scholarly journals A Social Media Website (Supporting Our Valued Adolescents) to Support Treatment Uptake for Adolescents With Depression and/or Anxiety and Their Parents: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Ana Radovic ◽  
Yaming Li ◽  
Douglas Landsittel ◽  
Bradley D Stein ◽  
Elizabeth Miller
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Health Beliefs ◽  
Mental Health Treatment ◽  
Controlled Trial ◽  
Health Treatment ◽  
Randomized Controlled ◽  
Primary Care Settings ◽  
Treatment Uptake ◽  
Pilot Randomized Controlled Trial

BACKGROUND Few adolescents who experience depression or anxiety connect to mental health treatment. Supporting Our Valued Adolescents (SOVA) is a stakeholder-informed technology intervention that consists of 2 blog-format websites—one for adolescents and another for parents. SOVA is designed to intervene on targets, which may increase the mental health treatment uptake when adolescents with depression or anxiety are identified in primary care settings. OBJECTIVE This study aims to describe the protocol for a pilot randomized controlled trial designed to refine recruitment and retention strategies, document intervention fidelity and implementation outcomes, and assess changes in health beliefs and knowledge, emotional or informational support, and parent-adolescent communication quality in adolescents and their parents. METHODS Adolescents identified with symptoms of depression or anxiety, for which a health care provider recommends treatment, and their parents will be recruited from clinics where adolescents are seen for primary care. Adolescent-parent dyads will be randomized at 1:1 to both receive the SOVA websites and enhanced usual care or enhanced usual care alone. Baseline measures and 6-week and 3-month outcomes will be collected by Web-based self-report surveys and electronic health record review. The main pilot outcome is the 6-week study retention rate. Analyses will also assess changes in health beliefs and knowledge, emotional support, and parent-adolescent communication in both adolescents and their parents. RESULTS The project was funded in 2017. Recruitment commenced in April 2018 and enrollment is ongoing, with completion anticipated at the end of 2019 with subsequent plans for data analysis and publication submission in early 2020. CONCLUSIONS The findings of this research will inform the design of a multisite hybrid effectiveness-implementation randomized controlled trial examining the effectiveness and optimal implementation strategies for using SOVA in community primary care settings. CLINICALTRIAL ClinicalTrials.gov NCT03318666; https://clinicaltrials.gov/ct2/show/NCT03318666 INTERNATIONAL REGISTERED REPOR PRR1-10.2196/12117

A Social Media Website (Supporting Our Valued Adolescents) to Support Treatment Uptake for Adolescents with Depression or Anxiety: Outcomes From a Pilot Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Ana Radovic ◽  
Yaming Li ◽  
Doug Landsittel ◽  
Kayla R Odenthal ◽  
Bradley D Stein ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Beliefs ◽  
Mental Health Treatment ◽  
Controlled Trial ◽  
Self Report ◽  
Health Treatment ◽  
Recruitment And Retention ◽  
Randomized Controlled ◽  
Treatment Uptake ◽  
Pilot Randomized Controlled Trial

BACKGROUND Adolescents with depression or anxiety initiate mental health treatment in low numbers due to multiple factors, with a top reason being negative attitudes towards treatment. We developed a peer-support website intervention, Supporting Our Valued Adolescents (SOVA), for adolescents seen in primary care settings and their parents with the goal of increasing treatment uptake through changing negative health beliefs, enhancing knowledge, offering peer emotional support, and increasing parent-adolescent communication about mental health. OBJECTIVE The aim of this pilot study was to refine recruitment and retention strategies, document intervention fidelity, and explore change in study outcomes (primary outcome being treatment uptake). METHODS We conducted a two-group, single blind, pilot randomized controlled trial in a single adolescent medicine clinic. Participants were aged 12 to 19 with clinician-identified symptoms of depression or anxiety for which a health care provider recommends treatment. The patient and parent, if interested, were randomized to receive the SOVA websites and Enhanced Usual Care (EUC) compared to EUC alone. Baseline, 6-week, and 3-month measures were collected by web-based self-report survey and blinded electronic health record review. Main pilot outcomes assessed were feasibility of recruitment and retention strategies. Implementation outcomes, intervention fidelity, missingness, and adequacy of safety protocols were documented. Descriptive statistics were used to summarize mental health service use, and target measures (examine change in health beliefs and knowledge, emotional support, and parent-adolescent communication) using 2-sample t tests to compare differences between arms. RESULTS A little under half of adolescents offered patient education material (195/461; 42%) were referred by their clinician to the study. Of 146 adolescents meeting inclusion criteria, 38 completed the baseline survey, qualifying them for randomization, and 25 (66%; 95% CI 51 - 81%) completed 6-week measures. There was limited engagement in the treatment arm with (5/11) 45% of adolescents who completed 6-week measures reporting accessing SOVA, mostly citing forgetting. Changes were found in target factors at 6-weeks, but not in per protocol analyses. Despite this, at 12 weeks, 15/18 (83%) adolescents randomized to SOVA received mental health treatment as compared to 10/20 (50%) adolescents randomized to EUC (P=.03), where receipt of treatment was measured by combined adolescent or parent self-report and a blinded manual EHR extraction. CONCLUSIONS In this pilot trial of a peer-support website intervention for adolescents with depression or anxiety we found lower than expected study enrollment post recruitment. While generalizability may be enhanced by not requiring parental permission for adolescent participation in trials of mental health interventions, this may limit study recruitment and retention. We found implementing patient education introducing the study into provider workflow was feasible and acceptable, resulting in almost 500 study referrals. Lastly, we found preliminary evidence that the SOVA intervention may increase uptake of mental health treatment as compared to usual care. CLINICALTRIAL ClinicalTrials.gov NCT03318666; https://clinicaltrials.gov/ct2/show/NCT03318666 INTERNATIONAL REGISTERED REPORT RR2-10.2196/12117

scholarly journals Protocol of a Multi-centric Randomized Controlled Trial to Evaluate Efficacy of Telephone-Based Psychosocial Interventions on Future Suicide Risk in Suicide Attempters

2020 ◽  
Vol 42 (6_suppl) ◽  
pp. S39-S45
Author(s):  
Ram Pratap Beniwal ◽  
Priya Sreedaran ◽  
Uttara Chari ◽  
Ashok MV ◽  
Triptish Bhatia
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Treatment ◽  
Suicide Attempts ◽  
Controlled Trial ◽  
Psychosocial Interventions ◽  
Health Treatment ◽  
Risk Of Death ◽  
Randomized Controlled ◽  
Telephone Reminders

Background: Persons with previous history of a suicide attempt are at increased future risk of death by suicide. These vulnerable individuals, however, do not seek receive or seek help from mental health services. Telephone-based psychosocial interventions are potential strategies in augmenting mental health care in such persons. Methods: We aim to compare the efficacy of telephone-based psychosocial interventions (TBPI) with routine telephone reminders in persons with recent suicide attempts using a multi-site, parallel group, rater-blind, two-arm randomized controlled trial design in 362 participants. In the first group, participants will receive three sessions of TBPI comprising of brief supportive interventions, problem-solving strategies, and reminders for adherence to prescribed mental health treatment at weekly intervals. In the second group, participants will receive three telephone reminders for adherence to prescribed mental health treatment at weekly intervals. We will follow up participants for 6 months. Primary outcomes are suicidal ideation scores on Beck’s Scale for Suicide Ideation and number of repeat suicide attempts. Secondary outcomes are scores on Beck’s Hopelessness Scale, Beck’s Depression Inventory, Connor–Davidson Resilience Scale and Visual Analogue Rating Scales for acceptability of interventions. Outcomes will be assessed at 1, 3, and 6 months after receiving telephone interventions or reminders. Results: The trial is currently underway after prospective registration under Clinical Trials Registry of India and has recruited 260 participants till August 15, 2020. Conclusion: This study has potential to generate evidence on additional strategies for use along with standard mental health treatments in management of high-risk suicide behaviors.

scholarly journals Insurance-Reimbursable Mindfulness for Safety-Net Primary Care Patients: a Pilot Randomized Controlled Trial

Mindfulness ◽  
2019 ◽  
Vol 10 (9) ◽  
pp. 1744-1759 ◽  
Author(s):  
Richa Gawande ◽  
Elizabeth Pine ◽  
Todd Griswold ◽  
Timothy Creedon ◽  
Zayda Vallejo ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Safety Net ◽  
Randomized Controlled ◽  
Primary Care Patients ◽  
Pilot Randomized Controlled Trial

Using PTSD Coach in primary care with and without clinician support: a pilot randomized controlled trial

2016 ◽  
Vol 38 ◽  
pp. 94-98 ◽  
Author(s):  
Kyle Possemato ◽  
Eric Kuhn ◽  
Emily Johnson ◽  
Julia E. Hoffman ◽  
Jason E. Owen ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Clinician Support ◽  
Pilot Randomized Controlled Trial

scholarly journals Managing Depression in Diabetes Mellitus: A Multicentric Randomized Controlled Trial Comparing Effectiveness of Fluoxetine and Mindfulness in Primary Care: Protocol for DIAbetes Mellitus ANd Depression (DIAMAND) Study

2020 ◽  
Vol 42 (6_suppl) ◽  
pp. S31-S38
Author(s):  
Mina Chandra ◽  
Dhanya Raveendranathan ◽  
Johnson Pradeep R. ◽  
Suravi Patra ◽  
Rushi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Diabetes Mellitus ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Glycemic Control ◽  
Collaborative Care ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Primary Care Settings

Background: Suboptimal management of depression in type 2 diabetes mellitus (T2DM) often translates into poor glycemic control, medical complications, and impaired quality of life. Feasibility and effectiveness of collaborative care models of depression in diabetes in low- and middle-income countries (LMICs) remain unexplored. DIAbetes Mellitus ANd Depression (DIAMAND) study, a multicentric single-blind randomized controlled trial (SBRCT) comparing effectiveness of fluoxetine and mindfulness in primary care settings, addresses this gap in scientific literature. Methods: This trial conducted in diverse geographic settings of New Delhi, Bengaluru, and Bhubaneswar will comprise module-based training of primary care providers (PCPs) for screening, diagnosing, and managing depression in diabetes in phase I. Phase II will involve four-arm parallel group RCT on 350 participants with T2DM with comorbid depressive episode randomly allocated to receive fluoxetine, mindfulness therapy, fluoxetine plus mindfulness therapy, or treatment as usual at primary care settings. Interventions would include fluoxetine (up to 60 mg/day) and/or sessions of mindfulness for 16 weeks. Primary outcomes on standardized rating scales include depression scores (Hamilton Depression Rating Scale), treatment adherence (Adherence to Refill and Medication Scale), self-care (Diabetes Self-Management Questionnaire), diabetes-related distress (Diabetes Distress Scale), and glycemic control. Secondary outcomes include quality of life (World Health Organization Quality of Life Brief version [WHO-QOL BREF]) and mindfulness (Five Facets Mindfulness Questionnaire). Discussion: This RCT will investigate the effectiveness of module-based training of PCPs and feasibility of collaborative care model for managing depression in T2DM in primary care settings in LMICs and effectiveness of fluoxetine and/or mindfulness in improving diverse outcomes of T2DM with major depression.

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