Acceptance and Commitment Therapy for Depression in Spinal Cord Injury

Overseen By Jereme Wilroy, PhD

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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Acceptance and Commitment Therapy (ACT) for depression in spinal cord injury?

Research shows that Acceptance and Commitment Therapy (ACT) can help reduce depression in people with physical disabilities and improve well-being in those with psychological issues after brain injuries. This suggests ACT might also be helpful for depression in people with spinal cord injuries. ^{1 2 3 4 5}

Is Acceptance and Commitment Therapy (ACT) safe for humans?

Acceptance and Commitment Therapy (ACT) is generally considered safe for humans, as it focuses on improving psychological flexibility and helping individuals accept their thoughts and feelings without trying to change them. It has been used for various conditions, including depression and anxiety, without significant safety concerns reported. ^{1 2 3 6 7}

How is Acceptance and Commitment Therapy (ACT) different from other treatments for depression in spinal cord injury?

Acceptance and Commitment Therapy (ACT) is unique because it focuses on helping individuals with spinal cord injury accept their thoughts and feelings rather than trying to change them, and it encourages them to commit to actions that align with their values, which can help reduce depressive symptoms. ^{1 2 3 8 9}

Research Team

Areum Han, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

The Craig H. Neilsen Foundation

Collaborator

Trials

62

Recruited

3,100+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. United States 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). [2022]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2018]

6. France pubmed.ncbi.nlm.nih.gov

[Acceptance and commitment therapy]. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of acceptance and commitment therapy on rehabilitation patients with spinal cord injury. [2021]

8. England 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Depression following spinal cord injury. [2022]