Assessment of the Efficacy of Digital CBT for Anxiety in Adults With Chronic Musculoskeletal Pain

NCT ID: NCT04907656

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2023-04-26

Brief Summary

The present study involves a randomized clinical trial of Digital Cognitive Behavioral Therapy (dCBT) targeting worry and anxiety symptoms in a population with chronic pain and clinical levels of generalized anxiety disorder (GAD) symptoms. The clinical trial calls for the recruitment and randomization of 80 individuals with chronic musculoskeletal pain and clinical levels of GAD symptoms to either a dCBT program or a waitlist (Control) condition. The current research represents the first-step investigation of a treatment strategy with the potential to enhance care for patients with chronic pain by introducing a scalable, affordable, and system-friendly digital intervention (dCBT) that targets a prominent source of distress and associated disability in these patients. The investigators propose that by targeting GAD in chronic pain in a way that does not tax engagement in ongoing medical care provision, there is the potential to improve the uptake of effective care and to address both GAD and associated distress and disability.

Detailed Description

An emerging body of research points to the significant impact of generalized anxiety disorder (GAD) on the functioning of adults with chronic pain. The importance of managing stress and anxiety is central to the fear/avoidance models of chronic pain, and fears of pain are elevated in those with GAD. Furthermore, the incidence of GAD is significantly higher in patients with chronic pain than in the general population. Likewise, severity of pain, degree of disability, opioid use, and medical costs have been found to be higher among those with comorbid GAD compared to those with chronic pain alone. The treatment of GAD in a chronic pain population has the potential to benefit pain-related distress and disability in addition to direct benefits on GAD and related quality of life.

Cognitive Behavior Therapy (CBT) is an excellent choice for targeting GAD symptoms in a chronic pain population. CBT is a recommended first-line treatment for GAD according to international guidelines. Despite the potential benefits of treatment, individuals with GAD face significant barriers in accessing CBT, including limitations on the availability of trained therapists, the costs and burden of in-person therapy, and stigma issues. These barriers are likely magnified for individuals with chronic pain who also face their own stigma issues as well as a high medical appointment burden. An innovative solution for overcoming these barriers and providing CBT for GAD at scale is to offer well-validated digital treatment that can be delivered by smartphones, tablets, or computers. Digital CBT (dCBT) offers a cost-effective and scalable alternative to in- person CBT with comparable maintenance of treatment gains to in-person CBT at four-year follow-up. Interest in digital health solutions is evident in those with chronic pain, and digital treatment may also offer a strategy for addressing the significant racial and ethnic disparities in care as well as disparities in the degree of psychological distress reported for those with chronic pain. At this time, however, the efficacy of dCBT for GAD has not been evaluated in patients with chronic pain.

The study contains two phases, with only Phase 2 being registered here. Following the achievement of benchmarks from Phase I, Phase 2 is a randomized clinical trial of Digital Cognitive Behavioral Therapy (dCBT) targeting worry and anxiety symptoms in a population with chronic pain and clinical levels of generalized anxiety disorder (GAD) symptoms. The dCBT under study is a commercially available smartphone application that provides weekly intervention sessions in 4 modules. An initial assessment drives an algorithm to personalize the program and individuals will have 10 weeks to complete the treatment. This randomized clinical trial calls for the recruitment and randomization of 80 individuals to either the dCBT program or a waitlist (control) condition. Specific aims for this project are:

1. To show that dCBT leads to lower GAD symptoms relative to the control condition.

2. To evaluate whether dCBT leads to greater changes in the secondary worry, mood, sleep, quality of life, and anxiety sensitivity outcomes than the control condition.

3. To evaluate whether dCBT leads to lower pain distress and disability outcomes than the wait-list control condition.

Conditions

Pain, Chronic; Pain, Musculoskeletal; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

dCBT Condition

The dCBT used in this study (Daylight) was selected due to its noted efficacy in treating GAD. 25 interventions will be provided in four modules, with an average duration of 20 minutes. Sessions are unlocked weekly, and completion of an initial assessment drives an algorithm to personalize the program. Individuals may progress through treatment at a slower pace than weekly sessions; 10 weeks is allowed for treatment completion. Treatment is based on principles of applied relaxation, stimulus control, cognitive restructuring, and imaginal exposure. Participants schedule a time for each session and receive prompts if they miss the appointment. All interventions are aided by the use of an animated therapist.

Group Type: EXPERIMENTAL

dCBT

Intervention Type: BEHAVIORAL

As per arm of the same name

Waitlist (control) Condition

Participants allocated to the waitlist (control) condition will not receive an active intervention during the study. Participants will still complete all scheduled study assessments. They will receive access to the dCBT after completion of all study assessments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

dCBT

As per arm of the same name

Intervention Type: BEHAVIORAL

Other Intervention Names

Daylight

Eligibility Criteria

Inclusion Criteria

• Chronic musculoskeletal pain patients engaged in noninvasive treatments
• Age 18 or older
• Post acute phase of chronic pain
• Clinical levels of Generalized Anxiety Disorder (GAD) (operationalized by a score of ≥10 on GAD-7)

Exclusion Criteria

• Factors that may impede the utilization of digital intervention (non-English speaker/literate; no access to a digital device; severely vision impaired, or severe cognitive impairment)
• Pending acute surgery or with a life prognosis of fewer than 6 months
• Current daily opioid use
• The presence [by self-report] of schizophrenia, psychosis, bipolar disorder, seizure disorder, or current substance use disorder (other than nicotine)
• The ability to isolate the effects of the intervention (initiation or change of psychotropic medication dosage within past 4 weeks, received CBT for anxiety in last 3 months)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Michael Otto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael W Otto, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

5975E

Identifier Type: -

Identifier Source: org_study_id