- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02448108
Internet Psychotherapy for Bipolar Disorder in Primary Care
Internet Psychotherapy for Treating Bipolar Disorder in Primary Care
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15213
- University of Pittsburgh Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
Andra namn:
|
|
Experimentell: 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.
Andra namn:
|
|
Övrig: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Client-Satisfaction Questionnaire
Tidsram: Up to Week 12
|
measure of client satisfaction
|
Up to Week 12
|
|
Social Rhythm Metric (measure of lifestyle regularity)
Tidsram: Up to 12 weeks
|
measure of lifestyle regularity
|
Up to 12 weeks
|
|
Supportive Accountability Questionnaire
Tidsram: Up to Week 12
|
assesses level of perceived accountability to another person for treatment participation
|
Up to Week 12
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quick Inventory of Depressive Symptoms
Tidsram: up to 12 weeks
|
measure of depressive symptoms
|
up to 12 weeks
|
|
Internal State Scale
Tidsram: up to 12 weeks
|
measure of mood symptoms
|
up to 12 weeks
|
|
Short Form-12
Tidsram: up to 12 weeks
|
measure of overall health status
|
up to 12 weeks
|
|
Functional Assessment Short Test
Tidsram: up to 12 weeks
|
assessment of impairment in functioning
|
up to 12 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Holly A Swartz, MD, University of Pittsburgh
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 00085129000
- R34MH107541 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
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