Optimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy

NCT04228575 | Completed

• 1 other identifier: 2019-197
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

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.

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

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 (Screening), weeks 1-12, 16 and 26 week from enrollment

• 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 (Screening), weeks 1-12 and 16 and 26 week from enrollment

Secondary Outcomes (10)

• Panic Disorder Severity Scale Self-report

  Baseline (Screening), week 8, 16 and 26 week from enrollment

• Social Interaction Anxiety Scale (6 items)

  Baseline (Screening), week 8, 16 and 26 week from enrollment

• Social Phobia Scale-Short form (6 items)

  Baseline (Screening), week 8, 16 and 26 week from enrollment

• Quality of Life (EQ-ED-5L)

  Baseline (Screening), week 8, 16 and 26 week from enrollment

• Mental Health Service Use, Medication, and Employment

  Baseline (Screening) and Week 26 week from enrollment

Study Arms (4)

Extended Contact

EXPERIMENTAL

Clients in the Extended Contact condition will be asked at the 6 week mark if they like they can extend their treatment and receive up to 12 weeks of support. They will be informed that this may be helpful if they feel they have fallen behind in reviewing of the materials, if they would like to receive support while they work on supplementary resources or if they would like extended support while they work on core lessons. If they would like additional support, participants will answer questions presented on the website about their desire for this additional support what they would like to focus on during this time. Those clients who indicate that they would like this extended support will automatically have their therapists check-in with them for up to 12 weeks. Those that do not request the additional support will end treatment as planned at the end of 8 weeks.

Behavioral: Internet-delivered cognitive behaviour therapy

8 Week ICBT no Booster

EXPERIMENTAL

In the standard condition, clients will receive 8 weeks of therapist support. They will not be given the option to extend their treatment and support to 12 weeks. The booster course will not be offered in this condition.

Behavioral: Internet-delivered cognitive behaviour therapy

Extended Contact with Booster

EXPERIMENTAL

Clients in the Extended Contact condition will receive an email at the 6 week mark letting them know that they if they like they can extend their treatment and receive up to 12 weeks of support. At week 6, clients will answer questions on the website about whether they would like this additional support or not and what they would like to focus on during this time. Clients who indicate they would like this extended support will automatically have their therapists check-in with them for up to 12 weeks. They will also be told that at 16 weeks they will have access to a booster session (online materials that go over core skills such as thought challenging, deep breathing, behavioural activation, and graded exposure). At 16 weeks, they will be sent an email reminder to log in for the booster course. The therapist will send a supportive email to the client offering to assist with any challenges the client reports in the check-in questionnaire by email or phone call over the next 2 weeks.

Behavioral: Internet-delivered cognitive behaviour therapy

8 week ICBT with Booster

EXPERIMENTAL

Clients in the booster condition will be told that at 16 weeks they will have access to a booster session (online materials that go over core skills such as thought challenging, deep breathing, behavioural activation, and graded exposure). At 16 weeks, they will be sent an email reminder to log in for the booster course. The therapist will send a supportive email to the client offering to assist with any challenges the client reports in the check-in questionnaire by email or phone call over the next 2 weeks.

Behavioral: Internet-delivered cognitive behaviour therapy

Interventions

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.

8 Week ICBT no Booster; 8 week ICBT with Booster; Extended Contact; Extended Contact with Booster

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• University of Regina: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Online Therapy Unit, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Heather Hadjistavropoulos, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 14, 2020
• Study Start: January 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

CA (1)