Clinical trial NCT04228575: Optimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy
Official title: Optimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy for Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: anxiety
depression
internet-delivered cognitive behaviour therapy
randomized controlled trial
patient-centred
personalized therapy
knowledge implementation
mental health system
therapist-assistance
booster session
factorial design
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-01-14
Enrollment: 410
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 are frequently under treated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered Cognitive Behaviour Therapy (ICBT) has emerged. ICBT involves delivering therapeutic content to manage depression and or anxiety via structured online lessons. This is often combined with brief therapist guidance, for example once per week for 8 weeks via secure messaging or phone calls. Although outcomes of ICBT are very impressive, there is room for improvement in terms of completion rates and outcomes. Feedback from patients suggest that some patients would prefer longer term support or follow-up care.

In this two-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of ICBT is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) and being offered a booster session at 16 weeks after treatment enrollment (yes vs no). Follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. Primary outcomes are reduced anxiety and depression. Secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use.

Detailed description: Past research of ICBT offered in routine care has found that patients and therapists often recommend "personalizing" the delivery of ICBT, for example, by increasing the length of time therapist support is available or offering booster sessions after treatment has ended. To date, in terms of ICBT, there has been limited research on the impact of extending support after treatment materials have been delivered or offering a booster session.

In this trial, the investigators will examine if the efficacy of ICBT is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) or by being offered a booster session at 16 weeks after treatment enrollment (yes vs no). Follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. Primary outcomes are reduced anxiety and depression. Secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use. The impact of these factors on intervention usage (e.g., completion rates, log-ins, emails sent) and treatment satisfaction will also be examined.

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 (Screening), weeks 1-12, 16 and 26 week from enrollment
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Baseline (Screening), weeks 1-12 and 16 and 26 week from enrollment
Secondary outcomes:
measure: Panic Disorder Severity Scale Self-report
timeFrame: Baseline (Screening), week 8, 16 and 26 week from enrollment
measure: Social Interaction Anxiety Scale (6 items)
timeFrame: Baseline (Screening), week 8, 16 and 26 week from enrollment
measure: Social Phobia Scale-Short form (6 items)
timeFrame: Baseline (Screening), week 8, 16 and 26 week from enrollment
measure: Quality of Life (EQ-ED-5L)
timeFrame: Baseline (Screening), week 8, 16 and 26 week from enrollment
measure: Mental Health Service Use, Medication, and Employment
timeFrame: Baseline (Screening) and Week 26 week from enrollment
measure: Treatment Satisfaction
timeFrame: Week 8, 16 and 26 week from enrollment
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline
measure: Sheehan Disability Scale (SDS)
timeFrame: Baseline (Screening), week 8, 16 and 26 week from enrollment
measure: Life Events Checklist for DSM-5 (LEC-5)
timeFrame: Baseline (Screening)
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline (Screening), week 8, 16 and 26 week from enrollment
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: