that well-being and mental illness are 2 separate dimensions of mental health. High well-being is associated with decreased risk of disease and mental illness and increased longevity. OBJECTIVE This study aims to test the efficacy of a mobile phone–based intervention on positive mental health. METHODS We are conducting a 2-armed randomized controlled trial of university students in Sweden. Recruitment will last for 6 months by digital advertising (eg, university websites). Participants will be randomly allocated to either an intervention (fully automated mobile phone–based mental health intervention) or control group (treatment as usual). The primary outcome will be self-assessed positive mental health (Mental Health Continuum Short Form). Secondary outcomes will be self-assessed depression anxiety symptomatology (Hospital Anxiety Depression Scale). Outcomes will be investigated at baseline, at 3, 6, and 12 months after randomization. Mediators (positive emotions and thoughts) will be investigated at baseline, midintervention, and at follow-ups using 2 single face-valid items. RESULTS Data will be collected between autumn 2018 and spring 2019. Results are expected to be published in 2020. CONCLUSIONS Strengths of the study include the use of a validated comprehensive instrument to measure positive mental health. Mechanisms of change are also investigated. A potential challenge could be recruitment; however, by setting a prolonged recruitment period, we believe that the study will recruit a sufficient sample. CLINICALTRIAL International Standard Randomized Controlled Trial Number: 54748632; http://www.isrctn.com/ ISRCTN54748632 INTERNATIONAL REGISTERED REPOR PRR1-10.2196/12396

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Mental Health Promotion Among University Students Using Text Messaging: Protocol for a Randomized Controlled Trial of a Mobile Phone–Based Intervention

JMIR Research Protocols ◽

10.2196/12396 ◽

2019 ◽

Vol 8 (8) ◽

pp. e12396 ◽

Cited By ~ 3

Author(s):

Kristin Thomas ◽

Marcus Bendtsen

Keyword(s):

Mental Health ◽

Mental Illness ◽

Randomized Controlled Trial ◽

University Students ◽

Mobile Phone ◽

Controlled Trial ◽

Well Being ◽

Positive Mental Health ◽

Control Group ◽

Randomized Controlled

Background There is a growing understanding that well-being and mental illness are 2 separate dimensions of mental health. High well-being is associated with decreased risk of disease and mental illness and increased longevity. Objective This study aims to test the efficacy of a mobile phone–based intervention on positive mental health. Methods We are conducting a 2-armed randomized controlled trial of university students in Sweden. Recruitment will last for 6 months by digital advertising (eg, university websites). Participants will be randomly allocated to either an intervention (fully automated mobile phone–based mental health intervention) or control group (treatment as usual). The primary outcome will be self-assessed positive mental health (Mental Health Continuum Short Form). Secondary outcomes will be self-assessed depression anxiety symptomatology (Hospital Anxiety Depression Scale). Outcomes will be investigated at baseline, at 3, 6, and 12 months after randomization. Mediators (positive emotions and thoughts) will be investigated at baseline, midintervention, and at follow-ups using 2 single face-valid items. Results Data will be collected between autumn 2018 and spring 2019. Results are expected to be published in 2020. Conclusions Strengths of the study include the use of a validated comprehensive instrument to measure positive mental health. Mechanisms of change are also investigated. A potential challenge could be recruitment; however, by setting a prolonged recruitment period, we believe that the study will recruit a sufficient sample. Trial Registration International Standard Randomized Controlled Trial Number: 54748632; http://www.isrctn.com/ ISRCTN54748632 International Registered Report Identifier (IRRID) PRR1-10.2196/12396

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Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

Health Informatics Journal ◽

10.1177/1460458221996409 ◽

2021 ◽

Vol 27 (1) ◽

pp. 146045822199640

Author(s):

Faranak Kazemi Majd ◽

Vahideh Zarea Gavgani ◽

Ali Golmohammadi ◽

Ali Jafari-Khounigh

Keyword(s):

Randomized Controlled Trial ◽

Hospital Readmission ◽

Medical Information ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Long Term Follow Up ◽

Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

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Effectiveness of Prompt Mental Health Care: Preliminary results from a randomized controlled trial

European Journal of Public Health ◽

10.1093/eurpub/ckz185.049 ◽

2019 ◽

Vol 29 (Supplement_4) ◽

Author(s):

