Feasibility and Acceptability of an Acceptance and Commitment Therapy Intervention for Caregivers of Dementia: A Single-Arm Randomized Controlled Trial

Last registered on November 01, 2023
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Pre-Trial

Trial Information

General Information

Title
Feasibility and Acceptability of an Acceptance and Commitment Therapy Intervention for Caregivers of Dementia: A Single-Arm Randomized Controlled Trial
RCT ID
AEARCTR-0012366
Initial registration date
October 26, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
November 01, 2023, 3:48 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country
Pakistan
Region
Punjab

Primary Investigator

Name
Mahvia Gul
Affiliation
Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2022-10-03
End date
2023-04-28
Keywords
Behavior, Education, Welfare
Additional Keywords
JEL code(s)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Purpose: Caregivers of individuals diagnosed with dementia frequently report elevated levels of anxiety, depression, burdens associated with caregiving, and existential suffering. However, individuals who receive adequate support and employ effective coping strategies tend to experience lower levels of distress and caregiving burden. Acceptance and Commitment Therapy (ACT) is designed to promote increased acceptance of internal experiences while encouraging actions aligned with one's personal values to enhance psychological flexibility. The primary objective of this single-arm pilot study was to assess the feasibility, acceptability, and preliminary effects of an online ACT intervention (OACTICs) on various aspects of well-being among caregivers dealing with dementia.
Methods: The caregiver must be ≥ 21 years of age (i.e., a parent, spouse, partner, sibling, or adult child), or they must be the primary caregiver of the person with dementia for ≥12 months and have scores that indicate moderate or higher on the scale of anxiety, depression, and poor quality of life. Participants received an online-based ACT over six weekly 1-hour sessions. The following outcome measures were administered at baseline (T1), immediately post-intervention (T2), and 3 months follow-up (T3): Generalized Anxiety Disorder-7, Patient Health Questionnaire-9, Zarit Burden Interview, The Experience of Suffering Measure, and Acceptance and Action Questionnaire-II
Finding: All 45 participants completed the study, and 93.3% rated their overall satisfaction with their OACTICs experience as “completely satisfied”.
Originality: OACTICs is a cost-effective and time-efficient treatment approach that enhances the psychological well-being of caregivers of dementia. Furthermore, this is a novel study conducted in Pakistan for this population.
Keywords: Caregiver, Dementia, Anxiety, Depression, Quality of life, Psychological flexibility
External Link(s)

Registration Citation

Citation
Gul, Mahvia. 2023. "Feasibility and Acceptability of an Acceptance and Commitment Therapy Intervention for Caregivers of Dementia: A Single-Arm Randomized Controlled Trial." AEA RCT Registry. November 01. https://doi.org/10.1257/rct.12366-1.0
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
Acceptance and commitment therapy (ACT) is a type of psychotherapy that was created in accordance with the Contextual Behavior Science Association's (CBSA 2015) guidelines and tailored to the needs of the participants. In this study, a psychologist offers dementia caregivers the Online Acceptance and Commitment Therapy Intervention for Caregivers (OACTICs). Following the baseline evaluation, the OACTICs session was planned 1-3 weeks later. OACTICs is a mindfulness-based behavioral therapy that incorporates the key ACT processes of growing acceptance of unfavorable, private events that are beyond a person's control and acknowledging a person's commitment to and actions in living a valued life. Caregivers were given an OACTIC binder before the first session, which contained reading materials, activities, and handouts summarizing the subjects covered throughout the sessions.
The 6-week intervention was made up of 1-hour online sessions. The intervention was composed of an introduction, an examination of the problems, abandonment of control, observation, mindfulness, values, commitment, and a conclusion. Different metaphors were used to achieve the target. These were all intended to promote psychological flexibility by practicing one or more of the six skills in each session (see Table 1 for session details). Using a systematic fidelity checklist similar to the one used in our past ACT interventions, 23 (25.6%) of the audio-recorded OACTIC sessions were evaluated for adherence to the intervention manual. The interventionist appears to have adhered closely to the intervention handbook based on the average fidelity rating of 98.6% (SD = 0.03) across all sessions. Participants got a brief summary of the session and their homework, which usually consisted of three practical exercises, at the end of each session. Every class began with a review of the previous day's homework.
Intervention Start Date
2022-11-01
Intervention End Date
2023-03-15

Primary Outcomes

Primary Outcomes (end points)
Generalized Anxiety Disorder Scale
Patient Health Questionnaire
Acceptance and Action Questionnaire-II
WHO-QOL
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Bristol Activities of Daily Living Scale (BADLS)
The Experience of Suffering measure
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
A single-arm randomized controlled trial was conducted, spanning the period from October 2022 to April 2023. The principal objective of this single-arm study was to evaluate the feasibility and acceptability of the intervention. Data pertaining to outcome measures were gathered both prior to and following the intervention, as well as during the 3-month follow-up interval.
Experimental Design Details
Randomization Method
A proficient research assistant collected caregivers' data online and securely inputted it into a REDCap (Research Electronic Data Capture) database.
Randomization Unit
Individuals
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
65 individuals
Sample size: planned number of observations
65 participants
Sample size (or number of clusters) by treatment arms
45 participants
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials