ISRCTN ISRCTN15417617
DOI https://doi.org/10.1186/ISRCTN15417617
Sponsor University of Regina
Funder Saskatchewan Health Research Foundation
Submission date
08/12/2025
Registration date
09/12/2025
Last edited
09/12/2025
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Caring for a loved one who lives in a long-term care (LTC) home can be both rewarding and emotionally demanding. Many informal caregivers, such as the family and friends of LTC residents, experience stress, worry, and feelings of guilt or sadness as they try to support their loved one.

The goal of this study is to test whether a single online session of Acceptance and Commitment Therapy (ACT) can help reduce caregiver burden, anxiety, and depression. ACT is a type of therapy that helps people learn to accept difficult thoughts and feelings, while focusing on what matters most to them.

This study compares the effects of an ACT session with a psychoeducation program, which provides information and tips about managing stress and burden. By comparing the two, we hope to learn whether ACT offers additional benefits for caregivers and whether these benefits last over time.

The study is part of a Ph.D. dissertation project in the Department of Psychology at the University of Regina.

Who can participate?
Informal adult caregivers (18 years or older) providing support to someone living in an LTC home, such as a spouse, parent, or close relative, but you are not paid to do so.

What does the study involve?
Participants will first complete a brief screening and enrolment session with the researcher over Zoom (about 10 minutes). This step helps to confirm that they meet the eligibility criteria and provides them with a chance to ask questions.

After enrolling, they will be asked to complete some online questionnaires about their caregiving experience, mental well-being, and social support. These questionnaires take about 15–30 minutes.

They will then be randomly assigned to one of two groups:
Acceptance and Commitment Therapy (ACT) Group: Participants will complete a one-time, online ACT session designed to help caregivers handle stress, accept difficult emotions, and reconnect with their personal values.

Psychoeducation Group: Participants will receive educational materials about stress management and coping with their caregiver challenges.

To see how their experience may change over time, they will be asked to complete follow-up questionnaires about 2 weeks later and again 3 months later.

As a thank-you for their time, they can enter a draw to win one of five $100 e-gift cards. Participants can enter the draw after completing the 3-month follow-up survey.

All study activities are completed online and can be done from home.

What are the possible benefits and risks of participating?
Possible Benefits:
By taking part, participants may learn helpful ways to manage stress and emotions related to caregiving. The ACT or psychoeducation materials may provide tools that can be used in daily life to improve well-being. Even if they do not experience direct benefits, their participation will help researchers better understand how to support caregivers in the future.

Possible Risks:
Some questions or parts of the session may bring up strong emotions or uncomfortable thoughts about their caregiving experience. They can stop participating at any time by closing your browser.

If participants feel upset or need support, they can contact one of the following free and confidential services:

Online Therapy Unit (University of Regina) – +1 (306) 337-3331, Online.Therapy.USER@uregina.ca

Canadian Mental Health Association – cmha.ca/find-help

Where is the study run from?
This study is being conducted through the Aging, Residents, and Caregivers Research Unit in the Department of Psychology at the University of Regina, Saskatchewan, Canada.

When is the study starting and how long is it expected to run for?
January 2026 to August 2027. Each participant’s involvement lasts about three months, including the follow-up surveys.

Who is funding the study?
The Saskatchewan Health Research Foundation, Canada.

Who is the main contact?
1. Principal Investigator: Kelsey Haczkewicz, Aging, Residents, and Caregivers Research Unit, Department of Psychology, University of Regina, kmh978@uregina.ca
2. Supervisor: Dr. Natasha Gallant, Aging, Residents, and Caregivers Research Unit, Department of Psychology, University of Regina, Natasha.Gallant@uregina.ca

Contact information

Dr Natasha Gallant
Principal investigator, Scientific

3737 Wascana Parkway
Regina
S4S0A2
Canada

Phone +1 3065854219
Email natasha.gallant@uregina.ca
Ms Kelsey Haczkewicz
Principal investigator, Public, Scientific

3737 Wascana Parkway
Regina
S4S0A2
Canada

Phone +1 3066213704
Email kmh978@uregina.ca

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingOpen (masking not used)
ControlActive
AssignmentParallel
PurposeTreatment
Scientific titleThe influence of a single-session digital acceptance and commitment therapy intervention on informal caregivers of long-term care residents: a randomized controlled trial 
Study acronymACT for Caregivers
Study objectivesThe purpose of the study is to examine the efficacy of the Acceptance and Commitment Therapy (ACT) Guide Lite on reducing symptoms of caregiver burden, depression, and anxiety symptoms in the family and friend caregivers of long-term care residents.
Ethics approval(s)

Approved 18/09/2025, University of Regina Research Ethics Board (3737 Wascana Parkway, Regina, S4S0A2, Canada; +1 (306) 585-4111; research.ethics@uregina.ca), ref: 1542

Health condition(s) or problem(s) studiedReduction of anxiety, depression, and caregiver burden symptoms in informal caregivers (family and friends) of long-term care residents.
InterventionParticipants will be randomly assigned to the intervention group or control group. Participants assigned to the intervention group will complete the ACT Guide Lite. The ACT Guide Lite was originally developed by Utah State University based on a previously developed 12-session ACT Guide Program. This program is an online, self-help program designed to be completed within a single session of approximately 45 minutes. It was designed to improve emotional well-being and to help individuals to cope with psychological symptoms of depression, anxiety, and stress by teaching new ways to interact with thoughts and feelings. Participants who are randomly assigned to the control group will receive access to an online webpage consisting of psychoeducational materials on the topic managing the stress and other adverse psychological outcomes commonly experienced when providing informal care to a loved one in LTC. Information on this webpage has been adapted from multiple caregiving and mental health association webpages including the Canadian Mental Health Association, Caregiver Action Network, Family Caregiver Alliance, National Institute on Aging, Public Health Agency of Canada, and the Regional Geriatric Program of Ontario. Eligible participants will be randomized to either the ACT intervention or to the psychoeducation control condition immediately after completing the demographics form. Randomization will be conducted automatically using Qualtrics, with no researcher involvement. A 1:1 allocation ratio and random block sizes will be used to ensure comparable group sizes using the Qualtrics Evenly Present Elements (Qualtrics, n.d.). Upon the completion of the demographics form, Qualtrics will immediately redirect participants to the condition they have been randomly assigned to.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Depression Symptoms measured using the Patient Health Questionnaire - 9 (PHQ-9) at baseline, 2-weeks and 3-months post-intervention
  2. Anxiety Symptoms measured using the Generalized Anxiety Disorder 7-Item Scale (GAD-7) at baseline, 2-weeks and 3-months post-intervention
  3. Caregiver Burden Symptoms measured using the Zarit Burden Interview (ZBI) at baseline, 2-weeks and 3-months post-intervention
Key secondary outcome measure(s)
  1. Psychological Flexibility measured using the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT) at baseline, 2-weeks and 3-months post-intervention
Completion date30/08/2027

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit100 Years
SexAll
Target sample size at registration178
Key inclusion criteria1. At least 18 years of age
2. Currently provide informal care to a LTC resident
3. Residing in Canada
4. Endorse at least a moderate level of anxiety with a score of 10 or more on the Generalized Anxiety Disorder 7-Item Scale (GAD-7) or depression with a score of 10 or on the Patient Health Questionnaire (PHQ-9); and 5 do not endorse current suicidal ideation (as indicated by a score of 1 or more on item 9 of the PHQ-9)
Key exclusion criteria1. Do not speak English
2. Currently receiving other psychological treatment
Date of first enrolment01/01/2026
Date of final enrolment30/08/2026

Locations

Countries of recruitment

  • Canada

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
IPD sharing plan

Editorial Notes

09/12/2025: Study’s existence confirmed by the University of Regina Research Ethics Board, Canada.