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
About this trial
This is an interventional treatment trial for Bipolar Disorder
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.
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
NCT ID
NCT02924415
First Posted
September 27, 2016
Last Updated
October 4, 2016
Sponsor
Basque Health Service
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
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Future Internet Social and Technological Alignment Research
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