Clinical trial NCT04810988: Outcomes of a Self-guided Versus Therapist-guided Online Mental Health Treatment
Official title: Variable-dose Support in an Online Mental Health Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Mood
Keywords: depression
anxiety
mood
mood disorder
digital health
mHealth
unified protocol
pilot study
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Charles Lafitte Foundation
First posted: 2021-03-23
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible, consented participants will be immediately randomized to one of two arms and remain in that arm for the duration of the study.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 18+ years old
* Fluent in reading and writing English
* Internet/data plan and computer/tablet/phone access for length of study
* Overall Depression Severity and Impairment Scale (ODSIS) and/or Overall Anxiety Severity and Impairment Scale (OASIS) summary score \>= 8
* Live in North Carolina for the duration of the study

Exclusion Criteria:

* Educational attainment greater than high school diploma/equivalent
* Currently receiving other psychotherapy or planning to receive other psychotherapy during course of intervention
* \>=8 sessions of cognitive-behavioral therapy in past 12 months
* Currently taking psychiatric medications or planning to take psychiatric medications during course of intervention
* Current suicidality, operationalized as a positive result on the Ask Suicide-Screening Questions (ASQ) Tool
* Self-harm in past 12 months
* Current psychosis, as measured by Mini International Neuropsychiatric Interview Subsection K. Psychotic Disorders
* Substance abuse (other than nicotine, cannabis or caffeine) in the past 12 months, as measured by Structured Clinical Interview for The Diagnostic and Statistical Manual of Mental Disorders-5 substance use disorders subsection (past 12 months only)
* BMI \<= 18.5

Primary outcomes:
measure: Change Between Baseline and Post-Treatment System Usability Scale Score
timeFrame: through study completion, an average of 12 weeks
measure: Weekly Change in Willingness to Refer
timeFrame: through study completion, an average of 12 weeks
measure: Total Number of Referrals (Sum Score)
timeFrame: through study completion, an average of 12 weeks
measure: Change in Cognitive Flexibility Inventory Score
timeFrame: through study completion, an average of 12 weeks
measure: Change in Cognitive and Affective Mindfulness Scale-Revised Score
timeFrame: through study completion, an average of 12 weeks
measure: Change in COPE Inventory - Avoidance Factor Score
timeFrame: through study completion, an average of 12 weeks
Secondary outcomes:
measure: Change in Overall Depression Severity and Impairment Scale Score
timeFrame: through study completion, an average of 12 weeks
measure: Change in Overall Anxiety Severity and Impairment Scale Score
timeFrame: through study completion, an average of 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Jack Brooks, MA
role: STUDY_DIRECTOR
affiliation: Duke University
name: Gary G Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
References: