Clinical trial NCT04787809: Living Well: A Digital ACT Intervention
Official title: Living Well: A Digital Acceptance and Commitment Therapy-Informed Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Emotional Disorders
Keywords: Acceptance and Commitment Therapy
digital mental health
depression
anxiety
emotional disorders
prevention
experiential avoidance
values
Lead sponsor: University of Texas at Tyler
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to a treatment (digital ACT-informed intervention) or control group.
Primary purpose: PREVENTION

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:

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

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).

Primary outcomes:
measure: Depression Anxiety Stress Scales-21 Depression Scale repeated measure of change
timeFrame: pre-intervention, two week post intervention, and four week post intervention
measure: Depression Anxiety Stress Scales-21 Anxiety Scale repeated measure of change
timeFrame: pre-intervention, two week post intervention, and four week post intervention
measure: Brief Experiential Avoidance Questionnaire repeated measure of change
timeFrame: pre-intervention, two week post intervention, and four week post intervention
measure: Valuing Questionnaire-Progress Scale repeated measure of change
timeFrame: pre-intervention, two week post intervention, and four week post intervention
Secondary outcomes:
Other outcomes:
measure: COVID-19 Impact Indicators repeated measure of change
timeFrame: Measured at baseline, 2 weeks post baseline, and 4 weeks post baseline
measure: Cognitive Fusion Questionnaire
timeFrame: Measured at baseline
measure: Treatment Experience/Perceived Need Questions
timeFrame: Measured at baseline
Locations:
city: Tyler
country: United States
facility: UT Tyler
state: Texas
Study officials:
affiliation: University of Texas at Tyler
name: Olga Berkout, PhD
role: PRINCIPAL_INVESTIGATOR
References: