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

Primary Purpose

Spinal Cord Injuries, Psychological Distress

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

acceptance and commitment therapy (ACT) combined with psychoeducation

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Acceptance and Commitment Therapy, Quality of life, Spinal cord injury, Psychological distress, Depression, Anxiety, Stress, Mindfulness, Self-compassion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

acceptance and commitment therapy (ACT) combined with psychoeducation

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04670406

First Posted

December 8, 2020

Last Updated

September 5, 2021

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT04670406

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

May 7, 2021 (Actual)

Primary Completion Date

August 23, 2021 (Actual)

Study Completion Date

August 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries, Psychological Distress

Keywords

Acceptance and Commitment Therapy, Quality of life, Spinal cord injury, Psychological distress, Depression, Anxiety, Stress, Mindfulness, Self-compassion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

acceptance and commitment therapy (ACT) combined with psychoeducation

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

acceptance and commitment therapy (ACT) combined with psychoeducation

Intervention Description

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

Primary Outcome Measure Information:

Title

Depression, Anxiety and Stress Scale (DASS) - 21

Description

Time Frame

Change from baseline to 8 weeks

Title

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

Description

Time Frame

Change from baseline to 8 weeks

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Change from baseline to 8 weeks

Title

Engagement in Meaningful Activities Survey (EMAS)

Description

Time Frame

Change from baseline to 8 weeks

Title

Action and Acceptance Questionnaire (AAQ)-II

Description

The Action and Acceptance Questionnaire (AAQ)-II is a 7-item self-report questionnaire measuring psychological flexibility. Higher scores indicate poor psychological flexibility.

Time Frame

Change from baseline to 8 weeks

Title

Cognitive Fusion Questionnaire (CFQ)-7

Description

The Cognitive Fusion Questionnaire (CFQ)-7 is a 7-item self-report questionnaire measuring cognitive fusion. Higher scores indicate greater levels of cognitive fusion.

Time Frame

Change from baseline to 8 weeks

Title

Spinal Cord Injury - Quality of Life (SCI-QOL) Grief and Loss Short form

Description

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.

Time Frame

Change from baseline to 8 weeks

Title

Spinal Cord Injury - Quality of Life (SCI-QOL) Resilience Short form

Description

SCI-QOL Resilience Short form has 8 items assessing resilience. Higher scores indicate more resilience.

Time Frame

Change from baseline to 8 weeks

Title

Mindful Attention Awareness Scale (MAAS)

Description

Time Frame

Change from baseline to 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Areum Han, PhD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35156500

Citation

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.

Results Reference

derived

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

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