Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

An Investigation of General Predictors for CBT Outcome for Anxiety Disorders in a Naturalistic Setting

30 april 2018 bijgewerkt door: Sara Kerstine Kaya Nielsen, University of Copenhagen

An Investigation of General Predictors for Cognitive Behavioral Therapy Outcome for Anxiety Disorders in a Naturalistic Setting

The aim of this study is to investigate the predictive value of emotion regulation and attentional control for outcome of Cognitive Behavioural Therapy for adults with anxiety disorders in a naturalistic setting.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

Anxiety disorders are a pervasive problem, with an estimated 12-month prevalence of 16.6 %, and they are associated with significant impairment and high social costs. Cognitive behavioral therapy (CBT) has shown to be effective and for treating of anxiety disorders. CBT is furthermore cost-effectiveness.This has made CBT the first choice of treatment for anxiety disorders in many mental health settings around the world. Despite this impressive evidence-base, a relatively large group of individuals do not benefit from CBT, relapse, or drop out of treatment. Thus, there is a clear and pressing need to improve the efficacy and effectiveness of CBT for anxiety disorders. One way in which to improve is to identify predictors of CBT outcome. In naturalistic clinical settings, identification of prognostic factors can help allocate resources to those presumed to benefit most from CBT, while also identifying those who may need additional CBT, adjunctive therapy, or entirely different treatment to maximize outcomes.

Current knowledge about who is most likely to benefit from CBT is sparse and stems primarily from well-controlled laboratory settings. These results may not generalize to patient outcomes in mental health settings, in which patients with more severe and comorbid disorders are often seen. Thus, naturalistic studies have the potential to significantly increase knowledge, inform clinical strategies, and thus improve the treatment offered in mental health settings. Furthermore, existing studies have mostly investigated socio-demographic factors as predictors of drop-out and non-response. However, these variables have shown to be either non-significant or inconsistent predictors of outcome. Results concerning comorbidity as a predictor are also mixed. In sum, knowledge on who is most likely to benefit from CBT is sparse, and to date no reliable predictors have been identified.

While prior work has primarily emphasized atheoretical predictors, it may prove more fruitful to focus on predictor variables stemming from psychological theories. Identifying such predictors can provide direct prognostic information for clinicians. Additionally, these predictors could also inform the development of adjunctive components of treatment that may optimize the treatment for those with poorer CBT outcome. Some exciting studies suggest that such a line of inquiry could yield relevant results.

Maintaining factors is one aspect highlighted by several therapeutic approaches/theories as crucial for the treatment of anxiety disorders, and accordingly these factors are often the target of cognitive and behavioral treatments. Emotion regulation and attentional control are examples of key maintaining factors in anxiety disorders. CBT, which aims to teach patients cognitive reappraisal of maladaptive cognitions and encourages approach (rather than avoidance) behavior via cognitive restructuring and exposure, may be more suitable for patients with certain characteristics. Specifically, recent research and theory suggest that it is crucial for effective treatment of anxiety disorders that clients learn to tolerate fear while being exposed to anxiety-provoking stimuli, rather than merely habituating to the stimuli. Learning to tolerate fear may require emotion regulation skills and the ability to control attention and this has been supported by recent studies. However, so far only certain areas of emotion regulation have been investigated and to date never in a naturalistic setting. Attentional control has never been examined as a predictor of CBT outcomes. Accordingly, this study is designed to investigate the predictive value of attentional control and of three facets of emotion regulation skills.

Attentional control There is strong evidence that individuals with anxiety disorders have biased attention towards threatening stimuli, but there is no consensus as to why these biases occur. Recent research suggests that it is not the threat bias per se that is problematic. Rather, individual differences in the ability to voluntarily control attention may affect the impact of threatening information hence increasing or decreasing the anxiety symptoms. A potential consequence may be that individuals with low ability to voluntarily control their attention have difficulties participating in exposure and/or do not progress in the exposure hierarchy, because the level of anxiety gets too high. This may subsequently lead to failure to learn that fear is not dangerous or even drop-out of CBT. Furthermore, a pronounced bias towards irrelevant negative information may take up so many resources that processing of important, relevant information is hampered, making it difficult to engage in goal-oriented behavior while experiencing anxiety.

Emotion regulation as predictor Novel theoretical frameworks emphasize that difficulties in emotion regulation are associated with the development and maintenance of anxiety disorders. Additionally, emotion regulation skills may be required to engage in and benefit from CBT. Furthermore, in an attempt to increase effectiveness, several newer treatments have included emotion regulation training in their treatments protocols.

The present study aims to examine attentional control and three facets of emotion regulation:

  1. awareness and understanding of emotions,
  2. acceptance of emotions, and
  3. the ability to engage in goal-directed behavior, and refrain from impulsive behavior, when experiencing negative emotions as general predictors of outcome in CBT for anxiety disorders in a naturalistic, community-based mental health setting.

Our secondary aim is to examine a theoretical variables (i.e., socio-demographic data and clinical characteristics, such as comorbidity) as predictors of CBT outcome, as these have yet to be examined as predictors in real-world clinical settings in a mixed anxious sample.

Investigators expect that low ability to control attention will be associated with poorer treatment outcome. Similarly, it is expected that high scores on emotion dysregulation will be related to poorer treatment outcome. Given the exploratory nature of this study we will also be interested in testing non-linear relationships.

Method In order to maximize external validity, investigators are conducting the study within two real-world treatment clinics and employing minimal exclusion criteria recruiting a sample with mixed principal anxiety disorders. Patients will be recruited from the two clinics.

Studietype

Observationeel

Inschrijving (Werkelijk)

120

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Copenhagen, Denemarken, 2200
        • University of Copenhagen

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients with anxiety disorders from outpatient clinics.

Beschrijving

Inclusion:

  1. meet the diagnostic criteria for an anxiety disorder (social anxiety, generalized anxiety, panic disorder and agoraphobia) as primary diagnosis whether first episode or recurrent
  2. are between 18 to 60 years of age
  3. provide written informed consent
  4. speak and understand Danish.

Exclusion:

  1. cognitive disabilities (assessed with sub scales from Wechsler Adult Intelligence Scale Fourth-Edition, < 70)
  2. alcohol or substance abuse (assessed during the preliminary consultations)
  3. receiving any other psychotherapy during the study. Patients receiving medical treatment (e.g., antidepressants, Benzodiazepines) will also be included in the study and the treatment will be monitored closely.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Case-Alleen
  • Tijdsperspectieven: Prospectief

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Beck Anxiety Inventory
Tijdsspanne: 9 months
Self-report questionnaire to assess level of anxiety symptoms.
9 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Sara KK Nielsen, MSc, Department of Psychology

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2015

Primaire voltooiing (Werkelijk)

1 december 2017

Studie voltooiing (Werkelijk)

1 december 2017

Studieregistratiedata

Eerst ingediend

16 december 2015

Eerst ingediend dat voldeed aan de QC-criteria

22 december 2015

Eerst geplaatst (Schatting)

23 december 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 mei 2018

Laatste update ingediend die voldeed aan QC-criteria

30 april 2018

Laatst geverifieerd

1 april 2018

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Precat

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren