Future Internet Social and Technological Alignment Research

NCT02924415 | Completed

• 1 other identifier: FISTAR
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Beck Depression Inventory (BDI-II)

  baseline-9 weeks

• State-Trait Anxiety Inventory (STAI)

  baseline-9 weeks

• Young Mania Rating Scale (YMRS)

  baseline-9 weeks

• Treatment dropout rate

  baseline-9 weeks

Study Arms (2)

Tele-care support

EXPERIMENTAL

Online psychoeducation treatment using new technologies

Behavioral: Tele-care support

Control group

ACTIVE COMPARATOR

Standard care

Other: Control group

Interventions

Tele-care support BEHAVIORAL

Psychoeducation treatment based on telemedicine

Tele-care support

Control group OTHER

Standard care

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Having listening, reading or writing problems.
• Having a diagnosis of mental retardation.
• Unavailability of a smartphone.
• Having suicidal ideation.

Sponsors & Collaborators

• Basque Health Service: lead

Related Publications (1)

• 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.

  PMID: 28007034 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ana González-Pinto, MD

  ANAMARIA.GONZALEZ-PINTOARRILLAGA@osakidetza.eus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 5, 2016
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share