Borderline Personality DisorderNCT01311193
Circadian Sleep-wake Cycles and Light Therapy in Borderline Personality Disorder
A study testing light therapy in people with Borderline Personality Disorder and Sleep Disturbances, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Individuals with borderline personality disorder (BPD) frequently suffer from emotional instability, daytime fatigue and sleep disturbances. The investigators examined circadian rhythms, sleep and well-being in women with BPD under their habitual life conditions with and without light treatment. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Borderline Personality Disorder, Sleep Disturbances, Depression
- What is being tested?
- light therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Start not givento not given
- 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 20 to 45 years
- Women only
- Adult
Who may be able to join
- Borderline Personality Disorder (DSM IV-criteria)
- German-speaking
- normal ocular function
Who cannot join
- lack of compliance
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre for Chronobiology, Psychiatric Hospital, University of Basel
Basel, Canton of Basel-City, 4012
About this study
Official title: Circadian Sleep-wake Cycles, Well-being and Light Therapy in Borderline Personality Disorder
Individuals with borderline personality disorder (BPD) frequently suffer from emotional instability, daytime fatigue and sleep disturbances. The investigators examined circadian rhythms, sleep and well-being in women with BPD under their habitual life conditions with and without light treatment.
Treated women diagnosed with BPD were investigated during 3 weeks without and 3 weeks with morning LT. Rest-activity cycles were continuously measured using wrist actigraphy, together with proximal skin temperature. Saliva samples were collected weekly to determine the diurnal melatonin rhythm. A range of self-ratings and questionnaires were used to assess depression and clinical state throughout the 6-week protocol. Ten matched healthy women followed the same 6-week protocol without light treatment.
- Being tested
- light therapy
- Keywords
- Circadian rhythms, Sleep-wake cycles, Melatonin, Borderline Personality Disorder, Light therapy
- Medical subject headings
- Borderline Personality Disorder, Parasomnias, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
light therapyOther
early morning exposures to bright light, 8000lux for 40min, daily during 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| light therapy | Experimental | Morning bright light treatment (at 8000 lux for 40min, daily during 3 weeks) Receives: Other: light therapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Velux Fonden, Lumie UK
- Investigators
- Christian Cajochen, PhD, Principal investigator, Centre for Chronobiology, Psychiatric Hospital, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311193
- Sponsor's protocol ID
- Velux-425
- Status last verified
- Mar 2011
- First submitted
- 3 Mar 2011
- Last updated
- 9 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Sleep-wake Cycles, Well-being and Light Therapy in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT01311193
- Acronym / sponsor ID
- Velux-425
- Keywords
- Circadian rhythms, Sleep-wake cycles, Melatonin, Borderline Personality Disorder, Light therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Velux Fonden, Lumie UK
- First posted
- 9 Mar 2011 (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.
Individuals with borderline personality disorder (BPD) frequently suffer from emotional instability, daytime fatigue and sleep disturbances. The investigators examined circadian rhythms, sleep and well-being in women with BPD under their habitual life conditions with and without light treatment.
Treated women diagnosed with BPD were investigated during 3 weeks without and 3 weeks with morning LT. Rest-activity cycles were continuously measured using wrist actigraphy, together with proximal skin temperature. Saliva samples were collected weekly to determine the diurnal melatonin rhythm. A range of self-ratings and questionnaires were used to assess depression and clinical state throughout the 6-week protocol. Ten matched healthy women followed the same 6-week protocol without light treatment.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| light therapy | Experimental | Other: light therapyMorning bright light treatment (at 8000 lux for 40min, daily during 3 weeks) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Borderline Personality Disorder (DSM IV-criteria)
- German-speaking
- normal ocular function
Key exclusion criteria (1 listed)
- lack of compliance
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 |
|---|---|---|
| light therapyearly morning exposures to bright light, 8000lux for 40min, daily during 3 weeks | Other | light therapy |
Primary outcome
Not reported in the source record.
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 9 Mar 2011.
- Related InfoLink provided by the sponsor.
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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.
Christian Cajochen, PhD principal investigator
Centre for Chronobiology, Psychiatric Hospital, University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing light therapy in people with Borderline Personality Disorder and Sleep Disturbances, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 1 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 9 Mar 2011. 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 Switzerland. 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.
Where can I read the original study information?
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 9 Mar 2011.