Acceptance and Commitment Therapy (ACT) Tele-Counselling

NCT05385458 | Completed

• 1 other identifier: MHRC-NBHRF Mental Health
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized 2-group controlled trial will be conducted to explore the potential effect and potential feasibility of a new Acceptance and Commitment Therapy (ACT) tele-counselling program to improve mental health services for family caregivers of persons with dementia in the province of New Brunswick in Canada. The ACT tele-counselling program was launched in January 2021 with the aim of improving access to high quality psychotherapy for family caregivers, particularly in rural areas. A target sample size of 80 participants will be recruited and randomly allocated to either the ACT program or to usual care services. Mixed methods (QUANTITATIVE + qualitative) will be used to evaluate the potential impact of the ACT program compared to usual care on participant's mental health, and to generate recommendations for the expansion and continuation of the program outside of the province.

Conditions

Acceptance and Commitment Therapy; Caregiver Burden; Digital Health; Technology; Mental Health; Psychotherapy; Counselling; Dementia

Outcome Measures

Primary Outcomes (4)

• Change in Baseline Depression, Anxiety and Stress up to 36 weeks as assessed by the Depression, Anxiety and Stress Scale

  The Depression, Anxiety and Stress Scale (DASS-21) scale has 21 items with a 3 point likert scale. Range is 0-189 with higher scores indicating greater symptoms of depression, anxiety and stress.

  Baseline through study completion up to 36 weeks

• Change in Baseline Caregiver Burden up to 36 weeks as assessed by the Zarit Burden Index

  The Zarit Burden Index (ZBI-12) is a 12 Item questionnaire with 5 point likert scale. Range is 0-48 with higher scores indicating higher symptoms of caregiver burden.

  Baseline through study completion up to 36 weeks

• Change in Baseline Caregiver Participation in Meaningful and Fulfilling Activities up to 36 weeks as assessed by the Engagement in Meaningful Activities Scale

  The Engagement in Meaningful Activities Scale (EMAS) assesses the alignment between a person's actions/activities in daily life and their personal values. Increasing engagement in meaningful activities is a goal of ACT. This scale has 12 items with 5 point likert scale. Range is 12-72 with higher scores indicating higher (better) engagement in meaningful activities.

  Baseline through study completion up to 36 weeks

• Change in Psychological Flexibility and Experiential Avoidance up to 36 weeks as assessed by the Acceptance and Action Questionnaire

  The Acceptance and Action Questionnaire (AAQ-II) was developed to evaluate the effectiveness of ACT behavioural therapy, which aims to increase psychological flexibility and decrease experiential avoidance. Psychological flexibility refers to a person's ability to recognize and adapt to situational demands; shift perspectives, thinking or behaviours that reduce personal or social functioning; maintain balance among important life domains; and be aware, open, and committed to behaviors that align with personal values (Kashdan, 2010). The questionnaire includes 7 Items with a 7 point likert scale. Range is 7-49 with lower scores indicating higher (better) psychological flexibility and lower (better) experiential avoidance.

  Baseline through study completion up to 36 weeks

Secondary Outcomes (3)

• Acceptability of ACT Intervention Technology Used for Remote Delivery up to 36 weeks as assessed by the System Usability Scale

  Through study completion up to 36 weeks

• Satisfaction with ACT Intervention Delivery, Content and Processes up to 36 weeks as assessed by the Client Satisfaction Questionnaire

  Through study completion up to 36 weeks

• Feasibility and Acceptability of Implementing the ACT Intervention as planned through study completion up to 1 year as assessed by recruitment, retention and attrition rates, and participant demographics

  Through study completion up to 1 year

Study Arms (2)

ACT Intervention

EXPERIMENTAL

Participants will attend 6-8 individual psychotherapy sessions via telephone, text or videoconference. Sessions will last approximately 1 hour and occur every 3-4 weeks. Participants will be enrolled in the Intervention Group for 18-36 weeks. All sessions will be audio recorded. Participants will also be able to attend all available usual care services such as: support groups, First Link, education classes at the Alzheimer Society. Any services utilized will be documented by Alzheimer Society staff.

Behavioral: ACT Intervention

Usual Care

ACTIVE COMPARATOR

Participants will be enrolled as an Alzheimer Society client. Participants will receive 1 First Link 'check-in' telephone call from a staff member at the time of enrolment. Participants will receive a 2nd 'check-in' First Link telephone call from a staff member 3-4 months following enrolment. Participants will be enrolled in the Usual Care Group 12-16 weeks. Participants will also be able to attend all available usual care services such as: support groups, etc. Any services utilized will be documented by Alzheimer Society staff.

Other: Usual Care

Interventions

ACT Intervention BEHAVIORAL

Acceptance and Commitment Therapy

ACT Intervention

Usual Care OTHER

Usual Care Services

Usual Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult over 19 years old residing in New Brunswick, Canada
• Able to speak and read English or French
• Unpaid, informal caregiver to a person living with dementia (no diagnosis required)
• High level on 2 subscales or less on the Depression, Anxiety and Stress Scale
• Current or previous use of any mental health services

You may not qualify if:

• Less than 19 years old or not residing in New Brunswick, Canada
• Unable to speak and read English or French
• Not an unpaid informal caregiver to a person living with dementia
• High level on more than 2 subscales on the Depression, Anxiety and Stress Scale
• Acute mental health disorder such as: schizophrenia or bipolar disorder

Sponsors & Collaborators

• University of New Brunswick: lead
• Alzheimer Society of New Brunswick: collaborator
• Mount Allison University: collaborator
• University of Ottawa: collaborator
• McMaster University: collaborator
• McGill University: collaborator

Study Sites (1)

Alzheimer Society of New Brunswick

Fredericton, New Brunswick, E3A 3R4, Canada

Location

Related Publications (1)

• Durepos P, Ricketts N, Olthuis JV, Gould ON, Boamah SA, McCloskey R, Lanteigne M, Giberson ER, Caverhill K, Pickford K, MacBean C, Kaasalainen S. Acceptance and Commitment Therapy Tele-Counselling Program With Care Partners of Persons Living With Dementia: A Pilot Feasibility RCT. J Appl Gerontol. 2026 Feb;45(2):225-236. doi: 10.1177/07334648251338303. Epub 2025 May 12.

  PMID: 40353485 DERIVED

MeSH Terms

Conditions

Caregiver Burden; Psychological Well-Being; Dementia

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Personal Satisfaction; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Pamela Durepos, PhD

  University of New Brunswick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One investigator who will have no contact with participants will generate a randomization sequence. The research assistant who enrols participants in the studies will be blinded to the randomization sequence. They will contact the investigator to be told what group the participant is allocated. It is not possible to mask participants. Investigators will be blinded to groups when assessing and comparing outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two group randomized controlled trial

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: May 23, 2022
• Study Start: May 30, 2022
• Primary Completion: March 25, 2023
• Study Completion: March 25, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)