NCT01474837

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P25-P50 for not_applicable depression

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 16, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

2.1 years

First QC Date

March 16, 2011

Last Update Submit

January 16, 2014

Conditions

Keywords

depressive disordersexercise therapy

Outcome Measures

Primary Outcomes (1)

  • change in Children Depression Inventory score

    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.

    Baseline, Post-intervention (at 12 weeks), six months follow-up

Secondary Outcomes (3)

  • change in Eq-5D score

    Baseline, post-intervention (6 weeks), six months follow-up

  • Client Services Receipt Inventory

    Post intervention (6 weeks)

  • Compliance with exercise

    post-intervention (6 weeks)

Study Arms (2)

Exercise with motivational interviewing

EXPERIMENTAL

Young people with depression exposed to exercise with motivational interviewing

Behavioral: Intervention: Exercise and motivational interviewing

Treatment as usual

NO INTERVENTION

Young people with depression receiving treatment as usual

Interventions

12 sessions of exercise with MI

Also known as: Exercise arm
Exercise with motivational interviewing

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham, School of Nursing, Midwifery & Physiotherapy

Nottingham, NG7 2HA, United Kingdom

Location

Related Publications (3)

  • Turner D, Carter T, Sach T, Guo B, Callaghan P. Cost-effectiveness of a preferred intensity exercise programme for young people with depression compared with treatment as usual: an economic evaluation alongside a clinical trial in the UK. BMJ Open. 2017 Nov 26;7(11):e016211. doi: 10.1136/bmjopen-2017-016211.

  • Carter T, Guo B, Turner D, Morres I, Khalil E, Brighton E, Armstrong M, Callaghan P. Preferred intensity exercise for adolescents receiving treatment for depression: a pragmatic randomised controlled trial. BMC Psychiatry. 2015 Oct 14;15:247. doi: 10.1186/s12888-015-0638-z.

  • Carter T, Callaghan P, Khalil E, Morres I. The effectiveness of a preferred intensity exercise programme on the mental health outcomes of young people with depression: a sequential mixed methods evaluation. BMC Public Health. 2012 Mar 13;12:187. doi: 10.1186/1471-2458-12-187.

MeSH Terms

Conditions

DepressionDepressive Disorder

Interventions

Motivational InterviewingExercise Test

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • patrick Callaghan

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2011

First Posted

November 18, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2013

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations