Early Assessment and Intervention for Adolescents at Risk for Bipolar Disorder

NCT03203707 | Completed

• 1 other identifier: MH091177-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Early Intervention

Keywords

IPSRT; early intervention; bipolar disorder

Outcome Measures

Primary Outcomes (2)

• Change in mood symptom severity

  Mood symptom severity assessed via clinical evaluator blind to treatment condition using validated instruments.

  Quarterly over 6 months

• Change in sleep

  actigraphy

  10 days at intake and 6 months

Study Arms (2)

Interpersonal and Social Rhythm Therapy+DIR

EXPERIMENTAL

IPSRT plus referral for community treatment for any psychiatric conditions identified through the psychiatric assessment at intake.

Behavioral: Interpersonal and Social Rhythm Therapy

Data-Informed Referral (DIR)

NO INTERVENTION

Referral for community treatment for any psychiatric conditions identified through the psychiatric assessment at intake.

Interventions

Interpersonal and Social Rhythm Therapy BEHAVIORAL

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.

Also known as: IPSRT

Interpersonal and Social Rhythm Therapy+DIR

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age between 12-18 years;
• primary residence with a parent or guardian;
• 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;
• a biological parent with a diagnosis of Bipolar Disorder I, II or Not Otherwise Specified (NOS) confirmed via semi-structured diagnostic interview;
• able and willing to give informed consent/assent to participate.

You may not qualify if:

• 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);
• a primary sleep disorder diagnosis by the Structured Interview for DSM-IV Sleep Disorders;
• 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);
• 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,
• a prior course of IPSRT treatment
• 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) -

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Western Psychiatric Institute and Clinic / University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (7)

• Bootzin RR, Stevens SJ. Adolescents, substance abuse, and the treatment of insomnia and daytime sleepiness. Clin Psychol Rev. 2005 Jul;25(5):629-44. doi: 10.1016/j.cpr.2005.04.007.

  PMID: 15953666 BACKGROUND

• Frank, E. (2005). Treating bipolar disorder: A clinician's guide to interpersonal and social rhythm therapy. New York: Guilford Press.

  BACKGROUND

• Frank E, Kupfer DJ, Thase ME, Mallinger AG, Swartz HA, Fagiolini AM, Grochocinski V, Houck P, Scott J, Thompson W, Monk T. Two-year outcomes for interpersonal and social rhythm therapy in individuals with bipolar I disorder. Arch Gen Psychiatry. 2005 Sep;62(9):996-1004. doi: 10.1001/archpsyc.62.9.996.

  PMID: 16143731 BACKGROUND

• Goodwin, F. K. & Jamison, K. R. (2007a). Course and outcome. In F.K.Goodwin & K. R. Jamison (Eds.), Manic-depressive illness (2 ed., pp. 119-154). New York: Oxford University Press.

  BACKGROUND

• Harvey AG. Sleep and circadian rhythms in bipolar disorder: seeking synchrony, harmony, and regulation. Am J Psychiatry. 2008 Jul;165(7):820-9. doi: 10.1176/appi.ajp.2008.08010098. Epub 2008 Jun 2.

  PMID: 18519522 BACKGROUND

• Miklowitz DJ, Otto MW, Frank E, Reilly-Harrington NA, Wisniewski SR, Kogan JN, Nierenberg AA, Calabrese JR, Marangell LB, Gyulai L, Araga M, Gonzalez JM, Shirley ER, Thase ME, Sachs GS. Psychosocial treatments for bipolar depression: a 1-year randomized trial from the Systematic Treatment Enhancement Program. Arch Gen Psychiatry. 2007 Apr;64(4):419-26. doi: 10.1001/archpsyc.64.4.419.

  PMID: 17404119 BACKGROUND

• Wolfson AR, Carskadon MA. Sleep schedules and daytime functioning in adolescents. Child Dev. 1998 Aug;69(4):875-87.

  PMID: 9768476 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Tina R Goldstein, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and parents complete clinical monitoring assessments with an evaluator blind to treatment condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: Randomized trail comparing Data-Informed Referral (DIR) for any clinical condition detected at intake assessment versus DIR + Brief Interpersonal Social Rhythm Therapy (IPSRT)

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 29, 2017
• Study Start: April 1, 2011
• Primary Completion: February 28, 2015
• Study Completion: February 28, 2015
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)