Bipolar DisorderNCT00576355
Interpersonal and Social Rhythm Therapy for Adolescents With Bipolar Disorder
A study testing Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A) and Treatment As Usual (TAU) in people with Bipolar Disorder, run by University of Washington at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of interpersonal and social rhythm therapy in treating adolescents with a bipolar spectrum disorder Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A) and Treatment As Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Aug 2010
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- DSM-IV diagnosis of bipolar spectrum disorder: type I, type II, or NOS
- Currently meets DSM-IV criteria for a depressed, manic, hypomanic, or mixed episode
- Youth assent/parental consent to outpatient psychotherapy for treatment of bipolar disorder
- Adequate access to transportation or close proximity in order to participate in therapy
Who cannot join
- DSM-IV diagnosis of schizophrenia, schizophreniform, or schizoaffective disorders
- Developmentally delayed
- Actively psychotic, suicidal, homicidal, or engages in repeated parasuicidal behaviors
- History of chronic suicidality (e.g., more than three suicidal gestures in the year prior to study entry)
- Neurological or other medical disorder that could potentially cause or complicate presenting psychiatric symptoms
- Meets current DSM-IV criteria for drug or alcohol abuse or dependence
- Life circumstances that would prohibit ability to participate, including absence of shelter or impending jail/prison for more than 2 weeks during study
- Parent/legal guardian refusal to participate with the adolescent
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Adjunctive Psychotherapy for Teens With Bipolar Disorder
This study will evaluate the effectiveness of interpersonal and social rhythm therapy in treating adolescents with a bipolar spectrum disorder
Read the detailed description
Bipolar disorder is a brain disorder that causes dramatic changes in a person's mood and energy. Bipolar spectrum disorders, including bipolar I, II, and not-otherwise-specified (NOS) disorders, usually form in late adolescence or early adulthood and require treatment for the rest of a person's life. People with a bipolar spectrum disorder undergo periods of extreme happiness and extreme sadness, known as episodes of mania and depression. Psychotherapy has proven an effective adjunct treatment to medications for people with bipolar disorder. Interpersonal and social rhythm therapy (IPSRT) is a specific type of psychotherapy that focuses on improving problems in interpersonal relationships that are related to a person's symptoms. Researchers believe that IPSRT helps people have more regular patterns of sleep, eating, and other activities that act to set a person's biological clock. This study will specifically adapt IPSRT to the developmental needs of adolescents and will determine the effectiveness of this approach in treating adolescents with a bipolar spectrum disorder.
Participants in this study will be randomly assigned to receive interpersonal and social rhythm therapy for adolescents (IPSRT-A) or treatment as usual (TAU). Participants assigned to IPSRT-A will take part in 18 sessions of IPSRT over a 20-week period. Beginning with the first session, participants will meet with a therapist weekly for 16 weeks and then every other week for 4 weeks. Each IPSRT session will last about 45 to 60 minutes, and parents will be asked to accompany the child to 2 to 4 of these sessions. During IPSRT sessions, the therapist will talk with participants about their relationships and how they relate to symptoms; work with participants to help improve understanding of how their social and sleep routines relate to symptoms; and teach participants about bipolar disorder. Participants assigned to TAU will be given educational information about bipolar disorder and its treatment. They will then be referred to a mental health provider for usual care treatment.
All participants and parents will complete questionnaires about symptoms every 4 weeks during the study. Follow-up assessments will occur at the end of treatment and again at Months 3 and 6 post-treatment. These assessments will last between 60 and 90 minutes and will include completing an interview and questionnaires. Participants will also be asked for permission to obtain grade point average (GPA) and attendance records from their schools.
- Conditions
- Bipolar Disorder
- Being tested
- Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A), Treatment As Usual (TAU)
- Keywords
- Adolescent, Psychopathology, Interpersonal Therapy, Interpersonal and Social Rhythm Therapy
- 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 for Adolescents (IPSRT-A)Behavioural
IPSRT-A involves 20 weeks of individual therapy, incorporating informed psychological, behavioral, and practical strategies adapted to the developmental needs of adolescents.
Treatment As Usual (TAU)Behavioural
TAU includes the offering of educational information about bipolar disorder and referral to a mental health provider.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Participants will receive treatment as usual Receives: Behavioral: Treatment As Usual (TAU) |
| 1 | Experimental | Participants will receive interpersonal and social rhythm therapy for adolescents Receives: Behavioral: Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Psychiatric Rating Scale for Children
Measured: Measured at pretreatment, every 4 weeks during treatment, post-treatment, and 3 and 6 month follow-ups
Secondary outcomes (1)
Mania Rating Scale (MRS), Beck Depression Inventory (BDI),Child Behavior Checklist (CBCL), Youth Self-Report Form (YSR), Social Adjustment Scale for Adolescents (SAS-SR-A), Conflict Behavior Questionnaire (CBQ)
Measured: Measured at pretreatment, post-treatment, 6 month follow-up, and various other times throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionAug 2010
- Study completionAug 2010
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 WashingtonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Stefanie Hlastala, PhD, Principal investigator, University of Washington, Children's Hospital and Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576355
- Sponsor's protocol ID
- K23MH070570
- Other IDs
- K23MH070570, 5K23MH070570-03, DDTR BK-TKAR
- Status last verified
- Jun 2012
- First submitted
- 17 Dec 2007
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Psychotherapy for Teens With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00576355
- Acronym / sponsor ID
- K23MH070570
- Conditions
- Bipolar Disorder
- Keywords
- Adolescent, Psychopathology, Interpersonal Therapy, Interpersonal and Social Rhythm Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 19 Dec 2007 (estimated)
- 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.
This study will evaluate the effectiveness of interpersonal and social rhythm therapy in treating adolescents with a bipolar spectrum disorder
Detailed description
Bipolar disorder is a brain disorder that causes dramatic changes in a person's mood and energy. Bipolar spectrum disorders, including bipolar I, II, and not-otherwise-specified (NOS) disorders, usually form in late adolescence or early adulthood and require treatment for the rest of a person's life. People with a bipolar spectrum disorder undergo periods of extreme happiness and extreme sadness, known as episodes of mania and depression. Psychotherapy has proven an effective adjunct treatment to medications for people with bipolar disorder. Interpersonal and social rhythm therapy (IPSRT) is a specific type of psychotherapy that focuses on improving problems in interpersonal relationships that are related to a person's symptoms. Researchers believe that IPSRT helps people have more regular patterns of sleep, eating, and other activities that act to set a person's biological clock. This study will specifically adapt IPSRT to the developmental needs of adolescents and will determine the effectiveness of this approach in treating adolescents with a bipolar spectrum disorder.
Participants in this study will be randomly assigned to receive interpersonal and social rhythm therapy for adolescents (IPSRT-A) or treatment as usual (TAU). Participants assigned to IPSRT-A will take part in 18 sessions of IPSRT over a 20-week period. Beginning with the first session, participants will meet with a therapist weekly for 16 weeks and then every other week for 4 weeks. Each IPSRT session will last about 45 to 60 minutes, and parents will be asked to accompany the child to 2 to 4 of these sessions. During IPSRT sessions, the therapist will talk with participants about their relationships and how they relate to symptoms; work with participants to help improve understanding of how their social and sleep routines relate to symptoms; and teach participants about bipolar disorder. Participants assigned to TAU will be given educational information about bipolar disorder and its treatment. They will then be referred to a mental health provider for usual care treatment.
All participants and parents will complete questionnaires about symptoms every 4 weeks during the study. Follow-up assessments will occur at the end of treatment and again at Months 3 and 6 post-treatment. These assessments will last between 60 and 90 minutes and will include completing an interview and questionnaires. Participants will also be asked for permission to obtain grade point average (GPA) and attendance records from their schools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Behavioral: Treatment As Usual (TAU)Participants will receive treatment as usual |
| 1 | Experimental | Behavioral: Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A)Participants will receive interpersonal and social rhythm therapy for adolescents |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- DSM-IV diagnosis of bipolar spectrum disorder: type I, type II, or NOS
- Currently meets DSM-IV criteria for a depressed, manic, hypomanic, or mixed episode
- Youth assent/parental consent to outpatient psychotherapy for treatment of bipolar disorder
- Adequate access to transportation or close proximity in order to participate in therapy
Key exclusion criteria (8 listed)
- DSM-IV diagnosis of schizophrenia, schizophreniform, or schizoaffective disorders
- Developmentally delayed
- Actively psychotic, suicidal, homicidal, or engages in repeated parasuicidal behaviors
- History of chronic suicidality (e.g., more than three suicidal gestures in the year prior to study entry)
- Neurological or other medical disorder that could potentially cause or complicate presenting psychiatric symptoms
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 for Adolescents (IPSRT-A)IPSRT-A involves 20 weeks of individual therapy, incorporating informed psychological, behavioral, and practical strategies adapted to the developmental needs of adolescents. | Behavioural | 1 |
| Treatment As Usual (TAU)TAU includes the offering of educational information about bipolar disorder and referral to a mental health provider. | Behavioural | 2 |
Primary outcome
Brief Psychiatric Rating Scale for Children
Time frame: Measured at pretreatment, every 4 weeks during treatment, post-treatment, and 3 and 6 month follow-ups
1 secondary outcome
Mania Rating Scale (MRS), Beck Depression Inventory (BDI),Child Behavior Checklist (CBCL), Youth Self-Report Form (YSR), Social Adjustment Scale for Adolescents (SAS-SR-A), Conflict Behavior Questionnaire (CBQ)
Time frame: Measured at pretreatment, post-treatment, 6 month follow-up, and various other times throughout study
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 20 Jun 2012.
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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.
Stefanie Hlastala, PhD principal investigator
University of Washington, Children's Hospital and Regional Medical Center
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 for Adolescents (IPSRT-A) and Treatment As Usual (TAU) in people with Bipolar Disorder, run by University of Washington 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 8 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 20 Jun 2012. 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?
Brief Psychiatric Rating Scale for Children (time frame: Measured at pretreatment, every 4 weeks during treatment, post-treatment, and 3 and 6 month follow-ups). 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 20 Jun 2012.