Cognitive Behavioral Therapy for Suicidal Thoughts in Physical Disabilities

Overseen By Lauren R Khazem, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Inability to consent, No internet, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a talk therapy called Brief Cognitive Behavioral Therapy to assist people with physical disabilities who have suicidal thoughts or have attempted self-harm. The goal is to determine if this therapy can reduce these thoughts and actions. It targets individuals with disabilities affecting vision, hearing, or movement who have recently experienced suicidal thoughts or attempts. Participants need internet access and a webcam to join the sessions. As an unphased trial, this study provides a unique opportunity to contribute to understanding how this therapy can support individuals with disabilities facing these challenges.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this therapy is safe for people with physical disabilities?

Research shows that Brief Cognitive Behavioral Therapy (CBT) safely and effectively manages suicidal thoughts, especially in individuals with physical disabilities. Studies have found that patients often express high satisfaction with this therapy. Importantly, no major safety issues have emerged. This therapy is well-received in various situations, including for those facing long-term pain and suicide risk. Overall, Brief CBT offers a promising option without the side effects associated with medication treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Brief Cognitive Behavioral Therapy (CBT) for people with physical disabilities because it offers a tailored approach to address suicidal thoughts, which is often not the focus in traditional treatments for physical disabilities. Unlike standard care options that may not specifically target the mental health challenges faced by individuals with physical disabilities, this treatment adapts cognitive behavioral techniques to address the unique psychological and emotional needs of these patients. The therapy is designed to be brief, making it potentially more accessible and less time-consuming than longer therapy models, while still aiming to deliver meaningful mental health improvements.

What evidence suggests that Brief Cognitive Behavioral Therapy might be an effective treatment for suicidal thoughts in physical disabilities?

Research shows that Cognitive Behavioral Therapy (CBT) can reduce suicidal thoughts and attempts. Studies have found that CBT changes harmful thought patterns. This therapy is also easy to provide to many people and is cost-effective. Although few studies focus specifically on Brief CBT for individuals with physical disabilities, CBT's success in other areas suggests it could be beneficial. In this trial, participants will receive Brief Cognitive Behavioral Therapy for People with Physical Disabilities, which teaches skills to manage thoughts and behaviors, potentially reducing suicidal feelings. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with physical disabilities affecting vision, hearing, or mobility who have had suicidal thoughts in the past week or a suicide attempt in the past month. Participants must be able to give informed consent and need internet access with a webcam.

Inclusion Criteria

I have thought about suicide in the last week or attempted it in the last month.

I have a disability that affects my vision, hearing, or ability to move.

Exclusion Criteria

Inability to provide informed consent

Lack of internet connection and web camera

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Brief Cognitive Behavioral Therapy for Suicide Prevention

12 weeks

Weekly sessions (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brief Cognitive Behavioral Therapy for People with Physical Disabilities

Trial Overview The study tests Brief Cognitive Behavioral Therapy aimed at reducing suicidal thoughts and attempts among people with physical disabilities. It's a psychotherapy approach that does not involve medication.

How Is the Trial Designed?

Group I: Brief Cognitive Behavioral Therapy for People with Physical Disabilities Experimental Treatment 1 Intervention

Brief Cognitive Behavioral Therapy for People with Physical Disabilities is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Brief CBT for:

• Chronic pain management
• Mental health conditions in individuals with physical disabilities

Approved in European Union as Brief Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Chronic pain management

Approved in Canada as CBT-CP for:

• Chronic pain management
• Mental health conditions in veterans and military personnel

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

American Foundation for Suicide Prevention

Collaborator

Trials

36

Recruited

10,500+

Published Research Related to This Trial

Psychological pain theory-based cognitive therapy (PPTBCT) significantly reduced suicidal ideation and depression scores in patients with major depressive disorder over an 8-week intervention, compared to a control group receiving usual psychological care.

While both groups showed improvements, the PPTBCT group maintained lower suicide ideation scores at a 4-week follow-up, whereas the control group experienced an increase, suggesting that PPTBCT may be more effective in sustaining reductions in suicide risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of psychological pain theory-based cognitive therapy in suicidal patients with major depressive disorder: A pilot study. Zou, Y., Li, H., Shi, C., et al.[2019]

A study involving 278 patients with chronic back pain found that an AI-driven cognitive behavioral therapy for chronic pain (AI-CBT-CP) was noninferior to standard telephone CBT-CP, showing similar effectiveness in reducing disability and pain over 6 months.

AI-CBT-CP not only achieved better clinical outcomes for patients but also required less than half the therapist time compared to traditional CBT-CP, suggesting it could improve access to treatment for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. Piette, JD., Newman, S., Krein, SL., et al.[2023]

Brief cognitive behavioral therapy (BCBT) is projected to prevent 23 to 25 more suicide attempts and 1 to 3 more suicide deaths per 100 patients compared to standard treatment for suicidal US Army soldiers, indicating its efficacy in reducing suicide risk.

BCBT is estimated to save the Department of Defense between $15,000 to $16,630 per patient compared to usual treatment, suggesting it may be a cost-effective intervention for addressing suicide risk among active-duty soldiers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic Evaluation of Brief Cognitive Behavioral Therapy vs Treatment as Usual for Suicidal US Army Soldiers. Bernecker, SL., Zuromski, KL., Curry, JC., et al.[2022]

Several effective psychosocial treatments for preventing suicide and self-inflicted injuries have been identified, including cognitive therapy, dialectical behavior therapy, problem-solving therapy, and interpersonal psychotherapy.

Outreach interventions, such as sending caring letters, are also important in suicide prevention, highlighting the need for comprehensive strategies that include both therapy and follow-up support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial treatments of suicidal behaviors: a practice-friendly review. Comtois, KA., Linehan, MM.[2022]

Among 374 adults studied, those with physical disabilities had higher odds of making suicide attempts compared to those who only experienced suicidal thoughts, highlighting a potential risk factor for more severe suicidality.

However, this increased risk was not significant when chronic pain conditions were considered as part of the health conditions, suggesting that chronic pain may play a critical role in the relationship between physical disabilities and suicidality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do physical disabilities differentiate between suicidal ideation and attempts? An examination within the lens of the ideation to action framework of suicide. Khazem, LR., Anestis, MD.[2020]

Cognitive-behavioral therapy (CBT) is an effective first-line treatment for chronic pain, supported by numerous randomized controlled trials showing improvements in pain and related issues across various chronic pain syndromes.

Recent innovations in CBT delivery, such as web-based and telephone formats, have expanded its accessibility and effectiveness for diverse populations, including children and older adults, indicating a promising direction for future treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Ehde, DM., Dillworth, TM., Turner, JA.[2022]

Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) shows promising effectiveness in primary care settings, with significant improvements in pain intensity and functional limitations observed by the third appointment among 118 patients.

The most effective components of Brief CBT-CP included psychoeducation, goal setting, pacing, and relaxation training, suggesting that these strategies are beneficial for managing chronic pain without relying on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Cognitive Behavioral Therapy For Chronic Pain: Results From a Clinical Demonstration Project in Primary Care Behavioral Health. Beehler, GP., Murphy, JL., King, PR., et al.[2020]

The RESOLVE trial is a large-scale, 3-arm randomized control trial designed to compare the effectiveness of telephonic/video and online CBT for chronic pain against usual care, involving diverse populations across urban and rural areas.

This study aims to assess not only the clinical effectiveness of these CBT interventions in reducing pain severity but also their cost-effectiveness, potentially improving access to treatment for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. Mayhew, M., Balderson, BH., Cook, AJ., et al.[2023]

Cognitive therapy effectively addresses key issues in suicidal patients, such as perfectionism, social sensitivity, and hopelessness, by helping them develop constructive thinking patterns.

The therapy involves planning activities and tracking negative thoughts, which can lead to a decrease in feelings of hopelessness and improve overall mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive therapy for the suicidal patient: a case study. Reilly, CE.[2019]

A survey of 34 primary care patients who underwent Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) showed that 91% found the treatment content useful and 89% were satisfied with their overall experience.

Patients reported an average improvement in pain-related functioning, indicating that Brief CBT-CP is a promising nonpharmacological treatment option for chronic pain in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' perspectives of brief cognitive behavioral therapy for chronic pain: Treatment satisfaction, perceived utility, and global assessment of change. Beehler, GP., Loughran, TA., King, PR., et al.[2021]

The study will evaluate the effectiveness of monthly telehealth booster contacts in enhancing the outcomes of the Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) among 716 patients with chronic pain, assessing results at multiple time points (3, 6, 12, and 18 months).

This pragmatic trial aims to determine if these booster contacts can help sustain the benefits of BCBT-CP, which is a nonpharmacological approach to pain management integrated into primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Chronic Pain in Primary Care Settings by Using Behavioral Health Consultants: Methods of a Randomized Pragmatic Trial. Goodie, JL., Kanzler, KE., McGeary, CA., et al.[2022]

The COPES trial demonstrated that interactive voice response-based cognitive behavioral therapy (IVR-CBT) is as effective as in-person CBT for managing chronic back pain, with similar reductions in pain intensity after 3 months.

IVR-CBT also showed lower dropout rates, suggesting it may be a more accessible and convenient option for patients, enhancing their ability to engage in treatment compared to traditional in-person therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial. Heapy, AA., Higgins, DM., Goulet, JL., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31318726/

Brief Cognitive Behavioral Therapy For Chronic Pain The aim of this project was to collect preliminary effectiveness data for Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04724694

Brief Cognitive Behavioral Therapy for Chronic Pain to ... To address this gap in care, the proposed study will test if Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is an effective treatment.

3. va.gov va.gov/PAINMANAGEMENT/CBT_CP/docs/Brief_CBT-CP-Manual-V2_5-6-2021.pdf

Brief Cognitive Behavioral Therapy for Chronic Pain Brief CBT-CP is designed to introduce patient self-management, improve pain self-efficacy, reduce functional limitations, and potentially reduce ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032722009235

The significance of cognitive-behavioral therapy on suicide Based on the current evidence, CBT could relieve suicide, including suicide ideation, suicide attempts. CBT is scalable and cost-effective.

5. withpower.com withpower.com/trial/phase-vision-disorders-2-2022-c93d8

Cognitive Behavioral Therapy for Suicidal Thoughts in ... The studies indicate that Brief CBT-CP is a safe and effective nonpharmacological treatment for chronic pain, with high patient satisfaction and reported ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8479594/

Brief Cognitive-Behavioral Therapy for Suicide Prevention ... The current study aims to examine the delivery of brief cognitive-behavioral therapy for suicide prevention (BCBT-SP) via Clinical Video Telehealth (CVT) to ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04072666

A Comparison of Brief Cognitive Behavioural Therapy ... The aim of this project is to assess if adding one of two structured suicide specific psychological interventions to a standardised clinical care approach ...

8. va.gov va.gov/PAINMANAGEMENT/CBT_CP/docs/Brief_CBT-CP_Patient_Guidebook-4-13-2021.pdf

Brief Cognitive Behavioral Therapy for Chronic Pain □ Read: Brief Cognitive Behavioral Therapy for Chronic Pain​​ This handout summarizes the main ideas behind this treatment program.

9. academic.oup.com academic.oup.com/milmed/article-pdf/190/7-8/1629/61146910/usae548.pdf

Safety and Tolerability of a Brief Cognitive-Behavioral Therapy ... Taken together, these results suggest that Brief CBT-CP can be a safe and tolerable treatment option for patients with chronic pain and varying suicide risk ...