Clinical trial NCT02924415: Future Internet Social and Technological Alignment Research
Official title: Future Internet Social and Technological Alignment Research (FISTAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2016-10-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functioning Assessment Short Test (FAST)
timeFrame: baseline-9 weeks
Secondary outcomes:
measure: Beck Depression Inventory (BDI-II)
timeFrame: baseline-9 weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: baseline-9 weeks
measure: Young Mania Rating Scale (YMRS)
timeFrame: baseline-9 weeks
measure: Treatment dropout rate
timeFrame: baseline-9 weeks
Other outcomes:
Locations:
Study officials:
affiliation: ANAMARIA.GONZALEZ-PINTOARRILLAGA@osakidetza.eus
name: Ana González-Pinto, MD
role: STUDY_CHAIR
References:
citation: 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.