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Future Internet Social and Technological Alignment Research (FISTAR)

B

Basque Health Service

Status

Completed

Conditions

Bipolar Disorder

Treatments

Other: Control group
Behavioral: Tele-care support

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Tele-care support
Experimental group
Description:
Online psychoeducation treatment using new technologies
Treatment:
Behavioral: Tele-care support
Control group
Active Comparator group
Description:
Standard care
Treatment:
Other: Control group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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