Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

March 3, 2020 updated by: Olof Johansson, Lund University
Depression treatments including physical activity and sleep management has been shown to relieve depressive symptoms among participants suffering depressive episodes. This study evaluates the potential of these methods as prevention of depressive relapse or recurrence

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne
      • Malmö, Skåne, Sweden, 21431
        • Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A history of at least one episode of Major Depression.
  • If medicating - Taking a stable (since one month) and therapeutic dosage of antidepressant medication
  • Being able to read and write Swedish
  • Having access to the internet

Exclusion Criteria:

  • Fulfilling the criteria for Major depression
  • Bipolar disorder
  • Psychosis
  • Substance abuse
  • Suicidality
  • Currently in psychotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapist-assisted iCBT
Internet-delivered cognitive behavioral therapy (iCBT), containing physical activity and sleep management for preventing depressive relapse. Monthly depression screening with therapist feedback.
Behavioral: Therapist-assisted iCBT
13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.
Behavioral: Monthly screening with feedback
Participants are screened with a depression inventory each month and receives feedback from a therapist on the results
Active Comparator: Monthly screening with feedback
Monthly depression screening with therapist feedback.
Behavioral: Monthly screening with feedback
Participants are screened with a depression inventory each month and receives feedback from a therapist on the results
No Intervention: Control
No intervention, follow-up along with all participants at 6 and 12-months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive relapse (change in diagnostic status, SCID-I)
Time Frame: Baseline - 12 months
Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated & Structured Clinical Interview for DSM IV
Baseline - 12 months
Change from baseline in depressive symptoms (MADRS-S)
Time Frame: Baseline - 6 months
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
Baseline - 6 months
Change from baseline in depressive symptoms (MADRS-S)
Time Frame: Baseline - 12 months
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
Baseline - 12 months
Change from baseline in depressive symptoms (MADRS-S)
Time Frame: Monthly, 0-12 months
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
Monthly, 0-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in health related quality of life (EQ-5D)
Time Frame: Baseline - 3 months
Health related quality of life will be measured by an internet based version of the EQ-5D.
Baseline - 3 months
Change from baseline in health related quality of life (EQ-5D)
Time Frame: Baseline - 6 months
Health related quality of life will be measured by an internet based version of the EQ-5D.
Baseline - 6 months
Change from baseline in health related quality of life (EQ-5D)
Time Frame: Baseline - 9 months
Health related quality of life will be measured by an internet based version of the EQ-5D.
Baseline - 9 months
Change from baseline in health related quality of life (EQ-5D)
Time Frame: Baseline - 12 months
Health related quality of life will be measured by an internet based version of the EQ-5D.
Baseline - 12 months
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Time Frame: Baseline - 3 months
The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time.
Baseline - 3 months
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Time Frame: Baseline - 6 months
The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time.
Baseline - 6 months
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Time Frame: Baseline - 9 months
The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time.
Baseline - 9 months
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Time Frame: Baseline - 12 months
The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time.
Baseline - 12 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline - 3 months
The International Physical Activity Questionnaire is a measure of physical activity
Baseline - 3 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline - 6 months
The International Physical Activity Questionnaire is a measure of physical activity
Baseline - 6 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline - 9 months
The International Physical Activity Questionnaire is a measure of physical activity
Baseline - 9 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline - 12 months
The International Physical Activity Questionnaire is a measure of physical activity
Baseline - 12 months
Morisky Medication Adherence Scale (MMAS-8)
Time Frame: Baseline - 3 months
Self-reported measure of medication adherence
Baseline - 3 months
Morisky Medication Adherence Scale (MMAS-8)
Time Frame: Baseline - 6 months
Self-reported measure of medication adherence
Baseline - 6 months
Morisky Medication Adherence Scale (MMAS-8)
Time Frame: Baseline - 9 months
Self-reported measure of medication adherence
Baseline - 9 months
Morisky Medication Adherence Scale (MMAS-8)
Time Frame: Baseline - 12 months
Self-reported measure of medication adherence
Baseline - 12 months
Insomnia Severity Index (ISI)
Time Frame: Baseline - 3 months
Insomnia issues
Baseline - 3 months
Insomnia Severity Index (ISI)
Time Frame: Baseline - 6 months
Insomnia issues
Baseline - 6 months
Insomnia Severity Index (ISI)
Time Frame: Baseline - 9 months
Insomnia issues
Baseline - 9 months
Insomnia Severity Index (ISI)
Time Frame: Baseline - 12 months
Insomnia issues
Baseline - 12 months
Alcohol Use Disorder Identification Test (AUDIT)
Time Frame: Baseline - 3 months
Baseline - 3 months
Alcohol Use Disorder Identification Test (AUDIT)
Time Frame: Baseline - 6 months
Baseline - 6 months
Alcohol Use Disorder Identification Test (AUDIT)
Time Frame: Baseline - 9 months
Baseline - 9 months
Alcohol Use Disorder Identification Test (AUDIT)
Time Frame: Baseline - 12 months
Baseline - 12 months
Time to depressive relapse
Time Frame: Baseline - 12 months
Time to depressive relapse is recorded as secondary outcome variable
Baseline - 12 months
Self reported treatment seeking
Time Frame: Baseline - 12 months
Treatment seeking among participants is recorded as secondary outcome variable
Baseline - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Investigators

  • Principal Investigator: Lars-Gunnar Lundh, Professor, Lund University, Departement of psychology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (Estimate)

November 6, 2015

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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