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LOF: Learning Oriented Physiotherapy - a New Approach

Sponsor
Helse Nord-Trøndelag HF (Other)
Overall Status
Completed
CT.gov ID
NCT02194036
Collaborator
Health North Trøndelag (Other), Health Møre and Romsdal (Other), South Coast Hospital Hf Dps Aust-Agder Units Arendal (Other)
81
Enrollment
3
Locations
2
Arms
37
Actual Duration (Months)
27
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Learning Oriented Physiotherapy
  • Behavioral: Widely Recognized Psychiatric Treatment
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effect of Learning Oriented Physiotherapy on Health-Related Functioning and Quality of Life in Patients With Various Anxiety Disorders
Actual Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Sep 1, 2017
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Learning oriented physiotherapy

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
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.
Other Names:
  • LOF

    		•
    Active Comparator: Widely Recognized Psychiatric Treatment

    Standard Outpatient Treatment within the Psychiatric clinic

    Behavioral: Widely Recognized Psychiatric Treatment
    Standard recognized psychiatric treatment tailored to individual needs.
    Other Names:
  • CBT
  • Speech Therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in Health Related Quality of Life (HRoQL) [From baseline to 6, 12 and 18 months of follow-up]

      In this study HRoQL will be measured by the validated EQ5D questionnaire

    Secondary Outcome Measures

    1. Changes in Levels of Anxiety and Depression [From baseline to 6, 12 and 18 months of follow-up]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regional Psychiatric Centre Aust-Agder Arendal Aust-Agder Norway
    2 Psychiatric Clinic Molde Møre And Romsdal Norway 7401
    3 Psychiatric Clinic Levanger North Trøndelag Norway 7601

    Sponsors and Collaborators

    • Helse Nord-Trøndelag HF
    • Health North Trøndelag
    • Health Møre and Romsdal
    • South Coast Hospital Hf Dps Aust-Agder Units Arendal

    Investigators

    • Study Director: Lars-Petter Granan, phD, Oslo University Hospital, Department of Pain Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Helse Nord-Trøndelag HF
    ClinicalTrials.gov Identifier:
    NCT02194036
    Other Study ID Numbers:
    • 2014/393 (REK)
    First Posted:
    Jul 18, 2014
    Last Update Posted:
    Jan 30, 2018
    Last Verified:
    Jan 1, 2018
    Keywords provided by Helse Nord-Trøndelag HF
    Ownership of body
    Bodily and mental balance
    Learning
    Body image
    Sensations
    Expectations
    Additional relevant MeSH terms:
    Dyssomnias
    Parasomnias
    Dizziness

    Study Results

    No Results Posted as of Jan 30, 2018