Clinical trial NCT03984786: Internet-delivered Therapy for Alcohol Misuse: Factorial Trial of Assessment and Guidance
Official title: Internet-delivered Cognitive Behaviour Therapy for Alcohol Misuse: A Factorial Trial Examining the Effects of Assessment Interview and Guidance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Misuse
Keywords: alcohol misuse
internet
guidance
ICBT
cognitive behaviour therapy
assessment
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Saskatchewan
name: Saskatchewan Health Research Foundation
name: Saskatchewan Centre for Patient-Oriented Research
First posted: 2019-06-13
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Factor 1: Guidance (yes or no)

Factor 2: Assessment interview (yes or no)

Each client will be randomized to one of four conditions:

Condition 1: Assessment interview and Guidance Condition 2: Assessment Interview and No Guidance Condition 3: No Assessment Interview and Guidance Condition 4: No Assessment Interview and No Guidance
Primary purpose: TREATMENT

Brief summary: Internet-delivered cognitive behaviour therapy (ICBT) shows considerable promise as a convenient treatment for alcohol misuse. ICBT may differ in whether the user works alone (self-guided) or along with an individual who guides treatment (e.g., therapist/health educator). Guided ICBT involves completing online lessons over several weeks coupled with support from a guide in the form of emails, online messages and/or brief telephone calls. Self-guided ICBT allows users to complete lessons by themselves without any contact with a guide. In some studies, guided-ICBT has shown greater reductions in alcohol consumption than self-guided ICBT. Further, some research on alcohol treatment shows that assessment in itself may have an effect on alcohol consumption, a phenomenon referred to in the literature as "assessment reactivity". It is believed that verbalizing one's drinking problems to another person might lead to greater realization of the problem extent and severity, which in turn can lead to initiation of the change process. Experimental studies have shown that extended and frequent assessments lead to greater alcohol reductions compared to brief and infrequent assessments.

Although ICBT for alcohol misuse is an attractive treatment option, it is not often available to clients as part of routine care. The Online Therapy Unit at the University of Regina is currently exploring extending services to include guided ICBT for alcohol misuse. The Unit has been providing treatment in ICBT for depression and anxiety as well as various health conditions since 2010 and has offered treatment to \~4200 individuals. The purpose of this study is to evaluate ICBT for individuals with alcohol misuse within the routine online clinic, and to investigate ways to optimize future modes of delivery. Of specific interest in this study, is how outcomes vary depending on whether or not weekly guidance from a health educator is available and whether or not an initial extended assessment telephone call is included or not compared to a briefer screening telephone call. Of interest will also be if the extended assessment leads to greater alcohol reductions and higher motivation pre-treatment.

Detailed description: Alcohol misuse refers to alcohol consumption that causes harm to the drinker, others, and/or greater society. Internet-delivered cognitive behaviour therapy (ICBT) shows considerable promise as a convenient treatment for alcohol misuse. The overall goal of ICBT for alcohol misuse is typically behavioural change measured in terms of reduction of drinks consumed, as opposed to abstinence. The design of these interventions may differ in whether the user works alone (self-guided) or along with an individual who guides treatment (e.g., therapist/health educator). Guided ICBT involves completing online lessons over several weeks coupled with support from a guide in the form of emails, online messages or brief telephone calls. Self-guided ICBT allows users to complete lessons by themselves without any contact with a guide. In some studies, guided-ICBT has shown greater reductions in alcohol consumption than self-guided ICBT. Further, some research on alcohol treatment shows that assessment in itself may have an effect on alcohol consumption, a phenomenon referred to in the literature as "assessment reactivity". It is believed that verbalizing one's drinking problems to another person might lead to greater realization of the problem extent and severity, which in turn can lead to initiation of the change process. Experimental studies have shown that extended and frequent assessments lead to greater alcohol reductions compared to brief and infrequent assessments.

Although ICBT for alcohol misuse is an attractive treatment option, it is not often available to clients as part of routine care. The Online Therapy Unit at the University of Regina is currently exploring extending services to include guided ICBT for alcohol misuse. The Unit has been providing treatment in ICBT for depression and anxiety as well as various health conditions since 2010 and has offered treatment to \~4200 individuals. The purpose of this study is to evaluate ICBT for individuals with alcohol misuse, and to investigate ways to optimize future modes of delivery. Of specific interest in this study, is how outcomes vary depending on whether or not weekly guidance from a health educator is available and whether or not an initial extended assessment telephone call is included or not compared to a briefer screening telephone call.

Clients will be recruited online, through use of Google Ads and/or Facebook ads. Clients may also learn of the course from providers/organizations who will be informed of the study through posters, emails, and phone calls. All interested clients will be directed to the study website (www.onlinetherapyuser.ca) to complete an online screening questionnaire. As part of this questionnaire, they will be presented with a consent form explaining the screening protocol. After consent is given, clients will be assessed for eligibility using an online screening questionnaire. The online screening questionnaire captures demographic information (e.g., sex, ethnicity, location), contact details (e.g., telephone number, email address), information about alcohol, depression and other mental health issues, and background information needed to deliver therapy (e.g., medical history, mental health history, symptoms).

