Acceptance and Commitment Therapy for Depression in Spinal Cord Injury

Not currently recruiting at 1 trial location

Overseen By Eva Okereke-Enechukwu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Cognitive deficits, Suicidal intent, Psychiatric hospitalizations, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an 8-week Acceptance and Commitment Therapy (ACT) program can improve mental health in people with spinal cord injuries (SCI) who also experience depression. Participants will either receive ACT through video sessions or continue with their usual care and be offered ACT later. The goal is to determine if ACT can reduce depression and enhance quality of life by teaching mindfulness and acceptance. Suitable candidates for this trial include those with SCI who have mild to severe depression and internet access. As an unphased trial, this study provides a unique opportunity to explore innovative therapy methods that could enhance mental health and quality of life.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual care, especially if you are in the wait-list control group.

What prior data suggests that Acceptance and Commitment Therapy (ACT) is safe for individuals with spinal cord injury?

Research has shown that Acceptance and Commitment Therapy (ACT) is generally safe and effective for reducing depression and improving quality of life. Although specific safety data for people with spinal cord injury and depression is lacking, studies have found that ACT aids in managing emotions and increasing mental flexibility, both crucial for mental health. ACT is a proven therapy, having been tested and shown to work well in other groups. This suggests it is safe to use, even without detailed safety data for this specific group yet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy (ACT) for depression in spinal cord injury patients because it offers a psychological approach that is different from traditional treatments like medication or standard cognitive-behavioral therapy. ACT focuses on helping individuals accept their thoughts and feelings without judgment and commit to actions aligned with their values, potentially leading to better emotional resilience. This therapy is delivered through videoconferencing, making it more accessible for individuals with mobility challenges. By emphasizing acceptance and mindfulness, ACT may offer a novel way to improve mental health outcomes for those living with spinal cord injuries.

What evidence suggests that Acceptance and Commitment Therapy might be an effective treatment for depression in individuals with spinal cord injury?

Research has shown that Acceptance and Commitment Therapy (ACT), which participants in this trial may receive, can reduce depression and improve mental health. ACT teaches individuals to manage difficult thoughts and feelings through mindfulness and acceptance. Studies have found that ACT's main techniques significantly lessen depression, even for those with spinal cord injuries (SCI). For individuals with SCI, ACT also encourages greater participation in meaningful activities. Overall, ACT is a proven method that effectively supports individuals in managing mental health challenges. ^{1 2 6 7 8}

Who Is on the Research Team?

Areum Han, PhD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for adults over 18 with spinal cord injuries who feel at least mildly depressed, as shown by a PHQ-9 score of 5 or more. Participants need internet access and a device like a computer or smartphone to join the videoconferencing sessions.

Inclusion Criteria

I am an adult living with a spinal cord injury.

I have a device like a computer or smartphone that can access the internet.

I have mild or more severe depression symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive eight weekly individual ACT sessions guided by a coach through videoconferencing

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a booster session at 1-month follow-up

2 months

1 booster session (virtual)

Wait-list Control

Participants in the wait-list control group maintain their usual care and have the option to receive ACT sessions after the study

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance and Commitment Therapy (ACT)

Trial Overview The study tests if Acceptance and Commitment Therapy (ACT) delivered through video calls can help improve mental health in people with spinal cord injuries and depression. It compares an 8-week ACT program with a wait-list group that continues usual care.

How Is the Trial Designed?

Group I: Acceptance and commitment therapy (ACT) group Experimental Treatment 1 Intervention

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.

Group II: Wait-list control group Active Control 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

The Craig H. Neilsen Foundation

Collaborator

Trials

62

Recruited

3,100+

Published Research Related to This Trial

In a study of 159 individuals with spinal cord injury, key components of Acceptance and Commitment Therapy (ACT) such as acceptance, values pursuit, and defusion were found to significantly reduce anxiety levels.

The overall ACT processes also contributed to lower perceived stress, suggesting that tailored ACT-based interventions could be effective in managing anxiety and stress for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Acceptance and Commitment Therapy Core Processes on Anxiety and Stress in Persons With Spinal Cord Injury: A Cross-sectional Study. Dorenkamp, MA., Waldron-Perrine, B., Hanks, R.[2023]

Acceptance and Commitment Therapy (ACT) significantly reduced depressive symptoms in physically disabled individuals, with a notable decrease of -10.39 points on the Beck Depression Inventory-II after eight weeks compared to the control group.

Participants receiving ACT also showed significant improvements in psychological flexibility, adaptive emotion regulation, and overall psychological well-being, indicating that ACT not only helps with depression but also enhances emotional and psychological resilience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for the treatment of depression in persons with physical disability: a randomized controlled trial. Zemestani, M., Mozaffari, S.[2022]

The study found that coach-guided videoconferencing acceptance and commitment therapy (ACT) significantly reduced depression, anxiety, stress, and grief in 10 individuals with spinal cord injury (SCI) after 8 sessions, indicating its potential as an effective psychological intervention.

Participants reported improved coping skills, self-compassion, and engagement in meaningful activities, suggesting that ACT can help individuals with SCI develop better mental health strategies, although it did not significantly change quality of life or resilience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Han, A., Wilroy, JD., Jenkins, J., et al.[2023]

Acceptance and Commitment Therapy (ACT) effectively enhances psychological flexibility and has shown efficacy in treating a variety of psychiatric disorders, including depression, anxiety, and PTSD, with a meta-analysis revealing an average effect size of 0.66 at post-treatment across 704 participants.

ACT not only improves mental health outcomes but also benefits other medical areas such as chronic pain management and smoking cessation, demonstrating its versatility and positive impact on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acceptance and commitment therapy]. Ducasse, D., Fond, G.[2019]

In a study of 159 individuals with spinal cord injury, Acceptance and Commitment Therapy (ACT) processes significantly predicted levels of depressive symptoms and pain interference, accounting for 29-56% of the variance in these outcomes.

Specifically, the core ACT processes of Pursuit of Values and Emotional Acceptance were strongly linked to lower depressive symptoms, while Self-as-Context and Emotional Acceptance were associated with reduced pain interference, suggesting these processes could be effective targets for therapeutic interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between Acceptance and Commitment Therapy (ACT) processes and depressive symptoms and pain interference in persons with spinal cord injury (SCI). Waldron-Perrine, B., Kisser, J., Robinett, E., et al.[2022]

The study emphasizes the need for clearer definitions and distinctions between diagnosable depression and other emotional responses like anxiety and distress in individuals with spinal cord injuries, which can improve understanding and treatment.

It reviews the correlates of depressive behaviors in this population and provides guidelines for more effective research and clinical practices in addressing depression among those with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression following spinal cord injury. Elliott, TR., Frank, RG.[2022]

In a study of 60 patients with spinal cord injury and PTSD, combining rehabilitation therapy with acceptance commitment therapy (ACT) significantly reduced PTSD symptoms and improved functional independence compared to rehabilitation alone.

Patients receiving the combined treatment showed greater improvements in their functional independence measure (FIM) scores at 2 and 3 months post-treatment, indicating that ACT enhances the effectiveness of rehabilitation for better self-care and overall recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of acceptance and commitment therapy on rehabilitation patients with spinal cord injury. Huang, G., Lin, BL., Hu, JH., et al.[2021]

Acceptance and Commitment Therapy (ACT) shows promising effectiveness in improving functionality and well-being for individuals with psychological disturbances or medical problems, including those with acquired brain injuries (ABI).

There is a growing body of evidence suggesting that ACT and mindfulness-based interventions could be beneficial in the rehabilitation of ABI patients, highlighting the need for further research to rigorously test their efficacy in helping these individuals lead meaningful lives despite their challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it time to act? The potential of acceptance and commitment therapy for psychological problems following acquired brain injury. Kangas, M., McDonald, S.[2021]

Acceptance and Commitment Therapy (ACT) showed significant improvements in global mental health, depression, cognitive fusion, and values in complex clients treated by both psychologists and non-psychologists in a National Health Service setting.

The positive effects of ACT were partially maintained at a 3-month follow-up, indicating its potential long-term benefits, and outcomes were similar regardless of the therapist's professional background.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of Acceptance and Commitment Therapy Delivered by Psychologists and Non-Psychologists in an NHS Community Adult Mental Health Service: a Preliminary Analysis. Richardson, T., Bell, L., Bolderston, H., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36048060/

Association between Acceptance and Commitment ... These results demonstrate that ACT core processes account for moderate to large amounts of the variance in indicators of depressive symptoms and pain ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06233656

NCT06233656 | Acceptance and Commitment Therapy for ... Acceptance and commitment therapy (ACT) is an evidence-based approach that can lessen symptoms of mental health disorders (e.g., depressive symptoms) and ...

3. psycnet.apa.org psycnet.apa.org/record/2022-94759-001

Association between Acceptance and Commitment Therapy ... Association between Acceptance and Commitment Therapy (ACT) processes and depressive symptoms and pain interference in persons with spinal cord injury (SCI).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8498220/

Effect of acceptance and commitment therapy on ... The combination of rehabilitation therapy and ACT could immediately reduce stress levels and significantly improve impaired function, lifelong self-care ability ...

5. archives-pmr.org archives-pmr.org/article/S0003-9993(22)01756-7/abstract

Influence of Acceptance and Commitment Therapy Core ... : The results of our study indicate that considerable variance in anxiety and stress in individuals with SCI is accounted for by the core ...

6. withpower.com withpower.com/trial/phase-wounds-and-injuries-2-2023-97904

Acceptance and Commitment Therapy for Depression in ... The provided research does not explicitly mention safety data for Acceptance and Commitment Therapy (ACT) in the context of depression in spinal cord injury.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jpr.12572

Acceptance and Commitment Therapy is Effective in ... Acceptance and Commitment Therapy is Effective in Reducing Strong Opioid Use in a Patient with Chronic Pain after Spinal Cord Injury: A Case ...

8. brieflands.com brieflands.com/articles/ijpbs-105378

The Effect of Acceptance and Commitment Therapy on ... According to the findings, ACT can improve psychological flexibility and emotional regulation in patients with spinal cord injuries.