NCT00184379

Brief Summary

The purpose of this study is to determine the effects of psychoeducation for relatives to patients with serious mental illness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2005

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

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

5.2 years

First QC Date

September 13, 2005

Last Update Submit

August 24, 2017

Conditions

Mental DisorderDepressive DisorderSchizophrenia

Keywords

FamilyCoping SkillsPsychoeducationStress, PsychologicalHealth Education

Outcome Measures

Primary Outcomes (4)

  • ECI (Experience of Caregiving Inventory) (Smuckler et al,1994)

    0-6 months

  • COOP/WONCA (Bowling, 1995)

    0-6 months

  • Selection of questions from COPE (Carver et al. 1989)

    0-6 months

  • Evaluation-questions

    0-6 months

Study Arms (4)

1 S+E

EXPERIMENTAL

Relatives of patients with schizophrenia, who receive education

Behavioral: Psychoeducation

2 S-E

NO INTERVENTION

Relatives of patients with schizophrenia, who do not receive education

3 B+E

EXPERIMENTAL

Relatives of patients with bipolar disorder, who receive education

Behavioral: Psychoeducation

4 B-E

NO INTERVENTION

Relatives of patients with bipolar disorder, who do not receive education

Interventions

PsychoeducationBEHAVIORAL

Structured disorder-related educational program for relatives

1 S+E3 B+E

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Relatives to patients having a psychotic or bipolar disorder
  • Good Norwegian language skills
  • Consent to participate
  • The patients' consent for their relatives to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Østmarka Psychiatric Department, St. Olavs Hospital, University Hospital of Trondheim

Trondheim, Norway

Location

Related Publications (1)

  • Moller T, Gudde CB, Folden GE, Linaker OM. The experience of caring in relatives to patients with serious mental illness: gender differences, health and functioning. Scand J Caring Sci. 2009 Mar;23(1):153-60. doi: 10.1111/j.1471-6712.2008.00605.x. Epub 2009 Jan 21.

    PMID: 19192243RESULT

MeSH Terms

Conditions

Mental DisordersDepressive DisorderSchizophreniaStress, PsychologicalHealth Education

Condition Hierarchy (Ancestors)

Mood DisordersSchizophrenia Spectrum and Other Psychotic DisordersBehavioral SymptomsBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Olav M Linaker, MD Prof

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

April 1, 2005

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

NO(1)