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Clinical Trials/NCT04052724
NCT04052724
Completed
N/A

Internet-based Treatment for Informal Caregivers in Lithuania LINGI: a Randomized Control Trial

Linkoeping University1 site in 1 country63 target enrollmentOctober 3, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Caregiver Distress
Sponsor
Linkoeping University
Enrollment
63
Locations
1
Primary Endpoint
Change on Caregiver Burden Inventory (CBI)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to evaluate efficacy of internet intervention for informal caregivers in Lithuania in reducing their care-giving burden.

Detailed Description

Intervention is going to take a form of an Internet based Cognitive Behavioural Treatment program (ICBT) consisting of eight modules. These are the themes, as listed chronologically: Introduction, Thoughts, Stress and relaxation, Problem Solving, Communication, Anxiety, Behavioural Activation, Maintenance. These themes were chosen after considering topics which might be the most useful for someone in a role of an informal caregiver, considering the trans-diagnostic nature of the intervention. Effect of the intervention will be compared against a wait-list control group. Intervention is in Lithuanian.

Registry
clinicaltrials.gov
Start Date
October 3, 2019
End Date
March 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Linkoeping University
Responsible Party
Principal Investigator
Principal Investigator

Gerhard Andersson

Principal Investigator

Linkoeping University

Eligibility Criteria

Inclusion Criteria

  • must be 18 years old or over
  • fluent in comprehending, writing and reading Lithuanian language
  • score 24 or more points on the Caregiver Burden Inventory
  • spent at least last couple of months for providing care
  • must have internet access and ability to use computer or any other compatible device

Exclusion Criteria

  • adverse life experiences as identified by LEC
  • alcohol addiction
  • having severe physical or mental impairments
  • suicide risk
  • severe interpersonal violence
  • the person in need of care has life expectancy below or approximately around 6 months

Outcomes

Primary Outcomes

Change on Caregiver Burden Inventory (CBI)

Time Frame: Pre-treatment, week 4, week 8 and 12 months post-treatment

This measure is used to evaluate caregiver burden. CBI contains 24 questions that are distributed within 5 facets - Time Dependency, Emotional Health, Development, Physical Health and Social Relationships. Answer options are presented on a 5-item Likert scale and ranges from from 0 ('Never') to 4 ('Nearly Always'). Total score on CBI is summed up and ranges from 0 to 96, higher score indicating higher levels of burden experienced.

Secondary Outcomes

  • Change on Perceived stress scale (PSS-14)(Pre-treatment, week 8 and 12 months post-treatment)
  • Change on The Patient Health Questionnaire (PHQ-9)(Pre-treatment, week 4, week 8 and 12 months post-treatment)
  • Change on Generalized anxiety disorder (GAD-7)(Pre-treatment, week 4, week 8 and 12 months post-treatment)
  • Change on World Health Organisation (WHO-5)(Pre-treatment, week 8 and 12 months post-treatment)
  • Change on The Brunnsviken Brief Quality of Life Scale (BBQ)(Pre-treatment, week 8 and 12 months post-treatment)

Study Sites (1)

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