Bipolar DisorderNCT03203707
Early Assessment and Intervention for Adolescents at Risk for Bipolar Disorder
A study testing Interpersonal and Social Rhythm Therapy in people with Bipolar Disorder and Early Intervention, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Bipolar Disorder, Early Intervention
- What is being tested?
- Interpersonal and Social Rhythm Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2011to 28 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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) -
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic / University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Bipolar Disorder, Early Intervention
- Being tested
- Interpersonal and Social Rhythm Therapy
- Keywords
- IPSRT, early intervention, bipolar disorder
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal and Social Rhythm TherapyBehavioural
Also called IPSRT
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.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal and Social Rhythm Therapy+DIR | Experimental | IPSRT plus referral for community treatment for any psychiatric conditions identified through the psychiatric assessment at intake. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mood symptom severity
Mood symptom severity assessed via clinical evaluator blind to treatment condition using validated instruments.
Measured: Quarterly over 6 months
Change in sleep
actigraphy
Measured: 10 days at intake and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 Apr 2011
- Primary completion28 Feb 2015
- Study completion28 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tina R Goldstein, University of Pittsburgh
- Investigators
- Tina R Goldstein, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203707
- Sponsor's protocol ID
- MH091177-01A1
- Status last verified
- Feb 2021
- First submitted
- 22 Jun 2017
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15953666Frank, E. (2005). Treating bipolar disorder: A clinician's guide to interpersonal and social rhythm therapy. New York: Guilford Press.
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.
PubMed 16143731Goodwin, 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.
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.
PubMed 18519522Miklowitz 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.
PubMed 17404119Wolfson AR, Carskadon MA. Sleep schedules and daytime functioning in adolescents. Child Dev. 1998 Aug;69(4):875-87.
PubMed 9768476
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Assessment and Intervention for Adolescents at Risk for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT03203707
- Acronym / sponsor ID
- MH091177-01A1
- Conditions
- Bipolar Disorder, Early Intervention
- Keywords
- IPSRT, early intervention, bipolar disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 28 Feb 2015 (actual)
- Study completion
- 28 Feb 2015 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Interpersonal and Social Rhythm Therapy+DIR | Experimental | Behavioral: Interpersonal and Social Rhythm TherapyIPSRT plus referral for community treatment for any psychiatric conditions identified through the psychiatric assessment at intake. |
| Data-Informed Referral (DIR) | No intervention | –Referral for community treatment for any psychiatric conditions identified through the psychiatric assessment at intake. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal and Social Rhythm TherapyAlso: IPSRTThe 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. | Behavioural | Interpersonal and Social Rhythm Therapy+DIR |
Primary outcome
Change in mood symptom severity
Time frame: Quarterly over 6 months
Mood symptom severity assessed via clinical evaluator blind to treatment condition using validated instruments.
Change in sleep
Time frame: 10 days at intake and 6 months
actigraphy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 15953666Bootzin 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.
- BackgroundFrank, E. (2005). Treating bipolar disorder: A clinician's guide to interpersonal and social rhythm therapy. New York: Guilford Press.
- Background: PubMed 16143731Frank 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.
- BackgroundGoodwin, 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: PubMed 18519522Harvey 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.
- Background: PubMed 17404119Miklowitz 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.
- Background: PubMed 9768476Wolfson AR, Carskadon MA. Sleep schedules and daytime functioning in adolescents. Child Dev. 1998 Aug;69(4):875-87.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina R Goldstein, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal and Social Rhythm Therapy in people with Bipolar Disorder and Early Intervention, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mood symptom severity (time frame: Quarterly over 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03203707, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.