Outcomes of a Self-guided Versus Therapist-guided Online Mental Health Treatment

Sponsor

Duke University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04810988

Collaborator

Charles Lafitte Foundation (Other)

Enrollment

Location

Arms

14.8

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety Mood	Behavioral: Unified Protocol Behavioral: Therapist Support	N/A

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:

depression symptom survey,
anxiety symptom survey,
information about their symptom change over time,
psychoeducational text
practice exercises,
home practice instructions,
writing exercise, and
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.Eligible, consented participants will be immediately randomized to one of two arms and remain in that arm for the duration of the study.

Masking:

None (Open Label)

Masking Description:

Neither participants nor study therapists will be blinded to participant condition, as it is not feasible to blind to whether or not someone is receiving therapist support.

Primary Purpose:

Treatment

Official Title:

Variable-dose Support in an Online Mental Health Intervention

Actual Study Start Date :

Apr 7, 2021

Actual Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Unsupported Participants in this arm will receive a 12-week Unified Protocol intervention delivered via the same web platform. Each week, participants will complete the following content: depression survey, anxiety survey, information about their symptom change over time, psychoeducational text practice exercises, home practice instructions, writing exercise, home practice worksheets. In the first week, participants will receive an emailed welcome message followed by a link to the first week's content. For every following week, participants will receive an email at the start of the week with automatically generated feedback on intervention usage, behavior change, and symptom change, as well as the link to the new week's intervention content.	Behavioral: Unified Protocol The Unified Protocol is an empirically supported, transdiagnostic treatment for emotion disorders based on principles of cognitive behavioral therapy. Treatment focuses on increasing awareness of maladaptive thoughts and behaviors and decreasing avoidance of emotions and physiological sensations. Module 1 is focused on increasing motivation, readiness and self-efficacy for change. Module 2 focuses on increasing understanding and awareness of emotions. Module 3 is focused on further expanding awareness of emotions. Module 4 focuses on the role of thoughts in emotional disorders. Module 5 is focused on the role of behaviors in emotional disorders. Module 6 focuses on the role of physical sensations in emotional disorders. Module 7 focuses on exposure to interoceptive and situational triggers for emotions. Module 8 is focused on maintenance of treatment progress and relapse prevention. Other Names: Hazel
Experimental: Partially Supported Participants in 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 will be introduced to their study therapist in week 8, at the start of Module 7 via email. During Module 7 (exposure; weeks 8-11), participants will receive four video therapy sessions. Session content will be based on principles of exposure therapy (developing a personalized exposure hierarchy, live demonstrations of exposure exercises, in-session exposure practices, post-exposure processing, home practice assignments, and therapist feedback).	Behavioral: Unified Protocol The Unified Protocol is an empirically supported, transdiagnostic treatment for emotion disorders based on principles of cognitive behavioral therapy. Treatment focuses on increasing awareness of maladaptive thoughts and behaviors and decreasing avoidance of emotions and physiological sensations. Module 1 is focused on increasing motivation, readiness and self-efficacy for change. Module 2 focuses on increasing understanding and awareness of emotions. Module 3 is focused on further expanding awareness of emotions. Module 4 focuses on the role of thoughts in emotional disorders. Module 5 is focused on the role of behaviors in emotional disorders. Module 6 focuses on the role of physical sensations in emotional disorders. Module 7 focuses on exposure to interoceptive and situational triggers for emotions. Module 8 is focused on maintenance of treatment progress and relapse prevention. Other Names: Hazel Behavioral: Therapist Support 4 video calls with study therapists

Arm

Intervention/Treatment

Active Comparator: Unsupported

Participants in this arm will receive a 12-week Unified Protocol intervention delivered via the same web platform. Each week, participants will complete the following content: depression survey, anxiety survey, information about their symptom change over time, psychoeducational text practice exercises, home practice instructions, writing exercise, home practice worksheets. In the first week, participants will receive an emailed welcome message followed by a link to the first week's content. For every following week, participants will receive an email at the start of the week with automatically generated feedback on intervention usage, behavior change, and symptom change, as well as the link to the new week's intervention content.

Behavioral: Unified Protocol

The Unified Protocol is an empirically supported, transdiagnostic treatment for emotion disorders based on principles of cognitive behavioral therapy. Treatment focuses on increasing awareness of maladaptive thoughts and behaviors and decreasing avoidance of emotions and physiological sensations. Module 1 is focused on increasing motivation, readiness and self-efficacy for change. Module 2 focuses on increasing understanding and awareness of emotions. Module 3 is focused on further expanding awareness of emotions. Module 4 focuses on the role of thoughts in emotional disorders. Module 5 is focused on the role of behaviors in emotional disorders. Module 6 focuses on the role of physical sensations in emotional disorders. Module 7 focuses on exposure to interoceptive and situational triggers for emotions. Module 8 is focused on maintenance of treatment progress and relapse prevention.

Other Names:

Hazel

Experimental: Partially Supported

Participants in 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 will be introduced to their study therapist in week 8, at the start of Module 7 via email. During Module 7 (exposure; weeks 8-11), participants will receive four video therapy sessions. Session content will be based on principles of exposure therapy (developing a personalized exposure hierarchy, live demonstrations of exposure exercises, in-session exposure practices, post-exposure processing, home practice assignments, and therapist feedback).

Behavioral: Unified Protocol

Other Names:

Hazel

Behavioral: Therapist Support

4 video calls with study therapists

Outcome Measures

Primary Outcome Measures

Change Between Baseline and Post-Treatment System Usability Scale Score [through study completion, an average of 12 weeks]
10-item, validated self-report user experience survey for digital systems answered on a five-point Likert scale
Weekly Change in Willingness to Refer [through study completion, an average of 12 weeks]
yes/no question if participants would recommend the intervention to others
Total Number of Referrals (Sum Score) [through study completion, an average of 12 weeks]
pts who select yes for willingness to refer will be given option to actually make referrals. this will calculate a sum score of total number of referrals
Change in Cognitive Flexibility Inventory Score [through study completion, an average of 12 weeks]
20-item measure of cognitive flexibility designed to be used for repeated measures over the course of an intervention
Change in Cognitive and Affective Mindfulness Scale-Revised Score [through study completion, an average of 12 weeks]
10-item questionnaire that assesses mindfulness of thoughts and emotions
Change in COPE Inventory - Avoidance Factor Score [through study completion, an average of 12 weeks]
COPE Inventory is a survey of coping strategies with 60-items split across 15 4-item scales; factor analysis has identified a 16-item avoidance factor, comprising 4 4-item subscales (mental disengagement, denial, behavioral disengagement, and substance use) which will be used for this study as the remaining items on the full COPE Inventory are not related to primary mechanisms of change in this intervention

Secondary Outcome Measures

Change in Overall Depression Severity and Impairment Scale Score [through study completion, an average of 12 weeks]
A 5-question survey measure of depression symptoms
Change in Overall Anxiety Severity and Impairment Scale Score [through study completion, an average of 12 weeks]
A 5-question survey measure of anxiety symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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