The Effects of Cognitive Behavioral Therapy and Transcranial Current Stimulation (tDCS) on Chroni… (NCT02483468) | Clinical Trial Compass
CompletedPhase 2/3
The Effects of Cognitive Behavioral Therapy and Transcranial Current Stimulation (tDCS) on Chronic Lower Back Pain
United States160 participantsStarted 2015-08
Plain-language summary
The primary objective of this study is to evaluate the effects of cognitive-behavioral therapy in combination with transcranial direct current stimulation in (1) improving pain and functionality, (2) reducing severity of opioid use disorders, and (3) reducing impairment in associated mental health areas (e.g., depression, anxiety, PTSD, sleep). The investigators will also determine the effects of treatment on neural activity in cognitive and limbic brain regions involved in pain regulation using functional magnetic resonance imaging (fMRI), and examine its relationship to opioid use severity.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Ages 18 to 70.
✓. United States Veteran or family member of a Veteran.
✓. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.
✓. Subjects must be able to comprehend English.
✓. Have a chronic pain condition and ≥3months duration of pain.
✓. BPI score \>4/10.
✓. Meet DSM-5 criteria for current (i.e., past 6 months) prescription opioid use disorder (assessed via the MINI 7.0).
✓. COMM score\>7.
Exclusion criteria
✕. Subjects with symptomatic psychotic/bipolar disorder and/or deemed too high risk by the study physician
✕. Subjects with current suicidal or homicidal ideation and intent.
. Subjects with a current eating disorder (bulimia, anorexia nervosa) or with dissociative identity disorder, as they are likely to require specific time-intensive psychotherapy in addition to the proposed therapy for stabilization.
✕. Subjects who would present a serious suicide risk or who are likely to require hospitalization during the course of the study.
✕. Subjects enrolled in ongoing behavioral therapy for pain or substance use disorders, who are not willing to discontinue these therapies for the duration of the trial. Attendance at therapeutic activities other than study sessions will be closely monitored using the Treatment Services Review.
✕. Subjects on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 4 weeks. If it is determined, based on clinical criteria, that a subject needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the course of the study, they will be discontinued from the treatment trial.