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

CompletedNot applicableNCT04907656
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

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
Conditions
Interventions
  • Behavioral: dCBT
Sponsor
Boston University Charles River Campus
Start date
2022-02-15
Primary completion
2023-04-26
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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)

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04907656