Psychiatric or Mood Diseases or ConditionsBRIANCT01357694
BRIA - Bridging Intervention in Anesthesiology
A study testing psychotherapeutic contacts in people with Psychiatric or Mood Diseases or Conditions, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The major purpose of this study is to determine whether psychotherapeutic contacts for surgical patients with psychological distress are an effective treatment during the postoperative period to improve the rate of treatment participation in subsequent psychosocial treatment programs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric or Mood Diseases or Conditions
- What is being tested?
- psychotherapeutic contacts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Sep 2014
- 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
- Written informed consent to participate in the first part of study after having been properly instructed
- patient of the preoperative anesthesiological assessment clinic
- age ≥18 years.
- Written informed consent to participate in the RCT after having been properly instructed
- acute significant psychiatric distress (scoring above of at least one of the cut-off values of WHO-5, PHQ-2, GAD-2, HADS-D, HADS-A, AUDIT) and/or being tobacco smoker, and/or having consumed illicit drugs during the last 12 months.
Who cannot join
- Surgery with an emergency or urgent indication
- inability to attend the preoperative assessment clinic (bedside visit)
- insufficient knowledge of German language
- members of the hospital staff
- admitted in police custody
- accommodation in an institution by official or court order
Show all 13Show fewer
- being under guardianship
- psychiatric, neurological or other condition associated with limited legal capability or limited capability of being properly instructed or giving informed consent.
- Additional inclusion and exclusion criteria of the RCT (Enrollment: 220 patients) were defined as follows:
- Acute severe psychiatric condition (acute episode of psychotic disorder, severe substance use disorder including serious withdrawal symptoms)
- severe acute suicidality
- homelessness
- participation in a psychopharmacological clinical trial at baseline assessment or 1 month before, respectively.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Germany
Berlin, State of Berlin, 10117
About this study
Official title: Open Monocentric Randomized Clinical Trial on the Efficacy of the Psychotherapeutic Bridging Intervention in Anesthesiology (BRIA)
The major purpose of this study is to determine whether psychotherapeutic contacts for surgical patients with psychological distress are an effective treatment during the postoperative period to improve the rate of treatment participation in subsequent psychosocial treatment programs.
Read the detailed description
The primary objective of this study is to investigate the efficacy of psychotherapeutic contacts that aim at motivating and supporting surgical patients with psychiatric disorders in participating in subsequent psychosocial treatment options like psycho- and addiction therapy (RCT). The secondary objective is to investigate whether preoperatively assessed psychosocial factors are associated with surgical outcomes (preoperative computer-assisted self assessment).
The Bridging Intervention in Anesthesiology (BRIA) has been designed as a feasible treatment option to reach patients from all surgical fields. Implemented in the preoperative anesthesiological assessment clinic this therapy program comprises two major elements: (1) A computer assisted self assessment of social, lifestyle and psychological factors including a comprehensive battery of psychiatric screening tests; (2) Psychotherapeutic contacts with the objective to motivate patients with psychiatric disorders and support them in participating in subsequent psychosocial treatment programs. The self assessment will be offered to all adult surgical patients of the preoperative anesthesiological assessment clinic during inclusion period (current 5104 patients). Data on surgical outcomes will be collected prospectively during a 6-month-follow-up, and regression analyses will be performed to determine the extent of associations between psychosocial factors and outcomes. Patients with clinically relevant psychological distress (i.e. scoring above the cut-off of one of applied standardized screening questionnaires) will be offered to participate in the RCT on the psychotherapy part of BRIA (220 patients). Data on primary and secondary outcomes will be collected 6 months and 24 months, respectively, after baseline assessment.
- Being tested
- psychotherapeutic contacts
- Keywords
- psychotherapy, depression, anxiety, surgical patients
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychotherapeutic contactsBehavioural
psychotherapeutic contacts during inpatient hospital stay and up to 3 months outpatient appointments after discharge
| Study group | Role | What they receive |
|---|---|---|
| psychotherapeutic contacts | Experimental | Not described Receives: Behavioral: psychotherapeutic contacts |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
participation in psychosocial therapy
rate of patients who participate in succeeding outpatient or inpatient psychosocial treatment (psychotherapy, addiction therapy)
Measured: six months after baseline assessment
Secondary outcomes (1)
psychiatric distress
Measured: 6 months after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychiatric or Mood Diseases or ConditionsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia D Spies, MD, Prof., Study director, Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357694
- Sponsor's protocol ID
- BRIA
- Acronym
- BRIA
- Status last verified
- Jan 2015
- First submitted
- 18 May 2011
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Krampe H, Goerling U, Spies CD, Gerhards SK, Enge S, Salz AL, Kerper LF, Schnell T. Sense of coherence, mental well-being and perceived preoperative hospital and surgery related stress in surgical patients with malignant, benign, and no neoplasms. BMC Psychiatry. 2020 Nov 27;20(1):567. doi: 10.1186/s12888-020-02953-x.
PubMed 33246438Krampe H, Barth-Zoubairi A, Schnell T, Salz AL, Kerper LF, Spies CD. Social Relationship Factors, Preoperative Depression, and Hospital Length of Stay in Surgical Patients. Int J Behav Med. 2018 Dec;25(6):658-668. doi: 10.1007/s12529-018-9738-8.
