Living Well: A Digital ACT Intervention
Primary Purpose
Depressive Symptoms, Anxiety, Emotional Disorders
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Living Well
Sponsored by
About this trial
This is an interventional prevention trial for Depressive Symptoms focused on measuring Acceptance and Commitment Therapy, digital mental health, depression, anxiety, emotional disorders, prevention, experiential avoidance, values
Eligibility Criteria
Inclusion Criteria:
- Undergraduate students aged 18 or older
- Mildly to moderately elevated symptoms of depression or anxiety as reflected by DASS-21 Depression (5-10) or Anxiety scores (4-7).
Exclusion Criteria:
- Participants under the age of 18
- Severe or extremely severe scores on DASS-21 Depression (11 or greater) or Anxiety (8 or greater).
Sites / Locations
- UT Tyler
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Living Well Intervention Group
Control Group
Arm Description
Participants in the Living Well treatment group will receive a brief digital intervention informed by Acceptance and Commitment Therapy.
Participants in the control group will not receive any intervention. These individuals will have the option to access the intervention at the conclusion of their study participation.
Outcomes
Primary Outcome Measures
Depression Anxiety Stress Scales-21 Depression Scale repeated measure of change
Depression Anxiety Stress Scales-21 (DASS-21) is a 21 item self report questionnaire assessing symptoms of depression, anxiety, and stress. The DASS-21 seven item Depression Scale will be used to assess symptoms of depression and with higher scores indicating greater depressive symptoms. Scores on the DASS-21 Depression Scale range from 0 to 21.
Depression Anxiety Stress Scales-21 Anxiety Scale repeated measure of change
Depression Anxiety Stress Scales-21 (DASS-21) is a 21 item self report questionnaire assessing symptoms of depression, anxiety, and stress. The DASS-21 seven item Anxiety Scale will be used to assess symptoms of anxiety with higher scores indicating greater anxiety symptoms. Scores on the DASS-21 Anxiety Scale range from 0 to 21.
Brief Experiential Avoidance Questionnaire repeated measure of change
Brief Experiential Avoidance Questionnaire (BEAQ) is a 15 item self report measure assessing experiential avoidance. Higher scores on the BEAQ indicate greater experiential avoidance. Scores on the BEAQ can range from 15 to 90.
Valuing Questionnaire-Progress Scale repeated measure of change
Valuing Questionnaire-Progress Scale (VQ-P) is a five item scale assessing the extent to which one made progress towards one's values that is a part of the ten item Valuing Questionnaire. Higher scores on the VQ-P indicate greater progress towards one's values and VQ-P scores can range from 0 to 30.
Secondary Outcome Measures
Full Information
NCT ID
NCT04787809
First Posted
February 3, 2021
Last Updated
December 27, 2021
Sponsor
University of Texas at Tyler
1. Study Identification
Unique Protocol Identification Number
NCT04787809
Brief Title
Living Well: A Digital ACT Intervention
Official Title
Living Well: A Digital Acceptance and Commitment Therapy-Informed Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 19, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Tyler
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
Depression and anxiety are frequently comorbid and share mechanisms contributing to dysfunction. Transdiagnostic approaches, such as Acceptance and Commitment Therapy, streamline intervention and allow a broader population to benefit in a cost-effective fashion. Brief ACT interventions targeting at-risk individuals have the potential to prevent negative outcomes. Delivering these in a digital format overcomes attitudinal and structural barriers to accessing treatment.
Detailed Description
Depression and anxiety disorders are among the most prevalent psychological difficulties and contribute to negative economic, social, and health outcomes. As they are frequently comorbid and share underlying mechanisms of dysfunction, many scholars have conceptualized these as a unified category of emotional disorders. Addressing processes contributing to dysfunction among individuals who are at risk for developing emotional disorders has the potential to prevent significant negative impact.
Acceptance and Commitment Therapy (ACT) has received empirical support in the treatment of depression and anxiety in a number of examinations. ACT aims to shape acceptance of challenging thoughts and feelings and engagement with areas of life one finds meaningful and important. The converse of acceptance, experiential avoidance, or the unwillingness to experience unpleasant thoughts and emotions even when doing so is maladaptive, has been predictive of symptoms of depression and anxiety. Reducing experiential avoidance and shaping alternative responses, such as acceptance and behavior consistent with one's values, termed committed action, is a promising strategy for targeting risk for emotional disorders.
Traditional means of delivering interventions fail to reach a substantial proportion of those who struggle with psychological difficulties. Barriers such as distance, time, and cost contribute to these challenges. Digital mental health interventions offer a means to overcome treatment barriers and increase access. These approaches can be delivered in individual's homes at the time of their choosing. Additionally, digital interventions can be delivered to many people at the same time, reducing cost. Support for the impact of ACT-informed digital interventions on symptoms of depression and anxiety has been obtained, suggesting that this framework is promising for reducing risk.
