Clinical trial NCT03957330: Therapeutic Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy
Official title: Therapeutics Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy for Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: Anxiety
Depression
Internet-delivered cognitive behaviour therapy
Randomized controlled trial
Therapist contact
Online therapy
Community mental health
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-05-21
Enrollment: 631
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: Baseline, weeks 2, 4, 5, 7, 8 and 3-, 6-, and 12-month follow-up
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Baseline, weeks 2, 4, 5, 7, 8, and 3-, 6-, and 12-month follow-up
Secondary outcomes:
measure: Panic Disorder Severity Scale Self-report
timeFrame: Time Frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
measure: Social Interaction Anxiety Scale (6 items) and Social Phobia Scale-Short form (6 items)
timeFrame: Time Frame: Baseline, Week 8, 3-, 6-, and 12-month follow-up
measure: PTSD Check List 5
timeFrame: Baseline, week 8 and 3-, 6-, and 12-month follow-up
measure: Short Health Anxiety Inventory-14
timeFrame: Baseline, week 8 and 3-, 6-, and 12-month follow-up
measure: Kessler Psychological Distress
timeFrame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
measure: Quality of life questionnaire (EQ-ED-5L)
timeFrame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
measure: Sheehan Disability Scale 3-item
timeFrame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
measure: Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada
timeFrame: Baseline and 3-, 6-, and 12-month follow-up
measure: Treatment Credibility Questionnaire
timeFrame: Baseline, week 8, and 3-month follow-up
measure: Working Alliance Inventory Short-Form
timeFrame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
measure: Treatment Engagement
timeFrame: Week 8
measure: Treatment Satisfaction and Negative Effects Questionnaires
timeFrame: Week 8
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit, University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sapkota RP, Peynenburg V, Dear BF, Titov N, Hadjistavropoulos HD. Engagement with homework in an Internet-delivered therapy predicts reduced anxiety and depression symptoms: A latent growth curve analysis. J Consult Clin Psychol. 2023 Feb;91(2):112-117. doi: 10.1037/ccp0000775. Epub 2022 Nov 17.