BRIA - Bridging Intervention in Anesthesiology

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01357694
First received: May 18, 2011
Last updated: July 18, 2014
Last verified: July 2014

May 18, 2011
July 18, 2014
May 2011
February 2013   (final data collection date for primary outcome measure)
participation in psychosocial therapy [ Time Frame: six months after baseline assessment ] [ Designated as safety issue: No ]
rate of patients who participate in succeeding outpatient or inpatient psychosocial treatment (psychotherapy, addiction therapy)
Same as current
Complete list of historical versions of study NCT01357694 on ClinicalTrials.gov Archive Site
psychiatric distress [ Time Frame: 6 months after baseline assessment ] [ Designated as safety issue: No ]
psychiatric distress [ Time Frame: 6 months after baseline assessment ] [ Designated as safety issue: No ]
GSI score of the Brief Symptom Inventory
Not Provided
Not Provided
 
BRIA - Bridging Intervention in Anesthesiology
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.

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 (appr. 5000 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Psychiatric or Mood Diseases or Conditions
Behavioral: psychotherapeutic contacts
psychotherapeutic contacts during inpatient hospital stay and up to 3 months outpatient appointments after discharge
  • Experimental: psychotherapeutic contacts
    Intervention: Behavioral: psychotherapeutic contacts
  • No Intervention: control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
220
December 2014
February 2013   (final data collection date for primary outcome measure)

Inclusion and exclusion criteria for participating at the preoperative computer-assisted self assessment were defined as follows:

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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
  • 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:

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01357694
BRIA
No
Claudia Spies, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Study Director: Claudia D Spies, MD, Prof. Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Germany
Charite University, Berlin, Germany
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP