Pilot Randomized Controlled Trial of Omega-3 and Individual-Family Psychoeducational Psychotherapy for Children and Adolescents With Depression

• Published in: Journal of clinical child and adolescent psychology Vol. 48; no. sup1; pp. S105 - S118
• Main Authors: Fristad, Mary A, Vesco, Anthony T, Young, Andrea S, Healy, K Zachary, Nader, Elias S, Gardner, William, Seidenfeld, Adina M, Wolfson, Hannah L, Arnold, L Eugene
• Format: Journal Article
• Language: English
• Published: England Routledge, Taylor & Francis Group 01-01-2019
• Subjects: Adolescent; Child; Children; Clinical trials; Depression (Psychology); Depression - drug therapy; Depression - therapy; Effect Size; Endogenous; Evaluators; Fatty acids; Fatty Acids, Omega-3 - pharmacology; Fatty Acids, Omega-3 - therapeutic use; Feasibility; Female; Fidelity; Humans; Individual psychotherapy; Male; Maternal depression; Mental depression; Modeling (Psychology); Pilot Projects; Psychosocial factors; Psychotherapy; Psychotherapy - methods; Randomized Controlled Trials; Rating Scales; Remission (Medicine); Resistance (Psychology); Severity; Side effects; Teenagers; Treatment Outcome
• ISSN: 1537-4416; 1537-4424
• DOI: 10.1080/15374416.2016.1233500

The goal of this study is to evaluate feasibility and estimate effect sizes of omega-3 fatty acids (Ω3), individual-family psychoeducational psychotherapy (PEP), their combination, and moderating effects of maternal depression and psychosocial stressors in youth with depression. In a pilot 2 × 2 randomized controlled trial, 72 youth (ages 7-14; 57% Caucasian, 57% male) with major depression, dysthymia, or depression not otherwise specified were randomized to 12 weeks of Ω3, PEP+placebo, Ω3+PEP, or placebo. Ω3 versus placebo was double-masked. Evaluators masked to condition assessed depressive severity at baseline (randomization) and at 2, 4, 6, 9, and 12 weeks using the Children's Depression Rating Scale-Revised. Side effects were either absent or mild. PEP was administered with 74% fidelity. Remission was 77%, Ω3+PEP; 61%, PEP+placebo; 44%, Ω3; 56%, placebo. Intent-to-treat analyses found small to medium effects of combined treatment (d = .29) and Ω3 monotherapy (d = .42), but negligible effect for PEP+placebo (d < .10), all compared to placebo alone. Relative to placebo, youth with fewer social stressors responded better to Ω3 (p = .04), PEP (p = .028), and their combination (p = .035), and those with maternal depression responded better to PEP (p = .020) than did those without maternal depression. Remission rates were favorable compared to other studies of psychotherapy and comparable to an existing randomized controlled trial of Ω3; results warrant further evaluation in a larger sample. Ω3 was well tolerated. Active treatments show significantly more placebo-controlled depression improvement in the context of maternal depression and fewer stressors, suggesting that they may benefit depression with a more endogenous than environmental origin.