Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04810988 |
| Other study ID # |
Pro #2021-0292 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 7, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
December 2023 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 therapy.27 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 worksheet(s).
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
week's 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 Duke's 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.
