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

Not Applicable

Completed

• Conditions: Spinal Cord Injuries; Psychological Distress
• Interventions: Behavioral: acceptance and commitment therapy (ACT) combined with psychoeducation

• Registration Number: NCT04670406
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-17
• Study Start: 2021-05-07
• Primary Completion: 2021-08-23
• Study Completion: 2021-08-23
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-05
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
acceptance and commitment therapy (ACT) combined with psychoeducation	acceptance and commitment therapy (ACT) combined with psychoeducation	Participants receive 8 weekly sessions, including 6 ACT sessions and 2 psychoeducation sessions, delivered by trained coaches through Zoom videoconferencing.

Primary Outcome Measures

Name	Time	Method
World Health Organization Quality of Life Instruments (WHOQOL-BREF) - psychological health component	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	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 Outcome Measures

Name	Time	Method
Action and Acceptance Questionnaire (AAQ)-II	Change from baseline to 8 weeks	The Action and Acceptance Questionnaire (AAQ)-II is a 7-item self-report questionnaire measuring psychological flexibility. Higher scores indicate poor psychological flexibility.
Spinal Cord Injury - Quality of Life (SCI-QOL) Resilience Short form	Change from baseline to 8 weeks	SCI-QOL Resilience Short form has 8 items assessing resilience. Higher scores indicate more resilience.
Self-Compassion Scale- Short Form (SCS-SF)	Change from baseline to 8 weeks	Self-Compassion Scale- Short Form (SCS-SF) has 12 items assessing the relation of self-compassion to positive psychological health. Higher scores indicate higher levels of self-compassion.
Engagement in Meaningful Activities Survey (EMAS)	Change from baseline to 8 weeks	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.
Spinal Cord Injury - Quality of Life (SCI-QOL) Grief and Loss Short form	Change from baseline to 8 weeks	SCI-QOL Grief and Loss Short form has 9 items assessing grief and loss due to spinal cord injuries. Higher scores indicate more grief/loss.
Cognitive Fusion Questionnaire (CFQ)-7	Change from baseline to 8 weeks	The Cognitive Fusion Questionnaire (CFQ)-7 is a 7-item self-report questionnaire measuring cognitive fusion. Higher scores indicate greater levels of cognitive fusion.
Mindful Attention Awareness Scale (MAAS)	Change from baseline to 8 weeks	The MAAS is a 15-item scale assessing dispositional mindfulness (i.e., open or receptive awareness of and attention to what is taking place in the present). Higher scores reflect higher levels of dispositional mindfulness.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States