Internet-based Psychotherapy for Depressed Elderly

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

Detailed Description
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Depresijos terapija


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to either control or intervention group. Participants in the control group will receive the same treatment after the intervention group is finished with the treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>8 module, 8 week long internet-based intervention for reducing burden of depression | Behavioral: Depresijos terapija<br>* 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.<br>|
| No Intervention: Control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9) | 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Internet-based cognitive behaviour therapy, Elderly, eHealth