Future Internet Social and Technological Alignment Research (FISTAR)

Future Internet Social and Technological Alignment Research (FISTAR)

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder
• Intervention / Treatment: Behavioral: Tele-care support; Other: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-care support; Online psychoeducation treatment using new technologies	Behavioral: Tele-care support; Psychoeducation treatment based on telemedicine
Active Comparator: Control group; Standard care	Other: Control group; Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline-9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory (BDI-II)	To analyze the improvement of depressive symptoms of patients measured by Beck Depression Inventory .	baseline-9 weeks
State-Trait Anxiety Inventory (STAI)	To analyze the improvement of anxiety symptoms of patients measured by State-Trait Anxiety Inventory .	baseline-9 weeks
Young Mania Rating Scale (YMRS)	To analyze the improvement of manic symptoms of patients measured by Young Mania Rating Scale .	baseline-9 weeks
Treatment dropout rate	To analyze satisfaction with the treatment received and the contact with the health service by treatment dropout rate.	baseline-9 weeks

Collaborators and Investigators

• Sponsor: Basque Health Service
• Investigators: Study Chair: Ana González-Pinto, MD, ANAMARIA.GONZALEZ-PINTOARRILLAGA@osakidetza.eus

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: FISTAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO