Clinical trial NCT04670406: A Guided Online ACT Intervention Combined With Psychoeducation for People With Spinal Cord Injury
Official title: A Guided Online Acceptance and Commitment Therapy (ACT) Intervention Combined With Psychoeducation for People With Spinal Cord Injury: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Psychological Distress
Keywords: Acceptance and Commitment Therapy
Quality of life
Spinal cord injury
Psychological distress
Depression
Anxiety
Stress
Mindfulness
Self-compassion
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this preliminary study is to examine the effects of a guided online acceptance and commitment therapy (ACT) intervention combined with psychoeducation on people with spinal cord injury (SCI) who experience psychological distress.

Detailed description: This project will employ a one-group pretest-posttest design to investigate the effects of a guided online acceptance and commitment therapy (ACT) intervention combined with psychoeducation on quality of life and mental health of people with spinal cord injury (SCI) who experience psychological distress. After the pretest evaluation, eligible participants will receive 8 weekly sessions, including 6 ACT sessions and 2 psychoeducation sessions, delivered by trained coaches through Zoom videoconferencing. Each session lasts for one hour. Primary outcome measures will be psychological distress measured by the Depression, Anxiety and Stress Scale (DASS)- 21 and Spinal Cord Injury - Quality of Life (SCI-QOL). A one-time interview at the completion of the 8 sessions will be conducted to explore participants' experiences in the sessions.

Eligibility criteria: Inclusion Criteria:

* community-dwelling adults (age 18 or over) living in the community who had a spinal cord injury
* suffering at least mild symptoms of psychological distress measured by the DASS-21
* having a computer/smartphone with internet access capable of doing web browsing and video-conferencing
* being able to provide informed consent by understanding the nature of study participation.

Exclusion Criteria:

* having cognitive, physical, or sensory deficits, or language barriers (non- English communicator) that impede study participation
* receiving a psychological therapy currently
* having psychiatric hospitalizations or diagnoses of mental illness in the previous 2 years
* taking antipsychotic or anticonvulsant medication at the time of recruitment
* having the possibility of study dropouts due to other medical conditions

Primary outcomes:
measure: Depression, Anxiety and Stress Scale (DASS) - 21
timeFrame: Change from baseline to 8 weeks
measure: World Health Organization Quality of Life Instruments (WHOQOL-BREF) - psychological health component
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: Self-Compassion Scale- Short Form (SCS-SF)
timeFrame: Change from baseline to 8 weeks
measure: Engagement in Meaningful Activities Survey (EMAS)
timeFrame: Change from baseline to 8 weeks
measure: Action and Acceptance Questionnaire (AAQ)-II
timeFrame: Change from baseline to 8 weeks
measure: Cognitive Fusion Questionnaire (CFQ)-7
timeFrame: Change from baseline to 8 weeks
measure: Spinal Cord Injury - Quality of Life (SCI-QOL) Grief and Loss Short form
timeFrame: Change from baseline to 8 weeks
measure: Spinal Cord Injury - Quality of Life (SCI-QOL) Resilience Short form
timeFrame: Change from baseline to 8 weeks
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Change from baseline to 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Areum Han, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han A, Wilroy JD, Jenkins J, Yuen HK. Effects of a coach-guided videoconferencing acceptance and commitment therapy intervention combined with psychoeducation on distressed individuals living with spinal cord injury: a preliminary mixed-methods study. Disabil Rehabil. 2023 Feb;45(4):644-654. doi: 10.1080/09638288.2022.2038283. Epub 2022 Feb 12.