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

NCT04907656 | Completed

• 1 other identifier: 5975E
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Pain, Musculoskeletal; Anxiety

Keywords

Anxiety; Worry; Depression; Sleep difficulties; Anxiety sensitivity; Pain intensity; Pain interference

Outcome Measures

Primary Outcomes (1)

• Anxiety Severity

  The Generalized Anxiety Disorder 7 (GAD 7) is a self-report measure that assesses the full range of symptoms associated with GAD. Responses are summed to create a composite score, with higher scores indicating more severe anxiety. Composite scores range from 0 to 21.

  Week 10

Secondary Outcomes (13)

• Worry Severity

  Week 0 (baseline), week 6, week 10 (post-intervention)

• Depression

  Week 0 (baseline), week 6, week 10 (post-intervention)

• Sleep Difficulty

  Week 0 (baseline), week 6, week 10 (post-intervention)

• Health status

  Week 0 (baseline), week 6, week 10 (post-intervention)

• Anxiety sensitivity

  Week 0 (baseline), week 6, week 10 (post-intervention)

Study Arms (2)

dCBT Condition

EXPERIMENTAL

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.

Behavioral: dCBT

Waitlist (control) Condition

NO INTERVENTION

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.

Interventions

dCBT BEHAVIORAL

As per arm of the same name

Also known as: Daylight

dCBT Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain; Anxiety Disorders; Depression; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Michael W Otto, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 1, 2021
• Study Start: February 15, 2022
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

US (1)