The goal of the current study is to compare the impact of a digital ACT-informed intervention on psychological symptoms and processes of change among individuals at risk for depression and anxiety. The following hypotheses will be evaluated:
Individuals in the treatment condition will experience a decrease in symptoms of depression and anxiety compared to those in the control group
Individuals in the treatment condition will experience a decrease in experiential avoidance and increase in values consistent behavior compared to those in the control group
The digital intervention will generally be rated positively
The relationship between cognitive fusion and treatment response will be explored
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety, Emotional Disorders
Keywords
Acceptance and Commitment Therapy, digital mental health, depression, anxiety, emotional disorders, prevention, experiential avoidance, values
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to a treatment (digital ACT-informed intervention) or control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Living Well Intervention Group
Arm Type
Experimental
Arm Description
Participants in the Living Well treatment group will receive a brief digital intervention informed by Acceptance and Commitment Therapy.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in the control group will not receive any intervention. These individuals will have the option to access the intervention at the conclusion of their study participation.
Intervention Type
Behavioral
Intervention Name(s)
Living Well
Intervention Description
Living Well is a single session digital intervention that aims to decrease experiential avoidance and increase engagement in values-consistent behavior.
Primary Outcome Measure Information:
Title
Depression Anxiety Stress Scales-21 Depression Scale repeated measure of change
Description
Depression Anxiety Stress Scales-21 (DASS-21) is a 21 item self report questionnaire assessing symptoms of depression, anxiety, and stress. The DASS-21 seven item Depression Scale will be used to assess symptoms of depression and with higher scores indicating greater depressive symptoms. Scores on the DASS-21 Depression Scale range from 0 to 21.
Time Frame
pre-intervention, two week post intervention, and four week post intervention
Title
Depression Anxiety Stress Scales-21 Anxiety Scale repeated measure of change
Description
Depression Anxiety Stress Scales-21 (DASS-21) is a 21 item self report questionnaire assessing symptoms of depression, anxiety, and stress. The DASS-21 seven item Anxiety Scale will be used to assess symptoms of anxiety with higher scores indicating greater anxiety symptoms. Scores on the DASS-21 Anxiety Scale range from 0 to 21.
Time Frame
pre-intervention, two week post intervention, and four week post intervention
Title
Brief Experiential Avoidance Questionnaire repeated measure of change
Description
Brief Experiential Avoidance Questionnaire (BEAQ) is a 15 item self report measure assessing experiential avoidance. Higher scores on the BEAQ indicate greater experiential avoidance. Scores on the BEAQ can range from 15 to 90.
Time Frame
pre-intervention, two week post intervention, and four week post intervention
Title
Valuing Questionnaire-Progress Scale repeated measure of change
Description
Valuing Questionnaire-Progress Scale (VQ-P) is a five item scale assessing the extent to which one made progress towards one's values that is a part of the ten item Valuing Questionnaire. Higher scores on the VQ-P indicate greater progress towards one's values and VQ-P scores can range from 0 to 30.
Time Frame
pre-intervention, two week post intervention, and four week post intervention
Other Pre-specified Outcome Measures:
Title
COVID-19 Impact Indicators repeated measure of change
Description
Participants will provide information on how they have been impacted by the COVID-19 pandemic. They will respond to the question "How has the COVID-19 outbreak affected you in the past two weeks (you can select multiple options)" selecting from among 10 possible options: Diagnosed with COVID-19, worked remotely or from home more than you usually do, worked more hours than usual, worked reduced hours, was not able to work, had difficulty arranging for childcare, incurred increased costs for childcare expenses, income or pay has been reduced, not paid at all, had serious financial problems. Participants may choose between 0 and 10 possible COVID-19 impacts. These do not belong to a standardized questionnaire, but have been used by other researchers to describe the impact of COVID-19.
Time Frame
Measured at baseline, 2 weeks post baseline, and 4 weeks post baseline
Title
Cognitive Fusion Questionnaire
Description
The Cognitive Fusion Questionnaire is a self report measure of cognitive fusion consisting of seven items. Higher scores indicate greater cognitive fusion and scores can range from 7 to 49.
Time Frame
Measured at baseline
Title
Treatment Experience/Perceived Need Questions
Description
Participants will respond to three questions about past experience with mental health treatment and perceived future need with yes/no responses. These questions do not belong to a standardized questionnaire, but have been used by other researchers to describe participant experience.
In the past 12 months, did you receive therapy from a professional counselor or therapist to help you with emotional or mental health problems such as feeling sad, blue, anxious, or nervous?
In the past 12 months, did a healthcare professional prescribe medications to help you with emotional or mental health problems such as feeling sad, blue, anxious, or nervous?
In the past 12 months, did you think you needed help for emotional or mental health problems such as feeling sad, blue, anxious, or nervous?
Time Frame
Measured at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Undergraduate students aged 18 or older
Mildly to moderately elevated symptoms of depression or anxiety as reflected by DASS-21 Depression (5-10) or Anxiety scores (4-7).
Exclusion Criteria:
Participants under the age of 18
Severe or extremely severe scores on DASS-21 Depression (11 or greater) or Anxiety (8 or greater).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Berkout, PhD
Organizational Affiliation
University of Texas at Tyler
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Living Well: A Digital ACT Intervention
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