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Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02599597
Enrollment
150
Registered
2015-11-06
Start date
2016-02-29
Completion date
2019-12-01
Last updated
2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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

Interventions

13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.

BEHAVIORALMonthly screening with feedback

Participants are screened with a depression inventory each month and receives feedback from a therapist on the results

Sponsors

Lund University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Depressive relapse (change in diagnostic status, SCID-I)Baseline - 12 monthsMonthly screening via Montgomery-Asberg Depression Rating Scale - Self rated & Structured Clinical Interview for DSM IV
Change from baseline in depressive symptoms (MADRS-S)Baseline - 6 monthsChange in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.

Secondary

MeasureTime frameDescription
Change from baseline in Outcomes Questionnaire 45 (OQ-45)Baseline - 3 monthsThe 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.
Self reported treatment seekingBaseline - 12 monthsTreatment seeking among participants is recorded as secondary outcome variable
Change from baseline in the International Physical Activity Questionnaire (IPAQ)Baseline - 3 monthsThe International Physical Activity Questionnaire is a measure of physical activity
Change from baseline in health related quality of life (EQ-5D)Baseline - 3 monthsHealth related quality of life will be measured by an internet based version of the EQ-5D.
Insomnia Severity Index (ISI)Baseline - 3 monthsInsomnia issues
Alcohol Use Disorder Identification Test (AUDIT)Baseline - 3 months
Morisky Medication Adherence Scale (MMAS-8)Baseline - 3 monthsSelf-reported measure of medication adherence
Time to depressive relapseBaseline - 12 monthsTime to depressive relapse is recorded as secondary outcome variable

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026