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Completed

NCT Number: NCT03957330

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

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).

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Online Therapy Unit, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-delivered cognitive behaviour therapy

Behavioral

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.

Primary outcomes

  1. Patient Health Questionnaire 9-item (PHQ-9)

    Time frame: 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)

    Time frame: 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 outcomes

  1. Panic Disorder Severity Scale Self-report

    Time frame: 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: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Week 8

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

Sponsors and collaborators

Lead sponsor

University of Regina

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Therapeutics Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy for Depression and Anxiety

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 21, 2019
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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