- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02448108
Internet Psychotherapy for Bipolar Disorder in Primary Care
Internet Psychotherapy for Treating Bipolar Disorder in Primary Care
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18 years and older;
- meet DSM 5 criteria for bipolar disorder I, II or Other Specified Bipolar and Related Disorder;
- using the SCID 5;
- score > or = to 9 on Patient Health Questionnaire-9 or score > or = 155 on Internal State Scale;
- receiving care from a Primary Care Physician in a designated study site;
- access to broadband Internet connection and telephone; and
- ability to read and speak English.
Exclusion Criteria:
- Self-reported visual impairment that would prevent completion of study procedures;
- Psychotic disorder, substance use disorder or current manic episode, which would deem participation in the study either inappropriate or dangerous;
- currently receiving specialty mental health services for bipolar disorder from a psychiatrist or therapist;
- planning to leave Primary Care Practice within next 3 months; and
- active suicidal ideation.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: i-IPSRT
Participants randomized to this arm will complete bi-weekly i-IPSRT modules over the course of 12 weeks and they will track their mood and SRM's via smartphones or computer.
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internet IPSRT (a form of psychotherapy for individuals with bipolar disorder) will be offered via 12 specially-designed modules. CH will have participated in a two day training about Bipolar Disorder and IPSRT.
Andre navne:
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Eksperimentel: i-IPSRT + CH
Participants randomized to this arm will complete bi-weekly i-IPSRT modules over the course of 12 weeks and they will track their mood and SRM's via smartphones or computer.
Additionally, i-IPSRT support will be delivered by Clinical Helpers, who will reach out to participants in this arm via 5-10 minute weekly phone calls.
|
internet IPSRT (a form of psychotherapy for individuals with bipolar disorder) will be offered via 12 specially-designed modules. CH will have participated in a two day training about Bipolar Disorder and IPSRT.
Andre navne:
|
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Andet: CC (Controlled Condition)
Participants randomized to this arm will receive brief written psychoeducational material that includes information about social rhythm regularity.
This information will be either mailed or e-mailed to them.
|
Written material about the importance of social rhythm regularity to mood stability in bipolar disorder
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Client-Satisfaction Questionnaire
Tidsramme: Up to Week 12
|
measure of client satisfaction
|
Up to Week 12
|
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Social Rhythm Metric (measure of lifestyle regularity)
Tidsramme: Up to 12 weeks
|
measure of lifestyle regularity
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Up to 12 weeks
|
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Supportive Accountability Questionnaire
Tidsramme: Up to Week 12
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assesses level of perceived accountability to another person for treatment participation
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Up to Week 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quick Inventory of Depressive Symptoms
Tidsramme: up to 12 weeks
|
measure of depressive symptoms
|
up to 12 weeks
|
|
Internal State Scale
Tidsramme: up to 12 weeks
|
measure of mood symptoms
|
up to 12 weeks
|
|
Short Form-12
Tidsramme: up to 12 weeks
|
measure of overall health status
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up to 12 weeks
|
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Functional Assessment Short Test
Tidsramme: up to 12 weeks
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assessment of impairment in functioning
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up to 12 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Holly A Swartz, MD, University of Pittsburgh
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 00085129000
- R34MH107541 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Maniodepressiv
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ProgenaBiomeTrukket tilbageManiodepressiv | Bipolar I lidelse | Bipolar II lidelse | Bipolar type I lidelse | Bipolar lidelse Mild | Bipolar lidelse Moderat | Bipolar lidelse AlvorligForenede Stater
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Vielight Inc.Ikke rekrutterer endnuBipolar lidelse (BD) | Bipolar | Bipolar lidelse DepressionCanada
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Xenon Pharmaceuticals Inc.RekrutteringManiodepressiv | Bipolar depression | Bipolar I lidelse | Bipolar II lidelseForenede Stater
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Xenon Pharmaceuticals Inc.Tilmelding efter invitationManiodepressiv | Bipolar depression | Bipolar I lidelse | Bipolar II lidelseForenede Stater
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Rush University Medical CenterThe Ryan Licht Sang Bipolar FoundationAfsluttetManiodepressiv | Bipolar depression | Bipolar I lidelse | Bipolar lidelse I | Bipolar affektiv lidelseForenede Stater
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University of Texas Southwestern Medical CenterThe Texas Child Mental Health Care Consortium (TCMHCC)RekrutteringFamiliemedlemmer med bipolar lidelse | Bipolar lidelse (BD) | Bipolar lidelse I eller II | ScreeningsværktøjForenede Stater
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University of California, Los AngelesUniversity of Colorado, Denver; University of Pittsburgh; University of Cincinnati og andre samarbejdspartnereRekrutteringTeenagere | Bipolar lidelse (BD) | Bipolar lidelse I eller II | Bipolar lidelse NOS | Bipolar spektrum lidelseForenede Stater
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Joshua RosenblatAfsluttetManiodepressiv | Bipolar depression | Bipolar I lidelse | Bipolar II lidelseCanada
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Otsuka Pharmaceutical Development & Commercialization...H. Lundbeck A/SAfsluttetBipolar IForenede Stater, Frankrig, Rumænien, Polen, Canada, Ungarn, Japan, Korea, Republikken, Malaysia, Taiwan
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Joshua RosenblatAfsluttetManiodepressiv | Bipolar depression | Bipolar I lidelse | Bipolar II lidelseCanada
Kliniske forsøg med i-IPSRT
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Holly SwartzNational Institute of Mental Health (NIMH)Afsluttet
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University of PittsburghAfsluttetBorderline personlighedsforstyrrelse | Bipolar I lidelseForenede Stater
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University of PittsburghThe Depressive and Bipolar Disorder Alternative Treatment FoundationAfsluttetBipolar lidelse NOSForenede Stater
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University of PittsburghAfsluttetManiodepressivForenede Stater
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University of PittsburghNational Alliance for Research on Schizophrenia and DepressionAfsluttetBipolar II lidelseForenede Stater
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University of WashingtonNational Institute of Mental Health (NIMH)Afsluttet
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University of PittsburghAfsluttetManiodepressiv | Tidlig indsatsForenede Stater
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University of PittsburghTrukket tilbageManiodepressivForenede Stater
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University of PittsburghNational Institute of Mental Health (NIMH)Rekruttering
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Ege UniversityAktiv, ikke rekrutterendeManiodepressiv | Bipolar I lidelse | Bipolar II lidelseKalkun