Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial

The study protocol of a prospective and randomized controlled trial for the assessment of the efficacy of nature activity therapy for people with Fibromyalgia (NAT-FM) is described. The primary outcome is the mean change from baseline in the Revised Fibromyalgia Impact Questionnaire (FIQR) score at post-treatment (12 weeks) and at 9 months of follow-up, and secondary outcomes are changes in the positive affect, negative affect, pain, fatigue, self-efficacy, catastrophising, and emotional regulation. A total of 160 patients with fibromyalgia will be divided into two arms: treatment-as-usual (TAU) and NAT-FM+TAU. Pre, during, post, +6, and +9 months assessments will be carried out, as well as an ecological momentary assessment (EMA) of intrasession and intersessions. Results will be subjected to a mixed group (NAT-FM+TAU vs. TAU) × phase (pre, post, +6 months, +9 months) general linear model. EMA intrasession measurements will be subjected to a 2 (pre vs. post) × 5 (type of activity) mixed-effects ANOVA. EMA between-session measurements obtained from both arms of the study will be analysed on both a time-domain and frequency-domain basis. Effect sizes and number needed to treat (NNT) will be computed. A mediation/moderation analysis will be conducted.

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The efficacy of iCBT added to treatment as usual for alcohol dependent patients in Primary Care: study protocol for a randomized controlled trial.

10.21203/rs.2.12886/v3 ◽

2019 ◽

Author(s):

Karin Hyland ◽

Anders Hammarberg ◽

Erik Hedman-Lagerlöf ◽

Magnus Johansson ◽

Sven Andreasson

Keyword(s):

Primary Care ◽

Randomized Controlled Trial ◽

Alcohol Dependence ◽

Controlled Trial ◽

Alcohol Problems ◽

Primary Study ◽

Mixed Effect ◽

Treatment As Usual ◽

Randomized Controlled ◽

Alcohol Dependent

Abstract Introduction Alcohol dependence is a common disorder with a continuum regarding severity. Most alcohol dependent persons have a moderate level of dependence and live under socially orderly conditions. Treatment seeking in this group is low, mainly due to stigma and because treatment options are seen as unappealing. Alcohol is a relevant topic to discuss in many primary care (PC) consultations and PC is less stigmatizing to visit compared to addiction care units for people with alcohol problems. General practitioners (GP) hesitate to engage in treating alcohol problems due to time constraints and lack of knowledge. Screening and brief interventions are effective for high consumers but there are few studies on dependence. Methods This is a two-group, parallel, randomized controlled trial (RCT). The aim is to study whether an Internet based Cognitive Behavioral Treatment (iCBT) when added to treatment as usual (TAU) is more effective than TAU only for alcohol dependence in PC. 260 adults with alcohol dependence will be included. Participants are randomized to iCBT and TAU or TAU only. The primary study outcome is alcohol consumption in grams per week and heavy drinking days. Secondary outcomes include alcohol related problem severity, number of diagnostic criteria for alcohol dependence, depression and anxiety symptoms, health related quality of life and biochemical markers for high consumption and liver pathology. Data will be analyzed using mixed-effect models. Discussion Internet based interventions are attractive to and have been shown to reach people with alcohol problems. Yet there are no studies investigating the efficacy of internet treatment of alcohol dependence in PC. In this study we hypothesize that iCBT when added to TAU will improve treatment outcome for alcohol dependence in PC, compared to TAU only. If effective, iCBT can be distributed to the public to a low cost for a stakeholder and has the opportunity to reduce both short term and long-term public health costs. Trial registration: ISRCTN69957414. Retrospectively registered 07/06/2018. http://www.isrctn.com/ISRCTN69957414

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