Back to resultsA Pilot Investigation of Clinician-guided Internet-Delivered Cognitive Behavioural Therapy for Depressed Patients (iCBT)
Primary Purpose
Depressive Symptoms
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet-delivered Cognitive Behavioural Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Symptoms
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Internet-delivered Cognitive Behavioural Therapy (iCBT)
Delayed Wait-list control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
Full Information
NCT ID
NCT04100785
First Posted
September 16, 2019
Last Updated
September 22, 2019
Sponsor
Institute of Mental Health, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT04100785
Brief Title
A Pilot Investigation of Clinician-guided Internet-Delivered Cognitive Behavioural Therapy for Depressed Patients
Acronym
iCBT
Official Title
A Pilot Investigation of Clinician-guided Internet-Delivered Cognitive Behavioural Therapy for Depressed Patients in an Outpatient Hospital Setting
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 9, 2015 (Actual)
Primary Completion Date
July 6, 2017 (Actual)
Study Completion Date
July 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Mental Health, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-delivered Cognitive Behavioural Therapy (iCBT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Wait-list control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered Cognitive Behavioural Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 (PHQ9)
Description
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).
Time Frame
week 1, week 3, week 4 and 3-month follow-up
Secondary Outcome Measure Information:
Title
Change in Generalised Anxiety Disorder-7 (GAD-7)
Description
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).
Time Frame
week 1, week 3, week 4 and 3-month follow-up
Title
Change in Work and Social Adjustment Scale (WSAS)
Description
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.
Time Frame
week 1, week 3, week 4 and 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon HX Lu, DPsych
Organizational Affiliation
Institute of Mental Health, Singapore
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Pilot Investigation of Clinician-guided Internet-Delivered Cognitive Behavioural Therapy for Depressed Patients
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