Activating primary medical care patients for a depression-preventive lifestyle with individualized e-health interventions (ActiLife)

Phase 2

• Conditions: subsyndromal depressive symptoms; F32; F34.1; Depressive episode; Dysthymia

• Registration Number: DRKS00011637
• Lead Sponsor: niversitätsmedizin Greifswald, Institut für Sozialmedizin und Prävention

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-25
• Study Completion: 2021-12-31
• Results First Posted: 2023-10-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 456

Inclusion Criteria

Subsyndromal depressive disorder or mild major depression in the past 12 months (DSM-5-classification, operationalized by PHQ-8: at least 2 DSM-5 criteria fulfilled including at least one core criterion)

Exclusion Criteria

Exclusion criteria are severe depression in the past 12 months and depressive symptoms in the past 2 weeks preceding recruitment (phq-8 score >= 20 and symptoms of depressed mood, anhedonia, powerlessness in the past 2 weeks), at risk alcohol consumption (defined by an average daily consumption of >= 12g / >= 24g pure alcohol or at least monthly >= 4 / >= 5 alcoholic drinks at one occasion for women and men, respectively), moderate or severe alcohol use disorder according to DSM-5 (operationalized by AUDIT score >= 20), cognitive impairment, analphabetism or severe disease precluding participation, neither smartphone nor regular e-mail use.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported reduction (twelve months preceeding baseline compared to six month preceeding follow-up) in depressive symptoms (assessed via PHQ-8) in the worst episode.

Secondary Outcome Measures

Name	Time	Method
Follow-up assessments will be conducted six and twelve months after study inclusion. The following parameters will be assessed (in case of parameters 2-9 change-scores in relation to baseline values will be analyzed): 1) reappearance of depressive episodes in the follow-up period (Screening items M-CIDI), 2) Change in use of depression preventive strategies (adapted and translated items from Levesque et al. 2011, Am J Health Promot), 4) Change in perceived loneliness (UCLA Loneliness Scale) 5) change in health related quality of life (VR-12) 6) change in well-being (WHO-5) 7) change in positive and negative affect (PANAS) 8) change in psychosocial impairment (role functioning, work impairments and inability; adapted items from M-CIDI Q-section), 9) Changes in health behaviors (physical activity (Godin), fruit and vegetable consumption (WHO-Steps), tobacco smoking), 10) reduction of depression related self-stigmatization (adapted version SSMI-SF).