Depressive SymptomsiCBTNCT04100785
A Pilot Investigation of Clinician-guided Internet-Delivered Cognitive Behavioural Therapy for Depressed Patients
A study testing Internet-delivered Cognitive Behavioural Therapy in people with Depressive Symptoms, run by Institute of Mental Health, Singapore.
Trial summary
This study aims to explore the efficacy and acceptability of a clinician-guided internet-based Cognitive Behavioural Therapy (iCBT) programme for patients with depression, in Singapore. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Internet-delivered Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 9 Aug 2015to 16 Jul 2017
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 to 65 years old
- Not currently seeing a therapist for any form of invidual or group therapy
- Diagnosed with a primary diagnosis of depression by IMH psychiatrist
- A total score of above 9 on the Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001), indicating at least mild symptoms
- If using medication for depression then on a stable dose for at least 1 month,
- Provides informed consent
- Able to read and speak at least Primary 6 level English
- Adequate IT skills to operate iCBT programme
Who cannot join
- Severe depression (i.e. score = 23 on PHQ-9)
- Strong suicidal ideation (i.e. score > 2 on Question 9 of the PHQ-9)
- Current active suicidal intention or plan
- Presenting problem is not depression
- Does not meet the minimum English language requirements stated above
- Participants who are concurrently attending other forms of group/individual psychotherapy
About this study
Official title: A Pilot Investigation of Clinician-guided Internet-Delivered Cognitive Behavioural Therapy for Depressed Patients in an Outpatient Hospital Setting
This study aims to explore the efficacy and acceptability of a clinician-guided internet-based Cognitive Behavioural Therapy (iCBT) programme for patients with depression, in Singapore.
Read the detailed description
All outpatients, from the Institute of Mental Health, Singapore, who are diagnosed with a primary diagosis of mild to moderate depression and were referred to the Psychology Department for therapy were invited to take part in this research. Participants were randomised into two groups: iCBT Intervention Group and Delayed Waitlist-Control Group. The four-week iCBT programme comprised of three face to face 30-minute sessions with a clinician and six online modules).The treatment group is hypothesised to exhibit pre-post improvements in depressive symptoms, compared to the control group.
- Conditions
- Depressive Symptoms
- Being tested
- Internet-delivered Cognitive Behavioural Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered Cognitive Behavioural TherapyBehavioural
The iCBT programme comprised on 6 online modules. Module 1 provided an introduction to the symptoms of depression, its causes and information on CBT. Module 2 covered problem-solving strategies. Module 3 provided information on problematic thought patterns and beliefs in depression. Module 4 entailed identifying problematic thought patterns and using various techniques to counter problematic thoughts. Module 5 covered pleasurable activities scheduling to help increase activity levels.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered Cognitive Behavioural Therapy (iCBT) | Experimental | The iCBT programme comprised of 6 online modules, delivered over 4 weeks, with 3 face-to-face sessions provided by a clinician.The face-to-face sessions were conducted at week 1, 3 and 4. The objectives of the face-to-face sessions was for participants to discuss with the clinician about the application of the content of the modules and the active therapeutic interventions were all found in the online modules. Receives: Behavioral: Internet-delivered Cognitive Behavioural Therapy |
| Delayed Wait-list control | No intervention | The delayed wait-list control did not receive any therapy interventions for 4 weeks from the pre-treatment assessment and from the fifth week onwards, they received the same intervention as the iCBT experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9 (PHQ9)
The PHQ-9 is a nine-item self-report measure of symptoms and severity of major depressive disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV; American Psychiatric Association, 2000) criteria for Major Depressive Disorder. Scores on each item range from 0 (not at all) to 3 (nearly every day). An overall cut-off score of 10 or greater has been found to be sensitive to a DSM-IV diagnosis of depression (Kroenke, Spitzer, Williams, amp; Löwe, 2010). The PHQ9 has an internal reliability of 0.86- 0.89, sensitivity of 88% and specificity of 88% for the clinical cut-off of 10. Test-retest reliability of 0.84, and moderately correlated(r=0.58) with the SF-20 mental health scale. (Kronke et al.,2001).
Measured: week 1, week 3, week 4 and 3-month follow-up
Secondary outcomes (2)
Change in Generalised Anxiety Disorder-7 (GAD-7)
The GAD-7 is a seven-item self-report measure of symptoms and severity of Generalised Anxiety Disorder (GAD), based on the DSM-IV criteria for GAD. Scores for each item range from 0 (not at all) to 3 (nearly every day). An overall cut-off score of 10 or greater has been found to be sensitive to DSM-IV diagnoses of GAD, social phobia and panic disorders (Kroenke, Spitzer, Williams, Monahan, amp; Lo ̈we, 2007). The GAD-7 has an internal reliability of 0.92, test-retest reliability of 0.83, and criterion validity of 0.75 with SF-20 mental health scale (Spitzer et al., 2006) .The GAD-7 is increasingly adopted in empirical studies and in large scale dissemination studies as a general measure of shifts in anxiety symptoms (Clark et al., 2009).
Measured: week 1, week 3, week 4 and 3-month follow-up
Change in Work and Social Adjustment Scale (WSAS)
The WSAS is a five-item self-report measure of the extent of impairment in work and social functioning. Scores ranged from 0 to 40. An overall score of above 20 appears to suggest moderately severe or worse psychopathology. Scores between 10 and 20 are associated with significant functional impairment but less severe clinical symptomatology. The WSAS has an internal reliability of 0.70-0.94, Test-retest reliability of 0.73. Convergent validity compared with clinical interviews and severity of depression is 0.76-0.86.
Measured: week 1, week 3, week 4 and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start9 Aug 2015
- Primary completion6 Jul 2017
- Study completion16 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mental Health, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon HX Lu, DPsych, Principal investigator, Institute of Mental Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100785
- Sponsor's protocol ID
- 2015/00404
- Other IDs
- 2015
- Acronym
- iCBT
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Investigation of Clinician-guided Internet-Delivered Cognitive Behavioural Therapy for Depressed Patients in an Outpatient Hospital Setting
- ClinicalTrials.gov ID
- NCT04100785
- Acronym / sponsor ID
- iCBT / 2015/00404
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Institute of Mental Health, SingaporeUniversity, hospital or other
- Study start
- 9 Aug 2015 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 16 Jul 2017 (actual)
- First posted
- 24 Sep 2019 (actual)
- 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 study aims to explore the efficacy and acceptability of a clinician-guided internet-based Cognitive Behavioural Therapy (iCBT) programme for patients with depression, in Singapore.
Detailed description
All outpatients, from the Institute of Mental Health, Singapore, who are diagnosed with a primary diagosis of mild to moderate depression and were referred to the Psychology Department for therapy were invited to take part in this research. Participants were randomised into two groups: iCBT Intervention Group and Delayed Waitlist-Control Group. The four-week iCBT programme comprised of three face to face 30-minute sessions with a clinician and six online modules).The treatment group is hypothesised to exhibit pre-post improvements in depressive symptoms, compared to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered Cognitive Behavioural Therapy (iCBT) | Experimental | Behavioral: Internet-delivered Cognitive Behavioural TherapyThe iCBT programme comprised of 6 online modules, delivered over 4 weeks, with 3 face-to-face sessions provided by a clinician.The face-to-face sessions were conducted at week 1, 3 and 4. The objectives of the face-to-face sessions was for participants to discuss with the clinician about the application of the content of the modules and the active therapeutic interventions were all found in the online modules. |
| Delayed Wait-list control | No intervention | –The delayed wait-list control did not receive any therapy interventions for 4 weeks from the pre-treatment assessment and from the fifth week onwards, they received the same intervention as the iCBT experimental group. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 21 to 65 years old
- Not currently seeing a therapist for any form of invidual or group therapy
- Diagnosed with a primary diagnosis of depression by IMH psychiatrist
- A total score of above 9 on the Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001), indicating at least mild symptoms
- If using medication for depression then on a stable dose for at least 1 month,
Key exclusion criteria (6 listed)
- Severe depression (i.e. score = 23 on PHQ-9)
- Strong suicidal ideation (i.e. score > 2 on Question 9 of the PHQ-9)
- Current active suicidal intention or plan
- Presenting problem is not depression
- Does not meet the minimum English language requirements stated above
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 |
|---|---|---|
| Internet-delivered Cognitive Behavioural TherapyThe iCBT programme comprised on 6 online modules. Module 1 provided an introduction to the symptoms of depression, its causes and information on CBT. Module 2 covered problem-solving strategies. Module 3 provided information on problematic thought patterns and beliefs in depression. Module 4 entailed identifying problematic thought patterns and using various techniques to counter problematic thoughts. Module 5 covered pleasurable activities scheduling to help increase activity levels. | Behavioural | Internet-delivered Cognitive Behavioural Therapy (iCBT) |
Primary outcome
Change in Patient Health Questionnaire-9 (PHQ9)
Time frame: week 1, week 3, week 4 and 3-month follow-up
The PHQ-9 is a nine-item self-report measure of symptoms and severity of major depressive disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV; American Psychiatric Association, 2000) criteria for Major Depressive Disorder. Scores on each item range from 0 (not at all) to 3 (nearly every day). An overall cut-off score of 10 or greater has been found to be sensitive to a DSM-IV diagnosis of depression (Kroenke, Spitzer, Williams, amp; Löwe, 2010). The PHQ9 has an internal reliability of 0.86- 0.89, sensitivity of 88% and specificity of 88% for the clinical cut-off of 10. Test-retest reliability of 0.84, and moderately correlated(r=0.58) with the SF-20 mental health scale. (Kronke et al.,2001).
2 secondary outcomes
Change in Generalised Anxiety Disorder-7 (GAD-7)
Time frame: week 1, week 3, week 4 and 3-month follow-up
Change in Work and Social Adjustment Scale (WSAS)
Time frame: week 1, week 3, week 4 and 3-month follow-up
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 24 Sep 2019.
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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.
Sharon HX Lu, DPsych principal investigator
Institute of Mental Health, Singapore
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered Cognitive Behavioural Therapy in people with Depressive Symptoms, run by Institute of Mental Health, Singapore.
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 8 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 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Patient Health Questionnaire-9 (PHQ9) (time frame: week 1, week 3, week 4 and 3-month follow-up). 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 24 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.