---
title: Acceptance and Commitment Therapy for Depressed People With Spinal Cord Injuries
nct_id: NCT06233656
overall_status: ACTIVE_NOT_RECRUITING
phase: NA
sponsor: University of South Florida
study_type: INTERVENTIONAL
primary_condition: Depression
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06233656.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06233656"
ct_last_update_post_date: 2026-02-05
last_seen_at: "2026-05-12T07:08:37.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Acceptance and Commitment Therapy for Depressed People With Spinal Cord Injuries

**Official Title:** Acceptance and Commitment Therapy for Depressed People With Spinal Cord Injuries: Testing Efficacy and Mechanisms of Change

**NCT ID:** [NCT06233656](https://clinicaltrials.gov/study/NCT06233656)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 140
- **Lead Sponsor:** University of South Florida
- **Collaborators:** The Craig H. Neilsen Foundation
- **Conditions:** Depression, Spinal Cord Injuries
- **Start Date:** 2024-04-30
- **Completion Date:** 2027-07
- **CT.gov Last Update:** 2026-02-05

## Brief Summary

Living with spinal cord injury (SCI) can have a significant negative impact on an individual's mental health and restrict participation in personally valued activities and roles. Acceptance and commitment therapy (ACT) is an evidence-based approach that can lessen symptoms of mental health disorders (e.g., depressive symptoms) and improve quality of life through mindfulness and acceptance processes and behavior change processes for valued living. Evidence for ACT for individuals living with SCI, however, is limited to a very few studies that involved in-person group-based ACT and did not focus on depressed individuals with SCI.

The primary goal of this study is to evaluate the effects of an 8-week videoconferencing ACT program on improving mental health outcomes in depressed individuals living with SCI. The primary hypotheses are that the ACT group will show improvements in depressive symptoms at posttest and 2-month follow-up compared to the wait-list control group. Investigators will invite 120 individuals living with SCI and reporting depressive symptoms and randomly assign them to either the ACT group or the wait-list control group. The ACT group will receive eight weekly individual ACT sessions guided by a coach through videoconferencing with a booster session at 1-month follow-up. The wait-list control group will continue his or her own care as usual during the study period and have the option to receive eight individual ACT sessions after study participation ends. Data will be collected at pretest, posttest, and 2-month follow-up and compared between the ACT group and the control group over time.

About 40% of individuals living with SCI report depressive symptoms and other mental health symptoms, and mental health disorders following SCI are associated with negative long-term outcomes. Managing uncomfortable or painful thoughts and emotions arising from functional limitations and accepting changed lives while moving forward for valued living through ACT skill practice will help individuals with SCI alleviate symptoms of mental health conditions, promote engagement in personally valued activities, and improve quality of life.

## Detailed Description

Living with spinal cord injury (SCI) can have a significant negative impact on an individual's mental health and restrict participation in personally valued activities and roles. About 40% of individuals with SCI report depressive symptoms and other mental health symptoms, which are associated with negative long-term outcomes.

Acceptance and commitment therapy (ACT) is an empirically supported transdiagnostic approach that can mitigate symptoms of mental health disorders and improve quality of life through mindfulness and acceptance processes and behavior change processes for valued living. ACT is based on the psychological flexibility model involving six processes that serve as a mechanism of change (i.e., acceptance, cognitive defusion, being present, observing self, values, and committed action). Evidence for ACT for individuals with SCI, however, is limited to a very few studies that involved in-person group-based ACT and did not focus on depressed individuals with SCI.

This project aims to test the efficacy of an 8-week videoconferencing ACT program for improving mental health in depressed individuals living with SCI. The hypotheses are that the ACT group will show improvements in depressive symptoms (the primary outcome), secondary mental health outcomes (e.g., anxiety, stress, and grief), and ACT processes (e.g., psychological flexibility and engaged living) at posttest and 2-month follow-up compared to the wait-list control group. Also, the project aims to examine the mediating effects of the ACT psychological flexibility processes on reducing depressive symptoms in individuals living with SCI.

This study will use a two-arm parallel-group, randomized controlled trial design. The investigators will recruit approximately 120-140 depressed individuals living with SCI and randomly assign them to either the ACT group or the wait-list control group. The ACT group will receive eight weekly individual ACT sessions guided by a coach through videoconferencing with a booster session at 1-month follow-up. The wait-list control group will maintain his or her own care as usual during the study period and have the option to receive eight individual ACT sessions after study participation ends. Data will be collected at pretest, posttest, and 2-month follow-up. The investigators will use generalized linear mixed-effects models to examine the relative impact on the ACT group compared to the wait-list control group at posttest and 2-month follow-up. The mediation analysis will consist of the outcome model and the mediator model. After fitting the models, the investigators will estimate direct effect and indirect effect (i.e., the mediated effect).

Managing uncomfortable or painful thoughts and emotions arising from functional limitations and accepting changed lives while moving forward for valued living through ACT skill practice will help individuals with SCI alleviate symptoms of mental health conditions, promote engagement in personally valued activities, and improve quality of life. The investigators expect the findings of this study to contribute to the limited evidence for internet-delivered ACT in individuals living with SCI and lay the necessary groundwork to provide important knowledge and guidance for future clinical trials and practice.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* community-dwelling adults (aged 18 years or older) living with spinal cord injuries
* having at least mild depressive symptoms as measured by the PHQ-9 (scores ≥ 5)
* having a web-enabled device (e.g., a computer or a smartphone) with internet access

Exclusion Criteria:

* having cognitive deficits or language barriers that might impede study participation
* having suicidal intent or attempts in the past 6 months
* having psychiatric hospitalizations in the previous 2 years
* having a diagnosis with bipolar disorder or psychotic disorders (e.g., schizophrenia)
* having a prior experience with acceptance and commitment therapy
```

## Arms

- **Acceptance and commitment therapy (ACT) group** (EXPERIMENTAL) — The ACT group will receive eight weekly individual ACT sessions guided by a coach through videoconferencing with a booster session at 1-month follow-up.
- **Wait-list control group** (NO_INTERVENTION) — The wait-list control group will maintain his or her own care as usual during the study period and receive eight individual ACT sessions after study participation ends.

## Interventions

- **Acceptance and commitment therapy (ACT)** (BEHAVIORAL) — Participants assigned to the ACT group will receive 8 weekly individual ACT sessions guided by a coach for one hour per week over 8 weeks through Zoom videoconferencing.

## Primary Outcomes

- **Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Patient Health Questionnaire-9 (PHQ-9)** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_ — The PHQ-9 is a 9-item questionnaire assessing depressive symptoms on a scale of 0 to 3. Scores range from 0 to 27. Higher scores indicate greater symptomatology in depression.

## Secondary Outcomes

- **Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Spinal Cord Injury-Quality of Life (SCI-QOL) Depression Short form** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_
- **Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Generalized Anxiety Disorder-7 (GAD-7)** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_
- **Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Perceived Stress Scale - 10 (PSS-10)** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_
- **Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the World Health Organization Quality of Life (WHOQOL) - Psychological health component** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_
- **Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Spinal Cord Injury-Quality of Life (SCI-QOL) Grief and Loss Short form** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_
- **Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the SCI-QOL Resilience Short form** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_
- **Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Self-Compassion Scale - Short Form (SCS-SF)** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_
- **Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Multidimensional Psychological Flexibility Inventory - 24 (MPFI-24)** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_
- **Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up on the Action and Acceptance Questionnaire-II (AAQ-II)** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_
- **Change from baseline to immediately after the intervention (or 2 weeks) and 2 month follow-up on the Cognitive Fusion Questionnaire -7 (CFQ-7)** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_
- **Change from baseline to immediately after the intervention (or 8 weeks) and 2-month follow-up on the Engaged Living Scale -9 (ELS-9)** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_
- **Change from baseline to immediately after the intervention (or 8 weeks) and 2-month follow-up on the Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_
- **Change from baseline to immediately after the intervention (or 8 weeks) and 2-month follow-up on the Satisfaction with Life Scale (SWLS)** _(time frame: Change from baseline to immediately after the intervention (or 8 weeks) and 2 month follow-up)_

## Locations (1)

- University of South Florida, Tampa, Florida, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of south florida|tampa|florida|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06233656.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06233656*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*