DepressionNCT02787148
Psychotherapy and Cardiovascular Risk Factors in Depression
A study testing Cognitive behavioral therapy in people with Depression, run by Philipps University Marburg at 1 site in Germany.
Trial summary
Prospective studies indicate that patients with depression are at increased risk for cardiovascular disease. Depression is also associated with a number of hemodynamic features, which are known risk factors for cardiovascular morbidity such as increased heart rate, reduced heart rate variability and blood pressure… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Oct 2019
- 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
- patients with Major Depression (DSM IV), BDI >=14
- age:18-65 years
- patients without antidepressive medication (stable for at least 2 weeks)
- comorbidity with other psychiatric disorders is permitted, as far as depressive symptoms are dominating
Who cannot join
- current psychotherapy
- psychotic disorder
- serious drug-addiction
- drugs which seriously affect immune status (except contraceptives) or central
- nervous system functions (except antidepressants)
- infections during the last 2 weeks
Show all 9Show fewer
- injuries during the last 2 weeks
- neurological disorders
- diseases which affect immune status or central nervous system functions (e.g. rheumatoid arthritis, CVD,etc.)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
Marburg, 35032
About this study
Official title: The Impact of Psychotherapy on Hemodynamic and Inflammatory Risk Factors for Cardiovascular Disease in Major Depression
Prospective studies indicate that patients with depression are at increased risk for cardiovascular disease. Depression is also associated with a number of hemodynamic features, which are known risk factors for cardiovascular morbidity such as increased heart rate, reduced heart rate variability and blood pressure alterations. These hemodynamic alterations may explain in part the increased cardiovascular risk associated with depression.
The purpose of this study is to determine whether treatment for depression with cognitive behavior therapy (CBT) is effective in reducing hemodynamic cardiovascular risk factors. Hemodynamic assessments including heart rate, heart rate variability, continues blood pressure, blood pressure variability, baroreceptor sensitivity and peripheral vascular resistance will be conducted at baseline, after treatment and 2-month follow up. In addition, circadian hemodynamic variations such as 24-hour heart rate variability, nocturnal blood pressure dipping and immunological biomarkers will be assessed. Eighty patients with Major Depression will be randomly assigned to either a CBT treatment condition (14 hour-long, weekly sessions) or a waitlist condition, to control for potential changes in hemodynamic parameters without any intervention and the impact of repeated-measurement.
- Conditions
- Depression
- Being tested
- Cognitive behavioral therapy
- Keywords
- cognitive behavioral therapy, psychotherapy, cardiovascular health, psychoneuroimmunology
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Cognitive behavioral therapy for Major Depression Receives: Behavioral: Cognitive behavioral therapy |
| Waitlist group | No intervention | Waitlist group to control for repeated physiological measures and fluctuations over time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms (BDI-II)
Measured: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Secondary outcomes (8)
Change in heart rate variability
Measured: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in blood pressure
Measured: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in baroreceptor sensitivity (ms/mmHg)
Measured: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in peripheral vascular resistance (dyne*s/cm5)
Measured: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in C-reactive protein
Measured: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in proinflammatory cytokines
Measured: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in anti-inflammatory interleukin-10
Measured: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in Subjective social status (MacArthur scale)
Measured: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. rer. nat. Frank Euteneuer, Philipps University Marburg
- Investigators
- Frank Euteneuer, PhD, Principal investigator, Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787148
- Sponsor's protocol ID
- DFG EU 154 2 1
- Status last verified
- Jul 2021
- First submitted
- 10 Feb 2016
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Psychotherapy on Hemodynamic and Inflammatory Risk Factors for Cardiovascular Disease in Major Depression
- ClinicalTrials.gov ID
- NCT02787148
- Acronym / sponsor ID
- DFG EU 154 2 1
- Conditions
- Depression
- Keywords
- cognitive behavioral therapy, psychotherapy, cardiovascular health, psychoneuroimmunology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 1 Jun 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.
Prospective studies indicate that patients with depression are at increased risk for cardiovascular disease. Depression is also associated with a number of hemodynamic features, which are known risk factors for cardiovascular morbidity such as increased heart rate, reduced heart rate variability and blood pressure alterations. These hemodynamic alterations may explain in part the increased cardiovascular risk associated with depression.
The purpose of this study is to determine whether treatment for depression with cognitive behavior therapy (CBT) is effective in reducing hemodynamic cardiovascular risk factors. Hemodynamic assessments including heart rate, heart rate variability, continues blood pressure, blood pressure variability, baroreceptor sensitivity and peripheral vascular resistance will be conducted at baseline, after treatment and 2-month follow up. In addition, circadian hemodynamic variations such as 24-hour heart rate variability, nocturnal blood pressure dipping and immunological biomarkers will be assessed. Eighty patients with Major Depression will be randomly assigned to either a CBT treatment condition (14 hour-long, weekly sessions) or a waitlist condition, to control for potential changes in hemodynamic parameters without any intervention and the impact of repeated-measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Behavioral: Cognitive behavioral therapyCognitive behavioral therapy for Major Depression |
| Waitlist group | No intervention | –Waitlist group to control for repeated physiological measures and fluctuations over time |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with Major Depression (DSM IV), BDI >=14
- age:18-65 years
- patients without antidepressive medication (stable for at least 2 weeks)
- comorbidity with other psychiatric disorders is permitted, as far as depressive symptoms are dominating
Key exclusion criteria (9 listed)
- current psychotherapy
- psychotic disorder
- serious drug-addiction
- drugs which seriously affect immune status (except contraceptives) or central
- nervous system functions (except antidepressants)
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 |
|---|---|---|
| Cognitive behavioral therapy | Behavioural | Cognitive behavioral therapy |
Primary outcome
Change in depressive symptoms (BDI-II)
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
8 secondary outcomes
Change in heart rate variability
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in blood pressure
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in baroreceptor sensitivity (ms/mmHg)
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in peripheral vascular resistance (dyne*s/cm5)
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in C-reactive protein
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in proinflammatory cytokines
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in anti-inflammatory interleukin-10
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
Change in Subjective social status (MacArthur scale)
Time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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 28 Jul 2021.
- 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.
Frank Euteneuer, PhD principal investigator
Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in people with Depression, run by Philipps University Marburg at 1 site in Germany.
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 4 inclusion and 9 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 28 Jul 2021. 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 Germany. 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 depressive symptoms (BDI-II) (time frame: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up). It is what the study was designed to measure, not a finding.
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 28 Jul 2021.