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

Sponsor
University of Regina (Other)
Overall Status
Completed
CT.gov ID
NCT03957330
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
631
Enrollment
1
Location
6
Arms
24
Actual Duration (Months)
26.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Internet-delivered cognitive behaviour therapy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
631 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Participant)
Masking Description:
Participants are told about the nature of their treatment but not about the exact nature of all the conditions.
Primary Purpose:
Treatment
Official Title:
Therapeutics Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy for Depression and Anxiety
Actual Study Start Date :
May 20, 2019
Actual Primary Completion Date :
May 20, 2021
Actual Study Completion Date :
May 20, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Community Mental Health Clinic

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
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.

Experimental: Once a week therapist contact

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

Behavioral: Internet-delivered cognitive behaviour therapy
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.

Experimental: Reflection Questionnaire

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): How much of the lesson were you able to review? How much effort were you able to put into the lesson? How difficult was the lesson? Please share any difficulties you had with the lesson. How understandable was the lesson? How helpful did you find the lesson? Please describe an example of what you learned. To what extent have you continued to use strategies from previous lessons If applicable, please provide an example of what you are working on from previous lessons Please indicate which Additional Resources you reviewed this week. If applicable, please share any skills you are working on from the Additional Resources.

Behavioral: Internet-delivered cognitive behaviour therapy
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.

Experimental: Specialized Internet Therapy Clinic

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
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.

Experimental: Twice a week therapist contact

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

Behavioral: Internet-delivered cognitive behaviour therapy
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.

Experimental: No Reflection Questionnaire

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

Behavioral: Internet-delivered cognitive behaviour therapy
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.

Outcome Measures

Primary Outcome Measures

  1. Patient Health Questionnaire 9-item (PHQ-9) [Baseline, weeks 2, 4, 5, 7, 8 and 3-, 6-, and 12-month follow-up]

    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.

  2. Generalized Anxiety Disorder 7-item (GAD-7) [Baseline, weeks 2, 4, 5, 7, 8, and 3-, 6-, and 12-month follow-up]

    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.

Secondary Outcome Measures

  1. Panic Disorder Severity Scale Self-report [Time Frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up]

    Change in panic symptoms. Items are summed into a total score. Total scores range between 0 and 28, with higher scores representing more severe self-reported symptoms of panic.

  2. 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]

    Change in social anxiety symptoms. Items from the two measures are summed into a total score. Total scores range between 0 and 48, with higher scores representing more severe self-reported symptoms of social anxiety

  3. PTSD Check List 5 [Baseline, week 8 and 3-, 6-, and 12-month follow-up]

    Change in post-traumatic symptoms. The measure consists of 20 questions rated 0 to 4; higher scores indicate more trauma symptoms The first section assesses for exposure to a traumatic event using a checklist question. If the client endorses exposure to a traumatic event, they are provided the second section, which assesses severity of trauma symptoms. Items are summed into a total score, which can range between 0 and 80. Higher scores represent more severe self-reported symptoms of trauma.

  4. Short Health Anxiety Inventory-14 [Baseline, week 8 and 3-, 6-, and 12-month follow-up]

    Change in health anxiety. 14 items with higher scores indicating higher levels of self-reported health anxiety.

  5. Kessler Psychological Distress [Baseline, week 8, and 3-, 6-, and 12-month follow-up]

    Change in psychological distress. Measured by 10-item scale rated 0 to 4; total score is created by summing items; higher scores signify greater psychological distress

  6. Quality of life questionnaire (EQ-ED-5L) [Baseline, week 8, and 3-, 6-, and 12-month follow-up]

    Change in quality of life. Items are summed into six sub-total scores. The first five sub-total scores respectively assess various domains of quality of life (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each of the five sub-total scores range between 1 and 5, with higher scores representing greater self-reported severity and impairment in these various domains. The last sub-total score provides an overall index of health and can range between 0 and 100, with higher scores representing better self-reported health.

  7. Sheehan Disability Scale 3-item [Baseline, week 8, and 3-, 6-, and 12-month follow-up]

    Change in disability. Measure consists of 3 items rated 0 to 10 and summed to create total score, with higher scores indicating greater disability

  8. Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada [Baseline and 3-, 6-, and 12-month follow-up]

    Change in treatment costs. A series of yes and no, rating, and frequency questions that are designed to ascertain the volume of medical consumption and productivity losses associated with mental health problems. Questions are independently analyzed and, therefore, the TIP-C does not include a total score.

  9. Treatment Credibility Questionnaire [Baseline, week 8, and 3-month follow-up]

    Change in treatment credibility. 4 items are summed into a total score. Higher scores representing greater perceptions of ICBT credibility.

  10. Working Alliance Inventory Short-Form [Baseline, week 8, and 3-, 6-, and 12-month follow-up]

    Measures therapeutic alliance. Scores are summed into three sub-total scores, which respectively assess various domains of the therapeutic relationship (i.e., goal, task, and bond). Sub-total scores each range between 5 and 20, with higher scores representing better therapeutic relationship in each of the three domains assessed.

  11. Treatment Engagement [Week 8]

    Measured by: number of lessons completed, number of days of access, number of emails sent to therapist, number of phone calls with therapist, number of emails from therapist to client, total words emailed to therapist, total words emailed from therapist to patient

  12. Treatment Satisfaction and Negative Effects Questionnaires [Week 8]

    Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Online Therapy Unit, University of ReginaReginaSaskatchewanCanadaS4S 0A2

Sponsors and Collaborators

  • University of Regina
  • Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Heather Hadjistavropoulos, PhD, University of Regina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Regina
ClinicalTrials.gov Identifier:
NCT03957330
Other Study ID Numbers:
  • 2019-038
First Posted:
May 21, 2019
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Regina
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021