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Living Well: A Digital ACT Intervention

27. prosince 2021 aktualizováno: Olga Berkout, University of Texas at Tyler

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.

Přehled studie

Postavení

Zápis na pozvánku

Podmínky

Intervence / Léčba

Detailní popis

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

Typ studie

Intervenční

Zápis (Očekávaný)

70

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Living Well Intervention Group
Participants in the Living Well treatment group will receive a brief digital intervention informed by Acceptance and Commitment Therapy.
Behaviorální: Living Well
Living Well is a single session digital intervention that aims to decrease experiential avoidance and increase engagement in values-consistent behavior.
Žádný zásah: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Depression Anxiety Stress Scales-21 Depression Scale repeated measure of change
Časové okno: 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.
pre-intervention, two week post intervention, and four week post intervention
Depression Anxiety Stress Scales-21 Anxiety Scale repeated measure of change
Časové okno: 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.
pre-intervention, two week post intervention, and four week post intervention
Brief Experiential Avoidance Questionnaire repeated measure of change
Časové okno: 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.
pre-intervention, two week post intervention, and four week post intervention
Valuing Questionnaire-Progress Scale repeated measure of change
Časové okno: 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.
pre-intervention, two week post intervention, and four week post intervention

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
COVID-19 Impact Indicators repeated measure of change
Časové okno: Measured at baseline, 2 weeks post baseline, and 4 weeks post baseline
Participants will provide information on how they have been impacted by the COVID-19 pandemic. They will respond to the question "How has the COVID-19 outbreak affected you in the past two weeks (you can select multiple options)" selecting from among 10 possible options: Diagnosed with COVID-19, worked remotely or from home more than you usually do, worked more hours than usual, worked reduced hours, was not able to work, had difficulty arranging for childcare, incurred increased costs for childcare expenses, income or pay has been reduced, not paid at all, had serious financial problems. Participants may choose between 0 and 10 possible COVID-19 impacts. These do not belong to a standardized questionnaire, but have been used by other researchers to describe the impact of COVID-19.
Measured at baseline, 2 weeks post baseline, and 4 weeks post baseline
Cognitive Fusion Questionnaire
Časové okno: Measured at baseline
The Cognitive Fusion Questionnaire is a self report measure of cognitive fusion consisting of seven items. Higher scores indicate greater cognitive fusion and scores can range from 7 to 49.
Measured at baseline
Treatment Experience/Perceived Need Questions
Časové okno: Measured at baseline

Participants will respond to three questions about past experience with mental health treatment and perceived future need with yes/no responses. These questions do not belong to a standardized questionnaire, but have been used by other researchers to describe participant experience.

In the past 12 months, did you receive therapy from a professional counselor or therapist to help you with emotional or mental health problems such as feeling sad, blue, anxious, or nervous?

In the past 12 months, did a healthcare professional prescribe medications to help you with emotional or mental health problems such as feeling sad, blue, anxious, or nervous?

In the past 12 months, did you think you needed help for emotional or mental health problems such as feeling sad, blue, anxious, or nervous?
Measured at baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Texas at Tyler

Vyšetřovatelé

  • Vrchní vyšetřovatel: Olga Berkout, PhD, University of Texas at Tyler

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

19. února 2021

Primární dokončení (Očekávaný)

1. prosince 2022

Dokončení studie (Očekávaný)

1. prosince 2022

Termíny zápisu do studia

První předloženo

3. února 2021

První předloženo, které splnilo kritéria kontroly kvality

4. března 2021

První zveřejněno (Aktuální)

9. března 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. prosince 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. prosince 2021

Naposledy ověřeno

1. prosince 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IRB-FY2021-74

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

Vzácné nemoci

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Místa

3
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