Early intervention for youth at high risk for bipolar disorder: A multisite randomized trial of family‐focused treatment

• DOI: 10.1111/eip.12463
• Publication Date: 2017-08-04T11:35:25Z
• Authors: David J. Miklowitz; Christopher D. Sc...; Patricia D. Walshaw; Amy S. Garrett; Manpreet K. Singh; Catherine A. Sugar; Kiki D. Chang
• Keywords: Male; Bipolar Disorder; 6.6 Psychological and behavioural; Adolescent; Biological Psychology; Clinical Trials and Supportive Activities; Clinical Sciences; prodromal; Prodromal Symptoms; Clinical sciences; Risk Assessment; Clinical and health psychology; 03 medical and health sciences; mania; 0302 clinical medicine; Patient Education as Topic; Clinical Research; Behavioral and Social Science; Psychology; Humans; 0501 psychology and cognitive sciences; Child; Problem Solving; Psychiatry; Depressive Disorder; Depressive Disorder, Major; Psychotropic Drugs; neuroimaging; Biomedical and Clinical Sciences; Depression; Prevention; 05 social sciences; Neurosciences; Evaluation of treatments and therapeutic interventions; Major; Serious Mental Illness; Combined Modality Therapy; Brain Disorders; 3. Good health; Mental Health; Treatment Outcome; expressed emotion; Mental health; family therapy; Family Therapy; Female

AimsDespite the considerable public health impact of bipolar disorder (BD), no psychosocial interventions have been systematically evaluated in its early prodromal stages. We describe the rationale, design and analytic methods for a 3‐site randomized trial of family‐focused treatment for youth at high risk (FFT‐HR) for BD.MethodsParticipants (ages 9‐17 years) have a diagnosis of unspecified BD or major depressive disorder, current mood symptoms and at least one first‐ or second‐degree relative with a lifetime history of BD I or II. Participants are randomly assigned to FFT‐HR (12 sessions in 4 months of family psychoeducation and skills training) or enhanced care (EC; 6 individual and family sessions over 4 months), with pharmacotherapy provided as needed. A subset of participants undergo pre‐ and post‐treatment functional MRI (fMRI) scans while performing face‐rating and family problem‐solving tasks designed to activate corticolimbic circuitry. Independent evaluators assess participants’ status every 4 to 6 months for up to 4 years.ResultsWe hypothesize that FFT‐HR will be more effective than EC in reducing the severity of mood symptoms (primary outcome) and the hazard of a first manic episode (secondary) over 4 years. Secondarily, we will explore whether FFT‐HR is associated with greater decreases in amygdala activation and increases in dorsolateral, ventrolateral or anterior medial prefrontal cortex activation from pre‐ to post‐treatment. Clinical characteristics of 133 subjects enrolled at baseline are described.ConclusionsThis study will test a novel intervention to reduce the early symptoms of BD, and identify neural and behavioural mechanisms that may help refine future treatments.