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

Abstract

Objective Toevaluate 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. Method In a pilot 2X2 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 vs. placebo was double-masked. Evaluators masked to condition assessed depressive severity at baseline (randomization), and 2, 4, 6, 9, and 12 weeks using the Children’s Depression Rating Scale-Revised. Results 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 comparedto 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. Conclusion Remission rates were favorable compared to other studies of psychotherapy and comparable to an existing RCT 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 they may benefit depression with a more endogenous than environmental origin.

Body weight affects ω-3 polyunsaturated fatty acid (PUFA) accumulation in youth following supplementation in post-hoc analyses of a randomized controlled trial

“…The participant sample was obtained from two NIMH-funded R34 studies (ClinicalTrials.gov identifiers: NCT01341925 NCT01507753), the goals of which were to determine feasibility and effects sizes for PUFA supplementation and family-focused, skills-based therapy for mood disorders [28, 29]. Secondary goals were to explore response curves over time, mediators and moderators, treatment response across a broad array of outcome variables, adherence to treatment, and side effects.…”

“…Only methods pertinent to the current analyses are described here; further details regarding recruitment and study design can be found elsewhere. [28, 29]…”

Is evidence‐based treatment helping my patient? Utilizing modified Brinley plots to measure clinical change.

“…As previously reported by Fristad et al (2016), 69 of 72 participants from the depression trial had sufficient follow-up data to be included in LME analyses. These analyses indicated that while average CDRS-R scores decreased significantly over time for all treatment groups, no statistically significant group differences could be detected ( placebo alone, a small-medium effect (d s = 0.42) was detected for the Ω3 +AM group (Cohen, 1992), and a small effect was detected for Ω3 + IF-PEP (d s = 0.29).…”

“…Participants in the first trial (n = 72; Fristad et al, 2016) were diagnosed with major depressive disorder (MDD), dysthymic disorder (DD), or depressive disorder not otherwise specified (D-NOS) using DSM-IV-TR criteria and were approximately 11.6 years old (SD = 2.1), 57% male, 57% Caucasian, and 10% Hispanic/Latino. Participants in the first trial (n = 72; Fristad et al, 2016) were diagnosed with major depressive disorder (MDD), dysthymic disorder (DD), or depressive disorder not otherwise specified (D-NOS) using DSM-IV-TR criteria and were approximately 11.6 years old (SD = 2.1), 57% male, 57% Caucasian, and 10% Hispanic/Latino.…”

“…A large effect size (d s = 0.81), however, was detected for the Ω3 + IF-PEP group compared to the placebo alone. (See Fristad et al, 2016Fristad et al, , 2015 for further information about therapist fidelity, PEP attendance, and Ω3/PBO pill adherence in both trials). When compared to placebo alone, the Ω3 monotherapy group demonstrated a large effect size, however (d s = 0.86).…”