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Introduction Seminar About Patient Participation and Treatment Options for Psychiatric Patients on Waiting List

Primary Purpose

Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Introduction seminar
Usual care
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorders focused on measuring Introduction seminar, Psychoeducation, Waiting list, Patient participation, Mental disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Tiller DPS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Introduction seminar

Usual care

Arm Description

Psychoeducation for patients on waiting list

Usual care

Outcomes

Primary Outcome Measures

Behavior and symptoms
Behavior and Symptom Identification Scale (BASIS-32)
knowledge on treatment preference
patient activation (coping)
measured with Patient Activation Measure (PAM)

Secondary Outcome Measures

Client satisfaction
Satisfaction measured with Client Satisfaction Questionnaire (CSQ-8)
Perceived participation
Perceived participation measured with Perception of care (PoC)
Psychiatric Out-Patient Experiences
Psychiatric Out-Patient Experiences Questionnaire (POPEQ)
Quality of Life
WHO-5
motivation for treatment
motivation for treatment (questions)
costs
data on health care use, sick leave, medication and other direct and indirect costs will be collected
Knowledge
measured using a self developed questionnaire

Full Information

First Posted
August 26, 2009
Last Updated
August 31, 2018
Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF
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1. Study Identification

Unique Protocol Identification Number
NCT00967265
Brief Title
Introduction Seminar About Patient Participation and Treatment Options for Psychiatric Patients on Waiting List
Official Title
Introduction Seminar About Patient Participation and Treatment Options for Patients on Waiting List in a Community Mental Health Centre - Development, Effect, Experiences and Costs
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Introduction seminar, Psychoeducation, Waiting list, Patient participation, Mental disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Introduction seminar
Arm Type
Experimental
Arm Description
Psychoeducation for patients on waiting list
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Introduction seminar
Other Intervention Name(s)
psychoeducation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
Behavior and symptoms
Description
Behavior and Symptom Identification Scale (BASIS-32)
Time Frame
12 months
Title
knowledge on treatment preference
Time Frame
1 month
Title
patient activation (coping)
Description
measured with Patient Activation Measure (PAM)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Client satisfaction
Description
Satisfaction measured with Client Satisfaction Questionnaire (CSQ-8)
Time Frame
Baseline, 4 and 12 months
Title
Perceived participation
Description
Perceived participation measured with Perception of care (PoC)
Time Frame
Baseline, 4 and 12 months
Title
Psychiatric Out-Patient Experiences
Description
Psychiatric Out-Patient Experiences Questionnaire (POPEQ)
Time Frame
Baseline, 4 and 12 months
Title
Quality of Life
Description
WHO-5
Time Frame
Baseline, 4 and 12 months
Title
motivation for treatment
Description
motivation for treatment (questions)
Time Frame
Baseline, 1 and 4 months
Title
costs
Description
data on health care use, sick leave, medication and other direct and indirect costs will be collected
Time Frame
Baseline, 1, 4 and 12 months
Title
Knowledge
Description
measured using a self developed questionnaire
Time Frame
Baseline, 1, 4 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aslak Steinsbekk, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tiller DPS
City
Trondheim
ZIP/Postal Code
7055
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
30157839
Citation
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.
Results Reference
result

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Introduction Seminar About Patient Participation and Treatment Options for Psychiatric Patients on Waiting List

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