DepressioniPSYDENCT04728204
Internet-based Psychotherapy for Depressed Elderly
A study testing Depresijos terapija in people with Depression, run by Vilnius University at 1 site in Lithuania.
Trial summary
This study aims to evaluate the effectiveness of internet-based cognitive behavioral therapy (CBT) for depressed elderly. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Depresijos terapija
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteLithuania
- Study dates
- 28 Jan 2021to 6 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- depressive symptoms
- have access to a computer/tablet/smartphone and to the internet
- have good knowledge of the Lithuanian language
Who cannot join
- alcohol addiction
- presently in any other psychological treatment
- severe depression
- suicidal ideation
- significant change in psychiatric medication (during last 6 weeks)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression
- Being tested
- Depresijos terapija
- Keywords
- Depression, Internet-based cognitive behaviour therapy, Elderly, eHealth
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depresijos terapijaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 8 module, 8 week long internet-based intervention for reducing burden of depression Receives: Behavioral: Depresijos terapija |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre-treatment, week 8, 3, 12 and 24 months post-treatment
Secondary outcomes (2)
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.
Measured: 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.
Measured: Pre-treatment, week 8, 3, 12 and 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start28 Jan 2021
- Primary completion15 Jul 2021
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Jonas Eimontas, Vilnius University
- Investigators
- Jonas Eimontas, PhD, Principal investigator, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728204
- Sponsor's protocol ID
- iPSYDE_1_2021
- Acronym
- iPSYDE
- Status last verified
- Sep 2025
- First submitted
- 15 Jan 2021
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eimontas J, Pakalniskiene V, Biliunaite I, Andersson G. A tailored Internet-delivered modular intervention based on cognitive behavioral therapy for depressed older adults: a study protocol for a randomized controlled trial. Trials. 2021 Dec 16;22(1):925. doi: 10.1186/s13063-021-05903-4.
PubMed 34915909
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavioral Therapy for Depressed Elderly: a Two-armed Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04728204
- Acronym / sponsor ID
- iPSYDE / iPSYDE_1_2021
- Conditions
- Depression
- Keywords
- Depression, Internet-based cognitive behaviour therapy, Elderly, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Depresijos terapija8 module, 8 week long internet-based intervention for reducing burden of depression |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- depressive symptoms
- have access to a computer/tablet/smartphone and to the internet
- have good knowledge of the Lithuanian language
Key exclusion criteria (5 listed)
- alcohol addiction
- presently in any other psychological treatment
- severe depression
- suicidal ideation
- significant change in psychiatric medication (during last 6 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depresijos terapijaIntervention 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. | Behavioural | Intervention group |
Primary outcome
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.
2 secondary outcomes
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Derived from this study: PubMed 34915909Eimontas J, Pakalniskiene V, Biliunaite I, Andersson G. A tailored Internet-delivered modular intervention based on cognitive behavioral therapy for depressed older adults: a study protocol for a randomized controlled trial. Trials. 2021 Dec 16;22(1):925. doi: 10.1186/s13063-021-05903-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Eimontas, PhD principal investigator
Vilnius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Depresijos terapija in people with Depression, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) (time frame: Pre-treatment, week 8, 3, 12 and 24 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04728204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.