Bipolar DisorderBETNCT01620866
A Eye Movement Desensitization Reprocessing (EMDR) Study in Bipolar Traumatized Patients
A study testing Eye Movement Desensitization Reprocessing (EMDR) in people with Bipolar Disorder and PTSD, run by FIDMAG Germanes Hospitalàries at 1 site in Spain.
Trial summary
The purpose of this pilot study is whether Eye Movement Desensitization Reprocessing (EMDR), an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning, quality of life, cognition and BDNF levels in subsyndromal bipolar patients with trauma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, PTSD
- What is being tested?
- Eye Movement Desensitization Reprocessing (EMDR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2010to Jun 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bipolar I or II disorder following DSM-IV criteria
- Instable, subsyndromal course defined as at evaluation baseline (HAMD > 8 < 15 and/or YMRS > 7 < 14)
- Good adherence to pharmacological treatment
- Major or minor traumatic life-events
- EMDR therapists > 3 years experience
- Able to sign informed consent
Who cannot join
- Major affective episode in last 3 months
- Active drug abuse/dependency
- Neurological disease
- Suicidal thoughts/ideation
- Prior treatment EMDR
- DES > 25
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled, Single-blind Pilot Study of EMDR in Bipolar, Subsyndromal Patients With Trauma
The purpose of this pilot study is whether Eye Movement Desensitization Reprocessing (EMDR), an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning, quality of life, cognition and BDNF levels in subsyndromal bipolar patients with trauma.
- Conditions
- Bipolar Disorder, PTSD
- Being tested
- Eye Movement Desensitization Reprocessing (EMDR)
- Keywords
- EMDR, bipolar disorder, trauma, subsyndromal symptoms, PTSD
- Medical subject headings
- Bipolar Disorder, Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization Reprocessing (EMDR)Other
EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients.
| Study group | Role | What they receive |
|---|---|---|
| EMDR | Experimental | Not described Receives: Other: Eye Movement Desensitization Reprocessing (EMDR) |
| TAU | No intervention | Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this study is a statistically significant reduction in the YMRS and/or HDRS in the EMDR group compared with the TAU group.
Patients with subsydromal symptoms, objectified by the YMRS and HDRS, are included in the study. After randomization to EMDR or TAU, group differences in changes in the YMRS and HRDS are measured at visit after intervention (3 months) and at follow-up (6 months). The hypothesize is that the EMDR group will statistically improve in both affective scales when compared to the TAU group.
Measured: 3 months and 6 months
Secondary outcomes (5)
The EMDR group improves statistically significant in trauma load when compared to TAU.
Secondary outcome measure includes changes in trauma scales (IES, CAPS)from baseline to 3 months and 6 months.
Measured: 3 months and 6 months
The EMDR group improves statistically significant in cognitive tests when compared to TAU.
Subjects underwent a neuropsychologcial battery to test various cognitive domains.
Measured: 3 months and 6 months
The EMDR group improves statistically significant in functioning when compared to TAU.
All subjects were evaluated with respect to their functioning using the FAST, a validated scale of functioning in bipolar disorder.
Measured: 3 months and 6 months
The EMDR group improves statistically significant in quality of life when compared to TAU.
Possible changes of Quality of life were tested in all subjects as well, using the SF-36.
Measured: 3 months and 6 months
Plasma levels of BDNF was statistically higher in the EMDR group after intervention when compared to TAU.
Levels of BDNF are lower in bipolar patients, and even lower when traumatized, when compared to the general population. We aimed to find higher levels of BDNF in the EMDR group.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startNov 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- FIDMAG Germanes Hospitalàries
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benedikt Amann, FIDMAG Germanes Hospitalàries
- Investigators
- Benedikt L Amann, MD, Principal investigator, FIDMAG Germanes Hospitalàries
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620866
- Sponsor's protocol ID
- BET-study
- Acronym
- BET
- Status last verified
- Jun 2012
- First submitted
- 11 Jun 2012
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kauer-Sant'Anna M, Tramontina J, Andreazza AC, Cereser K, da Costa S, Santin A, Yatham LN, Kapczinski F. Traumatic life events in bipolar disorder: impact on BDNF levels and psychopathology. Bipolar Disord. 2007 Jun;9 Suppl 1:128-35. doi: 10.1111/j.1399-5618.2007.00478.x.
