Exercise for Depression in Young People (HEALTH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01474837|
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : January 17, 2014
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 or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Intervention: Exercise and motivational interviewing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The H.E.A.L.T.H. Project: Help Enabling Active Lifestyles Toward Health in Young People With Depression.|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||November 2013|
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
- change in Children Depression Inventory score [ Time Frame: Baseline, Post-intervention (at 12 weeks), six months follow-up ]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.
- change in Eq-5D score [ Time Frame: Baseline, post-intervention (6 weeks), six months follow-up ]Measure of quality of life
- Client Services Receipt Inventory [ Time Frame: Post intervention (6 weeks) ]Measure of health and social costs associate
- Compliance with exercise [ Time Frame: post-intervention (6 weeks) ]Number of sessions of exercise attended
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474837
|University of Nottingham, School of Nursing, Midwifery & Physiotherapy|
|Nottingham, United Kingdom, NG7 2HA|
|Principal Investigator:||patrick Callaghan||University of Nottingham|