Clinical trial NCT04544930: Therapist-guided Internet Treatment for Hazardous and Harmful Alcohol Use. A Feasibility Study
Official title: Therapist-guided Internet Treatment for Hazardous and Harmful Alcohol Use. a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Internet-Based Intervention
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to test the feasibility of therapist-guided Internet treatment for hazardous (risky) and harmful alcohol use among adults 18 years and older. The hypothesis is that the intervention is feasible and that it can help people change risky drinking habits at an early stage before developing into problems that are more serious.The therapist-guided Internet treatment addresses the person's need for confidentiality and contributes to reducing the stigma associated with visiting a substance abuse clinic.

Detailed description: Background:

A significant proportion of people with substance abuse do not seek help for their problems and therefore do not receive the necessary help at an early stage. An important reason for this is the stigma associated with substance abuse. Therapist-guided Internet treatment has been developed and tested in recent years as an approach that increases access to effective treatment for a variety of mental and substance-related problems and disorders. Internet-based interventions increase the patient's choice of type of treatment and give the patient an experience of having control over their own behavior change. Moreover, such treatment is independent of where you live, and you do not need to attend a clinic. In addition, by offering therapist-guided Internet treatment, therapists can treat far more patients compared to regular face-to-face treatment. In this way, the health services, which are already under severe pressure due to many new and competing tasks, are relieved.

Research questions:

1. Is therapist-guided Internet treatment for hazardous and harmful alcohol use feasible for self-referred persons?
2. What factors contribute/do not contribute to the feasibility of treatment?
3. Can the intervention help people change risky drinking habits before it develops into problems that are more serious?
4. How do participants experience the intervention?

Methods:

Participants:

A total of 30 participants will be recruited through announcements in social media, newspapers and through GP's and other health care services. Participants will be recruited from the catchment area of Haukeland University Hospital, Western Norway, and Vestfold Hospital, Eastern Norway.

Design:

The study will be conducted as an open, 6-months follow-up study, to assess whether the design is suitable for a randomized controlled trial in the next round. Both quantitative and qualitative methods will be used to investigate the feasibility of the treatment program.

Data collection:

Assessments will be carried out at start of treatment (T1), through the treatment course (T2) and at the end of treatment (T3) and at follow-up (T4). Qualitative interviews will be conducted at the end of treatment.

Intervention:

The treatment program is developed at Vestfold Hospital, Norway. It is based on Internet- based cognitive behavior therapy (ICBT). The treatment program consists of eight text-based self-help modules on the Internet that participants can access via secure login using Bank identification (ID) (security level 4). The self-help modules include psychoeducation, tasks and exercises. The therapist guidance is secondary to the self-help modules. The therapist provides feedback to the patient online in the secured program once a week.

Statistics:

Sample size:

Since this is a feasibility study primarily intended to test the feasibility of therapist-guided Internet treatment for hazardous and harmful alcohol use, the sample will be limited to 30 participants. Therefore, power analysis is not performed.

Statistical methods:

Both statistical and interpretative methods will be used. Descriptive statistics (percentages, means, standard deviations), as well as statistical and clinical change. Qualitative in-depth interviews will be analyzed using thematic content analysis.

Plan for activities and dissemination:

Scheduled start of data collection is September 2020. The data collection will continue until the summer of 2021. The follow-up period will be completed by the end of 2021.

The results of the feasibility study will be published in peer-reviewed journals. Furthermore, the results will be disseminated to the public through media (including social media), and as information aimed at both health and social care professionals, patient groups and user forums.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* access to the Internet
* interested in receiving Internet treatment for changing drinking habits
* a score of 6 or higher for women and 8 or higher for men on the Alcohol Use Disorder Identification Test (AUDIT)

Exclusion Criteria:

* diagnosed alcohol dependence or addiction to other drugs and already in treatment
* serious reading and/or writing difficulties
* cognitive impairment/dementia
* severe mental disorder or in need of other treatment

Primary outcomes:
measure: The Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: AUDIT will measure whether there is a change in alcohol intake during the treatment period (8-12 weeks) and at follow-up (6 months after the end of treatment).
measure: The Timeline Followback (TLFB) for alcohol
timeFrame: TLFB will calculate the intake of alcohol units (AE) and change in the seven-day period from the first assessment to the 6 months follow-up.
Secondary outcomes:
measure: The Drug-Taking Confidence Questionnaire (DTCQ).
timeFrame: DTCQ will measure changes during the treatment course of 8-12 weeks, and at 6 months follow-up.
measure: Symptom Checklist -10 (SCL-10)
timeFrame: SCL-10 will measure changes in psychological distress during the treatment course of 8-12 weeks, and at 6 months follow-up.
measure: Patient Health Questionnaire, PHQ-9
timeFrame: Patient Health Questionnaire (PHQ-9) will measure changes in symptoms of depression during the treatment course of 8-12 weeks, and at 6 months follow-up.
measure: General Anxiety Disorder (GAD-7).
timeFrame: GAD-7 will measure changes in symptoms of anxiety during the treatment course of 8-12 weeks, and at 6 months follow-up.
measure: EuroQol five-dimensional (EQ-5D) descriptive system (EQ-5D-5L)
timeFrame: EQ-5D-5L will measure changes in health-related quality of life during the treatment course of 8-12 weeks, and at 6 months follow-up.
Other outcomes:
measure: Qualitative interviews
timeFrame: Qualitative interviews will be conducted at the end of treatment, immediately after 8-12 weeks completed treatment
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Tønsberg
country: Norway
facility: Vestfold Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Else Marie Løberg, PhD
role: STUDY_DIRECTOR
References: