Living Well: A Digital ACT Intervention

NCT04787809 | Completed

• 1 other identifier: IRB-FY2021-74
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Anxiety; Emotional Disorders

Keywords

Acceptance and Commitment Therapy; digital mental health; depression; anxiety; emotional disorders; prevention; experiential avoidance; values

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Other Outcomes (3)

• COVID-19 Impact Indicators repeated measure of change

  Measured at baseline, 2 weeks post baseline, and 4 weeks post baseline

• Cognitive Fusion Questionnaire

  Measured at baseline

• Treatment Experience/Perceived Need Questions

  Measured at baseline

Study Arms (2)

Living Well Intervention Group

EXPERIMENTAL

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

Behavioral: Living Well

Control Group

NO INTERVENTION

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.

Interventions

Living Well BEHAVIORAL

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

Living Well Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Participants under the age of 18
• Severe or extremely severe scores on DASS-21 Depression (11 or greater) or Anxiety (8 or greater).

Sponsors & Collaborators

• University of Texas at Tyler: lead

Study Sites (1)

UT Tyler

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Olga Berkout, PhD

  University of Texas at Tyler

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Model Details: Participants were randomly assigned to a treatment (digital ACT-informed intervention) or control group.

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: March 9, 2021
• Study Start: February 19, 2021
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)