Future Internet Social and Technological Alignment Research

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Future Internet Social and Technological Alignment Research (FISTAR)

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Behavioral: Tele-care support
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having a diagnosis of bipolar disorder. Being aged between 18-50 years. Being in remission (euthymic state). Being familiarity with new technologies (computer and /or smartphone). Being treatment in the mental health network of the Basque Country (Osakidetza). Exclusion Criteria: Having listening, reading or writing problems. Having a diagnosis of mental retardation. Unavailability of a smartphone. Having manic or depressive symptomatology at the time of inclusion (HAMD> 16 and YOUNG> 8). Having suicidal ideation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-care support<br>Online psychoeducation treatment using new technologies | Behavioral: Tele-care support<br>* Psychoeducation treatment based on telemedicine<br>|
| Active Comparator: Control group<br>Standard care | Other: Control group<br>* Standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |