Effectiveness of The Step Up Wellness Program for People With Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jennifer McClure, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00644995
First received: March 25, 2008
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

This study will evaluate the effectiveness of a mental and physical wellness program in improving mood, physical activity, and health behaviors of people with depression who also are physically inactive and smoke cigarettes.


Condition Intervention Phase
Depression
Behavioral: Step Up Wellness Program
Behavioral: Usual care
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Step Up Wellness Program for Depression, Physical Inactivity, and Smoking

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Depressive symptoms, physical activity, and smoking quit attempts [ Time Frame: Measured at Months 4 and 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking cessation, treatment participation, and satisfaction [ Time Frame: Measured at Months 4 and 6 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: November 2008
Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
Participants will receive usual care.
Behavioral: Usual care
Participants will receive usual care for depression for 3 months.
Experimental: II
Participants will receive the Step Up Wellness Program.
Behavioral: Step Up Wellness Program
Participants in the 3-month Step Up Wellness program will be invited to join a walking group that will meet three times per week for about 1 hour each session. Participants will also receive weekly 30- to 45-minute phone calls from a study health coach. During these calls, the coach will discuss ways to improve and manage mood, increase physical activity, and prepare to quit smoking.

Detailed Description:

Depression is a serious illness that affects a person's mood, thoughts, and physical well-being. People with depression often experience a constant feeling of tiredness, which makes it difficult for them to remain physically active or to carry out other health promoting behaviors. The benefits of exercise as a treatment for mental disorders has been long recognized. Although exercise may not cure a person's depression, the physical and psychological advantages of exercise may help in relieving the symptoms of depression. It is believed that exercise provides a distraction from the negative thoughts and anxiety of depression and provides an increase in self-esteem. It is also important for people with depression to stay physically active to prevent the development of more serious illnesses, such as diabetes and heart disease. The Step Up Wellness Program, a group mental and physical wellness program, may be an effective way of helping people with depression to exercise and thus, may alleviate their depressive symptoms. This study will evaluate the effectiveness of the Step Up Wellness Program in improving mood, physical activity, and health behaviors of people with depression who also are physically inactive and smoke cigarettes.

Participation in this study will last 6 months. All participants will first complete a baseline survey that will include questions about medical history, mood, smoking, alcohol consumption, and other health-related behaviors. Participants will then be assigned randomly to receive the Step Up Wellness Program or usual care for 3 months. Participants in the Step Up Wellness program will be invited to join a walking group that will meet three times per week for about 1 hour each session. Participants will also receive weekly 30- to 45-minute phone calls from a study health coach. During these calls, the coach will discuss ways to improve and manage mood, increase physical activity, and prepare to quit smoking. Participants will also be given program materials that they will be asked to review between calls. Participants in the usual care group will receive standard care for depression. All participants will repeat the baseline interview at Months 3 and 6 of follow-up. Participants in the Step Up Wellness Program will additionally be asked their opinions about the program during the Month 3 interview.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Member of Group Health insurance plan
  • Lives in Seattle area
  • Experiencing at least moderate depressive symptoms
  • Endorses low physical activity
  • Current smoker
  • Telephone accessibility
  • Reads and speaks English fluently
  • Without mobility or physical impairments that would prevent engaging in moderate physical activity
  • Without a hearing impairment that would prevent participation with the phone-based counseling or assessments
  • Medical clearance from Group Health primary care provider
  • Invitation to be screened for eligibility by the study personnel

Exclusion Criteria:

  • Suicidal thoughts
  • History of bipolar disorder or a psychotic disorder
  • Currently receiving specialty mental health care or smoking cessation treatment (some exceptions for antidepressant use allowed on the basis of symptomology and duration of medication use)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644995

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Investigators
Principal Investigator: Jennifer McClure, PhD Group Heatlh Research Institute
  More Information

Publications:
Responsible Party: Jennifer McClure, Principal Investigator, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00644995     History of Changes
Other Study ID Numbers: R34 MH080658, DAHBR 96-BHB
Study First Received: March 25, 2008
Last Updated: April 18, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Depression
Smoking
Physical Activity

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014