Clinical trial NCT05555264: Enhancing Internet-delivered Cognitive Behaviour Therapy for Alcohol Misuse
Official title: Enhancing Impact of Internet-delivered Cognitive Behaviour Therapy for Alcohol Misuse by Addressing Co-morbidity and Improving Patient Narratives: a Patient-Oriented Research Approach
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Misuse
Keywords: Internet-delivered cognitive behaviour therapy
Alcohol misuse
Substance misuse
Patient Narratives
Co-morbidities
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Research Foundation
name: Saskatchewan Centre for Patient-Oriented Research
First posted: 2022-09-26
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each client will choose one of the following: self-guided Alcohol Change Course Enhanced (8 weeks), therapist-guided Alcohol Change Course Enhanced (8 weeks)
Primary purpose: TREATMENT

Brief summary: Alcohol misuse is a common and disabling problem and 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. These interventions can be delivered in a therapist-guided format or self-guided format.

In past research on ICBT for alcohol misuse, stakeholders (e.g., patients, providers, and academics) highlighted the importance of ensuring that ICBT meets the needs of diverse residents of Saskatchewan, and that ICBT takes into account factors such as psychological comorbidity. Therefore, the goals of the current trial are to: 1) incorporate additional patient narratives to assist clients in learning how diverse individuals apply skills to their lives; and 2) provide additional optional resources to address potential co-morbid concerns. The study aims to examine how these materials are evaluated by clients. Furthermore, we will also examine the overall engagement and outcomes of the enhanced ICBT course for alcohol misuse benchmarked with past findings.

Detailed description: In Canada, it is estimated that 16.6% of individuals over the age of 12 engage in heavy drinking on a monthly basis. The cost of alcohol misuse is substantial, as it is associated with psychological distress, interpersonal problems, chronic health conditions, health care costs, and lost work productivity. Unfortunately, the under treatment of alcohol misuse is a significant problem, with many individuals with alcohol misuse never seeking treatment, for reasons such as stigma or lack of available services due to rural and/or remote location.

Internet-delivered cognitive behaviour therapy (ICBT) for alcohol misuse is a growing and impactful method of effectively delivering care that overcomes several barriers of face-to-face therapy. Reflecting this trend, ICBT for alcohol misuse has been funded by the Saskatchewan Ministry of Health since July 2019. Specifically, the government funds the Online Therapy Unit (OTU) to deliver the Alcohol Change Course (ACC) to SK residents. In addition to the ACC, the OTU has delivered ICBT treatment programs addressing anxiety, depression, and various health conditions to over 10418 clients since 2010.

While there is growing recognition of the effectiveness of ICBT, there is also awareness of the need to improve ICBT for alcohol misuse to increase the impact of this innovative treatment approach.

Research suggests that the integration of patient suggestions can improve the quality of care, by ensuring that programs are designed in such a way that they are acceptable to patients and fit with other services; when this approach is taken, there is evidence that services are more effective and more likely to be used and sustained longer-term. Through such a patient-oriented process employed by the OTU in their research and development of the ACC, two opportunities for improving the ACC were identified (i.e., 1 - refining the existing patient narratives and incorporating new patient narratives to be more diverse in nature; and 2 - providing optional additional resources to address common comorbid concerns).

1. Patient narratives (referred to as "Personal Reflections" in the ACCE) are incorporated in ICBT programs to motivate and support health-behaviour change. They are typically brief descriptions of an individual, challenges they face, and their strategy use. Research supports the efficacy of patient narratives for providing information, engaging clients in behavioural change, modeling behaviour, and comforting clients. To capture the diverse characteristics and experiences (e.g., alcohol use, age, location of residence, gender, ethnicity) of future ACCE clients, the ACC's personal reflections were revised, and new personal reflections were developed.
2. Given high comorbidity of alcohol misuse and various concerns (e.g., depression, anxiety, PTSD, cannabis use, relationship troubles, anger, etc.), both past ACC clients and OTU therapists indicate the benefits of broadening the topics covered by additional resources in the ACCE. As such, eight ACCE-specific additional resources were offered as part of the ACCE, including Addressing Anger, Improving Assertiveness and Communication, Changing Cannabis Use, Developing Cognitive Coping, Coping with Grief, Understanding PTSD, Improving Sleep Quality, and Managing Worry.

In this study, prospective clients may learn of the ACCE from providers/organizations, who will be informed through posters, emails, and phone calls. Clients interested in the ACCE will be directed to the study website to complete a consent form explaining the screening protocol. Once clients give consent, they will complete an online screening questionnaire assessing eligibility and capturing demographic, contact, alcohol use, and other information. After completing the screening, clients will book a telephone screening interview with unit staff through the online appointment booking software. During the telephone screening, clients will be asked follow-up questions to confirm their eligibility. (If clients meet the current trial's exclusion criteria, they will be referred to more appropriate mental health services in their area).

At the end of the telephone screening, Saskatchewan clients who meet eligibility criteria will indicate their preference for the therapist-guided or self-guided (with monitoring) ACCE; screening staff will enroll them in the chosen course. Clients from outside Saskatchewan will be offered self-guided ACCE only. All enrolled clients will receive a username and temporary password, and will be informed that they can access the ACCE on the following Monday.

Once clients log onto the treatment platform, they will complete a pre-treatment questionnaire and a consent form explaining the nature of treatment. All clients will receive the ACCE. Lesson content is based on cognitive behaviour therapy and relapse prevention. Materials are presented in a didactic and case-enhanced learning format.

Participants will complete online questionnaires at various times as outlined below. At mid-treatment and/or post-treatment, a subsample of clients will be invited for semi-structured interviews to discuss their experiences with the revised personal reflections and additional resources. A research associate will monitor client demographics to ensure that a diverse sample is represented in the interviews, and may directly reach out to clients with diverse demographic or clinical characteristics.

Eligibility criteria: Inclusion Criteria:

* are residing in Saskatchewan;
* are over the age of 17;
* endorse alcohol misuse;
* and have access to a computer and the Internet.

Exclusion Criteria:

* have a severe medical condition and/or psychiatric illness (e.g., psychosis);
* show signs of severe depression;
* are assessed as being at high risk of suicide;
* have severe problems with drugs (other than alcohol and/or cannabis; measured by scoring \> 24 on the DUDIT, or by clinical assessment);
* have severe cognitive impairment;
* demonstrate low motivation or concerns regarding completing the online treatment program;
* or do/will engage in ongoing or impending significant mental health treatment (i.e., \>2 visits per month).

Primary outcomes:
measure: Drinks Preceding Week as Measured by Timeline Followback (TLFB)
timeFrame: Baseline (screening), Week 4 (mid-treatment), Week 7 (post-treatment), Week 20 (follow-up)
measure: Heavy Drinking Days Preceding Week as Measured by Timeline Followback (TLFB)
timeFrame: Baseline (screening), Week 4 (mid-treatment), Week 7 (post-treatment), Week 20 (follow-up)
measure: Patient Reflections Questionnaire
timeFrame: Week 4 (mid-treatment), Week 7 (post-treatment)
measure: Additional Resources Questionnaire (Midpoint)
timeFrame: Week 4 (mid-treatment)
measure: Additional Resources Questionnaire
timeFrame: Week 8
Secondary outcomes:
measure: Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: Baseline (screening), Week 1, Week 4 (mid-treatment), Week 7 (post-treatment), Week 20 (follow-up)
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
measure: Penn Alcohol Craving Scale
timeFrame: Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
measure: The Cannabis Use Disorder Identification Test - Revised (CUDIT-R)
timeFrame: Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
measure: Couples Satisfaction Index 4-item (CSI-4)
timeFrame: Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
measure: Dimensions of Anger Reactions (DAR-5)
timeFrame: Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Week 4 (mid-treatment)
measure: Open-Ended Personal Reflections and Additional Resources Questionnaire
timeFrame: Week 4 (mid-treatment)
measure: Open-Ended Personal Reflections and Additional Resources Questionnaire
timeFrame: Week 7 (post-treatment)
measure: Change Goal Questionnaire
timeFrame: Week 2, Week 7 (post-treatment)
measure: (Treatment Satisfaction) Evaluation Questions and Negative Effects
timeFrame: Week 7 (post-treatment)
measure: Other Forms of Help
timeFrame: Week 7 (post-treatment), Week 20 (follow-up)
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
measure: Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5/PTSD Checklist for DSM-5 (LEC-5/PCL-5)
timeFrame: Baseline (screening)
measure: Short Form PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (SF-PCL-5)
timeFrame: Week 7 (post-treatment), Week 20 (follow-up)
measure: Motivation for Change
timeFrame: Baseline (screening), Week 4 (mid-treatment), Week 7 (post-treatment)
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
measure: Total Drinks in the Last Week
timeFrame: Week 1, Week 2, Week 3, Week 5, Week 6, Week 8
Other outcomes:
measure: Family History Density - Alcohol (FHD-Alcohol)
timeFrame: Baseline (screening)
measure: Drug Use Disorder Identification Test (DUDIT)
timeFrame: Baseline (screening)
measure: Homework Reflection Questionnaire
timeFrame: Weeks 2-8
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit, University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References: