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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lund University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
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