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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04670406
• Other study ID #: IRB-300006536
• Status: Completed
• Phase: N/A
• Start date: May 7, 2021
• Est. completion date: August 23, 2021

Study information

• Verified date: September 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 23, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychological Distress
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• 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.

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
Primary	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
Primary	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	Self-Compassion Scale- Short Form (SCS-SF)	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.	Change from baseline to 8 weeks
Secondary	Engagement in Meaningful Activities Survey (EMAS)	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 8 weeks
Secondary	Action and Acceptance Questionnaire (AAQ)-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 8 weeks
Secondary	Cognitive Fusion Questionnaire (CFQ)-7	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 8 weeks
Secondary	Spinal Cord Injury - Quality of Life (SCI-QOL) Grief and Loss Short form	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.	Change from baseline to 8 weeks
Secondary	Spinal Cord Injury - Quality of Life (SCI-QOL) Resilience Short form	SCI-QOL Resilience Short form has 8 items assessing resilience. Higher scores indicate more resilience.	Change from baseline to 8 weeks
Secondary	Mindful Attention Awareness Scale (MAAS)	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.	Change from baseline to 8 weeks