Internet-based Psychotherapy for Depressed Elderly

Depression Clinical Trial

— iPSYDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04728204
• Other study ID #: iPSYDE_1_2021
• Status: Completed
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: October 6, 2022

Study information

• Verified date: January 2021
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: October 6, 2022
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression

Intervention

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.

Locations

Country	Name	City	State
Lithuania	Vilnius University	Vilnius

Sponsors (2)

Lead Sponsor	Collaborator
Vilnius University	Linkoeping University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Alcohol Use Disorders Identification Test (AUDIT)	AUDIT will be used for alcohol consumption and related risks assessment.	Pre-treatment
Primary	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
Primary	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	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
Secondary	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