An interventional study of Tele-care support and Control group in Bipolar Disorder, sponsored by Basque Health Service. Completed. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-10-05.
Sponsored by Basque Health Service · Not applicable, Interventional, and Treatment
Bipolar disorder patients frequently presents recurring episodes and often experience subsyndromal symptoms, cognitive impairment and difficulties in the functioning with a low quality of life, relapses of disease and recurring hospitalization. Early diagnosis and appropriate intervention may play a role in preventing the neuroprogressive course of bipolar illness. The new technologies represent an opportunity to develop psychological standardized treatments using internet devices that minimizing the limitations of face to face treatments because of its accessibility that allow adjusting to the availability of each user. However, although exist many online psychological programs through web and mobile devices for bipolar disorder, there is not evidence about their efficacy and effectiveness due to the variability in measures and methodology used.
Future Internet Social and Technological Alignment Research (FI-STAR) clinical trial is a randomized simple blind evaluation within an European project. FISTAR is developed to compare this technical solution with treatment as usual. Bipolar disorder patients are to be included and randomly assigned to one of two treatment groups: 1) the experimental group (tele-care support) and the control group. Participants in both groups will be evaluated at baseline (pre-treatment) and at post-treatment.
1,637 studies on the registry are indexed under Bipolar Disorder; 258 are open to participants now.
This study's enrollment of 50 is below the median of 63 across 1,245 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Basque Health Service is the lead sponsor of 57 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Online psychoeducation treatment using new technologies
Behavioral: Tele-care support
Standard care
Other: Control group
Psychoeducation treatment based on telemedicine
Standard care
Functioning Assessment Short Test (FAST)
To analyze the effectiveness of a psychoeducation treatment based on telemedicine versus usual treatment in relation with better functional outcome of bipolar disorder measured by Functioning Assessment Short Test.
Time frame: baseline-9 weeks
Beck Depression Inventory (BDI-II)
To analyze the improvement of depressive symptoms of patients measured by Beck Depression Inventory .
Time frame: baseline-9 weeks
State-Trait Anxiety Inventory (STAI)
To analyze the improvement of anxiety symptoms of patients measured by State-Trait Anxiety Inventory .
Time frame: baseline-9 weeks
Young Mania Rating Scale (YMRS)
To analyze the improvement of manic symptoms of patients measured by Young Mania Rating Scale .
Time frame: baseline-9 weeks
Treatment dropout rate
To analyze satisfaction with the treatment received and the contact with the health service by treatment dropout rate.
Time frame: baseline-9 weeks
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Basque Health Service