BRIA - Bridging Intervention in Anesthesiology

Not Applicable

Completed

• Conditions: Psychiatric or Mood Diseases or Conditions
• Interventions: Behavioral: psychotherapeutic contacts

• Registration Number: NCT01357694
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-18
• Study First Submitted QC: 2011-05-19
• Study First Posted: 2011-05-23
• Primary Completion: 2013-02
• Study Completion: 2014-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-23
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
psychotherapeutic contacts	psychotherapeutic contacts	-

Primary Outcome Measures

Name	Time	Method
participation in psychosocial therapy	six months after baseline assessment	rate of patients who participate in succeeding outpatient or inpatient psychosocial treatment (psychotherapy, addiction therapy)

Secondary Outcome Measures

Name	Time	Method
psychiatric distress	6 months after baseline assessment

Trial Locations

Locations (1)

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