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Completed

NCT Number: NCT02266693

Transdiagnostic iCBT for Depression and Anxiety

This 8-week, pilot randomized, controlled trial to evaluate the benefits of transdiagnostic Internet-based CBT (iCBT) in young adults with MDD, SAD, PD or GAD. The investigators hypothesize that patients who receive iCBT will show significant improvement in anxiety symptoms and functioning, compared to a wait-list group. This pilot randomized controlled study will assess the efficacy of transdiagnostic iCBT in 60 young adults.

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

About this study

Unipolar depression and anxiety disorders (particularly social anxiety disorder [SAD], generalized anxiety disorder [GAD] and panic disorder [PD]) are among the most common forms of mental illnesses. They often have a chronic course, and are frequently associated with co-morbidities, significant disability, and poor quality of life. Published epidemiologic studies indicate that these conditions typically emerge during early adolescence and adulthood, and are often poorly recognized, resulting in delay of several years before help is sought. Such delay is often attributed to the non-recognition of the significance of the symptoms, lack of information on or access to services, and embarrassment and fear of stigma, but each effective early treatment can reduce co-morbidities and improve prognosis.

Cognitive behaviour therapy (CBT) is recognized as the single most effective psychological intervention for depression and anxiety, but accessibility is affected by therapist costs and long wait times for OHIP-covered services. Internet-based CBT (iCBT) is an innovative alternative with higher accessibility and cost-efficiency than group CBT, but with comparable efficacy. Transdiagnostic models of iCBT that treat depression, SAD, PD and GAD within one program have shown efficacy in preliminary trials and may offer even greater accessibility and economy, as several depressed and anxious populations can be treated with the same protocol. As a non-pharmacological treatment option enhanced by technological advances, iCBT is likely to appeal to tech-savvy young adults. However, it has not been evaluated specifically in a young adult population, thus far.

This 8-week, multi-site, randomized, controlled trial to evaluate the benefits of trandiagnostic iCBT in 60 young adults with unipolar depression and/or SAD, PD or GAD. We hypothesize that patients who receive iCBT will show significant improvement in depressive and anxiety symptoms and functioning, compared to a wait-list group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age range (18-29 years).
  • Primary diagnosis of MDD, SAD, PD and/or GAD, per the DSM-IV-TR.
  • A score ≥17 on the first 17 items of the Hamilton Depression Rating Scale (HAM-D)55
  • A score ≥17 on the Hamilton Anxiety Rating Scale (HAM-A)56.
  • Score ≥50 on the Leibowitiz Social Anxiety Scale (LSAS),57 ≥10 on the Panic Disorder Severity Scale (PDSS)58 and/or ≥60 the Penn State Worry Questionnaire (PSWQ).59
  • Currently unmedicated or on stable and adequate doses of medication for at least 4 weeks.
  • Co-morbidities are allowed and will be documented.

Exclusion criteria

  • Primary diagnosis of any psychotic disorder or any other anxiety disorder (OCD, PTSD).

Treatment and study plan

ICBT

Behavioral

The iCBT program consists of weekly online lessons, weekly homework assignments, regular automatic email reminders about lessons and homework, weekly contact via phone or email with a CBT therapist, and access to a large online library of written resources about depression and anxiety and application of CBT skills. The CBT therapist contacts all participants once a week to review lessons, assist patients with treatment difficulties, reinforce progress and encourage continued engagement with the program. Therapist-patient contact is limited to 10 minutes per patient per week.

Other names: Internet based Cognitive Behavioural Therapy

Primary outcomes

  1. Change in Hamilton Depression Rating Scale (HAM-D) Total Score

    Time frame: Baseline to study endpoint (Week 8)

  2. Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score

    Time frame: Baseline to study endpoint (Week 8)

  3. Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) Total Score

    Time frame: Baseline to study endpoint (Week 8)

  4. Change in Liebowitz Social Anxiety Scale (LSAS) Total Score

    Time frame: Baseline to study endpoint (Week 8)

  5. Change in Panic Disorder Severity Scale Total Score

    Time frame: Baseline to study endpoint (Week 8)

  6. Change in Penn State Worry Questionnaire Total Score

    Time frame: Baseline to study endpoint (Week 8)

Secondary outcomes

  1. Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score

    Time frame: Baseline to study endpoint (Week 8)

  2. Change in Sheehan Disability Scale (SDS) Total Score

    Time frame: Baseline to study endpoint (Week 8)

  3. Change in Clinical Global Impression (CGI)

    Time frame: Baseline to study endpoint (Week 8)

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

Efficacy of Transdiagnostic Internet-based CBT for Early Illness Unipolar Depression and Anxiety

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2014
Registry last updated
Feb 15, 2019

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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