Clinical trial NCT03203707: Early Assessment and Intervention for Adolescents at Risk for Bipolar Disorder
Official title: Early Assessment and Intervention for Adolescents at Risk for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Early Intervention
Keywords: IPSRT
early intervention
bipolar disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. age between 12-18 years;
2. primary residence with a parent or guardian;
3. English language fluency and at minimum a 3rd grade literacy level. Subjects must be able to speak and understand English because one of the study interventions, Brief IPSRT, is an experimental talk-therapy. This therapy cannot practically be translated;
4. a biological parent with a diagnosis of Bipolar Disorder I, II or Not Otherwise Specified (NOS) confirmed via semi-structured diagnostic interview;
5. able and willing to give informed consent/assent to participate.

Exclusion Criteria:

1. a current or lifetime bipolar spectrum disorder diagnosis (i.e., Bipolar Disorder I, II or NOS) by the Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL);
2. a primary sleep disorder diagnosis by the Structured Interview for DSM-IV Sleep Disorders;
3. current unstabilized psychiatric symptoms as evidenced by a CGI-Severity of \> 5 (markedly ill) and/or a C-GAS rating of \< 50 (denotes serious symptoms);
4. evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records,
5. a prior course of IPSRT treatment
6. the absence of parental participation for 18 year old potential participants (i.e. 18 year old adolescent subjects need a biological parent with a diagnosis of Bipolar Disorder I, II or Not Otherwise Specified (NOS) to particpate in the study in order for the adolescent to be able to participate) -

Primary outcomes:
measure: Change in mood symptom severity
timeFrame: Quarterly over 6 months
measure: Change in sleep
timeFrame: 10 days at intake and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic / University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Tina R Goldstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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