PubMed 30105602Krampe H, Salz AL, Kerper LF, Krannich A, Schnell T, Wernecke KD, Spies CD. Readiness to change and therapy outcomes of an innovative psychotherapy program for surgical patients: results from a randomized controlled trial. BMC Psychiatry. 2017 Dec 29;17(1):417. doi: 10.1186/s12888-017-1579-5.
PubMed 29284443
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Monocentric Randomized Clinical Trial on the Efficacy of the Psychotherapeutic Bridging Intervention in Anesthesiology (BRIA)
- ClinicalTrials.gov ID
- NCT01357694
- Acronym / sponsor ID
- BRIA / BRIA
- Keywords
- psychotherapy, depression, anxiety, surgical patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 May 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.
The major purpose of this study is to determine whether psychotherapeutic contacts for surgical patients with psychological distress are an effective treatment during the postoperative period to improve the rate of treatment participation in subsequent psychosocial treatment programs.
Detailed description
The primary objective of this study is to investigate the efficacy of psychotherapeutic contacts that aim at motivating and supporting surgical patients with psychiatric disorders in participating in subsequent psychosocial treatment options like psycho- and addiction therapy (RCT). The secondary objective is to investigate whether preoperatively assessed psychosocial factors are associated with surgical outcomes (preoperative computer-assisted self assessment).
The Bridging Intervention in Anesthesiology (BRIA) has been designed as a feasible treatment option to reach patients from all surgical fields. Implemented in the preoperative anesthesiological assessment clinic this therapy program comprises two major elements: (1) A computer assisted self assessment of social, lifestyle and psychological factors including a comprehensive battery of psychiatric screening tests; (2) Psychotherapeutic contacts with the objective to motivate patients with psychiatric disorders and support them in participating in subsequent psychosocial treatment programs. The self assessment will be offered to all adult surgical patients of the preoperative anesthesiological assessment clinic during inclusion period (current 5104 patients). Data on surgical outcomes will be collected prospectively during a 6-month-follow-up, and regression analyses will be performed to determine the extent of associations between psychosocial factors and outcomes. Patients with clinically relevant psychological distress (i.e. scoring above the cut-off of one of applied standardized screening questionnaires) will be offered to participate in the RCT on the psychotherapy part of BRIA (220 patients). Data on primary and secondary outcomes will be collected 6 months and 24 months, respectively, after baseline assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psychotherapeutic contacts | Experimental | Behavioral: psychotherapeutic contacts |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent to participate in the first part of study after having been properly instructed
- patient of the preoperative anesthesiological assessment clinic
- age ≥18 years.
- Written informed consent to participate in the RCT after having been properly instructed
- acute significant psychiatric distress (scoring above of at least one of the cut-off values of WHO-5, PHQ-2, GAD-2, HADS-D, HADS-A, AUDIT) and/or being tobacco smoker, and/or having consumed illicit drugs during the last 12 months.
Key exclusion criteria (13 listed)
- Surgery with an emergency or urgent indication
- inability to attend the preoperative assessment clinic (bedside visit)
- insufficient knowledge of German language
- members of the hospital staff
- admitted in police custody
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 |
|---|---|---|
| psychotherapeutic contactspsychotherapeutic contacts during inpatient hospital stay and up to 3 months outpatient appointments after discharge | Behavioural | psychotherapeutic contacts |
Primary outcome
participation in psychosocial therapy
Time frame: six months after baseline assessment
rate of patients who participate in succeeding outpatient or inpatient psychosocial treatment (psychotherapy, addiction therapy)
1 secondary outcome
psychiatric distress
Time frame: 6 months after baseline assessment
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 26 Jan 2015.
- Derived from this study: PubMed 33246438Krampe H, Goerling U, Spies CD, Gerhards SK, Enge S, Salz AL, Kerper LF, Schnell T. Sense of coherence, mental well-being and perceived preoperative hospital and surgery related stress in surgical patients with malignant, benign, and no neoplasms. BMC Psychiatry. 2020 Nov 27;20(1):567. doi: 10.1186/s12888-020-02953-x.
- Derived from this study: PubMed 30105602Krampe H, Barth-Zoubairi A, Schnell T, Salz AL, Kerper LF, Spies CD. Social Relationship Factors, Preoperative Depression, and Hospital Length of Stay in Surgical Patients. Int J Behav Med. 2018 Dec;25(6):658-668. doi: 10.1007/s12529-018-9738-8.
- Derived from this study: PubMed 29284443Krampe H, Salz AL, Kerper LF, Krannich A, Schnell T, Wernecke KD, Spies CD. Readiness to change and therapy outcomes of an innovative psychotherapy program for surgical patients: results from a randomized controlled trial. BMC Psychiatry. 2017 Dec 29;17(1):417. doi: 10.1186/s12888-017-1579-5.
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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.
Claudia D Spies, MD, Prof. study director
Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychotherapeutic contacts in people with Psychiatric or Mood Diseases or Conditions, run by Charite University, Berlin, Germany 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 5 inclusion and 13 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 26 Jan 2015. 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?
participation in psychosocial therapy (time frame: six months after baseline assessment). 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 NCT01357694, which also lists 3 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 26 Jan 2015.