M Knapstad ◽

L V Lervik ◽

S M M Saether ◽

L E Aaroe ◽

O R F Smith

Keyword(s):

Mental Health ◽

Health Care ◽

Randomized Controlled Trial ◽

Mental Health Care ◽

Controlled Trial ◽

Sensitivity Analyses ◽

Depression And Anxiety ◽

Symptoms Of Depression ◽

Randomized Controlled

Abstract Background Prompt Mental Health Care (PMHC) service is a Norwegian initiative, adapted from the English ‘Improved Access to Psychological Therapy’ (IAPT), aimed at improving access to primary care treatment for anxiety and depression. Thus far, both PMHC and IAPT have been evaluated by cohort studies only. Albeit yielding promising results, the extent to which these are attributable to the treatment thus remains unsettled. This study investigates the effectiveness of PMHC compared to treatment as usual (TAU) at six months follow-up. Methods Randomized controlled trial with parallel assignment in two PMHC sites from November 2015 to March 2018. Participants were 681 adults (aged ≥18 years) considered for admission to PMHC due to anxiety and/or mild to moderate depression. These were randomly assigned on a 70:30 ratio. Main outcomes were recovery rates and changes in symptoms of depression and anxiety between baseline and follow-up. Primary outcome data were available for 73%/67% in the PMHC/TAU group. Sensitivity analyses based on observed patterns of missingness were conducted. Results A reliable recovery rate of 58.5% was observed in the PMHC group and 31.9% in the TAU group, yielding a between-group effect size (ES) of 0.61 [95% CI 0.37-0.85, p<.001]. The differences in degree of improvement between PMHC and TAU yielded an ES of -0.88 [95% CI -1.23-0.43, p < 0.001] for symptoms of depression and -0.60 [95% CI -0.90-0.30, p < 0.001] for symptoms of anxiety in favour of PMHC. All sensitivity analyses pointed in the same direction with small variations in point estimates. Findings were slightly more robust for depressive than anxiety symptoms. Conclusions The PMHC treatment was substantially more effective than TAU in alleviating symptoms of anxiety and depression. This adaptation of IAPT is considered a viable supplement to existing health services to increase access of effective treatment for adults who suffer from anxiety and mild to moderate depression. Key messages This study is the first to evaluate the effectiveness of an IAPT-like treatment model in terms of a randomized controlled trial. Prompt Mental Health Care was substantially more effective than TAU in alleviating symptoms of depression and anxiety at 6-months follow-up.

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Effects of individualized follow-up with a smartphone-application after cardiac rehabilitation: protocol of a randomized controlled trial

BMC Sports Science Medicine and Rehabilitation ◽

10.1186/s13102-019-0148-2 ◽

2019 ◽

Vol 11 (1) ◽

Cited By ~ 2

Author(s):

Pernille Lunde ◽

Asta Bye ◽

Astrid Bergland ◽

Birgitta Blakstad Nilsson

Keyword(s):

Randomized Controlled Trial ◽

Cardiac Rehabilitation ◽

Controlled Trial ◽

Intervention Group ◽

Smartphone Application ◽

Control Group ◽

Power Calculation ◽

Large Sample Size ◽

Randomized Controlled

Abstract Background Cardiac rehabilitation (CR) programs are evidence-based and widely recommended. However, benefits from CR are likely lost among individuals who discontinue their regular exercise routines and healthy habits. One possible approach to enhance adherence to lifestyle advice after completion of CR, may be individualized follow-up enabled by a smartphone application (app). Methods A protocol of a single-blinded, pragmatic randomized controlled trial. The study will take place in the eastern part of Norway, and will include heart patients who have completed CR. Participants will be recruited from two CR centers. Based on power calculation, 113 participants will be included. The intervention group will receive individualized follow-up through an app on a weekly basis throughout a year. The app will be set up with the participant’s own goals, and the follow-up will be based on these individual goals. The control group will receive usual care, including general advice regarding physical activity, exercise and diet. The participants will be assessed at baseline (at completion of CR) and 12 months after baseline. Primary outcome of the study will be peak oxygen uptake. Secondary outcomes include exercise performance, quality of life, health status, health literacy, self-perceived goal achievement, exercise habits, body weight, blood pressure as well as lipids and triglycerides. Discussion To our knowledge, this will be the first study to examine the effects of individualized follow-up with an app for one year, in patients completing CR. Hence, it is reasonable to assume that the study may be groundbreaking. Due to the large sample size and the theoretically based intervention, the study has the potential to generate new knowledge that may improve the design of future technology-based follow-up interventions of patients that have completed rehabilitation. Trial registration ClinicalTrials.gov. NCT03174106. First registration, 19/05/2017.

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Long-term efficacy of indicated prevention of depression in non-professional caregivers: randomized controlled trial

Psychological Medicine ◽

10.1017/s0033291714002505 ◽

2014 ◽

Vol 45 (7) ◽

pp. 1401-1412 ◽

Cited By ~ 15

Author(s):

P. Otero ◽

F. Smit ◽

P. Cuijpers ◽

A. Torres ◽

V. Blanco ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Caregiver Burden ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Indicated Prevention ◽

Randomized Controlled ◽

Term Efficacy

BackgroundAlthough depression is a common problem among non-professional caregivers, only one trial has evaluated the efficacy of indicated prevention targeting this population and the long-term efficacy is unknown. The aim of this study was to evaluate the long-term efficacy of a brief intervention for the indicated prevention of depression in a sample of female caregivers.MethodA randomized controlled trial was conducted involving 173 participants (mean age 53.9 years) who were allocated to the intervention (n = 89) or the usual-care control group (n = 84). Blinded interviewers conducted assessments at 1, 3, 6 and 12 months of follow-up. The main outcome measure was the incidence of major depression and the secondary outcomes were compliance with treatment, depressive symptoms, emotional distress and caregiver burden.ResultsAt the 12-month follow-up, a lower incidence of depression as evaluated using the Structured Clinical Interview for Axis I Disorders of the DSM-IV was found in the intervention group compared with the control group (10.1%v.25.0%). The relative risk was 0.40 and statistically significant [χ2 = 6.68, degrees of freedom = 1,p = 0.010, 95% confidence interval (CI) 0.20–0.81], and the number needed to treat was 7 (95% CI 4–27). There was a significant delay in the onset of depression in the intervention group (p = 0.008). The good complier caregivers had a lower incidence of depression. The intervention effect on depressive symptoms, emotional distress and caregiver burden were maintained for 12 months.ConclusionsThis is the first study to demonstrate that a brief problem-solving intervention can prevent the onset of depression among non-professional caregivers over the longer term.

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Randomized Controlled Trial Evaluating Pictogram Augmentation of HIV Medication Information

Annals of Pharmacotherapy ◽

10.1345/aph.1q091 ◽

2011 ◽

Vol 45 (11) ◽

pp. 1378-1383 ◽

Cited By ~ 12

Author(s):

Kyle Wilby ◽

Carlo A Marra ◽

Jack H da Silva ◽

Maja Grubisic ◽

Stephanie Harvard ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Antiretroviral Therapy ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Fisher Exact Test ◽

Intended Meaning ◽

Randomized Controlled ◽

Medication Information

Background:: Antiretroviral therapy for the management of HIV typically requires the chronic use of 3 or more medications. As such, patients with HIV are required to manage complex dosing schedules and are at risk of multiple potential adverse effects. The use of pictograms on medication vials as a means of improving patients' understanding of medication information has been shown to positively influence understanding and adherence compared to those using text atone. Objective: To determine whether pictograms (Pharmaglyph) increase patient recall of targeted information associated with HIV medications and whether patients can interpret the intended meaning of pictograms that they had not seen previously. Methods: A randomized, controlled trial was conducted in HIV-positive patients aged 19 years or older who were receiving a new prescription for an antiretroviral medication from the ambulatory pharmacy at St. Paul's Hospital in Vancouver, British Columbia, Canada. Participants were randomized to receive either pictogram-enhanced medication information or standard counseling. At the first follow-up visit, each patient's recall of the medication information was evaluated, and differences between groups were compared. Results: Eighty-two subjects were randomized, 40 to the intervention group and 42 to the control arm. The mean (SD) number of HIV medications was nearly equal between the intervention and control groups: 3.0 (1.5) and 3.1 (1.4), respectively. After a mean of 34 days, 33 patients in the intervention arm and 39 in the control arm completed the study. The majority (88%) of the targeted pieces of information in the intervention group were correctly identified at follow-up, compared to only 2% in the control group (Fisher exact test; p < 0.0001). Conclusions: Pictograms improve the recall of targeted medication information among patients receiving antiretroviral therapy for HIV management; however, this appears to be dependent on the fact that these patients received a verbal explanation of each pictogram prior to use.

