Alcohol Use Disorders
Conditions
Brief summary
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.
Detailed description
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. Group 2: Participants in this group will have access to a briefer cognitive behavior treatment program with no access to a guide. Group 3: Participants in this group will be placed on a waiting list for 12 weeks. Thereafter, they will be given access to the same extended cognitive behavior treatment program as Group 1; they will also be offered a possibility to choose between three guidance options: Choice 1: guide with intensive support, Choice 2: guide with support only at request, Choice 3: no guide. Interim analyses will be undertaken in May 2016 by graduate students in Clinical psychology writing their MSc theses.
Interventions
BEHAVIORALExtended self-help program with guidance
See arm description for Experimental
BEHAVIORALBriefer Self-help program, no guidance
See arm description for Active Comparator
BEHAVIORALWL: Extended self-help program, choice of guidance intensity
See arm description for Waiting list.
Sponsors
Göteborg University
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Line Follow Back | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Abstinence Self Efficacy Scale | Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment | instrument measuring self-efficacy |
| Penn Alcohol Craving Scale | Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment | instrument measuring craving for alcohol |
| Montgomery Asberg Depression Rating Scale | Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment | instrument measuring depression |
| Euro-QOL 5 D | Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment | instrument measuring quality of life |
| Generalized Anxiety Disorder-7 | Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment | instrument measuring anxiety |
| Trimbos and iMTA questionnaire on cCosts associated with Psychiatric illness (TiC-P) | Screening, 12 months, 24 months post-treatment | Instrument measuring health care consumption and cost-effectiveness (Bouwmans et al., 2013 |
| Alcohol Use Disorders Identification Test | Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment | assessement of alcohol use problems |
| Adult ADHD Self Report Scale (ASRS) | Screening | Screening of ADHD symptoms to be used as predictor of treatment outcome |
| Health-relevant Personality traits from a Five-factor perspective (hp5i) | Screening | Screening of personality traits to be used as predictor of treatment outcome |
| Adverse Events | Halfway through treatment (6 weeks after before-treatment measure) and post-treatment (12 weeks after before-treatment measure) | Brief questionnaire with questions about any negative side effects of the treatment |
| Treatment Credibility Scale | 3 weeks after before-treatment measure | Brief questionnaire about if the treatment this far is perceived as effective |
| SCID- section of Alcohol Use Disorders (adjusted to DSM5) | Screening interview, 12 and 24 months post-treatment | Diagnostic interview via telephone, diagnostic criteria of Alcohol Use Disorders (this will be undertaken if resurces allow). This will be a masked assessment, the interviewer will not know which original group the participant was randomized to |
| Self-report questionnnaire on satisfaction with internet treatment usability features | Post-treatment (12 weeks after before-treatment measure) | This instrument contains 40 questions about satisfaction with various features of the internet-based treatment. Results will be analyzed on an aggregated group level. The questionnaire was constructed by the Internet psychiatry clinic in Stockholm. |
Countries
Sweden
Outcome results
None listed