Clinical trial NCT05725161: Acceptance and Commitment Therapy for Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years
Official title: Acceptance and Commitment Therapy Supplemented With Psychoeducation for Improving Mental Health of Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Spinal Cord Injuries
Keywords: Acceptance and Commitment Therapy
Anxiety
Depression
Grief
Mindfulness
Resilience
Self-compassion
Stress
Spinal cord injuries
Quality of life
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Paralyzed Veterans of America
First posted: 2023-02-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to assess effects of videoconferencing acceptance and commitment therapy (ACT) on mental health outcomes in individuals living with spinal cord injuries (SCI). A total of 34 individuals living with SCI sustained within 5 years and experiencing depressive symptoms will be recruited and randomly assigned to either the ACT group or the wait-list control group. The ACT group will receive 8 weekly individual ACT sessions guided by a coach through videoconferencing. The wait-list group will receive ACT sessions after the study period ends. We will provide psychoeducation materials related to SCI as supplemental resources to both groups. Mental health outcomes using self-reported questionnaires will be collected at pretest, posttest, and 2-month follow-up. Exploratory hypotheses are that the group undergoing the ACT intervention supplemented with psychoeducation will show improvements in mental health outcomes (e.g., depression) and ACT processes (e.g., psychological flexibility) at posttest and 2-month follow-up, compared to the wait-list control group provided with psychoeducation materials alone. Interviews will be conducted at posttest to explore the participants' experiences in ACT.

Detailed description: This randomized controlled trial aims to assess effects of videoconferencing acceptance and commitment therapy (ACT) on mental health outcomes in individuals living with spinal cord injuries (SCI). A total of 34 individuals living with SCI sustained within 5 years and experiencing depressive symptoms will be recruited and randomly assigned to either the ACT group or the wait-list control group. The ACT group will receive 8 weekly individual ACT sessions guided by a coach through videoconferencing. The wait-list group will receive ACT sessions after the study period ends. We will provide psychoeducation materials related to SCI as supplemental resources to both groups. Mental health outcomes using self-reported questionnaires will be collected at pretest, posttest, and 2-month follow-up. Exploratory hypotheses are that the group undergoing the ACT intervention supplemented with psychoeducation will show improvements in depression (primary outcome), secondary mental health outcomes (e.g., anxiety, stress, and grief), and ACT processes (e.g., psychological flexibility) at posttest and 2-month follow-up, compared to the wait-list control group provided with psychoeducation materials alone. Interviews will be conducted at posttest to explore the participants' experiences in ACT.

Eligibility criteria: Inclusion Criteria:

* community-dwelling adults (aged 18 years or older) living with spinal cord injuries sustained within 5 years
* having at least mild depression measured by the Patient Health Questionnaire-9
* having a computer or a smartphone and internet access at home

Exclusion Criteria:

* having cognitive deficits or language barriers that might impede study participation
* having suicidal attempts within 6 months;
* having a prior experience with acceptance and commitment therapy

Primary outcomes:
measure: Change from baseline to immediately after the intervention and 2 month follow-up on the Patient Health Questionnaire-9
timeFrame: Change from baseline to immediately after the intervention and 2 month follow-up
Secondary outcomes:
measure: Change from baseline to immediately after the intervention and 2 month follow-up on the Generalized Anxiety Disorder-7
timeFrame: Change from baseline to immediately after the intervention and 2 month follow-up
measure: Change from baseline to immediately after the intervention and 2 month follow-up on the Perceived Stress Scale
timeFrame: Change from baseline to immediately after the intervention and 2 month follow-up
measure: Change from baseline to immediately after the intervention and 2 month follow-up on the World Health Organization Quality of Life - Psychological health component
timeFrame: Change from baseline to immediately after the intervention and 2 month follow-up
measure: Change from baseline to immediately after the intervention and 2 month follow-up on the Spinal Cord Injury-Quality of Life (SCI-QOL) Grief and Loss Short form
timeFrame: Change from baseline to immediately after the intervention and 2 month follow-up
measure: Change from baseline to immediately after the intervention and 2 month follow-up on the SCI-QOL Resilience Short form
timeFrame: Change from baseline to immediately after the intervention and 2 month follow-up
measure: Change from baseline to immediately after the intervention and 2 month follow-up on the Self-Compassion Scale- Short Form
timeFrame: Change from baseline to immediately after the intervention and 2 month follow-up
measure: Change from baseline to immediately after the intervention and 2 month follow-up on the Action and Acceptance Questionnaire-II
timeFrame: Change from baseline to immediately after the intervention and 2 month follow-up
measure: Change from baseline to immediately after the intervention and 2 month follow-up on the Cognitive Fusion Questionnaire
timeFrame: Change from baseline to immediately after the intervention and 2 month follow-up
measure: Change from baseline to immediately after the intervention and 2-month follow-up on the Engaged Living Scale
timeFrame: Change from baseline to immediately after the intervention and 2 month follow-up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Areum Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: