Healthy Minds Program for Adolescent Depression
(AMPT Trial)
Recruiting in Palo Alto (17 mi)
Overseen byElizabeth Andersen, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of North Carolina, Chapel Hill
Must not be taking: Exogenous hormones, IUD, others
Disqualifiers: Manic episodes, Psychotic symptoms, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Starting at puberty, female adolescents are nearly three-times more likely to develop internalizing disorders, like depression, while male adolescents are two-times more likely to develop externalizing disorders, like attention deficit hyperactivity disorder (ADHD). This divergence between the sexes during puberty suggests sex-specific pathways of risk and differential effects of sex hormones. The purpose of this research is to determine: 1) sex-specific neural and endocrine features of the pubertal transition that may mediate sex differences in adolescent mood disorders, and 2) the neurophysiological basis of susceptibility to hormone change during puberty.
Will I have to stop taking my current medications?
The trial requires that you stop taking medications that directly alter cardiovascular or neurological function, as well as any form of exogenous hormones or intrauterine device (IUD) within one month of participation.
What data supports the effectiveness of the Healthy Minds Program treatment for adolescent depression?
Research shows that cognitive-behavioral programs, similar to the Healthy Minds Program, can effectively reduce depressive symptoms in adolescents. A study found that adolescents participating in a cognitive-behavioral program had significantly lower depression scores compared to those who did not receive the intervention.
12345Is the Healthy Minds Program for Adolescent Depression safe for humans?
The reviewed school-based programs, which may include similar approaches to the Healthy Minds Program, generally show small effects in reducing depression and anxiety symptoms in adolescents, with no significant safety concerns reported. These programs are often delivered by mental health professionals and are considered safe for use in school settings.
16789How does the Healthy Minds Program for Adolescent Depression treatment differ from other treatments for this condition?
The Healthy Minds Program is unique because it focuses on a cognitive-behavioral approach, which involves teaching adolescents skills to manage their thoughts and behaviors to prevent depression. This program is delivered in a school setting, making it more accessible and integrated into the students' daily environment, unlike traditional treatments that often require visits to clinics or therapists.
410111213Eligibility Criteria
This trial is for adolescents aged 11-14 who have faced a stressful event in the past year or show moderate depression. They must own a mobile device to download necessary apps. It's not for those with prior Healthy Minds Program experience, regular meditation practice, history of manic or psychotic symptoms, current suicidal intent, hormone treatments within the last month, or medications affecting heart or brain function.Inclusion Criteria
I am between 11 and 14 years old.
Experienced a stressful life event within the last year, or endorse moderate depression (defined by a CES-DC score 16 or higher)
Have their own personal mobile device and capability to download the MyCap and Healthy Minds apps
Exclusion Criteria
I have never had manic episodes, psychosis, or current thoughts of suicide.
I have not used hormones or an IUD in the last month.
I am on medication that affects my heart or brain function.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline
Participants undergo a 4-week baseline period before starting the intervention
4 weeks
Treatment
Participants in the experimental group begin the Healthy Minds Program immediately after the baseline period, while the waitlist control group waits an additional 4 weeks before starting the program
4 weeks
Follow-up
Participants are monitored for changes in CES-DC scores to assess depressive symptoms
4 weeks
Participant Groups
The study investigates how puberty affects mood disorders differently in males and females by looking at brain activity and hormone levels. Participants will use the Healthy Minds Program app designed to track these changes during their pubertal transition.
2Treatment groups
Experimental Treatment
Group I: Waitlist ControlExperimental Treatment1 Intervention
After the 4-week baseline period, participants in the waitlist control condition will wait an additional 4 weeks before starting the Healthy Minds Program.
Group II: Healthy Minds ProgramExperimental Treatment1 Intervention
Participants in this group will begin the Healthy Minds Program immediately following the 4-week baseline period.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Carolina Crossing B, Suite 1Chapel Hill, NC
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Who Is Running the Clinical Trial?
University of North Carolina, Chapel HillLead Sponsor
Foundation of Hope, North CarolinaCollaborator
References
Systematic review of school-based prevention and early intervention programs for depression. [2022]A systematic review was conducted to identify and describe school-based prevention and early intervention programs for depression and to evaluate their effectiveness in reducing depressive symptoms. Forty-two randomised controlled trials, relating to 28 individual school-based programs, were identified through the Cochrane Library, PsycInfo and PubMed databases. A large proportion of the programs identified were based on cognitive behavioural therapy (CBT), and delivered by a mental health professional or graduate student over 8-12 sessions. Indicated programs, which targeted students exhibiting elevated levels of depression, were found to be the most effective, with effect sizes for all programs ranging from 0.21 to 1.40. Teacher program leaders and the employment of attention control conditions were associated with fewer significant effects. Further school-based research is required that involves the use of attention controls, long-term follow-ups and which focuses on the training and evaluation of sustainable program leaders, such as teachers.
Improving care for depression and suicide risk in adolescents: innovative strategies for bringing treatments to community settings. [2023]This article reviews the literature on interventions and services for depression and suicide prevention among adolescents, with the goals of placing this science within the context of currently changing health care environments and highlighting innovative models for improving health and mental health. We examine the challenges and opportunities offered by new initiatives and legislation designed to transform the US health and mental health care systems; summarize knowledge regarding the treatment of depression and suicidality/self-harm in adolescents; and describe innovative models for partnering with health systems and communities. This review demonstrates that treatment models and service delivery strategies are currently available for increasing evidence-based care, particularly for depression, and concludes with recommendations for future research and quality improvement initiatives aimed at inspiring additional efforts to put science to work, bridge science and community practice, and develop strategies for partnering with communities to improve care, mental health, and well-being among adolescents.
A controlled trial of a school-based Internet program for reducing depressive symptoms in adolescent girls. [2022]This study evaluates the benefits of a self-directed Internet intervention for depression (MoodGYM) delivered as a part of the high school curriculum.
A randomized controlled trial of a cognitive-behavioral program for the prevention of depression in adolescents compared with nonspecific and no-intervention control conditions. [2018]Adolescent depression is a common and recurrent disorder associated with significant impairment and other forms of psychopathology. Finding an effective intervention that prevents depression in adolescents is an important public health priority. Participants were 518 high school students (mean age = 15.09; SD = 0.76) from the mid-south of the United States. Participants were randomly assigned to 1 of 3 conditions: a cognitive-behavioral program (CB; n = 166), nonspecific control (NSp; n = 175), or a no-intervention control condition (NIC; n = 177). Both the CB and NSp conditions consisted of 90-min sessions administered once a week over a 10-week period during regular school hours. Depressive symptoms were assessed with the Children's Depression Inventory (CDI) at baseline; postintervention; and at 4-, 8-, and 12-month follow-ups. The Time × Condition interaction was significant, F(8, 478.57) = 3.32, p = .001, indicating that at the 4-month follow-up, youth in the CB condition had significantly lower CDI scores compared with those in the NSp (p = .047, g = 0.29; CI [0.06, 0.52]) and the NIC conditions (p = .003, g = 0.30; CI [0.07, 0.53]). Future studies need to examine the importance of theory-driven change mechanisms, interpersonal relationships, and structural circumstances in schools as factors impacting the long-term effects of CB prevention programs.
An internet-based adolescent depression preventive intervention: study protocol for a randomized control trial. [2023]The high prevalence of major depressive disorder in adolescents and the low rate of successful treatment highlight a pressing need for accessible, affordable adolescent depression prevention programs. The Internet offers opportunities to provide adolescents with high quality, evidence-based programs without burdening or creating new care delivery systems. Internet-based interventions hold promise, but further research is needed to explore the efficacy of these approaches and ways of integrating emerging technologies for behavioral health into the primary care system.
School-based depression and anxiety prevention programs: An updated systematic review and meta-analysis. [2021]Depression and anxiety are often first experienced during childhood and adolescence, and interest in the prevention of these disorders is growing. The focus of this review was to assess the effectiveness of psychological prevention programs delivered in schools, and to provide an update to our previous review from five years ago (Werner-Seidler, Perry, Calear, Newby, & Christensen, 2017). Three electronic databases were systematically searched for published articles of randomised controlled trials (RCTs) evaluating the efficacy of school-based prevention programs until October 2020. There were 130 articles that met inclusion criteria, representing 118 unique trials and 45,924 participants. Small between-group effect sizes for depression (g = 0.21) and anxiety (g = 0.18) were detected immediately post-intervention. Subgroup analyses suggested that targeted prevention programs (for young people with risk factors or symptoms) were associated with significantly greater effect sizes relative to universal programs for depression, which was confirmed by meta-regression. There was also some evidence that external providers conferred some benefit over school-staff delivered programs. Overall, study quality was moderate and no association between risk of bias and effect size was detected. School-delivered psychological prevention programs have small effects in reducing symptoms of depression and anxiety. Refinement of these programs, and knowledge about how they can be sustainably delivered in schools beyond the trial period is now needed for population-level preventive effects. Systematic Review Registration Number: PROPSERO - CRD42020188323.
School-based depression and anxiety prevention programs for young people: A systematic review and meta-analysis. [2022]Depression and anxiety often emerge for the first time during youth. The school environment provides an ideal context to deliver prevention programs, with potential to offset the trajectory towards disorder. The aim of this review was to provide a comprehensive evaluation of randomised-controlled trials of psychological programs, designed to prevent depression and/or anxiety in children and adolescents delivered in school settings. Medline, PsycINFO and the Cochrane Library were systematically searched for articles published until February 2015. Eighty-one unique studies comprising 31,794 school students met inclusion criteria. Small effect sizes for both depression (g=0.23) and anxiety (g=0.20) prevention programs immediately post-intervention were detected. Small effects were evident after 12-month follow-up for both depression (g=0.11) and anxiety (g=0.13). Overall, the quality of the included studies was poor, and heterogeneity was moderate. Subgroup analyses suggested that universal depression prevention programs had smaller effect sizes at post-test relative to targeted programs. For anxiety, effect sizes were comparable for universal and targeted programs. There was some evidence that externally-delivered interventions were superior to those delivered by school staff for depression, but not anxiety. Meta-regression confirmed that targeted programs predicted larger effect sizes for the prevention of depression. These results suggest that the refinement of school-based prevention programs have the potential to reduce mental health burden and advance public health outcomes.
Effect modification of an effective transdiagnostic cognitive behavioral psychotherapy in youths with common mental health problems: Secondary analyses of the randomized mind-my-mind trial. [2023]Mind My Mind (MMM) cognitive behavioral therapy (CBT) manualized treatment is effective in the management of common emotional and behavioral mental health problems in youth, yet not all individuals respond satisfactorily to treatment. This study explored potential effect modifiers, i.e., baseline factors associated with a differential treatment effect. We conducted secondary effect modifier analyses with MMM trial data, which involved randomization of 396 youths aged 6-16 years to either MMM CBT treatment (9-13 sessions) or management as usual in local community settings. We examined sociodemographic- (sex, age, family composition, ethnicity, parental education, and income) and clinical variables (mental disorders and duration of mental health problems) as potential effect modifiers of the a) change in parent-rated impact of mental health problems measured by the Strengths and Difficulties Questionnaire (SDQ) or b) response (reduction of ≥1 on SDQ-impact). In intention-to-treat analyses, superior treatment (net) benefits from the MMM intervention were found among youths who met criteria for any mental disorder at baseline (-1.25 [95%CI: -1.67;-0.82]) compared to youths that did not meet diagnostic criteria (-0.22 [95%CI:-1.09;0.65]). Comorbidity vs no comorbidity (-1.84 [95%CI:-2.58;-1.10] vs -0.72 [95%CI:-1.15;-0.29]) and longer duration of untreated mental health problems, i.e., more vs less than 6 months (-1.16 [95%CI:-1.55;-0.78] vs 0.43 [95%CI:-1.01;1.86]) were also associated with superior treatment benefits. The sociodemographic factors were not associated with differential treatment effects in the intention-to-treat analyses. These findings suggest that community-based programs like the MMM are well-suited for youths with substantial mental health problems. Clinical Trials Identifier: NCT03535805.
A residents' program for educating adolescents about mental health issues. [2021]This paper describes a school-based program in which psychiatry residents educate adolescents about a variety of mental health topics. Adolescents responded positively to the program and were principally concerned about drugs, depression, suicide, and family problems. Residents also liked presenting in the schools. Participation in this program allowed residents to learn about agency consultation and secondary prevention. Possibilities for program expansion are discussed.
Recognizing and responding to adolescent depression. [2019]We have seen that depression is increasingly recognized as a problem which affects adolescents as well as adults. Race by itself is not a factor which increases vulnerability to depression, but the multitude of sociodemographic, biological, and personal factors contributing to the development of depression are not fully understood. Research is needed to better understand how these factors interact in order to better develop prevention strategies and treatment modalities. With regard to treatment, adolescents are truly underserved. There is an awkward fit between the traditional mental health system and the developmental needs of adolescents. Unlike the majority of depressed adults who receive some treatment from general practitioners and medical clinics, adolescents do not tend to visit their pediatricians when they are depressed. One proposed solution is the adolescent comprehensive health care clinic providing a holistic approach to assessment, early intervention, and collaborative treatment between primary provider and mental health worker. Data from our adolescent program suggest that this approach has been successful in dealing with the problem of depression, especially in its early stages. Again, more research is needed to support these preliminary findings, but we believe that the adolescent comprehensive health care approach can be an effective, efficient way of addressing the health needs, mental and physical, of our teens at risk. Federal money for research must be made available, liberalization of health insurance must occur, and state-sponsored services must be developed so that these programs can be made more effective and can be brought to more of the adolescents who need them.
A randomized effectiveness trial of interpersonal psychotherapy for depressed adolescents. [2022]Adolescent depression is highly prevalent and has substantial morbidity, including suicide attempts, school dropout, and substance abuse, but many depressed adolescents are untreated. The school-based health clinic offers the potential for accessible and efficient treatment, although it is unknown whether school-based clinicians can be trained to implement evidence-based psychotherapies for depression in routine care.
Effectiveness in Regular Practice of Collaborative Care for Depression Among Adolescents: A Retrospective Cohort Study. [2022]Depression is common among adolescents, but many lack ready access to mental health services. Integrated models of care for depression are needed, along with evidence to support their use in regular practice. The authors examined the effectiveness of an ongoing collaborative care program for depressed adolescents embedded in a busy primary care practice.
Prevention of depression among Icelandic adolescents. [2009]Major depression and dysthymia are frequent, debilitating, and chronic disorders, whose highest rate of initial onset is during the late adolescent years. The effectiveness of a program designed to prevent an initial episode of major depression or dysthymia among adolescents was investigated. Participants were 171 fourteen-year-old "at risk" Icelandic adolescents who were randomly assigned to a prevention program or a treatment-as-usual assessment only control group. They were identified as "at risk" by reporting the presence of depressive symptoms or a negative attributional style. The program was based on a developmental psychosocial model of enhancement of resilience to factors associated with the occurrence of mood disorders. The results indicated that the prevention program resulted in a significantly lower rate of major depression and dysthymia than did the control group. The study demonstrated that school personnel in the school setting can implement such prevention programs.