Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Time Line Follow Back
研究概览
简要总结
The purpose of this study is to determine whether extensive internet based cognitive behavior treatment program with guidance is a more effective method to treat individuals with alcohol use disorders than a briefer cognitive behavior treatment program without guidance.
详细描述
Two Internet based programs based on cognitive behavioral therapy and relapse prevention are evaluated among Internet help seekers, and compared to a waiting list. The design is a three armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption (mean consumption/week, number of heavy drinking days/week), problematic alcohol use, self efficacy, craving, as well as depression, anxiety and quality of life. In addition to this, the following instruments will be used as predictors: ASRS (ADHD), Hp5i (personality assessment). TIC-P, an instrument measuring cost effectiveness will also be used. Treatment Credibility and Adverse Events will also be assessed, the former once during the third week of treatment, and the latter once half way through treatment and once after treatment.
Primary hypothesis is that the more extended program with guidance (group 1) is more effective in reducing mean alcohol consumption and number of heavy drinking days compared to the briefer program with no guidance (group 2), as well as compared to a waiting list (group 3). A responder to treatment is defined as a participant drinking less than 9 (women)/ 14(men) glasses per week and no more than 3 (women)/4 (men) glasses per drinking day during that week.
A minimum of 169 participants will be recruited in two phases: first through an online screening and then through a diagnostic telephone assessment, where SCID will be used to diagnose Alcohol Use Disorders and MINI will be used to diagnose other psychiatric diagnoses. The telephone assessment and all guidance will be conducted by licensed psychologists or master students in psychology under supervision by licensed psychologists.
Included participants will be randomized into three groups:
Group 1: All participants in this group will have access to an extended cognitive behavioral treatment program and have access to a guide with basic training in psychotherapy (CBT) who assists and counsels the participant throughout the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years
- •access to the internet
- •consumption of at least 9 (females)/14 (males) glasses of alcohol during the preceding week
- •AUDIT ≥ 14 for females, ≥ 16 for men
- •have an Alcohol Use Disorder according to the DSM-5 (i.e., at least 2 out of 11 criteria)
排除标准
- •insufficient Swedish skills
- •reading or writing difficulties, if it is to a degree that it will hamper the treatment
- •concurrent other psychological treatment with a content resembling treatments in this study
- •severe depression defined as a score of more than 30 on the MADRS-S
- •suicide-risk defined as more than 4 points on the MADRS-S question 9, or based on the structured interview
- •Drug use problems defined as ≥ 8 p on the DUDIT
- •somatic or psychiatric disorders that are contraindicated for the treatment or impairs the ability to receive it (for example schizophrenia, bipolar disease, PTSD)
- •has during the last 3 weeks begun medication for alcohol problems or other psychiatric disorder
结局指标
主要结局
Time Line Follow Back
时间窗: Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment
Number of standard drinks during preceding week (using the Time Line Follow Back)
次要结局
- Self-report questionnnaire on satisfaction with internet treatment usability features(Post-treatment (12 weeks after before-treatment measure))
- Adult ADHD Self Report Scale (ASRS)(Screening)
- Health-relevant Personality traits from a Five-factor perspective (hp5i)(Screening)
- Adverse Events(Halfway through treatment (6 weeks after before-treatment measure) and post-treatment (12 weeks after before-treatment measure))
- Treatment Credibility Scale(3 weeks after before-treatment measure)
- SCID- section of Alcohol Use Disorders (adjusted to DSM5)(Screening interview, 12 and 24 months post-treatment)
- Alcohol Use Disorders Identification Test(Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment)
- Alcohol Abstinence Self Efficacy Scale(Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment)
- Penn Alcohol Craving Scale(Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment)
- Montgomery Asberg Depression Rating Scale(Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment)
- Euro-QOL 5 D(Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment)
- Generalized Anxiety Disorder-7(Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment)
- Trimbos and iMTA questionnaire on cCosts associated with Psychiatric illness (TiC-P)(Screening, 12 months, 24 months post-treatment)
研究者
Anne H Berman
Associate Professor
Karolinska Institutet