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Depression in teenagers and young adults: foundational studies of the new treatment paradigm TARA: Training for Awareness, Resilience, and Action
Umeå University, Faculty of Medicine, Department of Clinical Sciences, Child and Adolescent Psychiatry.ORCID iD: 0000-0003-0496-7158
2024 (English)Doctoral thesis, comprehensive summary (Other academic)Alternative title
Depression bland tonåringar och unga vuxna : grundläggande studier av det nya behandlingsparadigmet TARA: Training for Awareness, Resilience and Action (Swedish)
Abstract [en]

Introduction: Depression in adolescents and young adults is an increasing global health concern and available treatments are not convincingly effective. It is therefore important to develop and test novel treatments to improve treatment outcomes. This dissertation lays the foundation for the evaluation of a Swedish version of the treatment program Training for Awareness, Resilience, and Action (TARA), and tests the psychometric properties of the primary outcome measure for that evaluation.

Objectives: This dissertation aims to 1. Translate and pilot test TARA in Swedish medical students, 2. Evaluate the psychometric properties of the Swedish version of the Reynolds Adolescent Depression Scale second edition (RADS-2) in a clinical sample, 3. Perform a single arm multicenter clinical pilot study of the feasibility and safety of TARA and 4. Design a randomized controlled trial to test the clinical effectiveness of TARA.

Methods: The TARA manual was translated into Swedish and 23 self-selected medical students, with or without mental disorders, received TARA. Self-rating as well as qualitative evaluation was performed. Patients (N = 536 individuals) with a variety of psychiatric diagnoses completed RADS-2 and other questionnaires for psychometric evaluation of RADS- 2. Thirty-five adolescents and young adults with depression received TARA either face-to-face or online, with data collection before, during, and after the treatment. The study design and statistical analysis plan for the randomized controlled trial was conceived and developed.

Results: It was feasible and acceptable to give TARA to Swedish medical students and they described the program as an uncommon meeting ground for personal empowerment. Support was found for the four-factor structure of RADS-2, and the scale demonstrated good validity and acceptable to good reliability. The clinical pilot study further supported the feasibility and clinical safety of TARA, and preliminary signs of effectiveness were seen. A detailed description of the pragmatic, multicenter, randomized controlled superiority trial that will evaluate the clinical effectiveness of TARA compared to standard treatment for depression was outlined, peer reviewed, and published in a study protocol with a statistical analysis plan.

Conclusions: The present results indicate that TARA is feasible and safe in Swedish clinical and non-clinical contexts. RADS-2 is a suitable outcome measure to use in routine clinical practice as well as in the present and future trials of depression. The initiated randomized controlled trial will be an important next step logically following the studies and results presented in this dissertation.

Place, publisher, year, edition, pages
Umeå: Umeå University, 2024. , p. 114
Series
Umeå University medical dissertations, ISSN 0346-6612 ; 2294
Keywords [en]
Depression, adolescents, young adults, medical students, mental health, anxiety, psychological stress, qualitative research, randomization, yoga, mindfulness, psychotherapy, antidepressant drugs, biomarkers, clinical trial, feasibility studies, online intervention, reliability, validity, confirmatory factor analysis, measurement invariance
National Category
Other Clinical Medicine
Research subject
Child and Youth Psychiatry
Identifiers
URN: urn:nbn:se:umu:diva-222788ISBN: 978-91-8070-281-2 (print)ISBN: 978-91-8070-282-9 (electronic)OAI: oai:DiVA.org:umu-222788DiVA, id: diva2:1847466
Public defence
2024-04-26, Umeälven, byggnad 28, Norrlands universitetssjukhus, Umeå, 09:00 (English)
Opponent
Supervisors
Funder
Swedish Research CouncilRegion VästerbottenRegion VästernorrlandThe Kempe FoundationsFredrik och Ingrid Thurings StiftelseSwedish Society of MedicineAvailable from: 2024-04-05 Created: 2024-03-27 Last updated: 2024-04-02Bibliographically approved
List of papers
1. Training for Awareness, Resilience and Action (TARA) for medical students: a single-arm mixed methods feasibility study to evaluate TARA as an indicated intervention to prevent mental disorders and stress-related symptoms
Open this publication in new window or tab >>Training for Awareness, Resilience and Action (TARA) for medical students: a single-arm mixed methods feasibility study to evaluate TARA as an indicated intervention to prevent mental disorders and stress-related symptoms
Show others...
2022 (English)In: BMC Medical Education, E-ISSN 1472-6920, Vol. 22, no 1, article id 132Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
BioMed Central (BMC), 2022
Keywords
Anxiety, Depression, Medical students, Mental health, Psychological stress, Qualitative research
National Category
Psychiatry Nursing
Identifiers
urn:nbn:se:umu:diva-193011 (URN)10.1186/s12909-022-03122-2 (DOI)000762282000001 ()35227281 (PubMedID)2-s2.0-85125536398 (Scopus ID)
Funder
Region VästerbottenRegion VästernorrlandThe Kempe Foundations
Available from: 2022-03-10 Created: 2022-03-10 Last updated: 2024-03-27Bibliographically approved
2. Psychometric properties of the Swedish version of the Reynolds Adolescent Depression Scale second edition (RADS-2) in a clinical sample
Open this publication in new window or tab >>Psychometric properties of the Swedish version of the Reynolds Adolescent Depression Scale second edition (RADS-2) in a clinical sample
2023 (English)In: Nordic Journal of Psychiatry, ISSN 0803-9488, E-ISSN 1502-4725, Vol. 77, no 4, p. 383-392Article in journal (Refereed) Published
Abstract [en]

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 = 536, 129 male and 407 female, mean age 16.45 years, SD = 2.47, range 12 − 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.

Place, publisher, year, edition, pages
Taylor & Francis, 2023
Keywords
confirmatory factor analysis, Depression, measurement invariance, reliability, validity
National Category
Psychiatry
Research subject
Psychiatry
Identifiers
urn:nbn:se:umu:diva-201250 (URN)10.1080/08039488.2022.2128409 (DOI)000878905200001 ()36332154 (PubMedID)2-s2.0-85141355963 (Scopus ID)
Funder
Swedish Research CouncilRegion Västerbotten, RV967045Region VästernorrlandThe Kempe FoundationsSwedish Society of Medicine, SLS-935854
Available from: 2022-12-05 Created: 2022-12-05 Last updated: 2024-03-27Bibliographically approved
3. Clinical effectiveness of training for awareness, resilience, and action for adolescents and young adults with depression: the pilot phase of a multicenter randomized controlled trial
Open this publication in new window or tab >>Clinical effectiveness of training for awareness, resilience, and action for adolescents and young adults with depression: the pilot phase of a multicenter randomized controlled trial
Show others...
2023 (English)In: Frontiers in Psychiatry, E-ISSN 1664-0640, Vol. 14, article id 1130035Article in journal (Refereed) Published
Abstract [en]

Background: Depression 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.

Methods: As 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.

Results: TARA 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.

Discussion: Limitations 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.

Place, publisher, year, edition, pages
Frontiers Media S.A., 2023
Keywords
adolescents, clinical trial, depression, feasibility studies, mindfulness, online intervention, yoga, young adults
National Category
Psychiatry
Identifiers
urn:nbn:se:umu:diva-208087 (URN)10.3389/fpsyt.2023.1130035 (DOI)000970913600001 ()2-s2.0-85153392594 (Scopus ID)
Funder
Swedish Research Council, 2021- 02257Umeå University, 970831Region Västerbotten, RV-939199Region Västerbotten, RV-967045Region Västerbotten, RV-969368Region Västerbotten, RV-941585Region Västerbotten, RV-932919Region VästernorrlandThe Kempe Foundations, LVNFOU933598Swedish Society of Medicine, SLS-935854
Available from: 2023-05-09 Created: 2023-05-09 Last updated: 2024-03-27Bibliographically approved
4. Clinical Effectiveness of Training for Awareness Resilience and Action Online Compared to Standard Treatment for Adolescents and Young Adults With Depression: Study Protocol and Analysis Plan for a Pragmatic, Multi-Center Randomized Controlled Superiority Trial
Open this publication in new window or tab >>Clinical Effectiveness of Training for Awareness Resilience and Action Online Compared to Standard Treatment for Adolescents and Young Adults With Depression: Study Protocol and Analysis Plan for a Pragmatic, Multi-Center Randomized Controlled Superiority Trial
Show others...
2021 (English)In: Frontiers in Psychiatry, E-ISSN 1664-0640, Vol. 12, article id 674583Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Frontiers Media S.A., 2021
Keywords
adolescent depression, antidepressant drugs, biomarkers, psychotherapy, randomization, yoga, young adults
National Category
Psychiatry
Research subject
Psychiatry
Identifiers
urn:nbn:se:umu:diva-189121 (URN)10.3389/fpsyt.2021.674583 (DOI)000713179300001 ()34707516 (PubMedID)2-s2.0-85117953482 (Scopus ID)
Funder
The Kempe Foundations, LVNFOU933598Swedish Medical Products Agency, SLS-935854
Available from: 2021-11-12 Created: 2021-11-12 Last updated: 2024-03-27Bibliographically approved

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