BRIA - Bridging Intervention in Anesthesiology - Full Text View

Purpose

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.

Condition	Intervention
Psychiatric or Mood Diseases or Conditions	Behavioral: psychotherapeutic contacts

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Open Monocentric Randomized Clinical Trial on the Efficacy of the Psychotherapeutic Bridging Intervention in Anesthesiology (BRIA)

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

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)

Secondary Outcome Measures:

psychiatric distress [ Time Frame: 6 months after baseline assessment ] [ Designated as safety issue: No ]

Estimated Enrollment:	220
Study Start Date:	May 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: psychotherapeutic contacts	Behavioral: psychotherapeutic contacts psychotherapeutic contacts during inpatient hospital stay and up to 3 months outpatient appointments after discharge
No Intervention: control group

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 (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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357694

Locations

Germany
Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Germany
Berlin, Germany, 10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Study Director:

Claudia D Spies, MD, Prof.

Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Germany

More Information

No publications provided

Responsible Party:	Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT01357694 History of Changes
Other Study ID Numbers:	BRIA
Study First Received:	May 18, 2011
Last Updated:	April 25, 2013
Health Authority:	Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:

psychotherapy
depression
anxiety
surgical patients

Additional relevant MeSH terms:

Anesthetics
Psychotropic Drugs
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013