NCT01601587

Brief Summary

Patient participation (PP) in Hospital is a goal defined by the Norwegian Health Authorities and it is a mandatory activity for District Psychiatric out-patient Centres (DPC) in Norway: patients are entitled to have influence on their treatment and should receive sufficient information directed at empowerment. Nevertheless, studies from Norway have found that patients who seek help are dissatisfied with the information they receive and doubt their possibility for real influence on their treatment. One way to improve individual PP might be to give patients sufficient information and education before they start their treatment in the form of an educational group intervention, an introduction seminar (IS); this group intervention is less time and resource consuming than individual interventions. Aims: The main purpose of this project is to develop and evaluate an IS for patients on a waiting list of DPC. The seminar will educate patients, so they can actively participate in their own treatment and, thereby, choosing treatment, reducing the risk of dropping out of treatment. Another aim is to enable patients to participate in their own treatment, to cope with their problems while they are waiting for treatment by providing them contact with primary health care and user organizations during their waiting time, and to increase adherence. Methods: The project involves three components: an exploratory study of educational content of the seminar; RCT of that 4-hours program (to examine its effect on treatment preferences and choices, activation, satisfaction, mental health and cost-benefit) and then a post-seminar qualitative evaluation, which will be used to create a broad yet deep understanding of the practical side of the participants'experience and the seminar's effect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Typical duration 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, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

3.1 years

First QC Date

May 10, 2012

Last Update Submit

August 31, 2018

Conditions

Keywords

Introductory SeminarWaiting listCommunity Mental Health Centre

Outcome Measures

Primary Outcomes (4)

  • Selected Treatment

    one single question

    1 month

  • Health Care utilization

    Health care registration (adherence, attendance, consultations, dropout's rates and cost)

    1 year

  • Health Care utilization

    Health care registration (adherence, attendance, consultations, dropout's rates and cost)

    2 years

  • coping

    Patient Activation Measure (PAM-13)

    4 months

Secondary Outcomes (4)

  • Preferences for involvement in treatment decision making

    Baseline, 1, 4 and 12 months

  • Treatment Satisfaction

    Baseline, 1, 4, and 12 months

  • Quality of Life

    Baseline, 1, 4 and 12 months

  • Motivation

    Baseline, 1, 4 and 12 months

Study Arms (2)

Treatment as usual

NO INTERVENTION

Patients will receive treatment as usual

Introduction Seminar

OTHER

Psychoeducational group

Other: A psychoeducational group intervention.

Interventions

The intervention is an introduction seminar. It will be held over FOUR hours. Up to 15 patients can participate in each seminar. The content of the was developed based on study 1. The presentation about available treatment options and patient's rights are made by multi professional health personnel and user representatives. More specifically, this will be done under the following topics: 1. What is mental health? 2. Treatment options: orientation about individual and group based treatment modalities. 3. Former patients experience with their own treatment, self-help and participation. 4. How to influence and participate actively in the treatment and patient rights. 5. What can I do while I wait for treatment and where can I otherwise do to avoid aggravation?

Introduction Seminar

Eligibility Criteria

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

You may qualify if:

  • older than 18 years
  • referred for out-patient treatment
  • guarantee of starting treatment between 2 and 4 months

You may not qualify if:

  • guarantee of starting treatment in less than 2 months
  • Patients who do not understand the consequences of taking part of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tiller DPS

Trondheim, 7055, Norway

Location

Related Publications (1)

  • Lara-Cabrera ML, Salvesen O, Nesset MB, De las Cuevas C, Iversen VC, Grawe RW. The effect of a brief educational programme added to mental health treatment to improve patient activation: A randomized controlled trial in community mental health centres. Patient Educ Couns. 2016 May;99(5):760-8. doi: 10.1016/j.pec.2015.11.028. Epub 2015 Dec 2.

Study Officials

  • Olav Linaker, md phd

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 18, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 5, 2018

Record last verified: 2018-08

Locations