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Clinical Trials/NCT04728204
NCT04728204
Completed
Not Applicable

Internet-based Cognitive Behavioral Therapy for Depressed Elderly: a Two-armed Randomized Controlled Trial

Vilnius University1 site in 1 country84 target enrollmentJanuary 28, 2021
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Vilnius University
Enrollment
84
Locations
1
Primary Endpoint
Patient Health Questionnaire (PHQ-9)
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

This study aims to evaluate the effectiveness of internet-based cognitive behavioral therapy (CBT) for depressed elderly.

Detailed Description

Individuals of age 60+ with symptoms of depression will be assessed before the study. At week 0, participants who meet eligibility requirements will be randomized either to intervention group which will participate in an 8-week internet-based modular CBT or to a delayed treatment control group.

Registry
clinicaltrials.gov
Start Date
January 28, 2021
End Date
October 6, 2022
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jonas Eimontas

Associate Professor, Senior Research Fellow

Vilnius University

Eligibility Criteria

Inclusion Criteria

  • depressive symptoms
  • have access to a computer/tablet/smartphone and to the internet
  • have good knowledge of the Lithuanian language

Exclusion Criteria

  • alcohol addiction
  • presently in any other psychological treatment
  • severe depression
  • suicidal ideation
  • significant change in psychiatric medication (during last 6 weeks)

Outcomes

Primary Outcomes

Patient Health Questionnaire (PHQ-9)

Time Frame: Pre-treatment, week 8, 3, 12 and 24 months post-treatment

Change from baseline in depression symptoms post-treatment (week 8), at three months, at 12 months and at 24 months post-treatment. Measure contains 9 questions that have to be responded to by choosing an answer from a 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'. Higher score indicates more severe symptoms.

Geriatric Depression Scale (GDS)

Time Frame: Pre-treatment, week 8, 3, 12 and 24 months post-treatment

Change from baseline in depression symptoms post-treatment (week 8), at three months, at 12 months and at 24 months post-treatment. Measure contains 15 questions that have to be responded 'Yes' or 'No'. Higher score indicates more severe symptoms.

Secondary Outcomes

  • Generalized Anxiety Disorder-7 (GAD-7)(Pre-treatment, week 8, 3, 12 and 24 months post-treatment)
  • The World Health Organisation- Five Well-Being Index (WHO-5)(Pre-treatment, week 8, 3, 12 and 24 months post-treatment)

Study Sites (1)

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