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Depressive SymptomsNCT04757961

Evaluation of an Acceptance and Commitment Therapy-Based Narrative Intervention for Individuals Taking Antidepressants

A study testing LifeStories in people with Depressive Symptoms, run by Utah State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to compare the efficacy of LifeStories on depression symptomatology compared to antidepressant treatment alone, in addition to examining the effect of the intervention on health-related quality of life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depressive Symptoms
What is being tested?
LifeStories
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
17 Feb 2021to 8 May 2023
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Currently residing in the United States
  • Currently taking antidepressant medication prescribed by a primary care provider (PCP)
  • Meets criteria for at least moderate depression on the 9-item Patient Health Questionnaire
  • Fluent in English
  • Reliable access to an internet browser, and internet speed that is sufficient for streaming online videos

Who cannot join

  • Change in medication regimen in past 6 weeks
  • Presently seeing a mental health specialist (e.g. psychologist, psychiatrist, counselor, social worker)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Utah State University

    Logan, Utah, 84322

Other trials in United States

About this study

Official title: Evaluation of an ACT-based Narrative Intervention for Individuals Taking Antidepressant Medication

This study aims to compare the efficacy of LifeStories on depression symptomatology compared to antidepressant treatment alone, in addition to examining the effect of the intervention on health-related quality of life. Participants will be randomly assigned to either an online ACT-based narrative intervention (Lifestories) or the waitlist control condition (antidepressant treatment alone). It is hypothesized that participants who receive the LifeStories will result in decreased depression and increased quality of life, general functioning and decreased psychological inflexibility compared to the waitlist group.

Read the detailed description

The purpose of this study is to test the efficacy of an online, self-guided ACT-based narrative intervention for adults currently taking antidepressant medication. To test the effects of LifeStories on depression severity, quality of life, general functioning and psychological inflexibility, the investigators will conduct a randomized controlled trial with two conditions (LifeStories and waitlist control) using a sample of 90 adults currently taking antidepressant medication. Interested individuals will complete a screening survey to determine eligibility. After being informed about the study and potential risks, eligible participants who provide informed consent will be asked to complete a baseline survey. Participants will then be randomized to LifeStories or a waitlist control conditions, each lasting 4 weeks. Those in the waitlist group will be asked to not use other self-help websites or books for four weeks, after which they will be given weekly access to LifeStories modules. Participants in both groups will be asked to complete a midtreatment survey 2 weeks after baseline, and a posttreatment survey 4 weeks after baseline (i.e. after completing the 4-week video intervention for those in the active condition).

Being tested
LifeStories
Keywords
ACT, narrative intervention, story-telling intervention, depression, antidepressant
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LifeStoriesBehavioural

    The content of LifeStories is divided thematically into core ACT concepts across the four episodes as follows: 1) cultivating awareness of the transient nature of mood experiences and the benefit of trying out various strategies to cope with depression when it arises; 2) clarifying one's own values and setting personal goals related to these values; 3) developing a more accepting and nonjudgmental stance towards difficult thoughts and feelings and practicing self-compassion;and 4) living more mindfully in the present moment.

Study groups in NCT04757961
Study groupRoleWhat they receive
LifestoriesExperimentalParticipants in this condition will be actively participating in the online intervention for 4 weeks.
Receives: Behavioral: LifeStories
Waitlist Control ConditionNo interventionParticipant in the waitlist group will be asked to not use other self-help websites or books for four weeks, after which they will be given weekly access to LifeStories modules. All participants will be asked to continue their antidepressant treatment as usual as directed by their primary care provider.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in depression severity

    Patient Health Questionnaire 9-item (PHQ-9; Kroenke et al., 2001): The PHQ is a 9-item measure of depression severity, which asks respondents to report their frequency of depressive symptoms over the past two weeks, rated from 0 "not at all" to 3 "nearly every day". The PHQ-9 provides a total score which indicates current depression severity according to the following levels: minimal, mild, moderate, moderately severe, and severe. Higher scores indicate higher depression.

    Measured: Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)

Secondary outcomes (2)

  1. Change in health-related quality of life

    Short Form Health Survey (SF-12; Ware et al., 1996): The SF-12 is a 12-item measure of quality of life and general functioning. Respondents are asked to rate their present level of health or emotion-related impairment in daily activities. Items are rated on a scale from 1 "all of the time" to 6 "none of the time," with higher scores indicating greater health-related quality of life.

    Measured: Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)

  2. Change in psychological inflexibility

    Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011): The AAQ-II is a 10-item measure of psychological inflexibility and experiential avoidance. Items are rated on a 7-point scale ranging from 1 "never true" to 7 "always true." A total score is calculated by reverse coding so that higher scores indicate greater psychological flexibility.

    Measured: Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2021
  2. Study start17 Feb 2021
  3. Primary completion1 Dec 2021
  4. Study completion8 May 2023

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
Participants will be randomly assigned with equal likelihood to receive the online ACT-based intervention (LifeStories) or the waitlist control condition.
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04757961
Sponsor's protocol ID
11523
Status last verified
May 2023
First submitted
11 Feb 2021
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abramowitz JS, Moore EL, Braddock AE, Harrington DL. Self-help cognitive-behavioral therapy with minimal therapist contact for social phobia: a controlled trial. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):98-105. doi: 10.1016/j.jbtep.2008.04.004. Epub 2008 Apr 26.

    PubMed 18514614

  • Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.

    PubMed 22035996

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941

  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PubMed 8628042

  • Wilson, C.J., Deane, F.P., Ciarrochi, J. & Rickwood, D. (2005). Measuring help-seeking intentions: Properties of the General Help-Seeking Questionnaire. Canadian Journal of Counselling, 39(1), 15-28.

  • Brooke, J. (1996). SUS: A "Quick and Dirty" Usability Scale. In: Jordan, P.W., Thomas, B., Weerdmeester, B.A., McClelland (eds.) Usability Evaluation in Industry, pp. 189-194. Taylor & Francis, London.

  • Levin, M. E., Stocke, K., Pierce, B., & Levin, C. (2018). Do college students use online self-help? A survey of intentions and use of mental health resources. Journal of college student psychotherapy, 32(3), 181-198.

  • Lewis, J. R., & Sauro, J. (2009, July). The factor structure of the system usability scale. In International Conference on Human Centered Design (pp. 94-103). Springer, Berlin, Heidelberg.

  • Davis CH, Donahue ML, Gaudiano BA, Uebelacker LA, Twohig MP, Levin ME. Adding online storytelling-based acceptance and commitment therapy to antidepressant treatment for primary care patients: a randomized clinical trial. Cogn Behav Ther. 2024 Jan;53(1):48-69. doi: 10.1080/16506073.2023.2265560. Epub 2024 Jan 2.

    PubMed 37855277

Questions about this trial

What is this clinical trial studying?

A study testing LifeStories in people with Depressive Symptoms, run by Utah State University 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 6 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 10 May 2023. 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?

Change in depression severity (time frame: Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04757961, which also lists 9 linked publications.

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 10 May 2023; AzTrials last refreshed its copy on 27 Oct 2026.

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