Living Well: A Digital ACT Intervention

Anxiety Clinical Trial

Official title:

Living Well: A Digital Acceptance and Commitment Therapy-Informed Intervention

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04787809
• Other study ID #: IRB-FY2021-74
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 19, 2021
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: University of Texas at Tyler
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. Individuals in the treatment condition will experience a decrease in symptoms of depression and anxiety compared to those in the control group

2. 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

3. The digital intervention will generally be rated positively

4. The relationship between cognitive fusion and treatment response will be explored

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Emotional Disorders

Intervention

Behavioral:
• Living Well
Living Well is a single session digital intervention that aims to decrease experiential avoidance and increase engagement in values-consistent behavior.

Locations

Country	Name	City	State
United States	UT Tyler	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Tyler

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	COVID-19 Impact Indicators repeated measure of change	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.	Measured at baseline, 2 weeks post baseline, and 4 weeks post baseline
Other	Cognitive Fusion Questionnaire	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.	Measured at baseline
Other	Treatment Experience/Perceived Need Questions	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?	Measured at baseline
Primary	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.	pre-intervention, two week post intervention, and four week post intervention
Primary	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.	pre-intervention, two week post intervention, and four week post intervention
Primary	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.	pre-intervention, two week post intervention, and four week post intervention
Primary	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.	pre-intervention, two week post intervention, and four week post intervention