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Development of an integrated cognitive behavioral therapy for anxiety and opioid use disorder: Study protocol and methods.

ABSTRACT: Opioid use disorder is a highly disabling psychiatric disorder, and is associated with both significant functional disruption and risk for negative health outcomes such as infectious disease and fatal overdose. Even among those who receive evidence-based pharmacotherapy for opioid use disorder, many drop out of treatment or relapse, highlighting the importance of novel treatment strategies for this population. Over 60% of those with opioid use disorder also meet diagnostic criteria for an anxiety disorder; however, efficacious treatments for this common co-occurrence have not be established. This manuscript describes the rationale and methods for a behavioral treatment development study designed to develop and test an integrated cognitive-behavioral therapy for those with co-occurring opioid use disorder and anxiety disorders. The aims of the study are (1) to develop and pilot test a new manualized cognitive behavioral therapy for co-occurring opioid use disorder and anxiety disorders, (2) to test the efficacy of this treatment relative to an active comparison treatment that targets opioid use disorder alone, and (3) to investigate the role of stress reactivity in both prognosis and recovery from opioid use disorder and anxiety disorders. Our overarching aim is to investigate whether this new treatment improves both anxiety and opioid use disorder outcomes relative to standard treatment. Identifying optimal treatment strategies for this population are needed to improve outcomes among those with this highly disabling and life-threatening disorder.

SUBMITTER: McHugh RK

PROVIDER: S-EPMC5553551 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Development of an integrated cognitive behavioral therapy for anxiety and opioid use disorder: Study protocol and methods.

McHugh R Kathryn RK Votaw Victoria R VR Barlow David H DH Fitzmaurice Garrett M GM Greenfield Shelly F SF Weiss Roger D RD

Contemporary clinical trials 20170708

Opioid use disorder is a highly disabling psychiatric disorder, and is associated with both significant functional disruption and risk for negative health outcomes such as infectious disease and fatal overdose. Even among those who receive evidence-based pharmacotherapy for opioid use disorder, many drop out of treatment or relapse, highlighting the importance of novel treatment strategies for this population. Over 60% of those with opioid use disorder also meet diagnostic criteria for an anxiet ...[more]

PMID: 28689852

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Project description:BackgroundOpioid use disorder (OUD) is characterized by the inability to control opioid use despite attempts to stop use and negative consequences to oneself and others. The burden of opioid misuse and OUD is a national crisis in the United States with substantial public health, social, and economic implications. Although medication-assisted treatment (MAT) has demonstrated efficacy in the management of OUD, access to effective counseling and psychosocial support is a limiting factor and a significant problem for many patients and physicians. Digital therapeutics are an innovative class of interventions that help prevent, manage, or treat diseases by delivering therapy using software programs. These applications can circumvent barriers to uptake, improve treatment adherence, and enable broad delivery of evidence-based management strategies to meet service gaps. However, few digital therapeutics specifically targeting OUD are available, and additional options are needed.ObjectiveTo this end, we describe the development of the novel digital therapeutic MODIA.MethodsMODIA was developed by an international, multidisciplinary team that aims to provide effective, accessible, and sustainable management for patients with OUD. Although MODIA is aligned with principles of cognitive behavioral therapy, it was not designed to present any 1 specific treatment and uses a broad range of evidence-based behavior change techniques drawn from cognitive behavioral therapy, mindfulness, acceptance and commitment therapy, and motivational interviewing.ResultsMODIA uses proprietary software that dynamically tailors content to the users' responses. The MODIA program comprises 24 modules or "chats" that patients are instructed to work through independently. Patient responses dictate subsequent content, creating a "simulated dialogue" experience between the patient and program. MODIA also includes brief motivational text messages that are sent regularly to prompt patients to use the program and help them transfer therapeutic techniques into their daily routines. Thus, MODIA offers individuals with OUD a custom-tailored, interactive digital psychotherapy intervention that maximizes the personal relevance and emotional impact of the interaction.ConclusionsAs part of a clinician-supervised MAT program, MODIA will allow more patients to begin psychotherapy concurrently with opioid maintenance treatment. We expect access to MODIA will improve the OUD management experience and provide sustainable positive outcomes for patients.

Project description:BackgroundFarmers have higher rates of depression than nonfarmers and higher rates of suicide than the general population. Several barriers to help seeking have been identified in farmers, which may be overcome by offering web-based mental health support. Computerized cognitive behavioral therapy (cCBT) is an effective intervention used to prevent and treat mild to moderate depression but has not been evaluated in the farming community.ObjectiveThis study explored the feasibility of delivering a cCBT course tailored to farmers using a mixed methods approach.MethodsFarmers (aged ≥18 years) with no, minimal, or moderately severe depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score <20) were recruited using web-based and offline advertisements and given access to a cCBT course consisting of 5 core modules and automated and personalized email support. Depression (PHQ-9), anxiety (General Anxiety Disorder-7), and social functioning (Work and Social Adjustment Scale) were measured at baseline and the 8-week follow-up. Wilcoxon signed rank tests assessed changes in scores for all outcome measures over time. Telephone interviews focusing on participant use and satisfaction with the course were analyzed using thematic analysis.ResultsOverall, 56 participants were recruited; 27 (48%) through social media. Overall, 62% (35/56) of participants logged into the course. At baseline, almost half of the participants reported experiencing minimal depressive symptoms (25/56, 45%) and mild anxiety (25/56, 45%), and just over half (30/56, 54%) reported mild to moderate functional impairment. Posttreatment data were available for 27% (15/56) of participants (41/56, 73% attrition rate). On average, participants experienced fewer depressive symptoms (P=.38) and less functional impairment (P=.26) at the 8-week follow-up; these results were not statistically significant. Participants experienced significantly fewer symptoms of anxiety at the 8-week follow-up (P=.02). Most participants (13/14, 93%) found the course helpful and easy to access (10/13, 77%) and the email support helpful (12/14, 86%). Qualitative interviews identified heavy workloads and mental health stigma within the farming community as barriers to help seeking. Participants thought that web-based support would be helpful, being convenient and anonymous. There were concerns that older farmers and those with limited internet connections may have difficulty accessing the course. Improvements regarding the layout and content of the course were suggested. Dedicated support from someone with farming knowledge was recommended to improve retention.ConclusionscCBT may be a convenient way of supporting mental health within farming communities. However, challenges in recruiting and retaining farmers may indicate that cCBT supported only by email may not be an acceptable mode of mental health care delivery for many; however, it was valued by respondents. Involving farming organizations in planning, recruitment, and support may address these issues. Mental health awareness campaigns targeting farming communities may also help reduce stigma and improve recruitment and retention.

Dataset Information

Development of an integrated cognitive behavioral therapy for anxiety and opioid use disorder: Study protocol and methods.

Publications

Development of an integrated cognitive behavioral therapy for anxiety and opioid use disorder: Study protocol and methods.

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