Future Internet Social and Technological Alignment Research

Bipolar Disorder Clinical Trial

— FISTAR  

Official title:

Future Internet Social and Technological Alignment Research (FISTAR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02924415
• Other study ID #: FISTAR
• Status: Completed
• Phase: N/A
• First received: September 27, 2016
• Last updated: October 4, 2016
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain:Araba University Hospital Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Tele-care support
Psychoeducation treatment based on telemedicine

Other:
• Control group
Standard care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Beck Depression Inventory (BDI-II)	To analyze the improvement of depressive symptoms of patients measured by Beck Depression Inventory .	baseline-9 weeks	No
Secondary	State-Trait Anxiety Inventory (STAI)	To analyze the improvement of anxiety symptoms of patients measured by State-Trait Anxiety Inventory .	baseline-9 weeks	No
Secondary	Young Mania Rating Scale (YMRS)	To analyze the improvement of manic symptoms of patients measured by Young Mania Rating Scale .	baseline-9 weeks	No
Secondary	Treatment dropout rate	To analyze satisfaction with the treatment received and the contact with the health service by treatment dropout rate.	baseline-9 weeks	No