DepressionNCT01787513
Cognitive Bias Modification (CBM) Via Imagery and Internet Cognitive Behavioural Therapy (iCBT) for Depression
A study testing CBM and iCBT in people with Depression, run by St Vincent's Hospital, Sydney at 1 site in Australia.
Trial summary
A randomised controlled trial comparing Internet based cognitive behavioural therapy for major depressive disorder plus a cognitive bias modification intervention (OxIGen) version A vs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- CBM and iCBT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2013to Aug 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet Diagnostic and Statistical Manual of the American Psychiatric Association - 4th edition (DSM-IV) criteria for Major Depressive Disorder
- Internet and printer access
- Australian resident
- Fluent in written and spoken English
Who cannot join
- Current substance abuse/dependence
- Psychotic mental illness (Bipolar or Schizophrenia)
- Change in medication or psychological treatment during last 1 month or intended change during study duration
- Use of Benzodiazepines
- Severe depression (PHQ9> 23)
- Suicidal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial Comparing Internet Based Cognitive Behavioural Therapy for Major Depressive Disorder Plus a Cognitive Bias Modification Intervention (OxIGen)on Symptoms of Depression and Negative Interpretation Bias.
A randomised controlled trial comparing Internet based cognitive behavioural therapy for major depressive disorder plus a cognitive bias modification intervention (OxIGen) version A vs. Internet based cognitive behavioural therapy for major depressive disorder plus a cognitive bias modification intervention (OxIGen) version B on symptoms of depression and negative interpretation bias.
Read the detailed description
Cognitive accounts of depression and anxiety emphasize the importance of cognitive biases in the maintenance of disorders. One specific bias is the interpretation of ambiguous information. A negative interpretation bias is defined as a systematic tendency to interpret potentially ambiguous information in a negative rather than benign way and this bias has been associated with symptoms of depression. Research has led to the recent development of computerized cognitive bias modification (CBM) techniques to augment such biases and it has been suggested that CBM techniques may be useful as an adjunct to current treatments to enhance maintenance of treatment gains and minimize relapse rates. The fact that CBM procedures lend themselves to being delivered remotely, are cost-effective, and can be self-paced in ways that suit the patient make them an ideal candidate for inclusion in the Internet-based cognitive behavioural therapy (iCBT) programs currently offered through St. Vincent's Hospital and the University of New South Wales. Therefore, the primary aim of the current trial is to evaluate the acceptability and effectiveness of adding CBM procedures to the existing iCBT modules offered through St. Vincent's Hospital and the University of New South Wales. It is expected that iCBT + CBM (active version) will result in superior treatment outcomes as indexed by a standardized clinical battery compared to iCBT + CBM (control version).
- Conditions
- Depression
- Being tested
- CBM, iCBT
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBMOther
CBM is an Internet-based intervention comprised of delivery of auditory scenarios taking place over 1 week.
iCBTOther
iCBT is a validated online CBT treatment program for depression delivered in 6 lessons over 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CBM Version A + iCBT | Experimental | CBM Version A is an Internet-based intervention taking place over 1 week followed by iCBT, an Internet-based treatment for depression taking place over 10 weeks. Receives: Other: CBM; Other: iCBT |
| CBM Version B (Control) + iCBT | Placebo comparator | CBM Version B (Control) is an Internet-based intervention taking place over 1 week (identical to CBM Version A without the putative active components) followed by iCBT, an Internet-based treatment for depression taking place over 10 weeks. Receives: Other: CBM; Other: iCBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9 (PHQ-9)scores
Measured: Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Change in Beck Depression Inventory - second edition (BDI-II)scores
Measured: Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Change in Ambiguous Sentence Task (AST)scores
Measured: Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline).
Change in diagnostic status (MINI5 depression module)
Measured: Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Secondary outcomes (5)
Change in Kessler-10 (K10)scores
Measured: Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Change in WHO Disability Assessment Scale (WHO-DAS)scores
Measured: Administered at baseline (T1, post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Change in State Trait Anxiety Inventory (STAI)scores
Measured: Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Change in Repetitive Thinking Questionnaire (RTQ)scores
Measured: Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Change in Clinical Perfectionism Scale (PCS)scores
Measured: Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital, Sydney
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alishia Williams, St Vincent's Hospital, Sydney
- Investigators
- Gavin Andrews, MD, Principal investigator, UNSW; ST. Vincent's HospitalAlishia Williams, PhD, Principal investigator, UNSW; ST Vincent's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787513
- Sponsor's protocol ID
- 12/237
- Status last verified
- Aug 2014
- First submitted
- 4 Feb 2013
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Williams AD, Blackwell SE, Holmes EA, Andrews G. Positive imagery cognitive bias modification (CBM) and internet-based cognitive behavioural therapy (iCBT) versus control CBM and iCBT for depression: study protocol for a parallel-group randomised controlled trial. BMJ Open. 2013 Oct 29;3(10):e004049. doi: 10.1136/bmjopen-2013-004049.
PubMed 24171941
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing Internet Based Cognitive Behavioural Therapy for Major Depressive Disorder Plus a Cognitive Bias Modification Intervention (OxIGen)on Symptoms of Depression and Negative Interpretation Bias.
- ClinicalTrials.gov ID
- NCT01787513
- Acronym / sponsor ID
- 12/237
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- St Vincent's Hospital, SydneyUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Feb 2013 (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.
A randomised controlled trial comparing Internet based cognitive behavioural therapy for major depressive disorder plus a cognitive bias modification intervention (OxIGen) version A vs. Internet based cognitive behavioural therapy for major depressive disorder plus a cognitive bias modification intervention (OxIGen) version B on symptoms of depression and negative interpretation bias.
Detailed description
Cognitive accounts of depression and anxiety emphasize the importance of cognitive biases in the maintenance of disorders. One specific bias is the interpretation of ambiguous information. A negative interpretation bias is defined as a systematic tendency to interpret potentially ambiguous information in a negative rather than benign way and this bias has been associated with symptoms of depression. Research has led to the recent development of computerized cognitive bias modification (CBM) techniques to augment such biases and it has been suggested that CBM techniques may be useful as an adjunct to current treatments to enhance maintenance of treatment gains and minimize relapse rates. The fact that CBM procedures lend themselves to being delivered remotely, are cost-effective, and can be self-paced in ways that suit the patient make them an ideal candidate for inclusion in the Internet-based cognitive behavioural therapy (iCBT) programs currently offered through St. Vincent's Hospital and the University of New South Wales. Therefore, the primary aim of the current trial is to evaluate the acceptability and effectiveness of adding CBM procedures to the existing iCBT modules offered through St. Vincent's Hospital and the University of New South Wales. It is expected that iCBT + CBM (active version) will result in superior treatment outcomes as indexed by a standardized clinical battery compared to iCBT + CBM (control version).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBM Version A + iCBT | Experimental | Other: CBM, Other: iCBTCBM Version A is an Internet-based intervention taking place over 1 week followed by iCBT, an Internet-based treatment for depression taking place over 10 weeks. |
| CBM Version B (Control) + iCBT | Placebo comparator | Other: CBM, Other: iCBTCBM Version B (Control) is an Internet-based intervention taking place over 1 week (identical to CBM Version A without the putative active components) followed by iCBT, an Internet-based treatment for depression taking place over 10 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet Diagnostic and Statistical Manual of the American Psychiatric Association - 4th edition (DSM-IV) criteria for Major Depressive Disorder
- Internet and printer access
- Australian resident
- Fluent in written and spoken English
Key exclusion criteria (6 listed)
- Current substance abuse/dependence
- Psychotic mental illness (Bipolar or Schizophrenia)
- Change in medication or psychological treatment during last 1 month or intended change during study duration
- Use of Benzodiazepines
- Severe depression (PHQ9> 23)
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 |
|---|---|---|
| CBMCBM is an Internet-based intervention comprised of delivery of auditory scenarios taking place over 1 week. | Other | CBM Version A + iCBT, CBM Version B (Control) + iCBT |
| iCBTiCBT is a validated online CBT treatment program for depression delivered in 6 lessons over 10 weeks. | Other | CBM Version A + iCBT, CBM Version B (Control) + iCBT |
Primary outcome
Change in Patient Health Questionnaire-9 (PHQ-9)scores
Time frame: Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Change in Beck Depression Inventory - second edition (BDI-II)scores
Time frame: Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Change in Ambiguous Sentence Task (AST)scores
Time frame: Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline).
Change in diagnostic status (MINI5 depression module)
Time frame: Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
5 secondary outcomes
Change in Kessler-10 (K10)scores
Time frame: Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Change in WHO Disability Assessment Scale (WHO-DAS)scores
Time frame: Administered at baseline (T1, post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Change in State Trait Anxiety Inventory (STAI)scores
Time frame: Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Change in Repetitive Thinking Questionnaire (RTQ)scores
Time frame: Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Change in Clinical Perfectionism Scale (PCS)scores
Time frame: Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
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 12 Aug 2014.
- Derived from this study: PubMed 24171941Williams AD, Blackwell SE, Holmes EA, Andrews G. Positive imagery cognitive bias modification (CBM) and internet-based cognitive behavioural therapy (iCBT) versus control CBM and iCBT for depression: study protocol for a parallel-group randomised controlled trial. BMJ Open. 2013 Oct 29;3(10):e004049. doi: 10.1136/bmjopen-2013-004049.
Related trials for Depression
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Active, not recruiting
AI Mental Health Tool vs. Psychoeducation Control
Depressive Disorder, Depressive Symptoms
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
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.
Gavin Andrews, MD principal investigator
UNSW; ST. Vincent's Hospital
Alishia Williams, PhD principal investigator
UNSW; ST Vincent's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBM and iCBT in people with Depression, run by St Vincent's Hospital, Sydney at 1 site in Australia.
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 4 inclusion and 6 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 12 Aug 2014. 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 Australia. 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. Some participants in this study may receive a placebo. 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 Patient Health Questionnaire-9 (PHQ-9)scores (time frame: Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01787513, which also lists 1 linked publication.
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 12 Aug 2014.