Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Monthly screening with feedback; Behavioral: Therapist-assisted iCBT

• Registration Number: NCT02599597
• Lead Sponsor: Lund University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-05
• Study First Posted: 2015-11-06
• Study Start: 2016-02
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Depressive relapse (change in diagnostic status, SCID-I)	Baseline - 12 months	Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated \& Structured Clinical Interview for DSM IV
Change from baseline in depressive symptoms (MADRS-S)	Monthly, 0-12 months	Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö; 🇸🇪 Malmö, Skåne, Sweden