NCT02549547

Brief Summary

The WHO, the Pan American Health Organization, the EU Council of Ministers, the World Federation of Mental Health, and the UK Royal College of Psychiatrists all agree -"there can be no health without mental health". Within Canada, 6.7M people live with a mental illness and when family and caregivers are included almost everyone is affected. A systematic review (2014) concluded that physical activity has a significant potential for reducing depressive symptoms in people with a mental illness. Globally, physical inactivity is "pandemic". Current guidelines recommend a minimum of only a 150 minutes a week of moderately vigorous exercise but 85% of Canadians do not meet the national recommendations. How then can people with depression be motivated to become physically more active? Group Medical Visits (GMVs) can be used to provide health services and they have proven effective in some settings, including mood disorders. As well as providing economic and resource efficiencies, the GMV model has the potential to add a 'support group/accountability' element for behavioural interventions such as physical activity promotion; such influence is not present in an individual patient-physician consultation. "Jump Step" is a 14-week program within a GMV setting designed to motivate and support people with depression to engage in regular physical activity. The investigators seek to design, implement, and evaluate the effectiveness of the Group Medical Visits focused on promoting physical activity for patients with depression.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

3 active sites

Status
unknown

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

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

September 1, 2015

Last Update Submit

September 14, 2015

Conditions

Keywords

anxietydepressionexercisegroupgroup medical visitmood disorderphysical activityprimary care

Outcome Measures

Primary Outcomes (1)

  • 'Jump Step Intervention Questionnaire'

    We will interview participants about physical activity levels, as well as their experience within the Jump Step intervention and its impact on their lives. We will also collect demographic data (age, gender, annual income, education level, self-identified disabilities, etc.)

    Post-Intervention (14 weeks)

Secondary Outcomes (10)

  • Physical Activity

    Baseline

  • Physical Activity

    Post-Intervention (14 weeks)

  • Patient Activation

    Baseline

  • Patient Activation

    Post-Intervention (14 weeks)

  • Anxiety

    Baseline

  • +5 more secondary outcomes

Other Outcomes (2)

  • 'Jump Step Facilitators Questionnaire'

    Baseline

  • 'Jump Step Facilitators Questionnaire'

    Post-Intervention (14 weeks)

Study Arms (1)

Lifestyle Intervention

EXPERIMENTAL

Physical Activity focused, interdisciplinary, Group Medical Visits (GMVs)

Behavioral: Group Medical Visits

Interventions

Cohorts will participate in a weekly series of 14 Group Medical Visits (GMVs) co-led by a psychiatrist and an exercise professional. Each two-hour Group Medical Visit will be divided into three sections: * Group check in/out; enter patients weekly step count into database; review and outline the day's group program - 20 minutes * Group discussion, regarding selected physical activity topics including psychiatric issues - 50 minutes * Physical activity component - 50 minutes The 'content' or curriculum of the GMVs will support participant Self-Management/Activation. Research has consistently emphasized the role of positive feedback, social support, reinforcement, goal setting, and motivation for improving person's self-perception to uptake physical activity.

Lifestyle Intervention

Eligibility Criteria

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

You may qualify if:

  • are adults (≥18yrs)
  • have a confirmed psychiatric assessment of Major Depressive Disorder (MDD) and/or Bipolar II, depressive
  • are of moderate or higher severity (PHQ-9 \>14)
  • are community-dwelling and able to attend Group Medical Visits in the Lower Mainland
  • are able to comply with scheduled visits, treatment plan, and other procedures;
  • read, write, and speak English with acceptable auditory and visual acuity
  • provide signed/dated informed consent; and
  • able to walk independently.

You may not qualify if:

  • Active psychotic symptoms
  • a primary active diagnosis of substance abuse.
  • Participants will need to have a working proficiency in English as group discussions, accompanying texts, and instructions will all be in English. To provide adequate translation services for these elements in one or more other languages is beyond our budget and may also influence the dynamics of the GMV. It could be considered in a future iteration of this research program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre for Hip Health & Mobility, Department of Family Practice

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Mood Disorders Association of BC

Vancouver, British Columbia, V6B 5J3, Canada

RECRUITING

Robert Lee YMCA

Vancouver, British Columbia, V6Z 1Y2, Canada

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, MajorBipolar DisorderAnxiety DisordersDepressionMotor ActivityMood Disorders

Condition Hierarchy (Ancestors)

Depressive DisorderMental DisordersBipolar and Related DisordersBehavioral SymptomsBehavior

Study Officials

  • Joanie Sims-Gould, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Adams, BA, BFA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 15, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2016

Study Completion

June 1, 2017

Last Updated

September 15, 2015

Record last verified: 2015-09

Locations