NCT02349880

Brief Summary

"Shared decision-making" is being promoted as a promising approach for engaging patients with schizophrenia in medical decisions and improving satisfaction and adherence. To implement shared decision-making, both physicians and patients should commit to it and engage in a mutual decision process. Most research, however, has addressed interventions that either focus on the doctors' side (e.g. "communication skills") or on informing patients about treatment options (e.g. "decision aids"). These approaches have been shown to be feasible in clinical practice but had no strong effects on treatment patterns or adherence, possibly because they were insufficient to motivate and enable patients to engage actively in decision-making. Moreover, these interventions still rely on the doctor's willingness to share decisions, which has been shown to vary considerably. To overcome these limitations and since many patients do not feel competent to participate in decision-making we developed an intervention that focuses on patients' communicative competencies. this intervention, a five session group-training, will be implemented for inpatients suffering from schizophrenia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
264

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable schizophrenia

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

October 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

3.2 years

First QC Date

January 23, 2015

Last Update Submit

April 24, 2018

Conditions

SchizophreniaSchizo-affective Disorder

Outcome Measures

Primary Outcomes (1)

  • adherence to antipsychotic medication

    12 months

Study Arms (2)

control

ACTIVE COMPARATOR

5 hour cognitive training

Behavioral: shared decision making training

intervention

EXPERIMENTAL

5 hour shared decision making training

Behavioral: shared decision making training

Interventions

shared decision making trainingBEHAVIORAL
controlintervention

Eligibility Criteria

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

You may qualify if:

  • age 18-65
  • icd diagnosis F2
  • sufficient German language skills

You may not qualify if:

  • debility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 23, 2015

First Posted

January 29, 2015

Study Start

October 1, 2011

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

April 25, 2018

Record last verified: 2018-04