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Completed

NCT Number: NCT02924415

Future Internet Social and Technological Alignment Research

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tele-care support

Behavioral

Psychoeducation treatment based on telemedicine

Control Group

Other

Standard care

Primary outcomes

  1. Functioning Assessment Short Test (FAST)

    Time frame: 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 outcomes

  1. Beck Depression Inventory (BDI-II)

    Time frame: baseline-9 weeks

    To analyze the improvement of depressive symptoms of patients measured by Beck Depression Inventory .

  2. State-Trait Anxiety Inventory (STAI)

    Time frame: baseline-9 weeks

    To analyze the improvement of anxiety symptoms of patients measured by State-Trait Anxiety Inventory .

  3. Young Mania Rating Scale (YMRS)

    Time frame: baseline-9 weeks

    To analyze the improvement of manic symptoms of patients measured by Young Mania Rating Scale .

  4. Treatment dropout rate

    Time frame: baseline-9 weeks

    To analyze satisfaction with the treatment received and the contact with the health service by treatment dropout rate.

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Official study title

Future Internet Social and Technological Alignment Research (FISTAR)

Acronym: FISTAR

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 5, 2016
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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