NCT03957330

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
631

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started May 2019

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

May 16, 2019

Last Update Submit

November 17, 2021

Conditions

AnxietyDepression

Keywords

AnxietyDepressionInternet-delivered cognitive behaviour therapyRandomized controlled trialTherapist contactOnline therapyCommunity mental health

Outcome Measures

Primary Outcomes (2)

  • Patient Health Questionnaire 9-item (PHQ-9)

    Change in depression symptoms. 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.

    Baseline, weeks 2, 4, 5, 7, 8 and 3-, 6-, and 12-month follow-up

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

    Change in anxiety symptoms. 7 items are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.

    Baseline, weeks 2, 4, 5, 7, 8, and 3-, 6-, and 12-month follow-up

Secondary Outcomes (12)

  • Panic Disorder Severity Scale Self-report

    Time Frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up

  • Social Interaction Anxiety Scale (6 items) and Social Phobia Scale-Short form (6 items)

    Time Frame: Baseline, Week 8, 3-, 6-, and 12-month follow-up

  • PTSD Check List 5

    Baseline, week 8 and 3-, 6-, and 12-month follow-up

  • Short Health Anxiety Inventory-14

    Baseline, week 8 and 3-, 6-, and 12-month follow-up

  • Kessler Psychological Distress

    Baseline, week 8, and 3-, 6-, and 12-month follow-up

  • +7 more secondary outcomes

Study Arms (6)

Community Mental Health Clinic

EXPERIMENTAL

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.

Behavioral: Internet-delivered cognitive behaviour therapy

Once a week therapist contact

EXPERIMENTAL

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

Behavioral: Internet-delivered cognitive behaviour therapy

Reflection Questionnaire

EXPERIMENTAL

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.

Behavioral: Internet-delivered cognitive behaviour therapy

Specialized Internet Therapy Clinic

EXPERIMENTAL

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

Behavioral: Internet-delivered cognitive behaviour therapy

Twice a week therapist contact

EXPERIMENTAL

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

Behavioral: Internet-delivered cognitive behaviour therapy

No Reflection Questionnaire

EXPERIMENTAL

In this arm, no reflection questions will be asked of clients receiving ICBT.

Behavioral: Internet-delivered cognitive behaviour therapy

Interventions

Internet-delivered cognitive behaviour therapyBEHAVIORAL

All clients will receive the Wellbeing Course developed at Macquarie University, Australia. The Wellbeing Course is a transdiagnostic Internet-delivered cognitive behaviour intervention targeting symptoms of depressive and anxiety disorders. It comprises 5 online lessons targeting: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure; and 5) relapse prevention. Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills) and include homework activities. Lessons are released gradually in a standardized order over 8 weeks. Phone calls will only be made if there is a significant clinical issue requiring therapist attention that cannot be addressed over email (e.g., sudden increase in symptoms). Therapists will spend \~15 mins. per week/per client.

Community Mental Health ClinicNo Reflection QuestionnaireOnce a week therapist contactReflection QuestionnaireSpecialized Internet Therapy ClinicTwice a week therapist contact

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Online Therapy Unit, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 36395032DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Heather Hadjistavropoulos, PhD

    University of Regina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are told about the nature of their treatment but not about the exact nature of all the conditions.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 21, 2019

Study Start

May 20, 2019

Primary Completion

May 20, 2021

Study Completion

May 20, 2021

Last Updated

November 18, 2021

Record last verified: 2021-11

Locations

CA(1)