Major Depressive DisorderNCT02266693
Transdiagnostic iCBT for Depression and Anxiety
A study testing iCBT in people with Major Depressive Disorder and Social Anxiety Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Major Depressive Disorder, Social Anxiety Disorder, Panic Disorder
- What is being tested?
- iCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 1. Primary diagnosis of any psychotic disorder or any other anxiety disorder (OCD, PTSD).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Transdiagnostic Internet-based CBT for Early Illness Unipolar 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.
Read the detailed description
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.
- Conditions
- Major Depressive Disorder, Social Anxiety Disorder, Panic Disorder, Generalized Anxiety Disorder
- Being tested
- iCBT
- Keywords
- Cognitive Behavioural Therapy, Internet Based, CBT, Transdiagnostic, MDD, PD, SAD, GAD, iCBT
- Medical subject headings
- Depressive Disorder, Major, Phobia, Social, Panic Disorder, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBTBehavioural
Also called Internet based Cognitive Behavioural Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| ICBT Group | Experimental | 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. Receives: Behavioral: iCBT |
| Waitlist Group | No intervention | Upon completion of the 8-week study wait-list period (i.e. their study participation), the opportunity to participate in iCBT, outside the study framework will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Measured: Baseline to study endpoint (Week 8)
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Measured: Baseline to study endpoint (Week 8)
Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) Total Score
Measured: Baseline to study endpoint (Week 8)
Change in Liebowitz Social Anxiety Scale (LSAS) Total Score
Measured: Baseline to study endpoint (Week 8)
Change in Panic Disorder Severity Scale Total Score
Measured: Baseline to study endpoint (Week 8)
Change in Penn State Worry Questionnaire Total Score
Measured: Baseline to study endpoint (Week 8)
Secondary outcomes (3)
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score
Measured: Baseline to study endpoint (Week 8)
Change in Sheehan Disability Scale (SDS) Total Score
Measured: Baseline to study endpoint (Week 8)
Change in Clinical Global Impression (CGI)
Measured: Baseline to study endpoint (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Ravindran, Centre for Addiction and Mental Health
- Investigators
- Arun Ravindran, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266693
- Sponsor's protocol ID
- 057/2012
- Status last verified
- Feb 2019
- First submitted
- 7 Oct 2014
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transdiagnostic Internet-based CBT for Early Illness Unipolar Depression and Anxiety
- ClinicalTrials.gov ID
- NCT02266693
- Acronym / sponsor ID
- 057/2012
- Conditions
- Major Depressive Disorder, Social Anxiety Disorder, Panic Disorder, Generalized Anxiety Disorder
- Keywords
- Cognitive Behavioural Therapy, Internet Based, CBT, Transdiagnostic, MDD, PD, SAD, GAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICBT Group | Experimental | Behavioral: iCBTThe 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. |
| Waitlist Group | No intervention | –Upon completion of the 8-week study wait-list period (i.e. their study participation), the opportunity to participate in iCBT, outside the study framework will be provided. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Primary diagnosis of any psychotic disorder or any other anxiety disorder (OCD, PTSD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCBTAlso: Internet based Cognitive Behavioural TherapyThe 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. | Behavioural | ICBT Group |
Primary outcome
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Liebowitz Social Anxiety Scale (LSAS) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Panic Disorder Severity Scale Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Penn State Worry Questionnaire Total Score
Time frame: Baseline to study endpoint (Week 8)
3 secondary outcomes
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Sheehan Disability Scale (SDS) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Clinical Global Impression (CGI)
Time frame: Baseline to study endpoint (Week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Ravindran, MD, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCBT in people with Major Depressive Disorder and Social Anxiety Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale (HAM-D) Total Score (time frame: Baseline to study endpoint (Week 8)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.