Once clients have been assessed for eligibility through the online screening questionnaire, they will be asked to book a telephone interview with unit staff. During the telephone screening interview, clients will be asked a series of follow-up questions to the online screening questionnaire to ensure eligibility as per exclusion criteria. Clients who meet any of the exclusion criteria during the online telephone screening interview will be referred to more appropriate mental health services. Clients who are excluded in the screening questionnaire by reporting a low score on either TLFB or AUDIT, or a high score on PHQ-9, will be informed about relevant treatment options and will be offered unguided ICBT with no assessment interview. Clients who are included in the study, will be randomized by the interviewer, while the client is still on the phone, to one of four conditions. The two factors in the trial are:

Factor 1: Guidance (yes or no)

Factor 2: Assessment interview (yes or no)

As this is a factorial trial with two factors, each client will be randomized to one of four conditions:

Condition 1: Assessment interview and Guidance Condition 2: Assessment Interview and No Guidance Condition 3: No Assessment Interview and Guidance Condition 4: No Assessment Interview and No Guidance

After the randomization those randomized to either condition that includes assessment interview will receive this interview immediately. The assessment interview consists of the Alcohol Use Disorder section of Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders 5 (SCID5). Clients will then be provided a user-name and temporary password, Those randomized to conditions with no assessment interview will be provided user-name and password immediately after the randomization.

All clients will have access to the ICBT course on the second Monday after the screening interview, regardless of whether they have been randomized to assessment interview or not.

Before accessing the ICBT course with user-name and password, clients will be presented with a consent form that explains the nature of treatment, as well as a pre-treatment questionnaire, where participants will complete questions about alcohol consumption in the preceding week, depression and motivation to change.

All clients will receive the Alcohol Change Course, an internet intervention targeting alcohol misuse. The course is an adaptation of a program originally developed in Switzerland. The program has been adapted to better fit the programs that are commonly used at the Online Therapy Unit (8 weeks in length, gradual time release, downloadable exercises, wide range in age). Patient partners have also studied the program and provided feedback, which has led to additional changes. It comprises 12 online lessons (1 to 2 lessons per week over 8 weeks), and the content is based on cognitive behaviour therapy and relapse prevention. Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills). All clients are presented with worksheets at the end of each lesson that contain exercises that facilitate skill acquisition. In all conditions, lessons will be released gradually in a standardized order over 8 weeks with regular automatic emails informing clients about upcoming lessons. Clients will complete outcome questionnaires at screening, baseline (pre-treatment), 8 weeks (post-treatment) and at 3, 6 and 12 months after treatment.

Eligibility criteria: Inclusion Criteria:

* Timeline Followback (TLFB; preceding week alcohol consumption) \> 13 drinks
* Alcohol Use Disorders Identification Test (AUDIT) \> 7

Exclusion Criteria:

* Severe depression (measured by scoring \> 23 on PHQ-9)
* Suicidal ideation (measured by scoring \> 2 to question 9 of PHQ-9)
* Severe mental health or medical conditions
* Severe drug use problems (measured by scoring \> 24 on Drug Use Disorders Identification Test \[DUDIT\] or clinical assessment)
* Low motivation to do, or concerns regarding, online treatment
* Ongoing or impending significant mental health treatment
* Not residing in Canada for the duration of treatment
* Lack of or inconsistent access to a computer and internet at home or private place for the duration of treatment

Primary outcomes:
measure: Drinks preceding week as measured by Timeline Followback (TLFB)
timeFrame: Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment
measure: Heavy drinking days preceding week as measured by Timeline Followback (TLFB).
timeFrame: Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT).
timeFrame: Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment
measure: Penn Alcohol Craving Scale
timeFrame: Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment
measure: Brief Situational Confidence Questionnaire (BSCQ).
timeFrame: Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Screening (Pre-treatment), 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment
measure: Sheehan Disability Scale
timeFrame: Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment
measure: Treatment Credibility and Expectancy Scale
timeFrame: 4 weeks (mid-treatment)
measure: Readiness to Change Questionnaire Treatment Version (RCQ-TV)
timeFrame: Screening (Pre-treatment)
measure: Evaluation and Negative Effects Questionnaire
timeFrame: 8 weeks (post-treatment)
Other outcomes:
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sundstrom C, Peynenburg V, Chadwick C, Thiessen D, Wilhems A, Nugent M, Keough MT, Schaub MP, Hadjistavropoulos HD. Optimizing internet-delivered cognitive behaviour therapy for alcohol misuse-a randomized factorial trial examining effects of a pre-treatment assessment interview and guidance. Addict Sci Clin Pract. 2022 Jul 23;17(1):37. doi: 10.1186/s13722-022-00319-0.
citation: Sundstrom C, Hadjistavropoulos H, Wilhelms A, Keough M, Schaub M. Optimizing internet-delivered cognitive behaviour therapy for alcohol misuse: a study protocol for a randomized factorial trial examining the effects of a pre-treatment assessment interview and health educator guidance. BMC Psychiatry. 2020 Mar 17;20(1):126. doi: 10.1186/s12888-020-02506-2.