A Guided Online ACT Intervention Combined With Psychoeducation for People With Spinal Cord Injury

NCT04670406 | Completed

• 1 other identifier: IRB-300006536
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Depression, Anxiety and Stress Scale (DASS) - 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 8 weeks

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

  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.

  Change from baseline to 8 weeks

Secondary Outcomes (7)

• 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

• Action and Acceptance Questionnaire (AAQ)-II

  Change from baseline to 8 weeks

• Cognitive Fusion Questionnaire (CFQ)-7

  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

Study Arms (1)

acceptance and commitment therapy (ACT) combined with psychoeducation

EXPERIMENTAL

Participants receive 8 weekly sessions, including 6 ACT sessions and 2 psychoeducation sessions, delivered by trained coaches through Zoom videoconferencing.

Behavioral: acceptance and commitment therapy (ACT) combined with psychoeducation

Interventions

acceptance and commitment therapy (ACT) combined with psychoeducation BEHAVIORAL

Participants receive 8 weekly sessions, including 6 ACT sessions and 2 psychoeducation sessions, delivered by trained coaches through Zoom videoconferencing.

acceptance and commitment therapy (ACT) combined with psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 35156500 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Areum Han, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 17, 2020
• Study Start: May 7, 2021
• Primary Completion: August 23, 2021
• Study Completion: August 23, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)