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Future Internet Social and Technological Alignment Research (FISTAR)

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tele-care support
Control group
Sponsored by
Basque Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tele-care support

    Control group

    Arm Description

    Online psychoeducation treatment using new technologies

    Standard care

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Beck Depression Inventory (BDI-II)
    To analyze the improvement of depressive symptoms of patients measured by Beck Depression Inventory .
    State-Trait Anxiety Inventory (STAI)
    To analyze the improvement of anxiety symptoms of patients measured by State-Trait Anxiety Inventory .
    Young Mania Rating Scale (YMRS)
    To analyze the improvement of manic symptoms of patients measured by Young Mania Rating Scale .
    Treatment dropout rate
    To analyze satisfaction with the treatment received and the contact with the health service by treatment dropout rate.

    Full Information

    First Posted
    September 27, 2016
    Last Updated
    October 4, 2016
    Sponsor
    Basque Health Service
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02924415
    Brief Title
    Future Internet Social and Technological Alignment Research
    Acronym
    FISTAR
    Official Title
    Future Internet Social and Technological Alignment Research (FISTAR)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Basque Health Service

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tele-care support
    Arm Type
    Experimental
    Arm Description
    Online psychoeducation treatment using new technologies
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Standard care
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tele-care support
    Intervention Description
    Psychoeducation treatment based on telemedicine
    Intervention Type
    Other
    Intervention Name(s)
    Control group
    Intervention Description
    Standard care
    Primary Outcome Measure Information:
    Title
    Functioning Assessment Short Test (FAST)
    Description
    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.
    Time Frame
    baseline-9 weeks
    Secondary Outcome Measure Information:
    Title
    Beck Depression Inventory (BDI-II)
    Description
    To analyze the improvement of depressive symptoms of patients measured by Beck Depression Inventory .
    Time Frame
    baseline-9 weeks
    Title
    State-Trait Anxiety Inventory (STAI)
    Description
    To analyze the improvement of anxiety symptoms of patients measured by State-Trait Anxiety Inventory .
    Time Frame
    baseline-9 weeks
    Title
    Young Mania Rating Scale (YMRS)
    Description
    To analyze the improvement of manic symptoms of patients measured by Young Mania Rating Scale .
    Time Frame
    baseline-9 weeks
    Title
    Treatment dropout rate
    Description
    To analyze satisfaction with the treatment received and the contact with the health service by treatment dropout rate.
    Time Frame
    baseline-9 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ana González-Pinto, MD
    Organizational Affiliation
    ANAMARIA.GONZALEZ-PINTOARRILLAGA@osakidetza.eus
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28007034
    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.
    Results Reference
    derived

    Learn more about this trial

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