Depressive SymptomsNCT04787809
Living Well: A Digital ACT Intervention
A study testing Living Well in people with Depressive Symptoms and Anxiety, run by University of Texas at Tyler at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety, Emotional Disorders
- What is being tested?
- Living Well
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2021to 19 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Participants under the age of 18
- Severe or extremely severe scores on DASS-21 Depression (11 or greater) or Anxiety (8 or greater).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Living Well: A Digital Acceptance and Commitment Therapy-Informed Intervention
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.
Read the 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
- Conditions
- Depressive Symptoms, Anxiety, Emotional Disorders
- Being tested
- Living Well
- Keywords
- Acceptance and Commitment Therapy, digital mental health, depression, anxiety, emotional disorders, prevention, experiential avoidance, values
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living WellBehavioural
Living Well is a single session digital intervention that aims to decrease experiential avoidance and increase engagement in values-consistent behavior.
| Study group | Role | What they receive |
|---|---|---|
| Living Well Intervention Group | Experimental | Participants in the Living Well treatment group will receive a brief digital intervention informed by Acceptance and Commitment Therapy. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-intervention, two week post intervention, and four week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start19 Feb 2021
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to a treatment (digital ACT-informed intervention) or control group.
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Tyler
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Berkout, University of Texas at Tyler
- Investigators
- Olga Berkout, PhD, Principal investigator, University of Texas at Tyler
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787809
- Sponsor's protocol ID
- IRB-FY2021-74
- Status last verified
- Apr 2025
- First submitted
- 3 Feb 2021
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Well: A Digital Acceptance and Commitment Therapy-Informed Intervention
- ClinicalTrials.gov ID
- NCT04787809
- Acronym / sponsor ID
- IRB-FY2021-74
- Conditions
- Depressive Symptoms, Anxiety, Emotional Disorders
- Keywords
- Acceptance and Commitment Therapy, digital mental health, depression, anxiety, emotional disorders, prevention, experiential avoidance, values
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Texas at TylerUniversity, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to a treatment (digital ACT-informed intervention) or control group.
| Arm | Type | Receives |
|---|---|---|
| Living Well Intervention Group | Experimental | Behavioral: Living WellParticipants in the Living Well treatment group will receive a brief digital intervention informed by Acceptance and Commitment Therapy. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Participants under the age of 18
- Severe or extremely severe scores on DASS-21 Depression (11 or greater) or Anxiety (8 or greater).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living WellLiving Well is a single session digital intervention that aims to decrease experiential avoidance and increase engagement in values-consistent behavior. | Behavioural | Living Well Intervention Group |
Primary outcome
Depression Anxiety Stress Scales-21 Depression Scale repeated measure of change
Time frame: pre-intervention, two week post intervention, and four week post intervention
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
Time frame: pre-intervention, two week post intervention, and four week post intervention
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
Time frame: pre-intervention, two week post intervention, and four week post intervention
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
Time frame: pre-intervention, two week post intervention, and four week post intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Berkout, PhD principal investigator
University of Texas at Tyler
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Living Well in people with Depressive Symptoms and Anxiety, run by University of Texas at Tyler at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety Stress Scales-21 Depression Scale repeated measure of change (time frame: pre-intervention, two week post intervention, and four week post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.