Clinical trial NCT04907656: Assessment of the Efficacy of Digital CBT for Anxiety in Adults With Chronic Musculoskeletal Pain
Official title: Initial Assessment of the Feasibility and Efficacy of a Scaleable Digital CBT for Generalized Anxiety and Associated Symptoms in a Chronic Musculoskeletal Pain Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Pain, Musculoskeletal
Anxiety
Keywords: Anxiety
Worry
Depression
Sleep difficulties
Anxiety sensitivity
Pain intensity
Pain interference
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned to either the dCBT app or a waitlist (control) condition with a 1.5:1 allocation (dCBT:Control) using a blocked randomized sequence. If initially allocated to the control condition, participants will be given access to the dCBT app after week 10 (that is, after the post-treatment evaluation, participants in the control group will be provided (crossed over to) dCBT).
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Anxiety Severity
timeFrame: Week 10
Secondary outcomes:
measure: Worry Severity
timeFrame: Week 0 (baseline), week 6, week 10 (post-intervention)
measure: Depression
timeFrame: Week 0 (baseline), week 6, week 10 (post-intervention)
measure: Sleep Difficulty
timeFrame: Week 0 (baseline), week 6, week 10 (post-intervention)
measure: Health status
timeFrame: Week 0 (baseline), week 6, week 10 (post-intervention)
measure: Anxiety sensitivity
timeFrame: Week 0 (baseline), week 6, week 10 (post-intervention)
measure: Clinician-rated anxiety severity
timeFrame: Week 0 (baseline), Week 10 (post-intervention)
measure: Pain intensity
timeFrame: Week 0 (baseline), week 6, week 10 (post-intervention)
measure: Pain interference/disability
timeFrame: Week 0 (baseline), week 6, week 10 (post-intervention)
measure: Fear of pain
timeFrame: Week 0 (baseline), week 6, week 10 (post-intervention)
measure: Pain medication use
timeFrame: Week 0 (baseline), week 6, week 10 (post-intervention)
measure: Pain catastrophizing
timeFrame: Week 0 (baseline), week 6, week 10 (post-intervention)
measure: Anxiety Severity
timeFrame: Week 0 (baseline), week 3, week 6
measure: Resolution of clinical GAD
timeFrame: Week 10 (post-intervention)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Michael W Otto, PhD
role: PRINCIPAL_INVESTIGATOR
References: