Learning Oriented Physiotherapy - a New Approach

Study Overview
=================
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.

Official Title
-----------------
The Effect of Learning Oriented Physiotherapy on Health-Related Functioning and Quality of Life in Patients With Various Anxiety Disorders

Conditions
-----------------
Agitation, Anxiety, Dizziness, Pain, Numbness, Depression, Fatigue, Sleep Disturbances

Intervention / Treatment
-----------------
* Behavioral: Learning Oriented Physiotherapy
* Behavioral: Widely Recognized Psychiatric Treatment


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Learning oriented physiotherapy<br>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. | Behavioral: Learning Oriented Physiotherapy<br>* 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.<br>* Other names: LOF;|
| Active Comparator: Widely Recognized Psychiatric Treatment<br>Standard Outpatient Treatment within the Psychiatric clinic | Behavioral: Widely Recognized Psychiatric Treatment<br>* Standard recognized psychiatric treatment tailored to individual needs.<br>* Other names: Speech Therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Health Related Quality of Life (HRoQL) | In this study HRoQL will be measured by the validated EQ5D questionnaire | From baseline to 6, 12 and 18 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | From baseline to 6, 12 and 18 months of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ownership of body, Bodily and mental balance, Learning, Body image, Sensations, Expectations