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

NCT03984786 | Completed

• 1 other identifier: 2019-058
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Misuse

Keywords

alcohol misuse; internet; guidance; ICBT; cognitive behaviour therapy; assessment

Outcome Measures

Primary Outcomes (2)

• 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.

  Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment

• 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.

  Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment

Secondary Outcomes (9)

• Alcohol Use Disorders Identification Test (AUDIT).

  Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment

• Penn Alcohol Craving Scale

  Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment

• Brief Situational Confidence Questionnaire (BSCQ).

  Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment

• Generalized Anxiety Disorder 7-item (GAD-7)

  Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment

• Patient Health Questionnaire (PHQ-9)

  Screening (Pre-treatment), 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment

Study Arms (4)

ICBT for alcohol misuse: Assessment Interview/Guidance

EXPERIMENTAL

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; Behavioral: Guidance; Behavioral: ICBT for alcohol misuse

ICBT for alcohol misuse: Assessment Interview/No Guidance

EXPERIMENTAL

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; Behavioral: ICBT for alcohol misuse

ICBT alcohol misuse: No Assessment Interview/Guidance

EXPERIMENTAL

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; Behavioral: ICBT for alcohol misuse

ICBT for alcohol misuse: No Assessment Interview/No Guidance

EXPERIMENTAL

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

Interventions

Assessment Interview BEHAVIORAL

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.

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

Guidance BEHAVIORAL

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.

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

ICBT for alcohol misuse BEHAVIORAL

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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Timeline Followback (TLFB; preceding week alcohol consumption) \> 13 drinks
• Alcohol Use Disorders Identification Test (AUDIT) \> 7

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regina: lead
• Ministry of Health, Saskatchewan: collaborator
• Saskatchewan Health Research Foundation: collaborator
• Saskatchewan Centre for Patient-Oriented Research: collaborator

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S0A2, Canada

Location

Related Publications (2)

• Sundstrom C, Peynenburg V, Chadwick C, Thiessen D, Wilhems A, Nugent M, Keough MT, Schaub MP, Hadjistavropoulos HD. Optimizing internet-delivered cognitive behaviour therapy for alcohol misuse-a randomized factorial trial examining effects of a pre-treatment assessment interview and guidance. Addict Sci Clin Pract. 2022 Jul 23;17(1):37. doi: 10.1186/s13722-022-00319-0.

  PMID: 35871010 DERIVED

• Sundstrom C, Hadjistavropoulos H, Wilhelms A, Keough M, Schaub M. Optimizing internet-delivered cognitive behaviour therapy for alcohol misuse: a study protocol for a randomized factorial trial examining the effects of a pre-treatment assessment interview and health educator guidance. BMC Psychiatry. 2020 Mar 17;20(1):126. doi: 10.1186/s12888-020-02506-2.

  PMID: 32183769 DERIVED

MeSH Terms

Interventions

Counseling; Ethanol

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Alcohols; Organic Chemicals

Study Officials

• Heather Hadjistavropoulos, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 13, 2019
• Study Start: July 31, 2019
• Primary Completion: January 5, 2022
• Study Completion: April 11, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)