Enhancing Internet-delivered Cognitive Behaviour Therapy for Alcohol Misuse

Alcohol Misuse Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555264
• Other study ID #: 2022-082
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2023
• Source: University of Regina
• Contact: Marcie Nugent, MSW
• Phone: 306-337-2946
• Email: marcie.nugent[@]uregina.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Alcohol Misuse

Intervention

Behavioral:
• 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.
• 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).

Locations

Country	Name	City	State
Canada	Online Therapy Unit, University of Regina	Regina	Saskatchewan

Sponsors (3)

Lead Sponsor	Collaborator
University of Regina	Saskatchewan Centre for Patient-Oriented Research, Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Family History Density - Alcohol (FHD-Alcohol)	Measures clients' family history density of alcohol use and alcohol-related difficulties via 6 items. Total scores range from 0-2; higher scores indicate a greater family history density of alcohol use and alcohol use-related difficulties.	Baseline (screening)
Other	Drug Use Disorder Identification Test (DUDIT)	Measures problematic drug use via an 11-item screening tool. Items 1-9 are scored on a scale ranging from 0-4. Items 10 and 11 are scored as a 0, 2, or 4. Total scores for the DUDIT range from 0-44, with higher scores suggesting more problematic drug use.	Baseline (screening)
Other	Homework Reflection Questionnaire	Measures clients' week-to-week experience in the ACCE. This brief questionnaire has been developed by the research team, and does not have a sum score.	Weeks 2-8
Primary	Drinks Preceding Week as Measured by Timeline Followback (TLFB)	Change in preceding week alcohol consumption in terms of the total number of standard drinks consumed on each day during the previous 7 days.	Baseline (screening), Weeks 1-8, Week 20 (follow-up)
Primary	Heavy Drinking Days Preceding Week as Measured by Timeline Followback (TLFB)	Change in preceding week alcohol consumption in terms of the total number of heavy drinking days during the previous 7 days.	Baseline (screening), Week 4 (mid-treatment), Week 7 (post-treatment), Week 20 (follow-up)
Primary	Patient Reflections Questionnaire	Change in clients' opinions of and satisfaction with the personal reflections incorporated throughout the ACCE. This questionnaire has been developed by the research team, and does not have a sum score.	Week 4 (mid-treatment), Week 7 (post-treatment)
Primary	Additional Resources Questionnaire (Midpoint)	Clients' opinions of and satisfaction with the 8 additional resources offered alongside the ACCE that they have reviewed since the beginning of treatment. This questionnaire has been developed by the research team, and does not have a sum score.	Week 4 (mid-treatment)
Primary	Additional Resources Questionnaire (Post- Treatment)	Clients' opinions of and satisfaction with the 8 additional resources offered alongside the ACCE that they have reviewed since the Midpoint questionnaire. This questionnaire has been developed by the research team, and does not have a sum score.	Week 7 (post-treatment)
Secondary	Patient Health Questionnaire 9-item (PHQ-9)	Change in depression symptoms. 9 items are summed into a total score, ranging from 0-27. Higher scores indicate higher depression severity.	Baseline (screening), Week 1, Week 4 (mid-treatment), Week 7 (post-treatment), Week 20 (follow-up)
Secondary	Generalized Anxiety Disorder 7-item (GAD-7)	Change in anxiety symptoms. 7 items are summed into a total score, ranging from 0-21, with higher scores indicating more severe self-reported levels of anxiety.	Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
Secondary	Alcohol Use Disorder Identification Test (AUDIT)	Change in alcohol-related problems and behaviours measured via a total AUDIT score, which can range from 0-40. Greater scores indicate greater alcohol problems.	Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
Secondary	Penn Alcohol Craving Scale	Change in alcohol craving measured via a total score ranging between 0-30. Higher scores indicate greater alcohol craving.	Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
Secondary	The Cannabis Use Disorder Identification Test - Revised (CUDIT-R)	Change in cannabis-related problems and behaviours measured via total CUDIT-R score, which can range from 0-32 (8 items). Scoring >7 indicates hazardous cannabis use; scoring >11 indicates a possible cannabis use disorder.	Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
Secondary	Couples Satisfaction Index 4-item (CSI-4)	Change in relationship satisfaction. Higher total scores indicate greater relationship satisfaction, with scores <13.5 indicating notable dissatisfaction.	Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
Secondary	Dimensions of Anger Reactions (DAR-5)	Change in self-reported anger problems. Higher total scores indicate greater severity of anger problems. Scores range from 0-20.	Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
Secondary	Credibility and Expectancy Questionnaire (CEQ)	Measures treatment credibility via the first 3 items (ranging from 1-9) from the CEQ. Total scores range from 3-27, with higher scores indicating higher perceived treatment credibility.	Week 4 (mid-treatment)
Secondary	Open-Ended Personal Reflections and Additional Resources Questionnaire	Measures client's feedback regarding the ACCE's enhanced personal reflections and additional resources, via a structured interview process. The number of participants to be interviewed will be determined based on the saturation of themes yielded within preliminary qualitative analyses. The structured interview questions were created by the research team and the measure does not have a sum score.	Week 4 (mid-treatment)
Secondary	Open-Ended Personal Reflections and Additional Resources Questionnaire	Measures client's feedback regarding the ACCE's enhanced personal reflections and additional resources, via a structured interview process. The number of participants to be interviewed will be determined based on the saturation of themes yielded within preliminary qualitative analyses. The structured interview questions were created by the research team and the measure does not have a sum score.	Week 7 (post-treatment)
Secondary	Change Goal Questionnaire	Change in clients' goals related to their alcohol use. This brief questionnaire has been developed by the research team, and does not have a sum score.	Week 2, Week 7 (post-treatment)
Secondary	(Treatment Satisfaction) Evaluation Questions and Negative Effects	Measures negative effects experienced by clients during treatment. This questionnaire has been developed by the research team, and does not have a sum score.	Week 7 (post-treatment)
Secondary	Other Forms of Help	Change in other types of help that clients received during treatment. This questionnaire has been developed by the research team, and does not have a sum score.	Week 7 (post-treatment), Week 20 (follow-up)
Secondary	Insomnia Severity Index (ISI)	Change in insomnia severity. 7 items assess clients' difficulties falling asleep, staying asleep, and waking too early, each on a scale from 0 (None) to 4 (Very Severe). Total scores range from 0-28.	Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)
Secondary	Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5/PTSD Checklist for DSM-5 (LEC-5/PCL-5)	Measures PTSD symptoms. The LEC-5 is a checklist of common traumatic events used to establish the nature of the traumatic events a client has experienced. This questionnaire is not intended to be scored, but is used for descriptive purposes. Following the LEC-5, clients will complete the PCL-5 (a validated measure of PTSD, based on DSM-5 criteria); PCL-5 scores range from 0-80, and higher total scores indicate greater PTSD severity.	Baseline (screening)
Secondary	Short Form PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (SF-PCL-5)	Change in PTSD symptom severity. The SF-PCL-5 is A 4-item, short-form version of the PTSD Checklist for DSM-5. Higher total scores indicate greater PTSD severity. Scores range from 0-16.	Week 7 (post-treatment), Week 20 (follow-up)
Secondary	Motivation for Change	Change in clients' motivation for changing their alcohol use. On three scales from 1-10, clients self-report: 1) the importance of changing their alcohol use, 2) their confidence in their ability to change their alcohol use, and 3) their readiness to change their alcohol use.	Baseline (screening), Week 4 (mid-treatment), Week 7 (post-treatment)
Secondary	Work and Social Adjustment Scale (WSAS)	Change in impairment of functioning. Measure includes 5 questions assessing impairment of functioning. Items are scored on a scale of 0 to 8. Total scores on the WSAS range from 0 to 40 with higher scores suggesting severe impairment.	Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)