iPSYDE: Internet-based Psychotherapy for Depressed Elderly

• Sponsor: Vilnius University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04728204
• Collaborator: Linkoeping University (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 28.1
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Depresijos terapija	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Internet-based Cognitive Behavioral Therapy for Depressed Elderly: a Two-armed Randomized Controlled Trial
• Actual Study Start Date: Jan 28, 2021
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Patient Health Questionnaire (PHQ-9) [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) [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 Outcome Measures

1. Generalized Anxiety Disorder-7 (GAD-7) [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) [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 Outcome Measures

1. The Alcohol Use Disorders Identification Test (AUDIT) [Pre-treatment]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vilnius University	Vilnius		Lithuania	LT-01513

Sponsors and Collaborators

• Vilnius University
• Linkoeping University

Investigators

• Principal Investigator: Jonas Eimontas, PhD, Vilnius University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vilnius University
• ClinicalTrials.gov Identifier: NCT04728204
• Other Study ID Numbers: iPSYDE_1_2021
• First Posted: Jan 28, 2021
• Last Update Posted: Apr 23, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vilnius University: Depression; Internet-based cognitive behaviour therapy; Elderly; eHealth
• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of Apr 23, 2021