OBJECTIVE: To conduct a pilot randomized trial of Interpersonal and Social Rhythm Therapy plus Data-Informed Referral (IPSRT + DIR) versus DIR-alone for adolescents at-risk for bipolar disorder (BP).
METHOD: Eligible participants included youth (12-18) with a BP parent; youth with BP were excluded. Participants (n = 42) were randomized to receive IPSRT + DIR to treat any psychiatric disorders present at baseline, or DIR-alone. A blind evaluator assessed outcomes at baseline, 3- and 6-months. Participants wore an actigraph to measure sleep/wake patterns for 7 days at baseline and 6-months. Primary outcomes included mood and non-mood symptoms and sleep disturbance.
RESULTS: Youth randomized to IPSRT + DIR attended approximately half of scheduled IPSRT sessions. Although 33% of DIR-alone youth were referred for mental health services at intake (another 33% were already engaged in services), none initiated new services over follow-up. No youth developed new-onset mood disorder over follow-up. Self- and parent-reported mood and non-mood psychiatric symptoms did not distinguish the groups, although youth in DIR-alone tended to have higher baseline scores on most measures. Per clinician ratings, 1 youth receiving IPSRT + DIR displayed subthreshold hypo/manic symptoms, versus 2 receiving DIR-alone (OR = 14.7, p = 0.03), possibly signaling less subthreshold hypo/manic symptoms, and for fewer weeks (χ= 11.06, p = 0.0009), over 6-months with IPSRT + DIR. We found a small effect for youth in the IPSRT + DIR group to evidence more WASO at pre-treatment, but less at follow-up (cohen's d = 0.28). 2
LIMITATIONS: Small sample size limits statistical power, and we are unable to definitively attribute group differences to IPSRT versus greater clinical contact. Ability to examine distal/rare (i.e., BP onset) outcomes was limited.
CONCLUSIONS: Adolescents at-risk for BP present challenges to psychosocial treatment engagement and retention. IPSRT merits further study as an acceptable intervention for at-risk youth, though necessary frequency and intensity to affect outcomes should be examined. The potential to delay or prevent subthreshold hypo/manic symptoms via enhanced sleep continuity is an area for further examination. Future studies with larger samples and extended follow-up can help determine whether IPSRT may delay or prevent syndromal hypo/mania in youth at-risk.
