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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT04670406
Collaborator
(none)
10
1
1
3.5
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: acceptance and commitment therapy (ACT) combined with psychoeducation
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Guided Online Acceptance and Commitment Therapy (ACT) Intervention Combined With Psychoeducation for People With Spinal Cord Injury: A Preliminary Study
Actual Study Start Date :
May 7, 2021
Actual Primary Completion Date :
Aug 23, 2021
Actual Study Completion Date :
Aug 23, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

  • Principal Investigator: Areum Han, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Areum Han, Assistant professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT04670406
Other Study ID Numbers:
  • IRB-300006536
First Posted:
Dec 17, 2020
Last Update Posted:
Sep 8, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Areum Han, Assistant professor, University of Alabama at Birmingham
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2021