PubMed 17543031Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.
PubMed 17636720
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Single-blind Pilot Study of EMDR in Bipolar, Subsyndromal Patients With Trauma
- ClinicalTrials.gov ID
- NCT01620866
- Acronym / sponsor ID
- BET / BET-study
- Conditions
- Bipolar Disorder, PTSD
- Keywords
- EMDR, bipolar disorder, trauma, subsyndromal symptoms, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- FIDMAG Germanes HospitalàriesUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Jun 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 purpose of this pilot study is whether Eye Movement Desensitization Reprocessing (EMDR), an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning, quality of life, cognition and BDNF levels in subsyndromal bipolar patients with trauma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMDR | Experimental | Other: Eye Movement Desensitization Reprocessing (EMDR) |
| TAU | No intervention | –Treatment as usual (TAU) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Bipolar I or II disorder following DSM-IV criteria
- Instable, subsyndromal course defined as at evaluation baseline (HAMD > 8 < 15 and/or YMRS > 7 < 14)
- Good adherence to pharmacological treatment
- Major or minor traumatic life-events
- EMDR therapists > 3 years experience
Key exclusion criteria (6 listed)
- Major affective episode in last 3 months
- Active drug abuse/dependency
- Neurological disease
- Suicidal thoughts/ideation
- Prior treatment EMDR
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 |
|---|---|---|
| Eye Movement Desensitization Reprocessing (EMDR)EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients. | Other | EMDR |
Primary outcome
The primary outcome of this study is a statistically significant reduction in the YMRS and/or HDRS in the EMDR group compared with the TAU group.
Time frame: 3 months and 6 months
Patients with subsydromal symptoms, objectified by the YMRS and HDRS, are included in the study. After randomization to EMDR or TAU, group differences in changes in the YMRS and HRDS are measured at visit after intervention (3 months) and at follow-up (6 months). The hypothesize is that the EMDR group will statistically improve in both affective scales when compared to the TAU group.
5 secondary outcomes
The EMDR group improves statistically significant in trauma load when compared to TAU.
Time frame: 3 months and 6 months
The EMDR group improves statistically significant in cognitive tests when compared to TAU.
Time frame: 3 months and 6 months
The EMDR group improves statistically significant in functioning when compared to TAU.
Time frame: 3 months and 6 months
The EMDR group improves statistically significant in quality of life when compared to TAU.
Time frame: 3 months and 6 months
Plasma levels of BDNF was statistically higher in the EMDR group after intervention when compared to TAU.
Time frame: 3 months and 6 months
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 19 Jun 2012.
- Background: PubMed 17543031Kauer-Sant'Anna M, Tramontina J, Andreazza AC, Cereser K, da Costa S, Santin A, Yatham LN, Kapczinski F. Traumatic life events in bipolar disorder: impact on BDNF levels and psychopathology. Bipolar Disord. 2007 Jun;9 Suppl 1:128-35. doi: 10.1111/j.1399-5618.2007.00478.x.
- Background: PubMed 17636720Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.
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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.
Benedikt L Amann, MD principal investigator
FIDMAG Germanes Hospitalàries
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization Reprocessing (EMDR) in people with Bipolar Disorder and PTSD, run by FIDMAG Germanes Hospitalàries at 1 site in Spain.
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 6 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 19 Jun 2012. 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 Spain. 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?
The primary outcome of this study is a statistically significant reduction in the YMRS and/or HDRS in the EMDR group compared with the TAU group. (time frame: 3 months and 6 months). 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 NCT01620866, which also lists 2 linked publications.
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 19 Jun 2012.