Bipolar Disorder, Type IINCT01742351
Internet-based Cognitive Behaviour Therapy (CBT) for Persons Diagnosed With Bipolar II
A study testing Guided internet-based cognitive behavior therapy in people with Bipolar Disorder, Type II, run by Örebro County Council at 1 site in Sweden.
Trial summary
The aim of the study is to test the feasibility and acceptability of internet-based Cognitive Behaviour Therapy (CBT) for persons diagnosed with bipolar disorder, type II. The idea is to treat residual depressive symptoms as well as using psychoeducation to improve their prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Type II
- What is being tested?
- Guided internet-based cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2013to May 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of bipolar disorder type II
- Mild to moderate depressive symptoms
- 18 years of age
- Stable medication with a mood stabiliser
- Access to the internet
Who cannot join
- Diagnosis of psychosis
- Having received psychiatric in-patient care during the past year
- Ongoing psychotherapy
- Previous manic episode
- Previous suicide attempt
- Previous parasuicidal behavior documented in patient record (e.g. self-injury)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-based Cognitive Behaviour Therapy for Persons Diagnosed With Bipolar II - a Pilot Study
The aim of the study is to test the feasibility and acceptability of internet-based Cognitive Behaviour Therapy (CBT) for persons diagnosed with bipolar disorder, type II. The idea is to treat residual depressive symptoms as well as using psychoeducation to improve their prognosis. Each participant will have a personal therapist that will provide guidance and support throughout the treatment.
- Conditions
- Bipolar Disorder, Type II
- Being tested
- Guided internet-based cognitive behavior therapy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided internet-based cognitive behavior therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Guided internet-based cognitive behavior therapy (CBT) | Experimental | Not described Receives: Behavioral: Guided internet-based cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on the Montgomery-Åsberg Depression Rating Scale - Self rated (MADRS-S) between baseline and post treatment
A nine item questionnaire of depressive symptoms
Measured: 9 weeks
Secondary outcomes (1)
Change in the score on the Affective Self Rating Scale (AS-18-M) between baseline and post treatment
A nine item subscale of the AS-18 measuring symptoms of mania/hypomania.
Measured: 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 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionMay 2013
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 Disorder, Type IIStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Collaborators
- School of Law, Psychology and Social Work, Örebro University
- Responsible party
- Principal investigator, Fredrik Holländare, Örebro County Council
- Investigators
- Fredrik Holländare, PhD, Principal investigator, School of Health and Medical Science, Psychiatric Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742351
- Sponsor's protocol ID
- 39:2012
- Status last verified
- May 2013
- First submitted
- 16 Nov 2012
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hollandare F, Eriksson A, Lovgren L, Humble MB, Boersma K. Internet-Based Cognitive Behavioral Therapy for Residual Symptoms in Bipolar Disorder Type II: A Single-Subject Design Pilot Study. JMIR Res Protoc. 2015 Apr 23;4(2):e44. doi: 10.2196/resprot.3910.
PubMed 25908235
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behaviour Therapy for Persons Diagnosed With Bipolar II - a Pilot Study
- ClinicalTrials.gov ID
- NCT01742351
- Acronym / sponsor ID
- 39:2012
- Conditions
- Bipolar Disorder, Type II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Örebro County CouncilOther government
- Collaborators
- School of Law, Psychology and Social Work, Örebro University
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Dec 2012 (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.
The aim of the study is to test the feasibility and acceptability of internet-based Cognitive Behaviour Therapy (CBT) for persons diagnosed with bipolar disorder, type II. The idea is to treat residual depressive symptoms as well as using psychoeducation to improve their prognosis. Each participant will have a personal therapist that will provide guidance and support throughout the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided internet-based cognitive behavior therapy (CBT) | Experimental | Behavioral: Guided internet-based cognitive behavior therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of bipolar disorder type II
- Mild to moderate depressive symptoms
- 18 years of age
- Stable medication with a mood stabiliser
- Access to the internet
Key exclusion criteria (6 listed)
- Diagnosis of psychosis
- Having received psychiatric in-patient care during the past year
- Ongoing psychotherapy
- Previous manic episode
- Previous suicide attempt
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 |
|---|---|---|
| Guided internet-based cognitive behavior therapy | Behavioural | Guided internet-based cognitive behavior therapy (CBT) |
Primary outcome
Change in score on the Montgomery-Åsberg Depression Rating Scale - Self rated (MADRS-S) between baseline and post treatment
Time frame: 9 weeks
A nine item questionnaire of depressive symptoms
1 secondary outcome
Change in the score on the Affective Self Rating Scale (AS-18-M) between baseline and post treatment
Time frame: 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 3 May 2013.
- Derived from this study: PubMed 25908235Hollandare F, Eriksson A, Lovgren L, Humble MB, Boersma K. Internet-Based Cognitive Behavioral Therapy for Residual Symptoms in Bipolar Disorder Type II: A Single-Subject Design Pilot Study. JMIR Res Protoc. 2015 Apr 23;4(2):e44. doi: 10.2196/resprot.3910.
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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.
Fredrik Holländare, PhD principal investigator
School of Health and Medical Science, Psychiatric Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided internet-based cognitive behavior therapy in people with Bipolar Disorder, Type II, run by Örebro County Council at 1 site in Sweden.
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 6 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 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in score on the Montgomery-Åsberg Depression Rating Scale - Self rated (MADRS-S) between baseline and post treatment (time frame: 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 NCT01742351, 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 3 May 2013.