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Internet-delivered Therapy for Alcohol Misuse: Factorial Trial of Assessment and Guidance

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ClinicalTrials.gov Identifier: NCT03984786
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : August 8, 2019
Sponsor:
Collaborators:
Saskatchewan Ministry of Health
Saskatchewan Health Research Foundation
Saskatchewan Centre for Patient-Oriented Research
Information provided by (Responsible Party):
University of Regina

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.


Condition or disease Intervention/treatment Phase
Alcohol Misuse Behavioral: Assessment Interview Behavioral: Guidance Behavioral: ICBT for alcohol misuse Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Participants will be blinded to randomization, i.e. will not know which groups they can be randomized to. Health educators providing guidance to participants will be blinded to whether the client has been randomized to "Assessment Interview" factor (condition 1) or "No assessment interview (condition 3). All outcomes are collected online, so there is no need to blind any outcomes assessor.
Primary Purpose: Treatment
Official Title: Internet-delivered Cognitive Behaviour Therapy for Alcohol Misuse: A Factorial Trial Examining the Effects of Assessment Interview and Guidance
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: ICBT for alcohol misuse: Assessment Interview/Guidance

In this arm, an interviewer will administer a pre-treatment assessment interview. This 30-45 minute interview will be performed after randomization during the initial telephone screen, where the interviewer will use the AUD section from SCID-5.

Participants randomized to this arm will then receive the 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse with guidance from a health educator through regular weekly online messages. Participants may also be contacted through emails and phone calls. The team of guides consists of registered social workers, psychologists, and graduate students, with experience delivering ICBT.

Behavioral: Assessment Interview
An interviewer will administer a pre-treatment assessment interview. This 30-45 minute interview will be performed after randomization immediately after the initial telephone screen, where the interviewer will use the AUD section of the SCID-5.

Behavioral: Guidance
Guidance from a health educator through regular weekly online messages. Participants may also be contacted through emails and phone calls. The team of guides consists of registered social workers, psychologists, and graduate students, with experience delivering ICBT.

Behavioral: ICBT for alcohol misuse
The 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse. The course consists of 12 lessons distributed across 8 weeks (1 to 2 lessons a week).

Experimental: ICBT for alcohol misuse: Assessment Interview/No Guidance

In this arm, an interviewer will administer a pre-treatment assessment interview. This 30-45 minute interview will be performed after randomization during the initial telephone screen, where the interviewer will use the AUD section from SCID-5.

Participants randomized to this arm will receive the 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse. Participants are able to contact the Online Therapy Unit regarding any technical issues with logging onto the site. However, no guidance from a health educator will be provided. Clients will be monitored by providing brief measures on alcohol and depression each week. However, clients will only be contacted if there is a significant clinical issue requiring attention (e.g., sudden increase in symptoms of depression and suicidal ideation).

Behavioral: Assessment Interview
An interviewer will administer a pre-treatment assessment interview. This 30-45 minute interview will be performed after randomization immediately after the initial telephone screen, where the interviewer will use the AUD section of the SCID-5.

Behavioral: ICBT for alcohol misuse
The 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse. The course consists of 12 lessons distributed across 8 weeks (1 to 2 lessons a week).

Experimental: ICBT alcohol misuse: No Assessment Interview/Guidance

The client will not receive any assessment interview during the telephone screen.

Participants randomized to this arm will receive the 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse with guidance from a health educator through regular weekly online messages. Participants may also be contacted through emails and phone calls. The team of guides consists of registered social workers, psychologists, and graduate students, with experience delivering ICBT.

Behavioral: Guidance
Guidance from a health educator through regular weekly online messages. Participants may also be contacted through emails and phone calls. The team of guides consists of registered social workers, psychologists, and graduate students, with experience delivering ICBT.

Behavioral: ICBT for alcohol misuse
The 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse. The course consists of 12 lessons distributed across 8 weeks (1 to 2 lessons a week).

Experimental: ICBT for alcohol misuse: No Assessment Interview/No Guidance

The client will not receive any assessment interview during the telephone screen.

Participants randomized to this arm will receive the 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse. Participants are able to contact the Online Therapy Unit regarding any technical issues with logging onto the site. However, no guidance from a health educator will be provided. Clients will be monitored by providing brief measures on alcohol and depression each week. However, clients will only be contacted if there is a significant clinical issue requiring attention (e.g., sudden increase in symptoms of depression and suicidal ideation).

Behavioral: ICBT for alcohol misuse
The 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse. The course consists of 12 lessons distributed across 8 weeks (1 to 2 lessons a week).




