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

NCT04100785 | Completed DMC

• 1 other identifier: 2015/00404
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• 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).

  week 1, week 3, week 4 and 3-month follow-up

Secondary Outcomes (2)

• Change in Generalised Anxiety Disorder-7 (GAD-7)

  week 1, week 3, week 4 and 3-month follow-up

• Change in Work and Social Adjustment Scale (WSAS)

  week 1, week 3, week 4 and 3-month follow-up

Study Arms (2)

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.

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.

Interventions

Internet-delivered Cognitive Behavioural Therapy BEHAVIORAL

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.

Internet-delivered Cognitive Behavioural Therapy (iCBT)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Mental Health, Singapore: lead

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Sharon HX Lu, DPsych

  Institute of Mental Health, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 24, 2019
• Study Start: August 9, 2015
• Primary Completion: July 6, 2017
• Study Completion: July 16, 2017
• Last Updated: September 24, 2019

Record last verified: 2019-09