Early Assessment and Intervention for Adolescents at Risk for Bipolar Disorder
Condition: Bipolar Disorder; Early Intervention
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Bipolar disorder is a severe and chronic illness associated with significant occupational and
      social impairment, enormous public health costs, and high rates of suicide. The single most
      potent risk factor for the development of bipolar disorder is a first-degree family member
      with the illness; indeed, offspring of parents with bipolar disorder are a particularly
      high-risk group who typically display early onset and severe course of illness. Thus, early
      assessment and intervention for the children of parents with bipolar disorder focused on
      specific, measurable, and modifiable risk factors has the potential to prevent or ameliorate
      the progression of bipolar disorder in those at highest risk.
    

Detailed description: 
      The most potent risk factor for the development of bipolar disorder (BP) is a first-degree
      family member with the illness. Thus, offspring of parents with BP are a particularly
      high-risk group and typically experience early illness onset, severe course, and high rates
      of comorbid psychiatric disorders. It is well-established that poor sleep regulation is
      associated with the onset of depressive and manic episodes among individuals with a
      biological vulnerability to mood disorder. Furthermore, evidence supports sleep disturbance
      in at-risk youth who have not yet developed threshold mood disorders. The proposed study aims
      to address this core disturbance that we argue puts at-risk youth at even greater risk for
      development of BP-sleep and social rhythm disruption. Since adolescence is a period
      characterized by significant alterations in sleep/wake patterns and social routines, this
      period may prove optimal for assessment and treatment of sleep and psychiatric symptoms in
      those at-risk. The investigators adapted and piloted Interpersonal and Social Rhythm Therapy
      (IPSRT), an empirically-supported treatment for adults with BP that helps patients stabilize
      sleep/wake cycles and daily routines, for at-risk adolescents. Preliminary data indicate this
      approach holds promise for youth at-risk for the development of BP. The investigators also
      identified intervention for the heterogeneous conditions antecedent to BP as a second path to
      preventing or delaying BP onset in at-risk youth. The purpose of the proposed study is thus
      to further develop and examine IPSRT for the adolescent (age 12-18) offspring of parents with
      BP. The study involves conduct of a small controlled trial (n=50) comparing Brief IPSRT +
      Data-Informed Referral versus Data-Informed Referral alone to gather preliminary data on
      feasibility, acceptability and proximal outcomes associated with the intervention. All
      participants receive a thorough assessment of psychopathology and sleep disturbance (via
      objective and subjective methods) at baseline, followed by a single feedback session
      reviewing the findings. As clinically indicated, youth will be offered Data-Informed Referral
      for any psychiatric symptoms/disorders identified during the intake assessment. Youth will
      then be randomized to receive either Brief IPSRT or no Brief IPSRT; randomization will be
      stratified on sleep disturbance and psychopathology. Outcomes will be assessed at 4 time
      points over 6 months in all participants. Data will be used to inform the design and conduct
      of a future controlled trial. The proposed approach is in direct accord with strategies
      outlined in the National Institute of Mental Health (NIMH) Strategic Plan in which the
      development and testing of innovative interventions to reduce risk and positively alter
      trajectories of mental illness are informed by research findings regarding robust and
      malleable risk factors and core features of disease. Research in this area is of great public
      health importance, as it has the potential to prevent, delay, or ameliorate the progression
      of this chronic and devastating illness in those at highest risk.
    

Intervention name(s): Interpersonal and Social Rhythm Therapy
Intervention type(s): Behavioral
Intervention description(s): The Brief IPSRT intervention for at-risk youth includes : 1) Psychoeducation about risk for BP ; 2) Social rhythm therapy (SRT) aiming to establish and maintain stable routines to protect against onset of mood symptoms in vulnerable individuals ; and 3) Interpersonal Psychotherapy (IPT) centering on the adolescent's feelings about having a parent with BP, and linking stressful family events to mood. The intervention is delivered in 8 in-person sessions over 6 months of treatment. Parents are involved in the psychoeducation sessions, and further involvement is determined as clinically appropriate based on age and developmental status.
Other intervention name(s): IPSRT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized trail comparing Data-Informed Referral (DIR) for any clinical condition detected at intake assessment versus DIR + Brief Interpersonal Social Rhythm Therapy (IPSRT)
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: IPSRT; early intervention; bipolar disorder