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Completed

NCT Number: NCT04728204

Internet-based Psychotherapy for Depressed Elderly

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vilnius University

Vilnius, Lithuania, LT-01513

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Depresijos terapija

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. 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.

Other outcomes

  1. The Alcohol Use Disorders Identification Test (AUDIT)

    Time frame: Pre-treatment

    AUDIT will be used for alcohol consumption and related risks assessment.

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Collaborators

  • Linkoeping University

Registry information

Official study title

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

Acronym: iPSYDE

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 28, 2021
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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