Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

30. april 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Faktiske)

120

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Copenhagen, Danmark, 2200
        • University of Copenhagen

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with anxiety disorders from outpatient clinics.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Bare etui
  • Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Beck Anxiety Inventory
Tidsramme: 9 months
Self-report questionnaire to assess level of anxiety symptoms.
9 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2015

Primær fullføring (Faktiske)

1. desember 2017

Studiet fullført (Faktiske)

1. desember 2017

Datoer for studieregistrering

Først innsendt

16. desember 2015

Først innsendt som oppfylte QC-kriteriene

22. desember 2015

Først lagt ut (Anslag)

23. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. mai 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. april 2018

Sist bekreftet

1. april 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Precat

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere