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Feasibility and Preliminary Efficacy of a Novel RDoC-Based Treatment Program for Adolescent Depression: "Training for Awareness Resilience and Action" (TARA)-A Pilot Study.

Eva Henje Blom, Olga Tymofiyeva, Margaret A Chesney, Tiffany C Ho, Patricia J Moran, Colm G Connolly, Larissa G Duncan, Lisa Baldini, Helen Y. Weng, Michael Acree, Veronica Goldman, Frederick M Hecht, Tony T. Yang

Frontiers in Psychiatry January 16, 2017 DOI: 10.3389/fpsyt.2016.00208 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Single-arm trial Pilot study Peer reviewed
Sample size 26
Population Adolescents aged 14-18 years with clinically depressed and/or anxious symptoms (7 males, 19 females)
Interventions Training for Awareness Resilience and Action (TARA)
Duration 12-week group program; assessments before (T0), immediately after (T1), and 3 months after the end of TARA (T2)
Measures Reynolds Adolescent Depression Scale Second Edition, Multidimensional Anxiety Scale for Children
Topics Depression
Keywords Emotion regulation Adolescent depression Autonomic regulation Non-pharmacological Mindfulness-based Novel treatment development Yoga-based
Key findings TARA was feasible in clinically depressed and/or anxious adolescents and showed preliminary efficacy: depression and anxiety symptoms improved significantly from baseline to post-treatment and to 3-month follow-up, with improvements also in psychological flexibility, sleep, and mindfulness skills. The authors note the small sample and absence of a control condition limit the findings.

Abstract

Background: The novel group treatment program Training for Awareness, Resilience, and Action (TARA) was developed to target specific mechanisms based on neuroscience findings in adolescent depression and framed within the National Institute of Mental Health Research Domain Criteria. TARA contains training of autonomic and emotional self-regulation, interoceptive awareness, relational skills, and value-based committed action.

Methods: We performed a single-arm trial to test the feasibility and preliminary efficacy of TARA in reducing depression and anxiety levels and assessed whether the specific targeted domains of function reflected the hypothesized symptom change. Twenty-six adolescents (14-18 years old, 7 males and 19 females) participated in the 12-week group program. Assessment was performed before (T0), immediately after (T1), and 3 months after the end of TARA (T2).

Results: Significant improvement was seen in depression symptoms (Reynolds Adolescent Depression Scale Second Edition) between T0-T1 (t-value = -3.56, p = 0.002, CI = -6.64, -1.77) and T0-T2 (t-value = -4.17, p < 0.001, CI = -11.20, -3.75) and anxiety symptoms (Multidimensional Anxiety Scale for Children) between T0-T1 (t-value = -2.26, p = 0.033, CI = -4.61, -0.21) and T0-T2 (t-value = -3.06, p = 0.006, 95% confidence interval = -9.02, -1.73). Significant improvements in psychological flexibility, sleep, and mindfulness skills were also found between T0 and T2.

Limitations: The sample size was small without a control condition. The pilot design did not allow for testing the hypothesized brain changes and effect of TARA on relevant systemic biomarkers.

Conclusion: TARA is feasible in a sample of clinically depressed and/or anxious adolescents and preliminary efficacy was demonstrated by reduced depression and anxiety symptoms. The specific symptom and behavioral outcomes corresponded well with the hypothesized mechanisms of change.

Comparable studies

Other non-randomized and open-label trials on depression, most cited first.

Study Year Design Participants
Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. Patients with moderate-to-severe, unipolar, treatment-resistant major depression 2016 Open-label feasibility trial n = 12
Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Patients with severe, unipolar, treatment-resistant major depression 2017 Open-label trial n = 20
Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression Patients with treatment-resistant depression 2018 Clinical trial n = 20
Rapid Resolution of Suicidal Ideation After a Single Infusion of anN-Methyl-D-Aspartate Antagonist in Patients With Treatment-Resistant Major Depressive Disorder Subjects with DSM-IV-diagnosed treatment-resistant major depressive disorder 2010 Open-label trial n = 33
Antidepressant Effects of a Single Dose of Ayahuasca in Patients With Recurrent Depression Patients with recurrent depression 2015 Open-label trial n = 17

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