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Clinical Trials/NCT04670406
NCT04670406
Completed
Not Applicable

A Guided Online Acceptance and Commitment Therapy (ACT) Intervention Combined With Psychoeducation for People With Spinal Cord Injury: A Preliminary Study

University of Alabama at Birmingham1 site in 1 country10 target enrollmentMay 7, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
University of Alabama at Birmingham
Enrollment
10
Locations
1
Primary Endpoint
World Health Organization Quality of Life Instruments (WHOQOL-BREF) - psychological health component
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 7, 2021
End Date
August 23, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Areum Han

Assistant professor

University of Alabama at Birmingham

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

Outcomes

Primary Outcomes

World Health Organization Quality of Life Instruments (WHOQOL-BREF) - psychological health component

Time Frame: Change from baseline to 8 weeks

WHOQOL-BREF - psychological health component has 6 items measuring: bodily image and appearance; negative feelings; positive feelings; self-esteem; spirituality / personal beliefs; and thinking, learning, memory and concentration. Higher scores denote higher quality of life in terms of psychological health.

Depression, Anxiety and Stress Scale (DASS) - 21

Time Frame: Change from baseline to 8 weeks

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.

Secondary Outcomes

  • Action and Acceptance Questionnaire (AAQ)-II(Change from baseline to 8 weeks)
  • Spinal Cord Injury - Quality of Life (SCI-QOL) Resilience Short form(Change from baseline to 8 weeks)
  • Self-Compassion Scale- Short Form (SCS-SF)(Change from baseline to 8 weeks)
  • Engagement in Meaningful Activities Survey (EMAS)(Change from baseline to 8 weeks)
  • Spinal Cord Injury - Quality of Life (SCI-QOL) Grief and Loss Short form(Change from baseline to 8 weeks)
  • Cognitive Fusion Questionnaire (CFQ)-7(Change from baseline to 8 weeks)
  • Mindful Attention Awareness Scale (MAAS)(Change from baseline to 8 weeks)

Study Sites (1)

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