NCT00967265

Brief Summary

Patient participation is a central concept in Norwegian health policy. It is mandatory in hospitals and emphasised as one of the most prioritised areas by the Government. Studies from Norway have repeatedly found that patients who seek help in community mental health centres ("DPS") are dissatisfied with the information they receive and about their possibility for real influence in their treatment. One way to improve individual patient participation might be to give patients information before they start their treatment. This can be done as group based patient education to reduce the resources needed. Furthermore, as there are waiting lists for treatment, such introduction seminars could be held while patients are waiting to use this time in a meaningful way. The present study therefore aims at testing the effect of an introduction seminar for patients on waiting list in a community mental health centre.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

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

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

August 26, 2009

Last Update Submit

August 31, 2018

Conditions

Keywords

Introduction seminarPsychoeducationWaiting listPatient participationMental disorders

Outcome Measures

Primary Outcomes (3)

  • Behavior and symptoms

    Behavior and Symptom Identification Scale (BASIS-32)

    12 months

  • knowledge on treatment preference

    1 month

  • patient activation (coping)

    measured with Patient Activation Measure (PAM)

    4 months

Secondary Outcomes (7)

  • Client satisfaction

    Baseline, 4 and 12 months

  • Perceived participation

    Baseline, 4 and 12 months

  • Psychiatric Out-Patient Experiences

    Baseline, 4 and 12 months

  • Quality of Life

    Baseline, 4 and 12 months

  • motivation for treatment

    Baseline, 1 and 4 months

  • +2 more secondary outcomes

Study Arms (2)

Introduction seminar

EXPERIMENTAL

Psychoeducation for patients on waiting list

Behavioral: Introduction seminar

Usual care

ACTIVE COMPARATOR

Usual care

Other: Usual care

Interventions

The seminar will be held over two half days, each lasting 2.5 hours. Up to 30 patients can participate in each seminar. The details of the content of the program will be developed based on study one. The preliminarily plans are to give general information about the community mental health centre, the available treatment options and patients rights by presentations from health personnel and user representatives. At the end of each day, the patients will be divided into small groups mentored by health personnel were they can discuss the presentations and ask questions. In the breaks, literature and other type of information for patients will be on display. All participants will get a folder with details of the program and leaflets from patient organisations and governmental agencies.

Also known as: psychoeducation
Introduction seminar

Usual care

Usual care

Eligibility Criteria

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

You may qualify if:

  • Patients older than 18 years referred for out patient treatment who get a guarantee of starting treatment between 2 and 6 months will be included.

You may not qualify if:

  • patients with a guarantee of starting treatment in less than two months and
  • patients who do not understand the consequences of taking part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tiller DPS

Trondheim, 7055, Norway

Location

Related Publications (1)

  • Koksvik JM, Linaker OM, Grawe RW, Bjorngaard JH, Lara-Cabrera ML. The effects of a pretreatment educational group programme on mental health treatment outcomes: a randomized controlled trial. BMC Health Serv Res. 2018 Aug 29;18(1):665. doi: 10.1186/s12913-018-3466-2.

MeSH Terms

Conditions

Mental DisordersPatient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Aslak Steinsbekk, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 27, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

July 1, 2012

Last Updated

September 5, 2018

Record last verified: 2018-08

Locations