Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810988
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2021-03-18
Brief Title:
Outcomes of a Self-guided Versus Therapist-guided Online Mental Health Treatment
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Variable-dose Support in an Online Mental Health Intervention
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot study of an online mental health treatment The goals of the study are to determine the feasibility of an online treatment for depression and anxiety symptoms with little-to-no human support in a sample of 50 adults with limited educational attainment The treatment is based on the Unified Protocol an evidence-based treatment for mood and anxiety symptoms The study will enroll participants on a rolling basis until reaching the goal of 50 participants The intervention lasts 16 weeks with 12 weeks of online treatment focused on increasing mindfulness decreasing avoidance and increasing cognitive flexibility in order to decrease depression and anxiety symptoms Participants will complete surveys about their symptoms and how they feel about the treatment to help us establish the feasibility of a larger trial
Detailed Description:
The study is a 12-week randomized controlled trial Hazel comparing an intervention for depression and anxiety symptoms with two different levels of support Eligible participants will be randomized to receive 1 a Unified Protocol intervention with 4 weeks of human support during exposure exercises in weeks 8-11 Partially Supported or 2 a Unified Protocol intervention without support at any point the Unsupported arm At 4 weeks post-intervention participants will be sent a link to complete follow-up survey measures for depression and anxiety symptoms
The Unified Protocol is an empirically supported transdiagnostic treatment for emotion disorders based on principles of cognitive behavioral therapy27 The Unified Protocol can be delivered in 12 to 18 weeks with one one-hour session per week Treatment focuses on increasing awareness of maladaptive thoughts and behaviors while decreasing avoidance of emotions and physiological sensations Each week patients receive psychoeducation complete in-session practice exercises and self-monitor symptom change At the end of each session patients are assigned a home practice assignment to increase adaptive coping and generalize skill use outside of the therapy room
Participants in both arms will receive a 12-week Unified Protocol intervention delivered via the same web platform REDCap The intervention will include all 8 modules of the Unified Protocol Every week participants will be directed to complete the following content
1 depression symptom survey
2 anxiety symptom survey
3 information about their symptom change over time
4 psychoeducational text
5 practice exercises
6 home practice instructions
7 writing exercise and
8 home practice worksheets
The symptom surveys symptom graph and writing exercise will remain the same each week The psychoeducational text practice exercises and homework assignments will vary based on that weeks topic For the writing exercise participants will be prompted to write notes on their take-aways questions about the material and ways they can incorporate the lesson into their upcoming week The investigators will aim to write as much text as possible at a 5th grade reading level based on evidence that 52 of US residents read English at a 5th-grade level or below
Participants randomized to the unsupported arm will receive the intervention exactly as described above with no additional components Completion of all weeks will be entirely self- guided to emulate a publicly available standalone intervention
Participants randomized to the partially supported arm will receive all aspects of the intervention described above with no differences between arms for the first seven weeks of the intervention Modules 1-6 Participants in this arm will be introduced to their assigned study therapist in week 8 at the start of Module 7 via email During Module 7 exposure weeks 8-11 participants in this arm will receive four video therapy sessions These sessions will entail synchronous video-call contact with their assigned study therapist and session content will be based on principles of exposure therapy The first session will entail developing a personalized exposure hierarchy which will inform subsequent in-session and home practice assignments In all sessions study therapists will do live demonstrations of exposure exercises monitor participants during exposure practice and provide feedback as clinically indicated guide participants through post-exposure processing and assign in-vivo exposure practices for homework In the second through fourth sessions study therapists will also review and provide feedback on participants home practice
Study therapists will be clinical psychology graduate students at Duke University and will be trained and supervised by Dr Clair Robbins a clinical associate at Duke and expert in the Unified Protocol Dr Robbins is expected to pass licensure exams during the Spring 2021 semester Until then umbrella supervision will be provided by Dr M Zach Rosenthal a North Carolina-license psychologist and director of Dukes Cognitive Behavioral Research and Treatment Program
On recruitment and participant materials the study will be referred to by the name Hazel Hazel was chosen as a name because it is a relatively uncommon word that is both a name and a noun The investigators hope is that using a study title that can be a name will evoke a sense of warmth and personalization in the online intervention At the same time Hazel is not exclusively used a name which the investigators hope will prevent undue confusion or misleading respondents into thinking Hazel is a human therapist Finally the investigators hope that its relatively uncommon usage will help prevent confusion with any other similar studies or programs The name Hazel is incorporated into study materials in terms of color scheme and logo At the end of the intervention the hazelnut logo used throughout Hazel will be transformed into a hazelnut tree sprout symbolizing both the ways participants have grown over the course of the intervention and the possibility for ongoing growth as they continue applying their new skills after the intervention period ends
The Unified Protocol is an empirically supported transdiagnostic treatment for emotion disorders based on principles of cognitive behavioral therapy27 The Unified Protocol can be delivered in 12 to 18 weeks with one one-hour session per week Treatment focuses on increasing awareness of maladaptive thoughts and behaviors while decreasing avoidance of emotions and physiological sensations Each week patients receive psychoeducation complete in-session practice exercises and self-monitor symptom change At the end of each session patients are assigned a home practice assignment to increase adaptive coping and generalize skill use outside of the therapy room
Participants in both arms will receive a 12-week Unified Protocol intervention delivered via the same web platform REDCap The intervention will include all 8 modules of the Unified Protocol Every week participants will be directed to complete the following content
1 depression symptom survey
2 anxiety symptom survey
3 information about their symptom change over time
4 psychoeducational text
5 practice exercises
6 home practice instructions
7 writing exercise and
8 home practice worksheets
The symptom surveys symptom graph and writing exercise will remain the same each week The psychoeducational text practice exercises and homework assignments will vary based on that weeks topic For the writing exercise participants will be prompted to write notes on their take-aways questions about the material and ways they can incorporate the lesson into their upcoming week The investigators will aim to write as much text as possible at a 5th grade reading level based on evidence that 52 of US residents read English at a 5th-grade level or below
Participants randomized to the unsupported arm will receive the intervention exactly as described above with no additional components Completion of all weeks will be entirely self- guided to emulate a publicly available standalone intervention
Participants randomized to the partially supported arm will receive all aspects of the intervention described above with no differences between arms for the first seven weeks of the intervention Modules 1-6 Participants in this arm will be introduced to their assigned study therapist in week 8 at the start of Module 7 via email During Module 7 exposure weeks 8-11 participants in this arm will receive four video therapy sessions These sessions will entail synchronous video-call contact with their assigned study therapist and session content will be based on principles of exposure therapy The first session will entail developing a personalized exposure hierarchy which will inform subsequent in-session and home practice assignments In all sessions study therapists will do live demonstrations of exposure exercises monitor participants during exposure practice and provide feedback as clinically indicated guide participants through post-exposure processing and assign in-vivo exposure practices for homework In the second through fourth sessions study therapists will also review and provide feedback on participants home practice
Study therapists will be clinical psychology graduate students at Duke University and will be trained and supervised by Dr Clair Robbins a clinical associate at Duke and expert in the Unified Protocol Dr Robbins is expected to pass licensure exams during the Spring 2021 semester Until then umbrella supervision will be provided by Dr M Zach Rosenthal a North Carolina-license psychologist and director of Dukes Cognitive Behavioral Research and Treatment Program
On recruitment and participant materials the study will be referred to by the name Hazel Hazel was chosen as a name because it is a relatively uncommon word that is both a name and a noun The investigators hope is that using a study title that can be a name will evoke a sense of warmth and personalization in the online intervention At the same time Hazel is not exclusively used a name which the investigators hope will prevent undue confusion or misleading respondents into thinking Hazel is a human therapist Finally the investigators hope that its relatively uncommon usage will help prevent confusion with any other similar studies or programs The name Hazel is incorporated into study materials in terms of color scheme and logo At the end of the intervention the hazelnut logo used throughout Hazel will be transformed into a hazelnut tree sprout symbolizing both the ways participants have grown over the course of the intervention and the possibility for ongoing growth as they continue applying their new skills after the intervention period ends
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None