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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-care support | Experimental | Online psychoeducation treatment using new technologies |
|
| Control group | Active Comparator | Standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-care support | Behavioral | Psychoeducation treatment based on telemedicine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline-9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory (BDI-II) | To analyze the improvement of depressive symptoms of patients measured by Beck Depression Inventory . | baseline-9 weeks |
| State-Trait Anxiety Inventory (STAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana González-Pinto, MD | ANAMARIA.GONZALEZ-PINTOARRILLAGA@osakidetza.eus | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28007034 | Derived | Gonzalez-Ortega I, Ugarte A, Ruiz de Azua S, Nunez N, Zubia M, Ponce S, Casla P, Llano JX, Faria A, Gonzalez-Pinto A. Online psycho-education to the treatment of bipolar disorder: protocol of a randomized controlled trial. BMC Psychiatry. 2016 Dec 22;16(1):452. doi: 10.1186/s12888-016-1159-0. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group |
| Other |
Standard care |
|
To analyze the improvement of anxiety symptoms of patients measured by State-Trait Anxiety Inventory .
| baseline-9 weeks |
| Young Mania Rating Scale (YMRS) | To analyze the improvement of manic symptoms of patients measured by Young Mania Rating Scale . | baseline-9 weeks |
| Treatment dropout rate | To analyze satisfaction with the treatment received and the contact with the health service by treatment dropout rate. | baseline-9 weeks |
| D008722 | Methods |