Depression in adolescents and young adults is an increasing global health concern. Available treatments are not sufficiently effective and relapse rates remain high. The novel group-treatment program “Training for Awareness, Resilience and Action” (TARA) targets specific mechanisms based on neuroscientific findings in adolescent depression. TARA is framed within the National Institute of Mental Health's Research Domain Criteria and has documented feasibility and preliminary efficacy in the treatment of adolescent depression. Since neurodevelopment continues well into the mid-twenties, age-adapted treatments are warranted also for young adults. Patients 15–22 years old, with either major depressive disorder (MDD) or persistent depressive disorder (PDD) according to the DSM-IV/5 or a rating >40 on the clinician rating scale Children's Depression Rating Scale—Revised (CDRS-R), will be recruited from specialized Child and Adolescent Psychiatry and local Youth-Clinics and randomized to either TARA or standard treatment, including but not limited to antidepressant medication and/or psychotherapy. Outcome measures will be obtained before randomization (T0), after 3 months of treatment (T1) and at 6-months- (T2) and 24-months- (T3) follow-up. Additionally, dose-response measures will be obtained weekly in the TARA-arm and measures for mediation-analysis will be obtained halfway through treatment (T0.5). Primary outcome measure is Reynolds Adolescent Depression Scale (RADS-2) score at T1. Secondary outcome measures include RADS-2 score at T2, Multidimensional Anxiety Scale for Children at T1 and T2, and CDRS-R at T1. Additional outcome measures include self-report measures of depression-associated symptoms, systemic bio-indicators of depression from blood and hair, heartrate variability, brain magnetic resonance imaging, as well as three-axial accelerometry for sleep-objectivization. Qualitative data will be gathered to reach a more comprehensive understanding of the factors affecting adolescents and young adults with depression and the extent to which the different treatments address these factors. In summary, this article describes the design, methods and statistical analysis plan for pragmatically evaluating the clinical effectiveness of TARA. This will be the first RCT to examine the effects of TARA compared to standard treatment for adolescents and young adults with MDD or PDD. We argue that this study will extend the current knowledgebase regarding the treatment of depression.NCT Registration: identifier [NCT04747340].
Background: Due to the sharp global increase in prevalence of adolescent major depressive disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, we need internationally validated tools for multi-dimensional assessment. Reynolds Adolescent Depression Scale second edition (RADS-2) measures dysphoric mood, anhedonia/negative affect, negative self-evaluation and somatic complaints and is widely used internationally, but not yet available in Swedish. Aim: The aim of this study is to test the psychometric characteristics of the Swedish version of RADS-2 in a normative sample. Material and method: Data was gathered from junior and high school students in Northern Sweden (N ¼ 637). We performed: 1. Confirmatory factor analysis to examine the 4-factor structure proposed by Reynolds, 2. Measurement invariance analysis for sex (girls, boys) and age group (12-15 years, 16-20 years). 3. Reliability testing and 4. Tests for concurrent, discriminant and convergent validity using Beck's Youth Inventories of Emotional and Social Impairment Depression and Anger subscales, the Patient Reported Outcome Measurements Information System, Anxiety and Friends subscales and the World Health Organization Wellness Index. Results: The sample consisted of n ¼ 637 students (n ¼ 389 girls and n ¼ 248 boys), mean age 15.73 (SD ¼ 1.76); 12-20 years. The 4-factor structure was confirmed, as well as measurement invariance for sex and age group. Reliability was acceptable to excellent for all subscales and RADS-2 total scale. Concurrent, convergent and discriminant validity was good. Conclusion: The Swedish version of RADS-2 showed acceptable reliability and validity in a Swedish normative sample.
Objective: Observed and predicted increases in the global burden of disease caused by major depressive disorder (MDD) highlight the need for psychometrically robust multi-dimensional measures to use for clinical and research purposes. Reynolds Adolescent Depression Scale second edition (RADS-2) is an internationally well-validated scale measuring different dimensions of adolescent depression. The Swedish version has previously only been evaluated in a normative sample. Methods: We collected data from patients in child and adolescent psychiatry and primary care and performed: (1) Confirmatory factor analysis (CFA) to evaluate the established four-factor structure, (2) Analyses of reliability and measurement invariance, (3) Analyses of convergent and discriminant validity using the Montgomery-Asberg Depression Rating Scale, the depression subscales of the Beck Youth Inventories and the Revised Child Anxiety and Depression Scale, as well as the Patient Reported Outcome Measurements Information System, peer-relationships and physical activity item banks. Results: Recruited participants (n ¼ 536, 129 male and 407 female, mean age 16.45 years, SD ¼ 2.47, range 12 À 22 years) had a variety of psychiatric diagnoses. We found support for the four-factor structure and acceptable to good reliability for the subscale and total scores. Convergent and discriminant validity were good. Measurement invariance was demonstrated for age, sex, and between the present sample and a previously published normative sample. The RADS-2-scores were significantly higher in the present sample than in the normative sample. In this clinical study, the Swedish RADS-2 demonstrated good validity and acceptable to good reliability. Our findings support the use of RADS-2 in Swedish clinical and research contexts.
Background Medical students have a higher risk for depression, anxiety, stress-related symptoms, burnout, and suicide, and more rarely seek professional help or treatment than the general population. Appeals are being made to address the mental health and resilience of physicians-to-be. The novel program Training for Awareness, Resilience, and Action (TARA) was originally developed to treat depressed adolescents, targeting specific neuroscientific findings in this population. TARA has shown feasibility and preliminary efficacy in clinically depressed adolescents and corresponding brain-changes in mixed community adolescent samples. The present study investigated the feasibility and acceptability of TARA as a potential indicated prevention program for symptoms of depression, anxiety, stress and burnout in Swedish medical students. Methods We conducted a single-arm trial with 23 self-selected students in their early semesters of medical school (mean age 25.38 years, 5 males and 18 females), with or without mental disorders. All participants received TARA. Self-reported symptoms of depression, anxiety, perceived stress and psychological inflexibility were collected before (T0) and after the intervention (T1). Qualitative data on the participants’ experiences of TARA were collected in focus-group interviews conducted halfway through the program and upon completion of the program. Individual interviews were also conducted 2 years later. Qualitative content analysis was performed. Results The mean attendance rate was 61.22% and the dropout rate was 17.40%. The Child Session Rating Scale administered after every session reflected an overall acceptable content, mean total score 34.99 out of 40.00. Trends towards improvement were seen across all outcome measures, including the Hospital Anxiety and Depression Scale Anxiety (t = 1.13, p = 0.29) and Depression (t = 1.71, p = 0.11) subscales, Perceived Stress Scale (t = 0.67, p = 0.51) and Avoidance and Fusion Questionnaire for youth (t = 1.64, p = 0.10). None of the participants deteriorated markedly during the intervention. Qualitative content analysis resulted in a main theme labeled: “An uncommon meeting-ground for personal empowerment”, with 4 themes; “Acknowledging unmet needs”, “Entering a free zone”, “Feeling connected to oneself and others” and “Expanding self-efficacy”. Conclusion TARA is feasible and acceptable in a mixed sample of Swedish medical students. The students’ reports of entering an uncommon meeting-ground for personal empowerment supports effectiveness studies of TARA in this context.
BackgroundDepression is a top-ranking global health concern increasing in magnitude. Available treatments for adolescents and young adults are not convincingly effective and relapse rates remain high. Training for Awareness, Resilience and Action (TARA) is a group treatment program targeting specific pathophysiological mechanisms of depression in young people. TARA is feasible, acceptable, preliminarily efficacious in depressed American adolescents, and it affects postulated brain-circuitry.MethodsAs an initial step of a multicenter randomized controlled trial (RCT) we performed a single-arm multicenter pilot-study on TARA. Thirty-five depressed individuals (15–21 years old, 28 females) received TARA for 12 weeks face-to-face or online. Data was collected before (T0), during, and after the intervention (T1). The trial was pre-registered at clinicaltrials.gov, NCT Registration: identifier [NCT04747340]. Feasibility outcomes included recruitment, attendance rates, and session ratings. Adverse events were recorded weekly and extracted from medical records at the end of the trial. Primary effectiveness outcome was self-rated depression severity on Reynolds Adolescent Depression scale 2nd ed. at T1. Secondary outcomes were Children’s Depression Rating Scale-revised (CDRS-R) and Multidimensional Anxiety Scale for Children (MASC) at T1.ResultsTARA was feasible and safe in the present trial. No significant RADS-2-change was seen (adjusted mean difference –3.26, 95 % CI –8.35 to 1.83; p= 0.20), however a significant decrease in CDRS-R scores is reported (adjusted mean difference –9.99, 95% CI –14.76 to –5.22; p < 0.001). MASC-scores did not change significantly (adjusted mean difference 1.98, 95% CI –0.96 to 4.91; p=0.18). Additional feasibility aspects are presented and discussed.DiscussionLimitations include substantial loss-to-follow-up, no randomization to control, and that some participants received concomitant treatment(s). The Coronavirus pandemic complicated both implementation and interpretation of the trial. In conclusion TARA was feasible and safe in depressed adolescents and young adults. Preliminary signs of effectiveness were seen. The initiated RCT will be important and worthwhile to conduct, and several improvements to the design are suggested based on the present results.Clinical Trial Registrationclinicaltrials.gov, identifier NCT04747340.
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