NCT01357694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

1.8 years

First QC Date

May 18, 2011

Last Update Submit

January 23, 2015

Conditions

Psychiatric or Mood Diseases or Conditions

Keywords

psychotherapydepressionanxietysurgical patients

Outcome Measures

Primary Outcomes (1)

  • participation in psychosocial therapy

    rate of patients who participate in succeeding outpatient or inpatient psychosocial treatment (psychotherapy, addiction therapy)

    six months after baseline assessment

Secondary Outcomes (1)

  • psychiatric distress

    6 months after baseline assessment

Study Arms (2)

psychotherapeutic contacts

EXPERIMENTAL
Behavioral: psychotherapeutic contacts

control group

NO INTERVENTION

Interventions

psychotherapeutic contactsBEHAVIORAL

psychotherapeutic contacts during inpatient hospital stay and up to 3 months outpatient appointments after discharge

psychotherapeutic contacts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.
  • 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.
  • 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.
  • Acute severe psychiatric condition (acute episode of psychotic disorder, severe substance use disorder including serious withdrawal symptoms)
  • severe acute suicidality
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (3)

  • 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.

    PMID: 33246438DERIVED

  • Krampe 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.

    PMID: 30105602DERIVED

  • Krampe 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.

    PMID: 29284443DERIVED

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Claudia D Spies, MD, Prof.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany

Study Record Dates

First Submitted

May 18, 2011

First Posted

May 23, 2011

Study Start

May 1, 2011

Primary Completion

February 1, 2013

Study Completion

September 1, 2014

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

DE(1)