Clinical trial NCT04052724: Internet-based Treatment for Informal Caregivers in Lithuania LINGI
Official title: Internet-based Treatment for Informal Caregivers in Lithuania LINGI: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Distress
Keywords: informal caregivers
internet-based cognitive behaviour therapy
culturally adapted psychotherapy
eHealth
caregiver burden
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Vilnius University
name: University of Groningen
First posted: 2019-08-12
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to either control or intervention group. Participants in the control group will receive the same treatment once the intervention group is finished with the treatment.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change on Caregiver Burden Inventory (CBI)
timeFrame: Pre-treatment, week 4, week 8 and 12 months post-treatment
Secondary outcomes:
measure: Change on Perceived stress scale (PSS-14)
timeFrame: Pre-treatment, week 8 and 12 months post-treatment
measure: Change on The Patient Health Questionnaire (PHQ-9)
timeFrame: Pre-treatment, week 4, week 8 and 12 months post-treatment
measure: Change on Generalized anxiety disorder (GAD-7)
timeFrame: Pre-treatment, week 4, week 8 and 12 months post-treatment
measure: Change on World Health Organisation (WHO-5)
timeFrame: Pre-treatment, week 8 and 12 months post-treatment
measure: Change on The Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: Pre-treatment, week 8 and 12 months post-treatment
Other outcomes:
measure: Life Events Checklist (LEC)
timeFrame: Pre-treatment
measure: The Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Pre-treatment
Locations:
city: Linköping
country: Sweden
facility: Department of Behavioral Sciences and Learning, Linköping University
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biliunaite I, Kazlauskas E, Sanderman R, Truskauskaite-Kuneviciene I, Dumarkaite A, Andersson G. Internet-Based Cognitive Behavioral Therapy for Informal Caregivers: Randomized Controlled Pilot Trial. J Med Internet Res. 2021 Apr 7;23(4):e21466. doi: 10.2196/21466.