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Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Therapist-assisted iCBT
Monthly screening with feedback
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Therapist-assisted iCBT

Monthly screening with feedback

Control

Arm Description

Internet-delivered cognitive behavioral therapy (iCBT), containing physical activity and sleep management for preventing depressive relapse. Monthly depression screening with therapist feedback.

Monthly depression screening with therapist feedback.

No intervention, follow-up along with all participants at 6 and 12-months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in health related quality of life (EQ-5D)
Health related quality of life will be measured by an internet based version of the EQ-5D.
Change from baseline in health related quality of life (EQ-5D)
Health related quality of life will be measured by an internet based version of the EQ-5D.
Change from baseline in health related quality of life (EQ-5D)
Health related quality of life will be measured by an internet based version of the EQ-5D.
Change from baseline in health related quality of life (EQ-5D)
Health related quality of life will be measured by an internet based version of the EQ-5D.
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
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.
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
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.
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
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.
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
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.
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity
Morisky Medication Adherence Scale (MMAS-8)
Self-reported measure of medication adherence
Morisky Medication Adherence Scale (MMAS-8)
Self-reported measure of medication adherence
Morisky Medication Adherence Scale (MMAS-8)
Self-reported measure of medication adherence
Morisky Medication Adherence Scale (MMAS-8)
Self-reported measure of medication adherence
Insomnia Severity Index (ISI)
Insomnia issues
Insomnia Severity Index (ISI)
Insomnia issues
Insomnia Severity Index (ISI)
Insomnia issues
Insomnia Severity Index (ISI)
Insomnia issues
Alcohol Use Disorder Identification Test (AUDIT)
Alcohol Use Disorder Identification Test (AUDIT)
Alcohol Use Disorder Identification Test (AUDIT)
Alcohol Use Disorder Identification Test (AUDIT)
Time to depressive relapse
Time to depressive relapse is recorded as secondary outcome variable
Self reported treatment seeking
Treatment seeking among participants is recorded as secondary outcome variable

Full Information

First Posted
November 5, 2015
Last Updated
March 3, 2020
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT02599597
Brief Title
Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle
Official Title
Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapist-assisted iCBT
Arm Type
Experimental
Arm Description
Internet-delivered cognitive behavioral therapy (iCBT), containing physical activity and sleep management for preventing depressive relapse. Monthly depression screening with therapist feedback.
Arm Title
Monthly screening with feedback
Arm Type
Active Comparator
Arm Description
Monthly depression screening with therapist feedback.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention, follow-up along with all participants at 6 and 12-months.
Intervention Type
Behavioral
Intervention Name(s)
Therapist-assisted iCBT
Intervention Description
13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.
Intervention Type
Behavioral
Intervention Name(s)
Monthly screening with feedback
Intervention Description
Participants are screened with a depression inventory each month and receives feedback from a therapist on the results
Primary Outcome Measure Information:
Title
Depressive relapse (change in diagnostic status, SCID-I)
Description
Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated & Structured Clinical Interview for DSM IV
Time Frame
Baseline - 12 months
Title
Change from baseline in depressive symptoms (MADRS-S)
Description
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
Time Frame
Baseline - 6 months
Title
Change from baseline in depressive symptoms (MADRS-S)
Description
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
Time Frame
Baseline - 12 months
Title
Change from baseline in depressive symptoms (MADRS-S)
Description
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
Time Frame
Monthly, 0-12 months
Secondary Outcome Measure Information:
Title
Change from baseline in health related quality of life (EQ-5D)
Description
Health related quality of life will be measured by an internet based version of the EQ-5D.
Time Frame
Baseline - 3 months
Title
Change from baseline in health related quality of life (EQ-5D)
Description
Health related quality of life will be measured by an internet based version of the EQ-5D.
Time Frame
Baseline - 6 months
Title
Change from baseline in health related quality of life (EQ-5D)
Description
Health related quality of life will be measured by an internet based version of the EQ-5D.
Time Frame
Baseline - 9 months
Title
Change from baseline in health related quality of life (EQ-5D)
Description
Health related quality of life will be measured by an internet based version of the EQ-5D.
Time Frame
Baseline - 12 months
Title
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Description
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.
Time Frame
Baseline - 3 months
Title
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Description
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.
Time Frame
Baseline - 6 months
Title
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Description
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.
Time Frame
Baseline - 9 months
Title
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Description
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.
Time Frame
Baseline - 12 months
Title
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Description
The International Physical Activity Questionnaire is a measure of physical activity
Time Frame
Baseline - 3 months
Title
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Description
The International Physical Activity Questionnaire is a measure of physical activity
Time Frame
Baseline - 6 months
Title
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Description
The International Physical Activity Questionnaire is a measure of physical activity
Time Frame
Baseline - 9 months
Title
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Description
The International Physical Activity Questionnaire is a measure of physical activity
Time Frame
Baseline - 12 months
Title
Morisky Medication Adherence Scale (MMAS-8)
Description
Self-reported measure of medication adherence
Time Frame
Baseline - 3 months
Title
Morisky Medication Adherence Scale (MMAS-8)
Description
Self-reported measure of medication adherence
Time Frame
Baseline - 6 months
Title
Morisky Medication Adherence Scale (MMAS-8)
Description
Self-reported measure of medication adherence
Time Frame
Baseline - 9 months
Title
Morisky Medication Adherence Scale (MMAS-8)
Description
Self-reported measure of medication adherence
Time Frame
Baseline - 12 months
Title
Insomnia Severity Index (ISI)
Description
Insomnia issues
Time Frame
Baseline - 3 months
Title
Insomnia Severity Index (ISI)
Description
Insomnia issues
Time Frame
Baseline - 6 months
Title
Insomnia Severity Index (ISI)
Description
Insomnia issues
Time Frame
Baseline - 9 months
Title
Insomnia Severity Index (ISI)
Description
Insomnia issues
Time Frame
Baseline - 12 months
Title
Alcohol Use Disorder Identification Test (AUDIT)
Time Frame
Baseline - 3 months
Title
Alcohol Use Disorder Identification Test (AUDIT)
Time Frame
Baseline - 6 months
Title
Alcohol Use Disorder Identification Test (AUDIT)
Time Frame
Baseline - 9 months
Title
Alcohol Use Disorder Identification Test (AUDIT)
Time Frame
Baseline - 12 months
Title
Time to depressive relapse
Description
Time to depressive relapse is recorded as secondary outcome variable
Time Frame
Baseline - 12 months
Title
Self reported treatment seeking
Description
Treatment seeking among participants is recorded as secondary outcome variable
Time Frame
Baseline - 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars-Gunnar Lundh, Professor
Organizational Affiliation
Lund University, Departement of psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö
City
Malmö
State/Province
Skåne
ZIP/Postal Code
21431
Country
Sweden

12. IPD Sharing Statement

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Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

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