Affective DisordersISCIWNCT02752295
Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients
A study testing stress-coping week and additional two days follow-up weekend in people with Affective Disorders and Psychological Stress, run by Medical University of Vienna.
Trial summary
This study intents to determine who will benefit from an intensive brief stress coping intervention week (ISCIW) as secondary prevention for real world affective disorder patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Affective Disorders, Psychological Stress, Inflammation
- What is being tested?
- stress-coping week and additional two days follow-up weekend
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jul 2016
- 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
- Affective or anxiety disorder DSM-IV diagnosis (structured interview, M.I.N.I. International Neuropsychiatric Interview )
- Minimum 3-weeks previous therapeutic treatment as outpatient at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria
- Clinical Global Impression - Severity (CGI-S) score > 2 points
- Minimum improvement of 1 CGI-S points as outpatient
- Written informed consent
Who cannot join
- More than 60 days away sick per year in the last year before intervention
- Therapy adherence as outpatient at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria
- Work Ability Index (WAI) score < 25 points
- Major neurological or cognitive deficits
- Current psychotic symptoms
- Current or previous DSM-IV diagnosis of substance dependence, except for nicotine or current substance abuse
Show all 9Show fewer
- Failures to comply with the study protocol or to follow the instructions of the study team
- Currently requested application for retirement
- Middle to high suicidal tendency in the M.I.N.I.-examination
About this study
This study intents to determine who will benefit from an intensive brief stress coping intervention week (ISCIW) as secondary prevention for real world affective disorder patients.
Read the detailed description
Affective disorders are associated with a substantial personal and socio-economic burden. This study evaluates an intensive brief stress-coping intervention week (ISCIW) as feasible follow-up treatment for real world patients who suffer from this highly prevalent and chronic stress-related disorders. Stress-associated blood (Interleukin-6, Homocystein, Myeloperoxidase), saliva cortisol and psychosocial screening parameters will be analyzed to determine who will benefit from the ISCIW. All patients were identified in a preventive medical screening before pre-treatment for at least three month as outpatient and the following inclusion to the follow-up ISCIW-trial at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria. For the three planed groups and interventions see interventions and arms.
- Conditions
- Affective Disorders, Psychological Stress, Inflammation, Oxidative Stress, Anxiety Disorders, Mood Disorders
- Being tested
- stress-coping week, additional two days follow-up weekend
- Medical subject headings
- Mood Disorders, Stress, Psychological, Inflammation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress-coping weekBehavioural
The multidisciplinary team will offer Mindfulness-Based Stress Reduction (MBSR), group psychotherapy (resilience, Cognitive Behavioral Analysis System of Psychotherapy CBASP, psychodynamic therapy), relaxation training, nutrition course, stress-coping and physical training in a group setting.
additional two days follow-up weekendBehavioural
A two-days follow-up which recapitulates previous treatment elements.
| Study group | Role | What they receive |
|---|---|---|
| Waiting list, intervention after EOS | No intervention | control group / waiting list one week stress-coping intervention planned after end of study (EOS) without one week stress-coping intervention AND without an additional two days follow-up care |
| Stress-coping week without follow-up | Active comparator | active comparator with one week stress-coping intervention BUT without an additional two days follow-up weekend Receives: Behavioral: stress-coping week |
| Stress-coping week with follow-up | Active comparator | active comparator with one week stress-coping intervention AND with an additional two days follow-up weekend Receives: Behavioral: stress-coping week; Behavioral: additional two days follow-up weekend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of saliva cortisol
Measured: Change from baseline saliva sample at week 1 to end of study visit at week 38
Secondary outcomes (4)
Change of myeloperoxidase
Measured: Change from baseline at week 1 to end of study visit at week 38
Change of interleukin-6
Measured: Change from baseline at week 1 to end of study visit at week 38
Change of homocystein
Measured: Change from baseline at week 1 to end of study visit at week 38
Change of psychometric stress-index (Questionnaire)
Measured: Change from baseline at week 1 to end of study visit at week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startMay 2015
- Primary completionJul 2016
- Study completionJul 2016
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 Affective DisordersStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Sanatorium Hera Vienna
- Responsible party
- Principal investigator, Robert Winker, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752295
- Sponsor's protocol ID
- ISCIW trial
- Acronym
- ISCIW
- Status last verified
- Sep 2016
- First submitted
- 7 Apr 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pilger A, Haslacher H, Ponocny-Seliger E, Perkmann T, Bohm K, Budinsky A, Girard A, Klien K, Jordakieva G, Pezawas L, Wagner O, Godnic-Cvar J, Winker R. Affective and inflammatory responses among orchestra musicians in performance situation. Brain Behav Immun. 2014 Mar;37:23-9. doi: 10.1016/j.bbi.2013.10.018. Epub 2013 Oct 26.
PubMed 24513877
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients
- ClinicalTrials.gov ID
- NCT02752295
- Acronym / sponsor ID
- ISCIW / ISCIW trial
- Conditions
- Affective Disorders, Psychological Stress, Inflammation, Oxidative Stress, Anxiety Disorders, Mood Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Sanatorium Hera Vienna
- Study start
- May 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Apr 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.
This study intents to determine who will benefit from an intensive brief stress coping intervention week (ISCIW) as secondary prevention for real world affective disorder patients.
Detailed description
Affective disorders are associated with a substantial personal and socio-economic burden. This study evaluates an intensive brief stress-coping intervention week (ISCIW) as feasible follow-up treatment for real world patients who suffer from this highly prevalent and chronic stress-related disorders. Stress-associated blood (Interleukin-6, Homocystein, Myeloperoxidase), saliva cortisol and psychosocial screening parameters will be analyzed to determine who will benefit from the ISCIW. All patients were identified in a preventive medical screening before pre-treatment for at least three month as outpatient and the following inclusion to the follow-up ISCIW-trial at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria. For the three planed groups and interventions see interventions and arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Waiting list, intervention after EOS | No intervention | –control group / waiting list one week stress-coping intervention planned after end of study (EOS) without one week stress-coping intervention AND without an additional two days follow-up care |
| Stress-coping week without follow-up | Active comparator | Behavioral: stress-coping weekactive comparator with one week stress-coping intervention BUT without an additional two days follow-up weekend |
| Stress-coping week with follow-up | Active comparator | Behavioral: stress-coping week, Behavioral: additional two days follow-up weekendactive comparator with one week stress-coping intervention AND with an additional two days follow-up weekend |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Affective or anxiety disorder DSM-IV diagnosis (structured interview, M.I.N.I. International Neuropsychiatric Interview )
- Minimum 3-weeks previous therapeutic treatment as outpatient at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria
- Clinical Global Impression - Severity (CGI-S) score > 2 points
- Minimum improvement of 1 CGI-S points as outpatient
- Written informed consent
Key exclusion criteria (9 listed)
- More than 60 days away sick per year in the last year before intervention
- Therapy adherence as outpatient at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria
- Work Ability Index (WAI) score < 25 points
- Major neurological or cognitive deficits
- Current psychotic symptoms
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 |
|---|---|---|
| stress-coping weekThe multidisciplinary team will offer Mindfulness-Based Stress Reduction (MBSR), group psychotherapy (resilience, Cognitive Behavioral Analysis System of Psychotherapy CBASP, psychodynamic therapy), relaxation training, nutrition course, stress-coping and physical training in a group setting. | Behavioural | Stress-coping week with follow-up, Stress-coping week without follow-up |
| additional two days follow-up weekendA two-days follow-up which recapitulates previous treatment elements. | Behavioural | Stress-coping week with follow-up |
Primary outcome
Change of saliva cortisol
Time frame: Change from baseline saliva sample at week 1 to end of study visit at week 38
4 secondary outcomes
Change of myeloperoxidase
Time frame: Change from baseline at week 1 to end of study visit at week 38
Change of interleukin-6
Time frame: Change from baseline at week 1 to end of study visit at week 38
Change of homocystein
Time frame: Change from baseline at week 1 to end of study visit at week 38
Change of psychometric stress-index (Questionnaire)
Time frame: Change from baseline at week 1 to end of study visit at week 38
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 16 Sep 2016.
- Background: PubMed 24513877Pilger A, Haslacher H, Ponocny-Seliger E, Perkmann T, Bohm K, Budinsky A, Girard A, Klien K, Jordakieva G, Pezawas L, Wagner O, Godnic-Cvar J, Winker R. Affective and inflammatory responses among orchestra musicians in performance situation. Brain Behav Immun. 2014 Mar;37:23-9. doi: 10.1016/j.bbi.2013.10.018. Epub 2013 Oct 26.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing stress-coping week and additional two days follow-up weekend in people with Affective Disorders and Psychological Stress, run by Medical University of Vienna.
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 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 16 Sep 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?
Change of saliva cortisol (time frame: Change from baseline saliva sample at week 1 to end of study visit at week 38). 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 NCT02752295, 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 16 Sep 2016.