Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04458870
Other study ID # IRB-300005230
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date November 9, 2020

Study information

Verified date December 2020
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The pilot project aims to investigate the feasibility and the preliminary efficacy of a guided online acceptance and commitment therapy (ACT) intervention for distressed family caregivers of people with dementia. A one-group pretest-posttest design (n=15) will be used to investigate the potential effects of the 10 weekly online ACT intervention session on caregivers' outcomes at posttest (10 weeks).


Description:

This project will employ one-group pretest-posttest design to investigate the potential impact of a guided online ACT intervention on improving quality of life and psychological health in distressed family caregivers of people with dementia. After the baseline evaluation, eligible caregivers will receive 10 weekly ACT sessions, individually delivered by a licensed professional counselor online. Each session lasts for one hour. Primary outcome measures will be psychological distress measured by the Depression, Anxiety and Stress Scale (DASS)- 21 and care-related quality of life measured by the Care-related Quality of Life instrument (CarerQol). A one-time interview at the completion of the 10 weekly sessions will be conducted to explore caregivers' experiences in the intervention.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date November 9, 2020
Est. primary completion date November 9, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. community-dwelling adults (age 18 or over) who are currently taking primary responsibility for the care of a relative with dementia living in the community 2. devoting at least 1 hour daily to the care of the relative with dementia 3. having cared for a relative with dementia for at least 3 months 4. suffering at least mild symptoms of psychological distress measured by the DASS-21 (scores = 5 on Depression Subscale of DASS-21, scores = 4 on Anxiety Subscale, or scores = 8 on Stress Subscale) 5. having a computer/smartphone with internet access capable of doing web browsing and video-conferencing 6. being able to provide informed consent by understanding the nature of study participation. Exclusion Criteria: 1. having cognitive, physical, or sensory deficits, or language barriers (non-English communicator) that impede study participation 2. receiving a psychological therapy currently 3. having psychiatric hospitalizations or diagnoses of mental illness in the previous 2 years 4. taking antipsychotic or anticonvulsant medication at the time of recruitment 5. considering or planning to place family members of dementia in a nursing home within 6 months 6. having the possibility of study dropouts due to other medical conditions of family members with dementia (e.g., conditions that may impede study participation due to frequent hospitalization or death).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Acceptance and Commitment Therapy
Participants will receive 10 weekly individual acceptance and commitment therapy by a trained coach through zoom video-conferencing.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Cortisol levels by collecting fingernails A biological measure of stress will be assessed through analysis of cortisol levels in caregivers' nail samples. Change from baseline to 10 weeks
Other System Usability Scale The System Usability Scale (SUS) is a 10-item self-report questionnaire measuring usability of a program/intervention. Higher scores indicate greater levels of perceived usability of the intervention. at 10 weeks
Primary Depression, Anxiety and Stress Scale - 21 The Depression, Anxiety and Stress Scale (DASS)- 21 is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and stress. Higher scores represent greater symptomatology. Change from baseline to 10 weeks
Primary Care-related Quality of Life instrument Care-related Quality of Life instrument (CarerQol) assesses the impact of providing informal care on caregivers and combines a 7-item subjective burden measure (CarerQol-7D) with well-being (CarerQol-VAS). Higher scores indicate higher levels of quality of life. Change from baseline to 10 weeks
Secondary Zarit Burden Interview The Zarit Burden Interview (ZBI) is a 12-item self-report questionnaire assessing caregiver. Higher scores indicate higher levels of burden. Change from baseline to 10 weeks
Secondary Brief Coping Orientation to Problems Experienced Brief COPE (Coping Orientation to Problems Experienced) is a 28-item self-report questionnaire measuring coping strategies in response to stressors. Three composite subscales include problem-focused, emotion-focused, and dysfunctional coping strategies. Higher scores on a subscale indicates more frequent use of the relevant coping strategies. Change from baseline to 10 weeks
Secondary Engagement in Meaningful Activities Survey The Engagement in Meaningful Activities Survey (EMAS) is a 12-item self-assessment instrument that measures a person's subjective experience of the meaningfulness of everyday activities. Higher scores indicate greater levels of engagement in meaningful activities. Change from baseline to 10 weeks
Secondary Experiential Avoidance in Caregiving Questionnaire The Experiential Avoidance in Caregiving Questionnaire (EACQ) is a 15-item self-report questionnaire measuring experiential avoidance in caregivers. Higher scores indicate greater levels of experiential avoidance. Change from baseline to 10 weeks
Secondary Acceptance and Action Questionnaire-II The Action and Acceptance Questionnaire (AAQ)-II is a 7-item self-report questionnaire measuring psychological flexibility. Higher scores indicate poor psychological flexibility. Change from baseline to 10 weeks
Secondary Cognitive Fusion Questionnaire The Cognitive Fusion Questionnaire (CFQ)-7 is a 7-item self-report questionnaire measuring cognitive fusion. Higher scores indicate greater levels of cognitive fusion. Change from baseline to 10 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT05526235 - A Scalable Psychological Intervention to Reduce Psychological Distress Among Workers of Assisted Living Facilities N/A
Recruiting NCT05413941 - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease N/A
Completed NCT03720600 - Forms of Racial Discrimination Study N/A
Not yet recruiting NCT05400096 - Psychological Wellbeing in Clients in Tier 3 Weight Management Service N/A
Completed NCT02212236 - Psychological Intervention for Distress During HSCT Phase 2
Active, not recruiting NCT00892138 - Mindfulness Training for Stress Management N/A
Recruiting NCT04815278 - NC Works4Health: Reducing Chronic Disease Risks in Socioeconomically Disadvantaged, Unemployed Populations N/A
Recruiting NCT04936828 - Ecological Momentary Intervention for Stroke Caregivers' Psychological Support N/A
Withdrawn NCT03341364 - Acceptance and Commitment Based Group Therapy for Cancer Patients N/A
Recruiting NCT05137925 - Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum N/A
Completed NCT04376723 - Mental Health Apps for Mild Psychological Distress Amongst Adolescents N/A
Active, not recruiting NCT04020497 - Ensemble Programme an Early Intervention for Informal Caregivers of Psychiatric Patients N/A
Not yet recruiting NCT03652168 - Stress Free UC Merced: The Effect of 8 Weeks of Mindfulness App Headspace on Stress in a Sample of University Employees Phase 3
Terminated NCT03587896 - Implementation of Self Help Plus in Adult Syrian Refugees in Turkey (RE-DEFINE) N/A
Completed NCT03721770 - Psychological Impact in a Relative, Following the Announcement of the Death of a Loved One After Cardiac Arrest and the Early Request for Organ Donation
Recruiting NCT05849454 - Messy Memories: Mobile Application Therapy Following Critical Illness N/A
Recruiting NCT05525299 - Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors N/A
Recruiting NCT06052904 - Music Breathing for Caregivers of Children Newly Diagnosed With Cancer N/A