Bipolar Disorder
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALTele-care support
Psychoeducation treatment based on telemedicine
OTHERControl group
Standard care
Sponsors
Basque Health Service
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functioning Assessment Short Test (FAST) | baseline-9 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory (BDI-II) | baseline-9 weeks | To analyze the improvement of depressive symptoms of patients measured by Beck Depression Inventory . |
| State-Trait Anxiety Inventory (STAI) | baseline-9 weeks | To analyze the improvement of anxiety symptoms of patients measured by State-Trait Anxiety Inventory . |
| Young Mania Rating Scale (YMRS) | baseline-9 weeks | To analyze the improvement of manic symptoms of patients measured by Young Mania Rating Scale . |
| Treatment dropout rate | baseline-9 weeks | To analyze satisfaction with the treatment received and the contact with the health service by treatment dropout rate. |
Outcome results
None listed