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Clinical Trials/NCT05555264
NCT05555264Active, not recruitingNot Applicable

Enhancing Impact of Internet-delivered Cognitive Behaviour Therapy for Alcohol Misuse by Addressing Co-morbidity and Improving Patient Narratives: a Patient-Oriented Research Approach

University of Regina2 sites in 1 country205 target enrollmentStarted: September 16, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
205
Locations
2
Primary Endpoint
Drinks Preceding Week as Measured by Timeline Followback (TLFB)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Outcomes

Primary Outcomes

Drinks Preceding Week as Measured by Timeline Followback (TLFB)

Time Frame: Baseline (screening), Week 4 (mid-treatment), Week 7 (post-treatment), Week 20 (follow-up)

Change in preceding week alcohol consumption in terms of the total number of standard drinks consumed on each day during the previous 7 days.

Heavy Drinking Days Preceding Week as Measured by Timeline Followback (TLFB)

Time Frame: Baseline (screening), Week 4 (mid-treatment), Week 7 (post-treatment), Week 20 (follow-up)

Change in preceding week alcohol consumption in terms of the total number of heavy drinking days during the previous 7 days.

Patient Reflections Questionnaire

Time Frame: Week 4 (mid-treatment), Week 7 (post-treatment)

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.

Additional Resources Questionnaire (Midpoint)

Time Frame: Week 4 (mid-treatment)

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.

Additional Resources Questionnaire

Time Frame: Week 8

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.

Secondary Outcomes

  • Patient Health Questionnaire 9-item (PHQ-9)(Baseline (screening), Week 1, Week 4 (mid-treatment), Week 7 (post-treatment), Week 20 (follow-up))
  • Generalized Anxiety Disorder 7-item (GAD-7)(Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up))
  • Alcohol Use Disorder Identification Test (AUDIT)(Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up))
  • Penn Alcohol Craving Scale(Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up))
  • The Cannabis Use Disorder Identification Test - Revised (CUDIT-R)(Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up))
  • Couples Satisfaction Index 4-item (CSI-4)(Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up))
  • Dimensions of Anger Reactions (DAR-5)(Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up))
  • Credibility and Expectancy Questionnaire (CEQ)(Week 4 (mid-treatment))
  • Open-Ended Personal Reflections and Additional Resources Questionnaire(Week 7 (post-treatment))
  • Change Goal Questionnaire(Week 2, Week 7 (post-treatment))
  • (Treatment Satisfaction) Evaluation Questions and Negative Effects(Week 7 (post-treatment))
  • Other Forms of Help(Week 7 (post-treatment), Week 20 (follow-up))
  • Insomnia Severity Index (ISI)(Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up))
  • Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5/PTSD Checklist for DSM-5 (LEC-5/PCL-5)(Baseline (screening))
  • Short Form PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (SF-PCL-5)(Week 7 (post-treatment), Week 20 (follow-up))
  • Motivation for Change(Baseline (screening), Week 4 (mid-treatment), Week 7 (post-treatment))
  • Work and Social Adjustment Scale (WSAS)(Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up))
  • Total Drinks in the Last Week(Week 1, Week 2, Week 3, Week 5, Week 6, Week 8)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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