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Online Psychological Group Interventions

Primary Purpose

Depression, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Online Group CBT intervention
SilverCloud guided
SilverCloud Unguided
Mood Flow
Sponsored by
University of Stellenbosch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring online group psychological intervention, depression, anxiety, online group Cognitive Behavioural Therapy, App-based interventions, Randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18 or older years.
  2. Enrolled as a student at Stellenbosch University.
  3. Provide Informed Consent.
  4. Access to internet to join the online group.

Exclusion Criteria:

  1. No internet availability.
  2. Did not provide Informed Consent

Sites / Locations

  • Stellenbosch UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Online group CBT intervention

SilverCloud guided

SilverCloud unguided

Mood Flow

Arm Description

Online group CBT delivered via Microsoft Teams (a secure web-based video conferencing platform) in 10 weekly workshops of 60-75 minutes.

The SilverCloud app is a set of programs and courses that can be completed on a phone, tablet or computer. Students are also contacted by the SilverCloud support team which offers them guidance and support while using the app. Silvercloud uses principles borrowed from both a popular type of counseling called Cognitive Behavioral Therapy (CBT) and Mindfulness. Each module takes approximately 40minutes to complete. Students are encouraged to complete at least one module per week.

The SilverCloud app is a set of programs and courses that can be completed on a phone, tablet or computer. Students are encouraged to use the app as they see fit, although guidelines to using the app are provided. Silvercloud uses principles borrowed from both a popular type of counseling called Cognitive Behavioral Therapy (CBT) and Mindfulness. Each module takes approximately 40minutes to complete. Students are encouraged to complete at least one module per week.

The Moodflow app is a mood tracker and journal that helps students figure out what changes their mood. Students are encouraged to use the app as they see fit, although guidelines to using the app are provided.

Outcomes

Primary Outcome Measures

Change from baseline scores in the mean symptoms of depression as measured by the PHQ-9 at 3-months.
Determine if a 10-week online group CBT (GCBT) intervention effectively reduces mean scores of depression, between baseline and 3-month follow up, among university students when compared with three control group interventions (i.e., Mood Flow, SilverCloud guided, and SilverCloud unguided).
Change from baseline scores in the mean symptoms of anxiety as measured by the GAD-7 at 3-months.
Determine if a 10-week online group CBT (GCBT) intervention effectively reduces mean scores of anxiety, between baseline and 3-month follow up, among university students when compared with three control group interventions (i.e., Mood Flow, SilverCloud guided, and SilverCloud unguided).

Secondary Outcome Measures

Full Information

First Posted
August 4, 2021
Last Updated
August 17, 2021
Sponsor
University of Stellenbosch
Collaborators
Harvard University, West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT05016154
Brief Title
Online Psychological Group Interventions
Official Title
A Randomised Controlled Trial of Online Group CBT for Symptoms of Depression and Anxiety Among University Students in South Africa
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Stellenbosch
Collaborators
Harvard University, West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim is to assess the effectiveness of online group CBT for reducing symptoms of depression and anxiety among university students. The investigators will conduct a four-arm randomised control trial comparing a 10-session online group CBT intervention to three mental health apps (namely SilverCloud guided, SilverCloud unguided, and Mood Flow).
Detailed Description
Email invitations and information about the study will be sent to random samples of students inviting those with symptoms of depression, anxiety, or stress to join the trial. Students who express interest will be asked to complete an online consent form (providing more detailed information about the study and explaining potential risks and benefits of participation), following which they will complete a baseline assessment. Students who meet inclusion criteria will then be randomly allocated to one of four interventions. Follow-up assessments will be done at 3-, 6- and 12-months post intervention. The baseline assessment will include measures of depression and anxiety, as well as factors that could potentially predict treatment responses (such as gender, age, substance use, self-harm, adverse childhood experiences, and physical health). Follow-up assessments will include measures of depression and anxiety, as well as substance use, self-harm, and treatment seeking. The primary outcomes will be symptoms of depression and anxiety as measured by the GAD-7 and PHQ-9.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
online group psychological intervention, depression, anxiety, online group Cognitive Behavioural Therapy, App-based interventions, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online group CBT intervention
Arm Type
Experimental
Arm Description
Online group CBT delivered via Microsoft Teams (a secure web-based video conferencing platform) in 10 weekly workshops of 60-75 minutes.
Arm Title
SilverCloud guided
Arm Type
Active Comparator
Arm Description
The SilverCloud app is a set of programs and courses that can be completed on a phone, tablet or computer. Students are also contacted by the SilverCloud support team which offers them guidance and support while using the app. Silvercloud uses principles borrowed from both a popular type of counseling called Cognitive Behavioral Therapy (CBT) and Mindfulness. Each module takes approximately 40minutes to complete. Students are encouraged to complete at least one module per week.
Arm Title
SilverCloud unguided
Arm Type
Active Comparator
Arm Description
The SilverCloud app is a set of programs and courses that can be completed on a phone, tablet or computer. Students are encouraged to use the app as they see fit, although guidelines to using the app are provided. Silvercloud uses principles borrowed from both a popular type of counseling called Cognitive Behavioral Therapy (CBT) and Mindfulness. Each module takes approximately 40minutes to complete. Students are encouraged to complete at least one module per week.
Arm Title
Mood Flow
Arm Type
Active Comparator
Arm Description
The Moodflow app is a mood tracker and journal that helps students figure out what changes their mood. Students are encouraged to use the app as they see fit, although guidelines to using the app are provided.
Intervention Type
Behavioral
Intervention Name(s)
Online Group CBT intervention
Intervention Description
Group of participants complete 10 weeks of Online Group CBT intervention
Intervention Type
Behavioral
Intervention Name(s)
SilverCloud guided
Intervention Description
Group of participants make use of the SilverCloud guided app
Intervention Type
Behavioral
Intervention Name(s)
SilverCloud Unguided
Intervention Description
Group of participants make use of the SilverCloud Unguided app
Intervention Type
Behavioral
Intervention Name(s)
Mood Flow
Intervention Description
Group of participants make use of the Mood Flow app
Primary Outcome Measure Information:
Title
Change from baseline scores in the mean symptoms of depression as measured by the PHQ-9 at 3-months.
Description
Determine if a 10-week online group CBT (GCBT) intervention effectively reduces mean scores of depression, between baseline and 3-month follow up, among university students when compared with three control group interventions (i.e., Mood Flow, SilverCloud guided, and SilverCloud unguided).
Time Frame
Baseline and 3-month follow up assessment for experiment and control interventions groups.
Title
Change from baseline scores in the mean symptoms of anxiety as measured by the GAD-7 at 3-months.
Description
Determine if a 10-week online group CBT (GCBT) intervention effectively reduces mean scores of anxiety, between baseline and 3-month follow up, among university students when compared with three control group interventions (i.e., Mood Flow, SilverCloud guided, and SilverCloud unguided).
Time Frame
Baseline and 3-month follow up assessment for experiment and control interventions groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 or older years. Enrolled as a student at Stellenbosch University. Provide Informed Consent. Access to internet to join the online group. Exclusion Criteria: No internet availability. Did not provide Informed Consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elsie Breet, PhD
Phone
0760484289
Email
elsie@sun.ac.za
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Bantjes, PhD
Email
jbantjes@sun.ac.za
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Bantjes, PhD
Organizational Affiliation
University of Stellenbosch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stellenbosch University
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7550
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elsie Breet, PhD
Phone
0760484289
Email
elsie@sun.ac.za
First Name & Middle Initial & Last Name & Degree
Jason Bantjes, PhD
Email
jbantjes@sun.ac.za

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34042598
Citation
Bantjes J, Kazdin AE, Cuijpers P, Breet E, Dunn-Coetzee M, Davids C, Stein DJ, Kessler RC. A Web-Based Group Cognitive Behavioral Therapy Intervention for Symptoms of Anxiety and Depression Among University Students: Open-Label, Pragmatic Trial. JMIR Ment Health. 2021 May 27;8(5):e27400. doi: 10.2196/27400.
Results Reference
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Online Psychological Group Interventions

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