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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02194036
Other study ID # 2014/393 (REK)
Secondary ID
Status Completed
Phase N/A
First received July 14, 2014
Last updated January 26, 2018
Start date August 2014
Est. completion date September 1, 2017

Study information

Verified date January 2018
Source Central Norway Regional Health Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date September 1, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.
Widely Recognized Psychiatric Treatment
Standard recognized psychiatric treatment tailored to individual needs.

Locations

Country Name City State
Norway Regional Psychiatric Centre Aust-Agder Arendal Aust-Agder
Norway Psychiatric Clinic Levanger North Trøndelag
Norway Psychiatric Clinic Molde Møre And Romsdal

Sponsors (4)

Lead Sponsor Collaborator
Central Norway Regional Health Authority Health Møre and Romsdal, Health North Trøndelag, South Coast Hospital Hf Dps Aust-Agder Units Arendal

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Britt Fadnes, Kirsti Leira and Per Brodal. Learning-oriented physiotherapy. Theory and practice. University Press, 2013.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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