Therapeutic Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy

University of Regina

Status

Completed

Conditions

Depression

Anxiety

Treatments

Behavioral: Internet-delivered cognitive behaviour therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03957330

2019-038

Details and patient eligibility

About

Depression and anxiety are common and prevalent conditions that often go untreated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered cognitive behavioural therapy (ICBT) has emerged. ICBT involves delivering therapeutic content via structured online lessons. This is often combined with therapist guidance, such as once per week contact via secure messaging or phone calls over several months. Over the past several years, the investigators have been studying the efficacy of ICBT for symptoms of depression and anxiety and found ~70% of patient's fully complete treatment and demonstrate large improvement in symptoms. Although outcomes of ICBT are very impressive, there is some room for improvement in terms of completion rates and outcomes.

In this three-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of ICBT in routine practice is moderated by amount of contact (once versus twice a week), inclusion of homework reflection questionnaire (yes vs no) and location of therapist (specialized unit vs community mental health clinic). Follow-up measures will be carried out at 3, 6 and 12 months after randomization. Primary outcomes are reduced anxiety and depression. Secondary outcomes include psychological distress, panic, social anxiety, trauma, health anxiety, quality of life, disability, intervention usage (e.g., completion rates, log-ins, emails sent), satisfaction, therapeutic alliance, and costs (e.g., health care utilization).

Full description

Based on past research of ICBT in routine care, patients and therapists have expressed an interest in "personalizing" the delivery of ICBT, for example, by increasing the amount of therapist support available (from once a week to twice a week) to reflect the unique needs and preferences of the patients. Patients also express an interest in personalizing "therapy messages". One current barrier to offering more personalized messages, however, is that patients do not consistently provide information on their use of new treatment strategies, as well as strengths and challenges of using strategies. As a result, therapists find it difficult to personalize their messages. One method of overcoming this difficulty is to systematically ask patients to reflect on their use of treatment strategies (e.g., monitoring thoughts, challenging thoughts, controlled breathing, pleasant activities, and exposure) through questionnaires rather than relying on patients to provide this information in emails. Another factor that could moderate ICBT efficacy is therapist location. Some therapists who provide ICBT work in a specialized unit where there is primary focus on ICBT and daily attention to following ICBT guidelines. Other therapists deliver ICBT from community mental health clinics where the primary focus of the setting is on face-to-face care and there is lower familiarity with ICBT. It is possible that ICBT may be more effectively delivered in a setting where the primary focus is on ICBT.

Enrollment

631 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years or older
Endorse symptoms of anxiety or depression
Resident of Saskatchewan
Access to a computer and the Internet

Exclusion criteria

Have a severe psychiatric illness (e.g. psychosis)
Assessed as being at high risk of suicide
Report severe problems with alcohol or drugs
Report severe cognitive impairment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

631 participants in 6 patient groups

Community Mental Health Clinic

Experimental group

Description:

In this arm, clients will be assigned to therapists working in a community mental health clinic in Saskatchewan where the focus of the setting is primarily on face-to-face treatment and ICBT makes up a small component of the workload in the clinic.

Treatment:

Behavioral: Internet-delivered cognitive behaviour therapy

Once a week therapist contact

Experimental group

Description:

In once a week treatment, therapists will email their clients once a week on a pre-determined day.

Treatment:

Behavioral: Internet-delivered cognitive behaviour therapy

Reflection Questionnaire

Experimental group

Description:

In the reflection questionnaire, patients will be asked to complete the following questions five times during the treatment period (beginning lesson 2-5 and then at the point they complete post-questionnaires): 1. How much of the lesson were you able to review? 2. How much effort were you able to put into the lesson? 3. How difficult was the lesson? 4. Please share any difficulties you had with the lesson. 5. How understandable was the lesson? 6. How helpful did you find the lesson? 7. Please describe an example of what you learned. 8. To what extent have you continued to use strategies from previous lessons 9. If applicable, please provide an example of what you are working on from previous lessons 10. Please indicate which Additional Resources you reviewed this week. 11. If applicable, please share any skills you are working on from the Additional Resources.

Treatment:

Behavioral: Internet-delivered cognitive behaviour therapy

Specialized Internet Therapy Clinic

Experimental group

Description:

In this arm, clients will be assigned to therapists working in a specialized internet therapy clinic where the therapists only deliver ICBT.

Treatment:

Behavioral: Internet-delivered cognitive behaviour therapy

Twice a week therapist contact

Experimental group

Description:

In twice a week treatment, therapists will email their clients twice a week on pre-determined days.