NCT02194036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

3.1 years

First QC Date

July 14, 2014

Last Update Submit

January 26, 2018

Conditions

AgitationAnxietyDizzinessPainNumbnessDepressionFatigueSleep Disturbances

Keywords

Ownership of bodyBodily and mental balanceLearningBody imageSensationsExpectations

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes in Levels of Anxiety and Depression

    From baseline to 6, 12 and 18 months of follow-up

Study Arms (2)

Learning oriented physiotherapy

EXPERIMENTAL

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

Widely Recognized Psychiatric Treatment

ACTIVE COMPARATOR

Standard Outpatient Treatment within the Psychiatric clinic

Behavioral: Widely Recognized Psychiatric Treatment

Interventions

Learning Oriented PhysiotherapyBEHAVIORAL

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.

Also known as: LOF
Learning oriented physiotherapy
Widely Recognized Psychiatric TreatmentBEHAVIORAL

Standard recognized psychiatric treatment tailored to individual needs.

Also known as: CBT, Speech Therapy
Widely Recognized Psychiatric Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Participants should not
  • have ongoing substance abuse or addiction.
  • be psychotic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Regional Psychiatric Centre Aust-Agder

Arendal, Aust-Agder, Norway

Location

Psychiatric Clinic

Molde, Møre and Romsdal, 7401, Norway

Location

Psychiatric Clinic

Levanger, North Trøndelag, 7601, Norway

Location

Related Publications (1)

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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Psychomotor AgitationAnxiety DisordersDizzinessPainHypesthesiaDepressionFatigueParasomnias

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorMental DisordersSensation DisordersSomatosensory DisordersSleep Wake Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Lars-Petter Granan, phD

    Oslo University Hospital, Department of Pain Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 18, 2014

Study Start

August 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

NO(3)