Enhancing Internet-delivered Cognitive Behaviour Therapy for Alcohol Misuse

NCT ID: NCT05555264

Last Updated: 2024-12-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-16
• Study Completion Date: 2025-03-31

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.

Conditions

Alcohol Misuse

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-Guided Alcohol Change Course Enhanced

Clients who select or are assigned the self-guided condition will receive access to 6 ICBT core lessons, 6 associated worksheets to enhance skill acquisition, and 8 additional resources addressing potential co-morbid concerns (e.g., Addressing Anger, Improving Assertiveness and Communication, Changing Cannabis Use, Developing Cognitive Coping, Coping with Grief, Understanding PTSD, Improving Sleep Quality, and Managing Worry). The 6 lessons and 6 associated worksheets are released at a rate of 1 per week over 7 weeks, with no new content being released to participants in Week 4. The 8 additional resources are available at any time during the course.

Clients will not receive therapist support/guidance during the 8-week intervention.

Group Type: EXPERIMENTAL

Self-Guided

Intervention Type: BEHAVIORAL

Clients who select or are assigned the self-guided condition will be able to contact the Online Therapy Unit regarding any technical issues through the secure treatment platform; monitoring staff will respond by secure message to messages received however, no psychological intervention will be provided by monitoring staff as part of the ACCE treatment intervention. If there is a significant clinical issue requiring attention (e.g., a sudden increase in symptoms) monitoring staff will make a telephone call and crisis support will be provided if necessary.

Therapist-Guided Alcohol Change Course Enhanced

Clients who select the therapist-guided condition will receive access to 6 ICBT core lessons, 6 associated worksheets to enhance skill acquisition, and 8 additional resources addressing potential co-morbid concerns (e.g., sleep quality, cannabis use). The 6 lessons and 6 associated worksheets are released at a rate of 1 per week over 7 weeks, with no new content being released to participants in Week 4. The 8 additional resources are available at any time during the course.

Clients will receive therapist support/guidance during the 8-week intervention.

Group Type: EXPERIMENTAL

Therapist-Guided

Intervention Type: BEHAVIORAL

Therapists will spend \~15 minutes/week communicating with each client who selects the therapist-guided condition, primarily using secure messages. Phone calls will only be made if there is a significant clinical issue requiring attention that the therapist does not feel can be addressed in a message (e.g., a question about the materials that cannot be easily addressed in a text format, a sudden increase in symptoms, increased suicide risk).

Interventions

Self-Guided

Clients who select or are assigned the self-guided condition will be able to contact the Online Therapy Unit regarding any technical issues through the secure treatment platform; monitoring staff will respond by secure message to messages received however, no psychological intervention will be provided by monitoring staff as part of the ACCE treatment intervention. If there is a significant clinical issue requiring attention (e.g., a sudden increase in symptoms) monitoring staff will make a telephone call and crisis support will be provided if necessary.

Intervention Type: BEHAVIORAL

Therapist-Guided

Therapists will spend \~15 minutes/week communicating with each client who selects the therapist-guided condition, primarily using secure messages. Phone calls will only be made if there is a significant clinical issue requiring attention that the therapist does not feel can be addressed in a message (e.g., a question about the materials that cannot be easily addressed in a text format, a sudden increase in symptoms, increased suicide risk).

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saskatchewan Health Research Foundation

OTHER

Sponsor Role: collaborator

Saskatchewan Centre for Patient-Oriented Research

OTHER

Sponsor Role: collaborator

University of Regina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Hadjistavropoulos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Locations

Online Therapy Unit, University of Regina

Regina, Saskatchewan, Canada

Countries

Canada

Other Identifiers

2022-082

Identifier Type: -

Identifier Source: org_study_id