Future Internet Social and Technological Alignment Research

Not Applicable

Completed

• Conditions: Bipolar Disorder
• Interventions: Behavioral: Tele-care support; Other: Control group

• Registration Number: NCT02924415
• Lead Sponsor: Basque Health Service

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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2016-09-27
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-04
• Last Update Submitted: 2016-10-04
• Study First Posted: 2016-10-05
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tele-care support	Tele-care support	Online psychoeducation treatment using new technologies
Control group	Control group	Standard care

Primary Outcome Measures

Name	Time	Method
Functioning Assessment Short Test (FAST)	baseline-9 weeks	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

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