Primary Outcome Measures :
  1. Drinks preceding week as measured by Timeline Followback (TLFB) [ Time Frame: Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment ]
    Change in preceding week alcohol consumption in terms of the total number of standard drinks consumed on each day during the previous 7 days.

  2. Heavy drinking days preceding week as measured by Timeline Followback (TLFB). [ Time Frame: Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment ]
    Change in preceding week alcohol consumption in terms of the total number of heavy drinking days during the previous 7 days.


Secondary Outcome Measures :
  1. Alcohol Use Disorders Identification Test (AUDIT). [ Time Frame: Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment ]
    Change in alcohol-related problems and behaviours measured by total AUDIT score which can range from 0 to 40. Greater score indicates greater alcohol problems (worse outcome)

  2. Penn Alcohol Craving Scale [ Time Frame: Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment ]
    Change in alcohol craving as measured by a total score ranging between 0 to 30. Higher scores indicate greater craving (worse outcome).

  3. Brief Situational Confidence Questionnaire (BSCQ). [ Time Frame: Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment ]
    Change in confidence in resisting drinking urges in 8 situations rated from 0 to 100, rendering a sum score of 0-800. Higher scores indicate greater confidence (better outcome). There are 8 subscales, one for each item, assessed on a scale of 0-100. Thus, each subscale has a sum score of 0-100-. A higher score indicates greater confidence on the subscale.

  4. Generalized Anxiety Disorder 7-item (GAD-7) [ Time Frame: Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment ]
    Change in total GAD-7 anxiety score which can range from 0 to 21. Higher scores indicate greater anxiety (worse outcome)

  5. Patient Health Questionnaire (PHQ-9) [ Time Frame: Screening (Pre-treatment), 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment ]
    Change in total PHQ-9 score which can range from 0 to 27. Higher scores indicate greater depression (worse outcome)

  6. Sheehan Disability Scale [ Time Frame: Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment ]
    Change in three scores assessing functional impairment in three domains: 1) work/school, 2) social and 3) family life (each domain score ranges from 0 to 10, rendering a sum score of 0-30). Higher score indicates greater ability on the specified domain score (better outcome). Each domain score (subscale) renders a sum score of 0-10.

  7. Treatment Credibility and Expectancy Scale [ Time Frame: 4 weeks (mid-treatment) ]
    Measures the participant's thoughts and feelings about the treatment and the treatment's effectiveness in reducing participant's symptoms and increasing participant's functioning. Consists of 6 items. The first three of these and the 5th render a score of 1- 9. The other three questions render a score of 0-10. There are two subscales; 1) treatment credibility and 2) treatment expectancy. The first three questions are summed to render a score on the credibility subscale (0-27). The last three questions, the expectancy subscale, render a score of 0-29.

  8. Readiness to Change Questionnaire Treatment Version (RCQ-TV) [ Time Frame: Screening (Pre-treatment) ]
    Measures participants' motivation to change their drinking behaviours and determines at which stage of the Stages of Change model they are in (precontemplation, contemplation, or action). There is no sum score. Instead the items related to each stage are summed, and the individual is allocated to the stage that has the greatest score out of these three. (For more information about the scoring of this instrument, see Heather & Hönekopp, 2009).

  9. Evaluation and Negative Effects Questionnaire [ Time Frame: 8 weeks (post-treatment) ]
    Measures negative effects experienced by participants during treatment. This questionnaire has been developed by the research team, and does not have a sum score.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984786


Contacts
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Contact: Christopher Sundström, PhD 3063374903 Christopher.Sundstrom@uregina.ca
Contact: Marcie Nugent, MSW 3063372946 Marcie.Nugent@uregina.ca

Locations
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Canada, Saskatchewan
University of Regina Recruiting
Regina, Saskatchewan, Canada, S4S0A2
Contact: Marcie Nugent, MSW    3063373331    Marcie.Nugent@uregina.ca   
Sponsors and Collaborators
University of Regina
Saskatchewan Ministry of Health
Saskatchewan Health Research Foundation
Saskatchewan Centre for Patient-Oriented Research
Investigators
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Principal Investigator: Heather Hadjistavropoulos, PhD University of Regina

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Responsible Party: University of Regina
ClinicalTrials.gov Identifier: NCT03984786     History of Changes
Other Study ID Numbers: 2019-058
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Regina:
alcohol misuse
internet
guidance
ICBT
cognitive behaviour therapy
assessment

Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs