Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

Depression Clinical Trial

Official title:

Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599597
• Other study ID #: rel-prev
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2020
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Therapist-assisted iCBT
13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.
• Monthly screening with feedback
Participants are screened with a depression inventory each month and receives feedback from a therapist on the results

Locations

Country	Name	City	State
Sweden	Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö	Malmö	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive relapse (change in diagnostic status, SCID-I)	Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated & Structured Clinical Interview for DSM IV	Baseline - 12 months
Primary	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.	Baseline - 6 months
Primary	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.	Baseline - 12 months
Primary	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.	Monthly, 0-12 months
Secondary	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.	Baseline - 3 months
Secondary	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.	Baseline - 6 months
Secondary	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.	Baseline - 9 months
Secondary	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.	Baseline - 12 months
Secondary	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.	Baseline - 3 months
Secondary	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.	Baseline - 6 months
Secondary	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.	Baseline - 9 months
Secondary	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.	Baseline - 12 months
Secondary	Change from baseline in the International Physical Activity Questionnaire (IPAQ)	The International Physical Activity Questionnaire is a measure of physical activity	Baseline - 3 months
Secondary	Change from baseline in the International Physical Activity Questionnaire (IPAQ)	The International Physical Activity Questionnaire is a measure of physical activity	Baseline - 6 months
Secondary	Change from baseline in the International Physical Activity Questionnaire (IPAQ)	The International Physical Activity Questionnaire is a measure of physical activity	Baseline - 9 months
Secondary	Change from baseline in the International Physical Activity Questionnaire (IPAQ)	The International Physical Activity Questionnaire is a measure of physical activity	Baseline - 12 months
Secondary	Morisky Medication Adherence Scale (MMAS-8)	Self-reported measure of medication adherence	Baseline - 3 months
Secondary	Morisky Medication Adherence Scale (MMAS-8)	Self-reported measure of medication adherence	Baseline - 6 months
Secondary	Morisky Medication Adherence Scale (MMAS-8)	Self-reported measure of medication adherence	Baseline - 9 months
Secondary	Morisky Medication Adherence Scale (MMAS-8)	Self-reported measure of medication adherence	Baseline - 12 months
Secondary	Insomnia Severity Index (ISI)	Insomnia issues	Baseline - 3 months
Secondary	Insomnia Severity Index (ISI)	Insomnia issues	Baseline - 6 months
Secondary	Insomnia Severity Index (ISI)	Insomnia issues	Baseline - 9 months
Secondary	Insomnia Severity Index (ISI)	Insomnia issues	Baseline - 12 months
Secondary	Alcohol Use Disorder Identification Test (AUDIT)		Baseline - 3 months
Secondary	Alcohol Use Disorder Identification Test (AUDIT)		Baseline - 6 months
Secondary	Alcohol Use Disorder Identification Test (AUDIT)		Baseline - 9 months
Secondary	Alcohol Use Disorder Identification Test (AUDIT)		Baseline - 12 months
Secondary	Time to depressive relapse	Time to depressive relapse is recorded as secondary outcome variable	Baseline - 12 months
Secondary	Self reported treatment seeking	Treatment seeking among participants is recorded as secondary outcome variable	Baseline - 12 months