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Effectiveness of a smartphone-based, augmented reality exposure app to reduce fear of spiders in real-life: a randomized controlled trial

10.31219/osf.io/cjrgk ◽

2021 ◽

Author(s):

Anja Zimmer ◽

Nan Wang ◽

Merle Ibach ◽

Bernhard Fehlmann ◽

Nathalie Schicktanz ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Augmented Reality ◽

Controlled Trial ◽

Intervention Group ◽

Real Life ◽

Control Group ◽

Randomized Controlled ◽

Distress Scale

Although in vivo exposure therapy is highly effective in the treatment of specific phobias, only a minority of patients seeks therapy. Exposure to virtual objects has been shown to be better tolerated, equally efficacious, but the technology has not been made widely accessible yet. We developed an augmented reality (AR) application (app) to reduce fear of spiders and performed a randomized controlled trial comparing the effects of our app (six 30-min sessions at home over a two-week period) with no intervention. Primary outcome was subjective fear, measured by a Subjective Units of Distress Scale (SUDS) in a Behavioural Approach Test (BAT) in a real-life spider situation at six weeks follow-up. Between Oct 7, 2019, and Dec 6, 2019, 66 individuals were enrolled and randomized. The intervention led to significantly lower subjective fear in the BAT compared to the control group (intervention group, baseline: 7·12 [SD 2·03] follow-up: 5·03 [SD 2·19] vs. control group, baseline: 7·06 [SD 2·34], follow-up 6·24 [SD 2.21]; adjusted group difference -1·24, 95% CI -2·17 to -0·31; Cohen’s d=0·57, p=0·01). The repeated use of the AR app reduces subjective fear in a real-life spider situation, providing a low-threshold and low-cost treatment for fear of spiders.

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Influence of a Survival Swimming Training Programme on Water Safety Knowledge, Attitudes and Skills: A Randomized Controlled Trial among Young Adults in Sri Lanka

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph182111428 ◽

2021 ◽

Vol 18 (21) ◽

pp. 11428

Author(s):

Jeewanthika Ekanayaka ◽

Chan Kim Geok ◽

Bernadette Matthews ◽

Samath D. Dharmaratne

Keyword(s):

Randomized Controlled Trial ◽

Young Adults ◽

Sri Lanka ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Water Safety ◽

Randomized Controlled ◽

Safety Knowledge

Drowning among young adults is high in Sri Lanka. Water safety education is a recommended strategy for drowning prevention but is often overlooked for young adults. This study aimed to evaluate the effectiveness of an adapted educational intervention, “Swim for Safety” on improving water safety knowledge, attitudes and survival swimming skills among undergraduates (19–28 years) in Sri Lanka. This study employed a parallel-group, two-arm randomized controlled trial design. The intervention group (n = 78) received a face-to-face, 12-lesson education programme, and the control group (n = 78) received a brochure and weekly mobile phone messages for six consecutive weeks. Baseline, post-intervention and three-month follow-up knowledge, attitudes and skills were evaluated. Knowledge and attitudes were assessed using a self-administered questionnaire and skills were evaluated following a skills assessment protocol. In total 116 participants, 60 intervention group and 56 control group, completed the study. At baseline there were no differences between groups in median scores of water safety knowledge, attitudes and survival swimming skills. The intervention group demonstrated statistically significant increases in median water safety knowledge, attitudes and survival swimming skill scores compared with the control group, following the intervention and maintained at three-month follow-up (p < 0.05). The adapted Swim for Safety programme significantly improved water safety knowledge, attitudes, and survival swimming skills among young adults in Sri Lanka. Therefore, it is recommended that the SfS programme be implemented widely to prevent drowning in young adults.

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

Child and Adolescent Psychiatry and Mental Health ◽

10.1186/s13034-021-00389-z ◽

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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