Internet-based Psychotherapy for Depressed Elderly (iPSYDE)

January 3, 2023 updated by: Vilnius University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Vilnius, Lithuania, LT-01513
        • Vilnius University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
8 module, 8 week long internet-based intervention for reducing burden of depression
Behavioral: Depresijos terapija
Intervention is based on the principles of cognitive behavioral therapy and culturally adapted to elderly Lithuanian population. The main purpose of the intervention is to reduce the symptoms of depression and increase psychological well-being. Intervention contains psychoeducation, examples, exercises and consultation with a psychologist.
No Intervention: Control group
Participants randomized to the control group will be instructed to wait until the intervention group finishes the treatment and that they will be able to use the same intervention afterwards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-treatment, week 8, 3, 12 and 24 months post-treatment
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.
Pre-treatment, week 8, 3, 12 and 24 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Pre-treatment, week 8, 3, 12 and 24 months post-treatment
Change from baseline in anxiety symptoms post-treatment (week 8), at three months, at 12 months and at 24 months post-treatment. Measure contains 7 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.
Pre-treatment, week 8, 3, 12 and 24 months post-treatment
The World Health Organisation- Five Well-Being Index (WHO-5)
Time Frame: Pre-treatment, week 8, 3, 12 and 24 months post-treatment
Change from baseline in well-being post-treatment (week 8), at three months, at 12 months and at 24 months post-treatment. WHO-5 contains 5 statements about individuals well-being in the past two weeks. Respondents have to choose the best corresponding answer using a 6-item Likert scale where a score of 0 indicates 'At no time' and a score of 5 - 'All the time'. Higher score indicates higher well-being.
Pre-treatment, week 8, 3, 12 and 24 months post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: Pre-treatment
AUDIT will be used for alcohol consumption and related risks assessment.
Pre-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vilnius University

Collaborators

Linkoeping University

Investigators

  • Principal Investigator: Jonas Eimontas, PhD, Vilnius University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2021

Primary Completion (Actual)

July 15, 2021

Study Completion (Actual)

October 6, 2022

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 23, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iPSYDE_1_2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe