Bipolar DisorderFISTARNCT02924415
Future Internet Social and Technological Alignment Research
A study testing Tele-care support in people with Bipolar Disorder, run by Basque Health Service.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Tele-care support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Tele-care support, Control group
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-care supportBehavioural
Psychoeducation treatment based on telemedicine
Control groupOther
Standard care
| Study group | Role | What they receive |
|---|---|---|
| Tele-care support | Experimental | Online psychoeducation treatment using new technologies Receives: Behavioral: Tele-care support |
| Control group | Active comparator | Standard care Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline-9 weeks
Secondary outcomes (4)
Beck Depression Inventory (BDI-II)
To analyze the improvement of depressive symptoms of patients measured by Beck Depression Inventory .
Measured: baseline-9 weeks
State-Trait Anxiety Inventory (STAI)
To analyze the improvement of anxiety symptoms of patients measured by State-Trait Anxiety Inventory .
Measured: baseline-9 weeks
Young Mania Rating Scale (YMRS)
To analyze the improvement of manic symptoms of patients measured by Young Mania Rating Scale .
Measured: baseline-9 weeks
Treatment dropout rate
To analyze satisfaction with the treatment received and the contact with the health service by treatment dropout rate.
Measured: baseline-9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ana María González-Pinto, Basque Health Service
- Investigators
- Ana González-Pinto, MD, Study chair, ANAMARIA.GONZALEZ-PINTOARRILLAGA@osakidetza.eus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924415
- Sponsor's protocol ID
- FISTAR
- Acronym
- FISTAR
- Status last verified
- Oct 2016
- First submitted
- 27 Sep 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 28007034
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Future Internet Social and Technological Alignment Research (FISTAR)
- ClinicalTrials.gov ID
- NCT02924415
- Acronym / sponsor ID
- FISTAR / FISTAR
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-care support | Experimental | Behavioral: Tele-care supportOnline psychoeducation treatment using new technologies |
| Control group | Active comparator | Other: Control groupStandard care |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-care supportPsychoeducation treatment based on telemedicine | Behavioural | Tele-care support |
| Control groupStandard care | Other | Control group |
Primary outcome
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.
4 secondary outcomes
Beck Depression Inventory (BDI-II)
Time frame: baseline-9 weeks
State-Trait Anxiety Inventory (STAI)
Time frame: baseline-9 weeks
Young Mania Rating Scale (YMRS)
Time frame: baseline-9 weeks
Treatment dropout rate
Time frame: baseline-9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Derived from this study: PubMed 28007034Gonzalez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana González-Pinto, MD study chair
ANAMARIA.GONZALEZ-PINTOARRILLAGA@osakidetza.eus
Questions about this trial
What is this clinical trial studying?
A study testing Tele-care support in people with Bipolar Disorder, run by Basque Health Service.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functioning Assessment Short Test (FAST) (time frame: baseline-9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02924415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.