scholarly journals A smartphone-online intervention for youth diagnosed with major depressive disorders: Protocol for a randomized controlled trial. (Preprint)

2018 ◽  
Author(s):  
Paul Ritvo ◽  
Zafiris Daskalakis ◽  
George Tomlinson ◽  
Arun Ravindran ◽  
Renee Linklater ◽  
...  
Keyword(s):  
Mental Health ◽  
First Nations ◽  
Depressive Disorders ◽  
Psychiatric Care ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Major Depressive ◽  
Randomized Controlled ◽  
Cognitive Behavioural

BACKGROUND Seventy percent of mental health problems appear before the age of 25 years and when untreated can become long-standing, and significant, impairing multiple life domains (1). Although the problem is especially acute for youth from First Nations backgrounds, all Canadian youth aged 15- to 25 years are highly likely to experience mental health disorders, substance dependencies and suicide. Progress in the treatment of youth that capitalizes on tendencies to respond to online contacts strategically addresses mental health problems, particularly depressive disorders. OBJECTIVE We will conduct a randomized controlled trial (RCT), to compare online mindfulness-based cognitive behavioural therapy combined with standard psychiatric care vs. psychiatric care alone (wait-list controls) in youth diagnosed with major depressive disorder. We will enrol N = 168 subjects in the age range of 18-30 years, 50% of whom will be from First Nations backgrounds and the other 50% from all other ethnic backgrounds, equally stratified in two intervention groups and two (wait-list) control groups (42 subjects per group, where INT1 and CTL1 are FN background, and INT2 and CTL2 are non-FN background). METHODS In this RCT, the primary outcome will be self-reported depression on the Beck Depression Inventory II. Secondary outcomes include anxiety (Beck Anxiety Inventory), depression (Quick Inventory of Depressive Symptomatology, 24-item Hamilton Rating Scale for Depression (HRSD-24)), pain (Brief Pain Inventory) and mindfulness (Five-Facet Mindfulness Questionnaire). RESULTS Recruitment/retention rates will be assessed with estimates for the proportion of participants with complete data per outcome and time points divided by the total number of study participants. Variability of the main and interaction effects will be examined in the primary clinical outcome and each secondary outcome using separate repeated measures ANCOVA models, with Bonferroni corrections applied to the models applied. Hedges' g and associated confidence intervals will be calculated as an estimate of the effect size both over time (within groups) and between groups. Missing data will be evaluated on a case-by-case basis such that drop-outs will be excluded. CONCLUSIONS If results confirm hypotheses that youth can be effectively treated with online mindfulness-based cognitive behavioural therapy at reduced costs, effective services can be delivered more widely with less geographic restrictions. CLINICALTRIAL Clinical Trials.gov

scholarly journals An Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth Diagnosed With Major Depressive Disorders: Protocol for a Randomized Controlled Trial

10.2196/11591 ◽  
2019 ◽  
Vol 8 (7) ◽  
pp. e11591
Author(s):  
Paul Ritvo ◽  
Zafiris J Daskalakis ◽  
George Tomlinson ◽  
Arun Ravindran ◽  
Renee Linklater ◽  
...  
Keyword(s):  
Mental Health ◽  
Depressive Disorders ◽  
Psychiatric Care ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Mental Health Disorders ◽  
Major Depressive ◽  
Randomized Controlled ◽  
The Past ◽  
Health Disorders

Background About 70% of all mental health disorders appear before the age of 25 years. When untreated, these disorders can become long-standing and impair multiple life domains. When compared with all Canadian youth (of different ages), individuals aged between 15 and 25 years are significantly more likely to experience mental health disorders, substance dependencies, and risks for suicidal ideation and death by suicide. Progress in the treatment of youth, capitalizing on their online responsivity, can strategically address depressive disorders. Objective We will conduct a randomized controlled trial to compare online mindfulness-oriented cognitive behavioral therapy (CBT-M) combined with standard psychiatric care versus psychiatric care alone in youth diagnosed with major depressive disorder. We will enroll 168 subjects in the age range of 18 to 30 years; 50% of subjects will be from First Nations (FN) backgrounds, whereas the other 50% will be from all other ethnic backgrounds. There will be equal stratification into 2 intervention groups (INT1 and INT2) and 2 wait-list control groups (CTL1 and CTL2) with 42 subjects per group, resulting in an equal number of INT1 and CTL1 of FN background and INT2 and CTL2 of non-FN background. Methods The inclusion criteria are: (1) age 18 to 30 years, FN background or other ethnicity; (2) Beck Depression Inventory (BDI)-II of at least mild severity (BDI-II score ≥14) and no upper limit; (3) Mini-International Neuropsychiatric Interview (MINI)–confirmed psychiatric diagnosis of major depressive disorder; and (4) fluent in English. All patients are diagnosed by a Centre for Addiction and Mental Health psychiatrist, with diagnoses confirmed using the MINI interview. The exclusion criteria are: (1) individuals receiving weekly structured psychotherapy; (2) individuals who meet the Diagnostic and Statistical Manual of Mental Disorders criteria for severe alcohol/substance use disorder in the past 3 months, or who demonstrate clinically significant suicidal ideation defined as imminent intent, or who have attempted suicide in the past 6 months; and (3) individuals with comorbid diagnoses of borderline personality, schizophrenia, bipolar disorder, and/or obsessive compulsive disorder. All subjects are provided standard psychiatric care defined as 1 monthly session that focuses on appropriate medication, with session durations of 15 to 30 min. Experimental subjects receive an additional intervention consisting of the CBT-M online software program (in collaboration with Nex J Health, Inc). Exposure to and interaction with the online workbooks are combined with navigation-coaching delivered by phone and secure text message interactions. Results The outcomes selected, combined with measurement blinding, are key features in assessing whether significant benefits regarding depression and anxiety symptoms occur. Conclusions If results confirm the hypothesis that youth can be effectively treated with online CBT-M, effective services may be widely delivered with less geographic restriction. International Registered Report Identifier (IRRID) PRR1-10.2196/11591

scholarly journals Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth With Major Depressive Disorders: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Paul Ritvo ◽  
Yuliya Knyahnytska ◽  
Meysam Pirbaglou ◽  
Wei Wang ◽  
George Tomlinson ◽  
...  
Keyword(s):  
Mental Health ◽  
Depressive Disorders ◽  
Psychiatric Care ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Mental Health Disorders ◽  
Major Depressive ◽  
Randomized Controlled ◽  
Score Difference ◽  
Health Disorders

BACKGROUND Approximately 70% of mental health disorders appear prior to 25 years of age and can become chronic when ineffectively treated. Individuals between 18 and 25 years old are significantly more likely to experience mental health disorders, substance dependencies, and suicidality. Treatment progress, capitalizing on the tendencies of youth to communicate online, can strategically address depressive disorders. OBJECTIVE We performed a randomized controlled trial (RCT) that compared online mindfulness-based cognitive behavioral therapy (CBT-M) combined with standard psychiatric care to standard psychiatric care alone in youth (18-30 years old) diagnosed with major depressive disorder. METHODS Forty-five participants were randomly assigned to CBT-M and standard care (n=22) or to standard psychiatric care alone (n=23). All participants were provided standard psychiatric care (ie, 1 session per month), while participants in the experimental group received an additional intervention consisting of the CBT-M online software program. Interaction with online workbooks was combined with navigation coaching delivered by phone and secure text messaging. RESULTS In a two-level linear mixed-effects model intention-to-treat analysis, significant between-group differences were found for the Beck Depression Inventory-II score (difference –8.54, <i>P</i>=.01), Quick Inventory of Depressive Symptoms score (difference –4.94, <i>P</i>=.001), Beck Anxiety Inventory score (difference –11.29, <i>P</i>&lt;.001), and Brief Pain Inventory score (difference –1.99, <i>P</i>=.03), while marginal differences were found for the Five Facet Mindfulness Questionnaire–Nonjudging subscale (difference –2.68, <i>P</i>=.05). CONCLUSIONS These results confirm that youth depression can be effectively treated with online CBT-M that can be delivered with less geographic restriction. CLINICALTRIAL Clinical Trials.gov NCT03406052; https://www.clinicaltrials.gov/ct2/show/NCT03406052

scholarly journals Caregivers’ effects of augmented cognitive-behavioural therapy for post-stroke depressive symptoms in patients: secondary analyses to a randomized controlled trial

2019 ◽  
Vol 33 (6) ◽  
pp. 1056-1065 ◽  
Author(s):  
Joyce A Kootker ◽  
Caroline M van Heugten ◽  
Bart Kral ◽  
Sascha MC Rasquin ◽  
Alexander C Geurts ◽  
...  
Keyword(s):  
Mental Health ◽  
Depressive Symptoms ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Well Being ◽  
Behavioural Therapy ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Cognitive Behavioural ◽  
Secondary Analyses

Objective: To investigate the concomitant effects of two patient-directed interventions for post-stroke depressive symptoms on caregivers’ well-being. Design: Secondary analyses of the results of a randomized controlled trial. Subjects: Fifty caregivers of stroke patients receiving outpatient rehabilitation. Interventions: Stroke patients and their caregivers were randomly allocated to either cognitive-behavioural therapy augmented with movement or occupational therapy ( n = 23) or computerized cognitive training ( n = 27) to alleviate depressive symptoms in patients. Main measures: Emotional burden (Involvement Evaluation Questionnaire), practical burden (Caregiver Strain Index), mental health (General Health Questionnaire) and emotional complaints (Hospital Anxiety and Depression Scale). Results: Caregivers of patients who received cognitive-behavioural therapy reported significantly higher mental health levels (mean difference (MD) = 1.78, 95% confidence interval (CI) = 0.43–3.13, P = 0.01) and less worrying about patients’ well-being (MD = 1.9, 95% CI = 0.56–3.24, P < 0.01). In addition, there were positive time effects on the Involvement Evaluation Questionnaire for Brain Injury, particularly the subscales Worrying, Supervision and Tension. Conclusion: The results suggest that augmented cognitive-behavioural therapy aimed at improving patients’ emotional, behavioural and social functioning positively affects some aspects of caregivers’ well-being.

scholarly journals Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Patient Education ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Group Differences ◽  
Post Intervention ◽  
Cognitive Behavioural ◽  
Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

scholarly journals COMmunity PARticipation through Education (COMPARE): effectiveness of supported education for students with mental health problems, a mixed methods study – study protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jacomijn Hofstra ◽  
Jorien van der Velde ◽  
Petra Jannette Havinga ◽  
Lies Korevaar
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Secondary Outcome ◽  
Study Success ◽  
Randomized Controlled ◽  
Supported Education

Abstract Background The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow post-secondary education, which is a major channel in our society to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health problems to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on remaining at school, study success, and satisfaction of students with mental health problems studying at an institute for intermediate vocational education and a university of applied sciences in the Netherlands. Methods/design The design combines quantitative research (Randomized Controlled Trial; RCT) with qualitative research (monitoring, interviews, focus groups). One hundred students with mental health problems recruited from the two educational institutes will be randomly allocated to either the intervention or control condition. The students in the intervention condition receive the Supported Education intervention given by a Supported Education specialist, the students in the active control condition receive support as usual plus advice from a trained staff member on potential supportive resources regarding studying with mental health problems. The primary outcome ‘remaining at school’, and the secondary outcome ‘study success’ will be determined using data from the school’s administration. The secondary outcome ‘student satisfaction’ and other variables that will be studied in a more exploratory way, such as self-efficacy and study skills, will be determined through online questionnaires at baseline, at 6 and at 12 months follow-up. Focus groups and interviews with the students and Supported Education specialists will be carried out to complement the trial. Discussion This RCT is the first to assess the effect of Supported Education on remaining at school, next to study success and student satisfaction among students with mental health problems. The use of a mixed-methods design will result in a thorough evaluation of the effect of the intervention. Issues regarding the influx and possible attrition of students in the follow-up are discussed. Trial registration The study was registered with Trialregister.nl, no. NL8349, date registered: February 4th 2020. Register name: Community participation through education. Effectiveness of Supported Education for youth with mental health problems, a mixed methods study – Study protocol for a Randomized Controlled Trial. Protocol Version: 3, date: May 28th, 2021.

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