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An evaluation of the feasibility, acceptability, and preliminary efficacy of cognitive-behavioral therapy for opioid use disorder and chronic pain.

ABSTRACT: AIMS:The primary study aim was to evaluate the feasibility and acceptability of cognitive-behavioral therapy (CBT) for opioid use disorder and chronic pain. The secondary aim was to examine its preliminary efficacy. METHODS:In a 12-week pilot randomized clinical trial, 40 methadone-maintained patients were assigned to receive weekly manualized CBT (n?=?21) or Methadone Drug Counseling (MDC) to approximate usual drug counseling (n?=?19). RESULTS:Twenty of 21 patients assigned to CBT and 18 of 19 assigned to MDC completed the pilot study. Mean (SD) sessions attended were 8.4 (2.9) for CBT (out of 12 possible) and 3.8 (1.1) for MDC (out of 4 possible); mean (SD) patient satisfaction ratings (scored on 1-7 Likert-type scales) were 6.6 (0.5) for CBT and 6.0 (0.4) for MDC (p?

SUBMITTER: Barry DT

PROVIDER: S-EPMC6312460 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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An evaluation of the feasibility, acceptability, and preliminary efficacy of cognitive-behavioral therapy for opioid use disorder and chronic pain.

Barry Declan T DT Beitel Mark M Cutter Christopher J CJ Fiellin David A DA Kerns Robert D RD Moore Brent A BA Oberleitner Lindsay L Madden Lynn M LM Liong Christopher C Ginn Joel J Schottenfeld Richard S RS

Drug and alcohol dependence 20181113

<h4>Aims</h4>The primary study aim was to evaluate the feasibility and acceptability of cognitive-behavioral therapy (CBT) for opioid use disorder and chronic pain. The secondary aim was to examine its preliminary efficacy.<h4>Methods</h4>In a 12-week pilot randomized clinical trial, 40 methadone-maintained patients were assigned to receive weekly manualized CBT (n = 21) or Methadone Drug Counseling (MDC) to approximate usual drug counseling (n = 19).<h4>Results</h4>Twenty of 21 patients assigne ...[more]

PMID: 30508769

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Project description:BackgroundChronic pain is common among individuals with opioid use disorder (OUD) who are maintained on medications for OUD (MOUD; eg, buprenorphine or methadone). Chronic pain is associated with worse retention and higher levels of substance use. Treatment of individuals with chronic pain receiving MOUD can be challenging due to their increased clinical complexity. Given the acute and growing nature of the opioid crisis, MOUD is increasingly offered in a wide range of settings, where high-quality, clinician-delivered, empirically validated behavioral treatment for chronic pain may not be available. Therefore, digital treatments that support patient self-management of chronic pain and OUD have the potential for wider implementation to fill this gap.ObjectiveThis study aims to evaluate the efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), an interactive digital treatment program with asynchronous coach feedback, compared to treatment as usual (TAU) in individuals with chronic pain and OUD receiving MOUD.MethodsAdult participants (n=160) receiving MOUD and reporting bothersome or high-impact chronic pain will be recruited from outpatient opioid treatment programs in Connecticut (United States) and randomized 1:1 to either IMPACT+TAU or TAU only. Participants randomized to IMPACT+TAU will complete an interactive digital treatment that includes 9 modules promoting training in pain and addiction coping skills and a progressive walking program. The program is augmented with a weekly personalized voice message from a trained coach based on daily participant-reported pain intensity and interference, craving to use opioids, sleep quality, daily steps, pain self-efficacy, MOUD adherence, and engagement with IMPACT collected through digital surveys. Outcomes will be assessed at 3, 6, and 9 months post randomization. The primary outcome is MOUD retention at 3 months post randomization (ie, post treatment). Secondary outcomes include pain interference, physical functioning, MOUD adherence, substance use, craving, pain intensity, sleep disturbance, pain catastrophizing, and pain self-efficacy. Semistructured qualitative interviews with study participants (n=34) randomized to IMPACT (completers and noncompleters) will be conducted to evaluate the usability and quality of the program and its outcomes.ResultsThe study has received institutional review board approval and began recruitment at 1 site in July 2022. Recruitment at a second site started in January 2023, with a third and final site anticipated to begin recruitment in January 2024. Data collection is expected to continue through June 2025.ConclusionsEstablishing efficacy for a digital treatment for addiction and chronic pain that can be integrated into MOUD clinics will provide options for individuals with OUD, which reduce barriers to behavioral treatment. Participant feedback on the intervention will inform updates or modifications to improve engagement and efficacy.Trial registrationClinicalTrials.gov NCT05204576; https://clinicaltrials.gov/ct2/show/NCT05204576.International registered report identifier (irrid)DERR1-10.2196/54342.

