Clinical trial NCT02599597: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Depressive relapse (change in diagnostic status, SCID-I)
timeFrame: Baseline - 12 months
measure: Change from baseline in depressive symptoms (MADRS-S)
timeFrame: Baseline - 6 months
measure: Change from baseline in depressive symptoms (MADRS-S)
timeFrame: Baseline - 12 months
measure: Change from baseline in depressive symptoms (MADRS-S)
timeFrame: Monthly, 0-12 months
Secondary outcomes:
measure: Change from baseline in health related quality of life (EQ-5D)
timeFrame: Baseline - 3 months
measure: Change from baseline in health related quality of life (EQ-5D)
timeFrame: Baseline - 6 months
measure: Change from baseline in health related quality of life (EQ-5D)
timeFrame: Baseline - 9 months
measure: Change from baseline in health related quality of life (EQ-5D)
timeFrame: Baseline - 12 months
measure: Change from baseline in Outcomes Questionnaire 45 (OQ-45)
timeFrame: Baseline - 3 months
measure: Change from baseline in Outcomes Questionnaire 45 (OQ-45)
timeFrame: Baseline - 6 months
measure: Change from baseline in Outcomes Questionnaire 45 (OQ-45)
timeFrame: Baseline - 9 months
measure: Change from baseline in Outcomes Questionnaire 45 (OQ-45)
timeFrame: Baseline - 12 months
measure: Change from baseline in the International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline - 3 months
measure: Change from baseline in the International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline - 6 months
measure: Change from baseline in the International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline - 9 months
measure: Change from baseline in the International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline - 12 months
measure: Morisky Medication Adherence Scale (MMAS-8)
timeFrame: Baseline - 3 months
measure: Morisky Medication Adherence Scale (MMAS-8)
timeFrame: Baseline - 6 months
measure: Morisky Medication Adherence Scale (MMAS-8)
timeFrame: Baseline - 9 months
measure: Morisky Medication Adherence Scale (MMAS-8)
timeFrame: Baseline - 12 months
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline - 3 months
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline - 6 months
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline - 9 months
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline - 12 months
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Baseline - 3 months
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Baseline - 6 months
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Baseline - 9 months
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Baseline - 12 months
measure: Time to depressive relapse
timeFrame: Baseline - 12 months
measure: Self reported treatment seeking
timeFrame: Baseline - 12 months
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö
state: Skåne
Study officials:
affiliation: Lund University, Departement of psychology
name: Lars-Gunnar Lundh, Professor
role: PRINCIPAL_INVESTIGATOR
References: