A Pilot Investigation of Clinician-guided Internet-Delivered Cognitive Behavioural Therapy for Depressed Patients

Not Applicable

Completed

• Conditions: Depressive Symptoms
• Interventions: Behavioral: Internet-delivered Cognitive Behavioural Therapy

• Registration Number: NCT04100785
• Lead Sponsor: Institute of Mental Health, Singapore

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.

Study Timeline

• Study Start: 2015-08-09
• Primary Completion: 2017-07-06
• Study Completion: 2017-07-16
• Status Verified: 2019-09
• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-22
• Last Update Submitted: 2019-09-22
• Study First Posted: 2019-09-24
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Internet-delivered Cognitive Behavioural Therapy (iCBT)	Internet-delivered Cognitive Behavioural Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in Patient Health Questionnaire-9 (PHQ9)	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).

Secondary Outcome Measures

Name	Time	Method
Change in Generalised Anxiety Disorder-7 (GAD-7)	week 1, week 3, week 4 and 3-month follow-up	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)	week 1, week 3, week 4 and 3-month follow-up	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.