NCT01573130

Brief Summary

The purpose of the study is to investigate the effects of an internet-administered, therapist-assisted physical exercise program for the treatment of depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Mar 2012

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

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

March 31, 2012

Last Update Submit

October 29, 2016

Conditions

Depression

Keywords

DepressionPhysical exerciseInternet

Outcome Measures

Primary Outcomes (10)

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    9-item depression rating scale.

    24 hours

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    9-item depression rating scale.

    6 months

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    9-item depression rating scale.

    Week 1 of treatment duration

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    9-item depression rating scale.

    Week 2 of treatment duration

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    9-item depression rating scale.

    Week 3 of treatment duration

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    9-item depression rating scale.

    Week 4 of treatment duration

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    9-item depression rating scale.

    Week 5 of treatment duration

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    9-item depression rating scale.

    Week 6 of treatment duration

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    9-item depression rating scale.

    Week 7 of treatment duration

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    9-item depression rating scale.

    Week 8 of treatment duration

Secondary Outcomes (10)

  • Change from baseline in Beck Depression Inventory (BDI)

    24 hours

  • Change from baseline in Beck Depression Inventory (BDI)

    6 months

  • Change from baseline in Beck Anxiety Inventory (BAI)

    24 hours

  • Change from baseline in Beck Anxiety Inventory (BAI)

    6 months

  • Change from baseline in Quality Of Life Inventory (QOLI)

    24 hours

  • +5 more secondary outcomes

Study Arms (2)

Initial treatment group

EXPERIMENTAL

Group receives treatment.

Behavioral: Physical exercise program

Waiting list control group

NO INTERVENTION

The waiting list control group receives treatment after 9 weeks, before which they do weekly ratings.

Interventions

Physical exercise programBEHAVIORAL

An individualized physical exercise program, administered per internet. Some therapist-support will also be included.

Initial treatment group

Eligibility Criteria

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

You may qualify if:

  • Satisfy DSM-IV criteria for depression
  • Living in Sweden and being able to read Swedish
  • Access to computer with internet connection

You may not qualify if:

  • Currently receiving other psychological treatment
  • Non-stable use of psychoactive medication
  • Deemed to suffer from a too severe depression, or being suicidal
  • Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, Umeå University

Umeå, Västerbotten County, 90181, Sweden

Location

Related Publications (1)

  • Strom M, Uckelstam CJ, Andersson G, Hassmen P, Umefjord G, Carlbring P. Internet-delivered therapist-guided physical activity for mild to moderate depression: a randomized controlled trial. PeerJ. 2013 Oct 3;1:e178. doi: 10.7717/peerj.178. eCollection 2013.

    PMID: 24109561RESULT

MeSH Terms

Conditions

DepressionMotor Activity

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Per Carlbring, Professor

    Department of Psychology, Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2012

First Posted

April 6, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2013

Study Completion

October 1, 2013

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

SE(1)