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Completed

NCT Number: NCT04670406

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

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.

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Key information

Conditions

Spinal Cord Injuries Anxiety Disorders Behavior Behavioral Symptoms Central Nervous System Diseases Depression Mental Disorders Nervous System Diseases Psychological Distress Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Self-Compassion Scale- Short Form (SCS-SF)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2020
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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