Bipolar DisorderKEYNCT04815239
Early Intervention for Youth at High Risk for Bipolar Disorder
A study testing Interpersonal and Social Rhythm Therapy (IPSRT) and The Healthy Lifestyle Behavior Intervention (HL) in people with Bipolar Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
Investigators will conduct a confirmatory efficacy trial of Interpersonal and Social Rhythm Therapy (IPSRT) delivered via telehealth for offspring of bipolar parents (OBP; age 12-18, n=120) at elevated risk for BP onset via risk calculator score. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Interpersonal and Social Rhythm Therapy (IPSRT) and The Healthy Lifestyle Behavior Intervention (HL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 12-18 years
- A parent with a diagnosis of BP I or II
- Baseline Risk Calculator score>0.05;
- Able/willing to give informed consent/assent
Who cannot join
- A lifetime diagnosis of BP I or II
- Current unstabilized psychiatric symptoms
- Evidence of developmental disorder or central nervous system disorder
Trial locations and contacts
1 site in 1 country.
About this study
Investigators will conduct a confirmatory efficacy trial of Interpersonal and Social Rhythm Therapy (IPSRT) delivered via telehealth for offspring of bipolar parents (OBP; age 12-18, n=120) at elevated risk for BP onset via risk calculator score. All participants receive a baseline clinical assessment of psychiatric symptoms and sleep disturbance (via objective and subjective methods), followed by a feedback session. Youth are then randomized to receive 8 sessions of IPSRT or a manualized Healthy Lifestyle Behaviors Program (HL) delivered via secure videoconference. As clinically indicated, youth are offered Community Treatment Referral (CTR) for any psychiatric symptoms/disorders identified at intake. Primary outcome domains over 18 months include mania and affective lability. Investigators will also further investigate the hypothesized mechanism underlying IPSRT (i.e., sleep/circadian disruption) across levels of analysis, and the contribution of interpersonal stress to sleep/circadian disruptions. Application of Implementation Science methods throughout maximizes ultimate scalability and feasibility if efficacious. Investigators will also examine whether passive cellphone sensing may serve as a portable, cost-effective measure of mechanisms and outcomes to enhance ultimate dissemination.
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; individuals with family history typically experience early BP onset and severe course. Up to 25% of offspring of parents with BP (OBP) develop BP by young adulthood. Using longitudinal data from the Pittsburgh Bipolar Offspring Study (BIOS MH60952), investigators developed a clinical tool ("risk calculator") that reliably predicts an individual OBP's 5-year risk for BP using a subset of demographic and clinical variables. This innovation offers the ideal opportunity to identify OBP at greatest risk and deliver indicated preventive interventions. Yet, to date, there is no evidence-based intervention for OBP who have not already developed mood disorder. Per the experimental therapeutics framework, promising approaches should be informed by, and target, factors that cause and sustain illness. Evidence suggests the pathway to develop BP among biologically vulnerable youth involves sleep and circadian disturbances. Investigators adapted Interpersonal and Social Rhythm Therapy (IPSRT), an evidence-based treatment for BP adults that helps stabilize sleep/ circadian patterns, for adolescent OBP. In an open pilot and subsequent R34 randomized trial (MH091177), Investigators established a preliminary efficacy signal for IPSRT with OBP. Investigators' data further indicate IPSRT, but not Community Treatment Referral (CTR), engages and alters the hypothesized mechanism of action--sleep/ circadian disturbance, although practical barriers impacted treatment attendance. This proposal represents a vital next step in this program of research: a confirmatory efficacy trial of IPSRT delivered via telehealth for OBP (age 12-18, n=120) at elevated risk for BP onset via risk calculator score. All participants receive a baseline clinical assessment of psychiatric symptoms and sleep disturbance (via objective and subjective methods), followed by a feedback session. Youth are then randomized to receive 8 sessions of IPSRT or a manualized Healthy Lifestyle Behaviors Program (HL) delivered via secure videoconference to enhance attendance and reach. As clinically indicated, youth are offered CTR for any psychiatric symptoms/disorders identified at intake. Primary outcome domains over 18 months include mania and affective lability--2 potent near-term predictors of BP in OBP that are themselves associated with morbidity and impairment. Investigators will also further investigate the hypothesized mechanism underlying IPSRT-sleep/circadian disruption--across levels of analysis using reliable, cost-effective methods (actigraphy and daily diary ratings), and the contribution of interpersonal stress to sleep/circadian disruptions. Application of Implementation Science methods throughout maximizes ultimate scalability and feasibility if efficacious. Investigators will also examine whether passive cellphone sensing may serve as a portable, cost-effective measure of mechanisms and outcomes to enhance ultimate dissemination. Research in this area has the potential to prevent, delay, or ameliorate the progression of this chronic and devastating illness in those at highest risk.
- Conditions
- Bipolar Disorder
- Being tested
- Interpersonal and Social Rhythm Therapy (IPSRT), The Healthy Lifestyle Behavior Intervention (HL)
- Keywords
- psychosocial treatment, early intervention, prevention, adolescent
- 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 Therapy (IPSRT)Behavioural
Interpersonal and Social Rhythm Therapy (IPSRT) is an evidence-based treatment for BP adults that prevents or delays mood episodes by stabilizing sleep and daily routines.
The Healthy Lifestyle Behavior Intervention (HL)Behavioural
HL includes structured psychoeducational modules that aim to teach patients about health risks and help them achieve a balanced lifestyle to optimize physical and mental health.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal and Social Rhythm Therapy (IPSRT) | Active comparator | Interpersonal and Social Rhythm Therapy (IPSRT) for at-risk offspring includes 8 sessions over 6 months delivered via secure telemedicine platform. The basis of the intervention is the treatment manual iteratively developed and tested in close consultation with content experts during our open pilot study and R34.The intervention focuses on education about BP risk, stabilizing sleep and daily routines and interpersonal relationships. Receives: Behavioral: Interpersonal and Social Rhythm Therapy (IPSRT) |
| Healthy Lifestyle Intervention (HL) | Active comparator | HL is based on the treatment manual developed in a prior trial for adults and adolescents with BP. HL includes psychoeducational modules that aim to teach patients about health risks and help them achieve a balanced lifestyle to optimize physical and mental health. In HL, patients are taught to develop and maintain an individualized lifestyle plan and provided support and encouragement for making progress toward their goals. HL clinicians will deliver 8 sessions over 6 months via secure telehealth platform. Receives: Behavioral: The Healthy Lifestyle Behavior Intervention (HL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk for Subthreshold or Threshold Manic Episodes
Adolescent Longitudinal Interval Follow-Up Evaluation (ALIFE) Psychiatric Status Ratings (PSR; Range 1-6)
Measured: 18 months
Rate of Subthreshold or Threshold Manic Symptoms
Kiddie Schedule for Affective Disorders and Schizophrenia-Mania Rating Scale (KMRS; Range 0-64)
Measured: 18 months
Severity of Affective lability
Children's Affective Lability Scale (CALS; Range 0-80)
Measured: 18 months
Secondary outcomes (4)
Total sleep time (Objective)
Actigraphy-derived mean total sleep time
Measured: 18 months
Total sleep time (subjective)
Daily diary-derived mean total sleep time
Measured: 18 months
Sleep variability (objective)
Actigraphy-derived sleep variability
Measured: 18 months
Sleep variability (subjective)
Daily diary-derived sleep variability
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Sep 2021
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Tina R Goldstein, University of Pittsburgh
- Investigators
- Tina R Goldstien, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815239
- Sponsor's protocol ID
- STUDY21010149
- Other IDs
- R01MH125971
- Acronym
- KEY
- Status last verified
- Jun 2026
- First submitted
- 17 Mar 2021
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In order to gain access to data from this project, outside Investigators must submit a detailed proposal of the study aims, hypotheses to be tested, variables/constructs and analytic approach to be used. Prior to the receipt of data, outside investigators would be required to sign a data sharing agreement and confidentiality statement that stipulates a commitment to: a) using the data for the stated research purposes only; b) securing the data using appropriate computer technology; c) not manipulating the data in order to identify participants; d) destroying or returning the data after analyses are completed. No data can be transferred to other researchers who have not submitted a formal request to the study PIs.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention for Youth at High Risk for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT04815239
- Acronym / sponsor ID
- KEY / STUDY21010149
- Conditions
- Bipolar Disorder
- Keywords
- psychosocial treatment, early intervention, prevention, adolescent
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Mar 2021 (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.
