NCT03528278

Brief Summary

The current research project aims at investigating whether it is possible to obtain an increase in physical activity among inpatients with schizophrenia spectrum disorders by the use of motivational interviewing and environmental interventions, and whether interventions will be associated with an increase in physical fitness and/or improvement in mental health. The Norwegian health care system operates with a catchment-area based organization, which make high levels of representability of patients possible. Patients will be recruited from intermediate-long term inpatient departments where patients typically have schizophrenia spectrum disorders and are admitted for longer periods. There are thus unique possibilities for coordinated efforts to motivate for and change dysfunctional habits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2015

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

2.1 years

First QC Date

April 24, 2018

Last Update Submit

May 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Level of Physical Activity at 6 months

    Level of physical activity is assessed by the product of the answers to the questions of frequency (range1-5), intensity (range 1-3) and duration (range 1-4) of physical activity in the Health Survey of Northern Trondelag (HUNT) questionnaire, creating a physical activity index (PA-index). A higher score indicates higher levels of activity. Total range for the PA-index is 3-60.

    At baseline and at 6 months follow-up

Secondary Outcomes (20)

  • Change from Baseline Level of Self-esteem at 6 months

    At baseline and at 6 months follow-up

  • Change from Baseline Level of Motivation at 6 months

    At baseline and at 6 months follow-up

  • Change from Baseline BMI at 6 months

    At baseline and at 6 months follow-up

  • Change from Baseline Life Satisfaction at 6 months

    At baseline and at 6 months follow-up

  • Change from Baseline Level of Psychotic Symptoms at 6 months

    At baseline and at 6 months follow-up

  • +15 more secondary outcomes

Interventions

* Revision of ward routines towards facilitating physical activity in patients and motivational work by staff * Education of staff with certified MI-expert organized as an intensive course and follow-up guidance. The first course held shortly before start of interventions, the rest arranged within a month * Training equipment * Motivational Interviewing (MI) techniques applied by staff * Weekly treatment plans including physical activity which may consist of any continuous physical exercise.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients at closed-door wards at the psychiatric departments at Gaustad and Dikemark of the Oslo University Hospital and at the Skjelfoss Psychiatric center in Hobøl.

You may qualify if:

  • Inpatients at the psychiatric departments of Oslo University Hospital or at the Skjelfoss Psychiatric center
  • DSM-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified (NOS), bipolar I disorder or bipolar disorder NOS and/or current use of antipsychotic medication
  • Informed consent to participation

You may not qualify if:

  • Pronounced cognitive deficit (IQ \< 70)
  • Severe brain damage
  • BMI\<17.5
  • Inability to speak Scandinavian or English
  • Inability to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Skjelfoss Psychiatric Centre

Hobøl, 1827, Norway

Location

Oslo University Hospital

Oslo, 0450, Norway

Location

Related Publications (1)

  • Ringen PA, Falk RS, Antonsen B, Faerden A, Mamen A, Rognli EB, Solberg DK, Martinsen EW, Andreassen OA. Using motivational techniques to reduce cardiometabolic risk factors in long term psychiatric inpatients: a naturalistic interventional study. BMC Psychiatry. 2018 Aug 15;18(1):255. doi: 10.1186/s12888-018-1832-6.

MeSH Terms

Conditions

SchizophreniaBipolar Disorder

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Petter Andreas Ringen, MD, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Consultant

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 17, 2018

Study Start

January 23, 2013

Primary Completion

March 10, 2015

Study Completion

March 10, 2015

Last Updated

May 17, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Currently no IPD sharing plan

Locations