Exercise for Depression in Young People (HEALTH)

This study has been completed.
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01474837
First received: March 16, 2011
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

Exercise as an adjunct to routine treatment may be useful for helping young people recover from distressing mental health problems, but they seldom get sufficient support to help them to exercise. The reasons for this may be that services cannot agree on the benefits of exercise, and the lack of reliable evidence showing the benefits of exercise in young people who use mental health services. Compliance with prescribed exercise is generally low, but the investigators think that relatively few young people will drop out of our specially designed programme. The investigators have found that young 'healthy' people may respond better if exercise is matched to their ability. The investigators are not sure if this would work with young people with mental health difficulties, so the investigators want to test it. The investigators have also found that our enabling exercise plan, with social support and motivational coaching, helps people with depression to take part, and not to drop out. The aims of our study are to see if exercise matched to their ability, with support in taking part, helps young people recover from distressing mental health difficulties. The investigators also want to ask young people how they feel about exercise as a part of their recovery. The investigators want to see if motivational coaching can help ongoing participation in exercise, and the investigators want to follow up the young people after six months to see if they are still doing exercise. The investigators believe that this study is important because it will help young people feel better about themselves, and improve their quality of life. This is an important national public health goal and should enable young people to grow into healthy adults, and maintain their health throughout adulthood. If our study is successful, the investigators believe that it has the potential to change the way in which mental health services deliver care to young people. If the investigators can help young people feel better about themselves, and improve their general health and well being through exercise, the investigators may reduce their reliance on mental health services.

Research hypotheses A tailored exercise intervention will lead to significantly improved mental health outcomes and reduced exercise attrition rates in young people with depression.


Condition Intervention
Depression
Behavioral: Intervention: Exercise and motivational interviewing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The H.E.A.L.T.H. Project: Help Enabling Active Lifestyles Toward Health in Young People With Depression.

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • change in Children Depression Inventory score [ Time Frame: Baseline, Post-intervention (at 12 weeks), six months follow-up ] [ Designated as safety issue: No ]
    The CDI has 5 scales measuring negative mood, interpersonal difficulties, negative self-esteem, ineffectiveness and anhedonia. It is designed for 7-17 year olds, is sensitive to changes over the proposed timescale, quick to administer and yields an aggregate score indicating depressive illness and clinically significant depression.


Secondary Outcome Measures:
  • change in Eq-5D score [ Time Frame: Baseline, post-intervention (6 weeks), six months follow-up ] [ Designated as safety issue: No ]
    Measure of quality of life

  • Client Services Receipt Inventory [ Time Frame: Post intervention (6 weeks) ] [ Designated as safety issue: No ]
    Measure of health and social costs associate

  • Compliance with exercise [ Time Frame: post-intervention (6 weeks) ] [ Designated as safety issue: No ]
    Number of sessions of exercise attended


Enrollment: 86
Study Start Date: October 2011
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise with motivational interviewing
Young people with depression exposed to exercise with motivational interviewing
Behavioral: Intervention: Exercise and motivational interviewing
12 sessions of exercise with MI
Other Name: Exercise arm
No Intervention: Treatment as usual
Young people with depression receiving treatment as usual

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants whose initial presenting problem is identified as depression will be eligible for the study

Exclusion Criteria:

  • Young people, who at the time of the study, are unable to participate on account of any injury or physical health problem that precludes their participation, and those who are regular exercisers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474837

Locations
United Kingdom
University of Nottingham, School of Nursing, Midwifery & Physiotherapy
Nottingham, United Kingdom, NG7 2HA
Sponsors and Collaborators
University of Nottingham
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: patrick Callaghan University of Nottingham
  More Information

No publications provided by University of Nottingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01474837     History of Changes
Other Study ID Numbers: H.E.A.L.T.H
Study First Received: March 16, 2011
Last Updated: January 16, 2014
Health Authority: United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
depressive disorders
exercise therapy

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

ClinicalTrials.gov processed this record on July 24, 2014