Investigators will conduct a confirmatory efficacy trial of Interpersonal and Social Rhythm Therapy (IPSRT) delivered via telehealth for offspring of bipolar parents (OBP; age 12-18, n=120) at elevated risk for BP onset via risk calculator score. All participants receive a baseline clinical assessment of psychiatric symptoms and sleep disturbance (via objective and subjective methods), followed by a feedback session. Youth are then randomized to receive 8 sessions of IPSRT or a manualized Healthy Lifestyle Behaviors Program (HL) delivered via secure videoconference. As clinically indicated, youth are offered Community Treatment Referral (CTR) for any psychiatric symptoms/disorders identified at intake. Primary outcome domains over 18 months include mania and affective lability. Investigators will also further investigate the hypothesized mechanism underlying IPSRT (i.e., sleep/circadian disruption) across levels of analysis, and the contribution of interpersonal stress to sleep/circadian disruptions. Application of Implementation Science methods throughout maximizes ultimate scalability and feasibility if efficacious. Investigators will also examine whether passive cellphone sensing may serve as a portable, cost-effective measure of mechanisms and outcomes to enhance ultimate dissemination.
Detailed description
The most potent risk factor for the development of bipolar disorder (BP) is a first-degree family member with the illness; individuals with family history typically experience early BP onset and severe course. Up to 25% of offspring of parents with BP (OBP) develop BP by young adulthood. Using longitudinal data from the Pittsburgh Bipolar Offspring Study (BIOS MH60952), investigators developed a clinical tool ("risk calculator") that reliably predicts an individual OBP's 5-year risk for BP using a subset of demographic and clinical variables. This innovation offers the ideal opportunity to identify OBP at greatest risk and deliver indicated preventive interventions. Yet, to date, there is no evidence-based intervention for OBP who have not already developed mood disorder. Per the experimental therapeutics framework, promising approaches should be informed by, and target, factors that cause and sustain illness. Evidence suggests the pathway to develop BP among biologically vulnerable youth involves sleep and circadian disturbances. Investigators adapted Interpersonal and Social Rhythm Therapy (IPSRT), an evidence-based treatment for BP adults that helps stabilize sleep/ circadian patterns, for adolescent OBP. In an open pilot and subsequent R34 randomized trial (MH091177), Investigators established a preliminary efficacy signal for IPSRT with OBP. Investigators' data further indicate IPSRT, but not Community Treatment Referral (CTR), engages and alters the hypothesized mechanism of action--sleep/ circadian disturbance, although practical barriers impacted treatment attendance. This proposal represents a vital next step in this program of research: a confirmatory efficacy trial of IPSRT delivered via telehealth for OBP (age 12-18, n=120) at elevated risk for BP onset via risk calculator score. All participants receive a baseline clinical assessment of psychiatric symptoms and sleep disturbance (via objective and subjective methods), followed by a feedback session. Youth are then randomized to receive 8 sessions of IPSRT or a manualized Healthy Lifestyle Behaviors Program (HL) delivered via secure videoconference to enhance attendance and reach. As clinically indicated, youth are offered CTR for any psychiatric symptoms/disorders identified at intake. Primary outcome domains over 18 months include mania and affective lability--2 potent near-term predictors of BP in OBP that are themselves associated with morbidity and impairment. Investigators will also further investigate the hypothesized mechanism underlying IPSRT-sleep/circadian disruption--across levels of analysis using reliable, cost-effective methods (actigraphy and daily diary ratings), and the contribution of interpersonal stress to sleep/circadian disruptions. Application of Implementation Science methods throughout maximizes ultimate scalability and feasibility if efficacious. Investigators will also examine whether passive cellphone sensing may serve as a portable, cost-effective measure of mechanisms and outcomes to enhance ultimate dissemination. Research in this area 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 controlled trial
| Arm | Type | Receives |
|---|---|---|
| Interpersonal and Social Rhythm Therapy (IPSRT) | Active comparator | Behavioral: Interpersonal and Social Rhythm Therapy (IPSRT)Interpersonal and Social Rhythm Therapy (IPSRT) for at-risk offspring includes 8 sessions over 6 months delivered via secure telemedicine platform. The basis of the intervention is the treatment manual iteratively developed and tested in close consultation with content experts during our open pilot study and R34.The intervention focuses on education about BP risk, stabilizing sleep and daily routines and interpersonal relationships. |
| Healthy Lifestyle Intervention (HL) | Active comparator | Behavioral: The Healthy Lifestyle Behavior Intervention (HL)HL is based on the treatment manual developed in a prior trial for adults and adolescents with BP. HL includes psychoeducational modules that aim to teach patients about health risks and help them achieve a balanced lifestyle to optimize physical and mental health. In HL, patients are taught to develop and maintain an individualized lifestyle plan and provided support and encouragement for making progress toward their goals. HL clinicians will deliver 8 sessions over 6 months via secure telehealth platform. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 12-18 years
- A parent with a diagnosis of BP I or II
- Baseline Risk Calculator score>0.05;
- Able/willing to give informed consent/assent
Key exclusion criteria (3 listed)
- A lifetime diagnosis of BP I or II
- Current unstabilized psychiatric symptoms
- Evidence of developmental disorder or central nervous system disorder
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 Therapy (IPSRT)Interpersonal and Social Rhythm Therapy (IPSRT) is an evidence-based treatment for BP adults that prevents or delays mood episodes by stabilizing sleep and daily routines. | Behavioural | Interpersonal and Social Rhythm Therapy (IPSRT) |
| The Healthy Lifestyle Behavior Intervention (HL)HL includes structured psychoeducational modules that aim to teach patients about health risks and help them achieve a balanced lifestyle to optimize physical and mental health. | Behavioural | Healthy Lifestyle Intervention (HL) |
Primary outcome
Risk for Subthreshold or Threshold Manic Episodes
Time frame: 18 months
Adolescent Longitudinal Interval Follow-Up Evaluation (ALIFE) Psychiatric Status Ratings (PSR; Range 1-6)
Rate of Subthreshold or Threshold Manic Symptoms
Time frame: 18 months
Kiddie Schedule for Affective Disorders and Schizophrenia-Mania Rating Scale (KMRS; Range 0-64)
Severity of Affective lability
Time frame: 18 months
Children's Affective Lability Scale (CALS; Range 0-80)
4 secondary outcomes
Total sleep time (Objective)
Time frame: 18 months
Total sleep time (subjective)
Time frame: 18 months
Sleep variability (objective)
Time frame: 18 months
Sleep variability (subjective)
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. In order to gain access to data from this project, outside Investigators must submit a detailed proposal of the study aims, hypotheses to be tested, variables/constructs and analytic approach to be used. Prior to the receipt of data, outside investigators would be required to sign a data sharing agreement and confidentiality statement that stipulates a commitment to: a) using the data for the stated research purposes only; b) securing the data using appropriate computer technology; c) not manipulating the data in order to identify participants; d) destroying or returning the data after analyses are completed. No data can be transferred to other researchers who have not submitted a formal request to the study PIs.
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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 Goldstien, 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 (IPSRT) and The Healthy Lifestyle Behavior Intervention (HL) in people with Bipolar Disorder, 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Risk for Subthreshold or Threshold Manic Episodes (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.