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Learning Oriented Physiotherapy - a New Approach (LOF)

Primary Purpose

Agitation, Anxiety, Dizziness

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Learning Oriented Physiotherapy
Widely Recognized Psychiatric Treatment
Sponsored by
Helse Nord-Trøndelag HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitation focused on measuring Ownership of body, Bodily and mental balance, Learning, Body image, Sensations, Expectations

Eligibility Criteria

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

The study population will be recruited among patients referred to three Norwegian psychiatric outpatient clinics for anxiety-like conditions. The same criteria for inclusion and exclusion will be applied for the experimental and active comparator group.

Inclusion Criteria:

Participants should be

  • 18 years or older
  • able to read, write and speak Norwegian
  • understand the project information and consent

Exclusion Criteria:

Participants should not

  • have ongoing substance abuse or addiction.
  • be psychotic.

Sites / Locations

  • Regional Psychiatric Centre Aust-Agder
  • Psychiatric Clinic
  • Psychiatric Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Learning oriented physiotherapy

Widely Recognized Psychiatric Treatment

Arm Description

Learning oriented physiotherapy is a treatment approach based on knowledge from neuroscience and particularly aimed to curb physical symptoms and ailments, but also to regain a sense of better physical balance and mental control. Therapy sessions are normally given every 2 weeks with individual homework lessons between. The therapy will last between 6 to 12 months depending on learning process and individual needs.

Standard Outpatient Treatment within the Psychiatric clinic

Outcomes

Primary Outcome Measures

Changes in Health Related Quality of Life (HRoQL)
In this study HRoQL will be measured by the validated EQ5D questionnaire

Secondary Outcome Measures

Changes in Levels of Anxiety and Depression
Hospital Anxiety and Depression Scale (HAD) will be used as instrument to assess levels and changes in anxiety and depression over time .

Full Information

First Posted
July 14, 2014
Last Updated
January 26, 2018
Sponsor
Helse Nord-Trøndelag HF
Collaborators
Health North Trøndelag, Health Møre and Romsdal, South Coast Hospital Hf Dps Aust-Agder Units Arendal
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1. Study Identification

Unique Protocol Identification Number
NCT02194036
Brief Title
Learning Oriented Physiotherapy - a New Approach
Acronym
LOF
Official Title
The Effect of Learning Oriented Physiotherapy on Health-Related Functioning and Quality of Life in Patients With Various Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Nord-Trøndelag HF
Collaborators
Health North Trøndelag, Health Møre and Romsdal, South Coast Hospital Hf Dps Aust-Agder Units Arendal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Outpatients that suffer from different anxiety disorders may have physical ailments that negatively affect daily life functioning and quality of life. LOF is a physical therapy approach focusing on the link between bodily and mental balance and through defined, but simple movements, patients are expected to learn how to cope and reduce health complaints. This study aims to investigate the short- and longterm effect of LOF compared to other standardized psychiatric treatments given in the clinic on levels of anxiety and depression, health related function and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation, Anxiety, Dizziness, Pain, Numbness, Depression, Fatigue, Sleep Disturbances
Keywords
Ownership of body, Bodily and mental balance, Learning, Body image, Sensations, Expectations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Learning oriented physiotherapy
Arm Type
Experimental
Arm Description
Learning oriented physiotherapy is a treatment approach based on knowledge from neuroscience and particularly aimed to curb physical symptoms and ailments, but also to regain a sense of better physical balance and mental control. Therapy sessions are normally given every 2 weeks with individual homework lessons between. The therapy will last between 6 to 12 months depending on learning process and individual needs.
Arm Title
Widely Recognized Psychiatric Treatment
Arm Type
Active Comparator
Arm Description
Standard Outpatient Treatment within the Psychiatric clinic
Intervention Type
Behavioral
Intervention Name(s)
Learning Oriented Physiotherapy
Other Intervention Name(s)
LOF
Intervention Description
Clinical practice based on a new understanding of the neurobiological basis for the interaction between body and mind, the foundation of learning and what is needed to bring about change of behavior.
Intervention Type
Behavioral
Intervention Name(s)
Widely Recognized Psychiatric Treatment
Other Intervention Name(s)
CBT, Speech Therapy
Intervention Description
Standard recognized psychiatric treatment tailored to individual needs.
Primary Outcome Measure Information:
Title
Changes in Health Related Quality of Life (HRoQL)
Description
In this study HRoQL will be measured by the validated EQ5D questionnaire
Time Frame
From baseline to 6, 12 and 18 months of follow-up
Secondary Outcome Measure Information:
Title
Changes in Levels of Anxiety and Depression
Description
Hospital Anxiety and Depression Scale (HAD) will be used as instrument to assess levels and changes in anxiety and depression over time .
Time Frame
From baseline to 6, 12 and 18 months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The study population will be recruited among patients referred to three Norwegian psychiatric outpatient clinics for anxiety-like conditions. The same criteria for inclusion and exclusion will be applied for the experimental and active comparator group. Inclusion Criteria: Participants should be 18 years or older able to read, write and speak Norwegian understand the project information and consent Exclusion Criteria: Participants should not have ongoing substance abuse or addiction. be psychotic.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars-Petter Granan, phD
Organizational Affiliation
Oslo University Hospital, Department of Pain Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Regional Psychiatric Centre Aust-Agder
City
Arendal
State/Province
Aust-Agder
Country
Norway
Facility Name
Psychiatric Clinic
City
Molde
State/Province
Møre And Romsdal
ZIP/Postal Code
7401
Country
Norway
Facility Name
Psychiatric Clinic
City
Levanger
State/Province
North Trøndelag
ZIP/Postal Code
7601
Country
Norway

12. IPD Sharing Statement

Citations:
Citation
Britt Fadnes, Kirsti Leira and Per Brodal. Learning-oriented physiotherapy. Theory and practice. University Press, 2013.
Results Reference
background
Links:
URL
http://www.balansekoden.no
Description
A website with information about the learning-oriented therapy as a new approach, based on new knowledge in neuroscience

Learn more about this trial

Learning Oriented Physiotherapy - a New Approach

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