Project description:BackgroundCognitive behavioral therapy for chronic insomnia (CBT-i) is the treatment of choice for this condition but is underutilized in patients who attend primary care. The purpose of the present feasibility-pilot study was to assess the feasibility and acceptability of a cluster-randomized study of CBT-i in a primary care setting.MethodsThis study, performed at two primary health care centers in Majorca, Spain, was a mixed methods feasibility-pilot study of a parallel cluster-randomized design comparing CBT-i and usual care (UC). Patients were included if they were 18 to 65 years-old; had diagnoses of chronic insomnia according to the Insomnia Severity Index (ISI ≥ 8); had insomnia for more than 3 months. Twenty-five GPs and nurses and 32 patients were randomly allocated to two groups. The main outcome of the intervention was improvement of dimensions of sleep quality, measured using the Spanish version of the Pittsburgh Sleep Quality Index, at baseline and at 3 months after the intervention. Other primary outcomes of the study were the feasibility and applicability of the intervention, collected through nominal groups. A thematic analysis was performed to classify primary care provider (PCP) proposals. Additionally, we assessed the recruitment process, compliance with the intervention sessions, and patient retention.ResultsWe adapted the CBT-i approach of Morin to a primary care context. After intervention training, PCPs expressed the need for more extensive training in the different aspects of the therapy and the discussion of more cases. PCPs considered the intervention as adequate but wanted fewer but longer sessions as well as to discard the cognitive restructuring component. PCPs considered it crucial to prepare each session in advance and to establish a specific agenda for the CBT-i. Regular reminders given to PCPs and patients were suggested to improve study participation. Compared to the UC group, higher proportions of patients in the intervention group had short sleep latency, slept for longer than 5 h, and had fewer sleep disruptions.ConclusionsThis feasibility-pilot study identified several key issues that must be addressed before performing a CBT-i intervention in future clinical trial in a primary care setting.Trial registrationNCT04565223 . (Clinical trials.gov) Registered 1 September 2020-Retrospectively registered.

Project description:Although fitness may benefit cognition in youth, most attention has been given to cardiorespiratory fitness despite the health benefits of muscular fitness. Few studies have examined interventions that incorporate both cardiorespiratory and muscular fitness or have been offered during school recess. Furthermore, most fitness intervention studies examining cognitive outcomes have not reported on implementation information. The purpose of this pilot study was to examine the feasibility, acceptability, and preliminary efficacy on fitness and cognition of a recess intervention in elementary school children. Two schools were randomized to either a 3-month cardiorespiratory and muscular fitness intervention (15 minutes/weekday during recess) or control condition (standard recess activities). Process evaluation (feasibility and acceptability) measures were recorded daily (research staff questionnaire), weekly (accelerometer and heart rate monitors), and post-intervention (participant and school-staff questionnaires). Preliminary efficacy measures included pre- and post-intervention inhibition/attention, working memory, and cardiorespiratory and muscular fitness scores. Some feasibility and acceptability measures were favorable (88% of the lessons were implemented, 78% of the lessons were implemented as planned, and the majority of students and school staff were satisfied with most aspects of the intervention). However, intensity adherence during the intervention sessions based on accelerometry (% of time spent in moderate-to-vigorous activity: 41.7 ± 14.5) and participation (19.4% attendance rate) were lower than expected. Preliminary efficacy of the intervention on cognitive and fitness outcomes was not demonstrated. This study provided evidence that some aspects of the fitness intervention were acceptable during school recess. However, important implementation factors (i.e., intervention exposure) should be targeted to improve youth fitness programs offered during this school setting.

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An evaluation of the feasibility, acceptability, and preliminary efficacy of cognitive-behavioral therapy for opioid use disorder and chronic pain.

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An evaluation of the feasibility, acceptability, and preliminary efficacy of cognitive-behavioral therapy for opioid use disorder and chronic pain.

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