Living Well: A Digital ACT Intervention

NCT ID: NCT04787809

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-19
• Study Completion Date: 2021-11-19

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

Conditions

Depressive Symptoms; Anxiety; Emotional Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Living Well Intervention Group

Participants in the Living Well treatment group will receive a brief digital intervention informed by Acceptance and Commitment Therapy.

Group Type: EXPERIMENTAL

Living Well

Intervention Type: BEHAVIORAL

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

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Living Well

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

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas at Tyler

OTHER

Sponsor Role: lead

Responsible Party

Olga Berkout

Assistant Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olga Berkout, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Tyler

Locations

UT Tyler

Tyler, Texas, United States

Countries

United States

Other Identifiers

IRB-FY2021-74

Identifier Type: -

Identifier Source: org_study_id