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Imagery-based CBT for Social Anxiety Disorder: Piloting a Treatment Augmentation Protocol

28. desember 2016 oppdatert av: Karen Rowa, St. Joseph's Healthcare Hamilton
The purpose of this pilot study is to explore whether there is a differential impact of verbal versus imagery-based cognitive behavioural therapy (CBT) as a treatment augmentation strategy for individuals with social anxiety disorder (SAD). Clients who have not demonstrated clinically significant change following group CBT for SAD will receive four additional sessions of either verbal-based CBT or imagery-based CBT. We hypothesize that that individuals who receive imagery-based CBT will experience even stronger improvements and be more satisfied with their treatment than individuals who received traditional verbal-linguistic CBT.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Social Anxiety Disorder (SAD) is a debilitating disorder, marked by significant functional impairment and high personal distress for those who suffer. Psychological treatment for SAD has traditionally been verbal-linguistic cognitive behavioural therapy (CBT). However, a significant number of individuals who complete CBT for SAD do not achieve full response and continue to struggle with significant residual symptoms. One innovation that has received attention recently in the literature is using imagery-based CBT as a way to augment treatment outcome in SAD. Results from a pilot and benchmarking study suggest that participants who received imagery-based CBT were more likely to complete treatment than those who received traditional CBT and treatment outcome was strong for both groups, but stronger in the imagery-based CBT group.

However, before re-training hundreds of practitioners in using a completely novel treatment approach, it is important to see if a brief augmentation of traditional CBT programs is effective in producing further change for individuals with residual symptoms after group CBT. It is possible that individuals just require a few more sessions of the same verbal-linguistic CBT to consolidate treatment gains or work on lingering triggers of anxiety. It is also possible that more of the same is not as valuable as offering therapy using a different modality, such as imagery. Therefore, we propose to evaluate a brief imagery-based augmentation of traditional group CBT to explore its effects on further symptom reduction.

Studietype

Intervensjonell

Registrering (Faktiske)

9

Fase

  • Ikke aktuelt

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 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Completed eight out of twelve sessions of standard verbal-linguistic group cognitive behavioural therapy for social anxiety disorder
  • Presented with a Social Phobia Inventory (SPIN) score of greater than 19 post-treatment
  • Interested in further treatment

Exclusion Criteria:

  • Has another mental health concern of greater importance than social anxiety disorder

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Verbal-linguistic CBT
Participants will receive 4 sessions of verbal cognitive restructuring and exposure therapy delivered in an individual therapy format.
Participants will receive 4 sessions of individual therapy focused on traditional cognitive restructuring and exposure therapy.
Eksperimentell: Imagery-based CBT
Participants will receive 4 sessions of imagery-based cognitive work and behavioural experiments delivered in an individual therapy format.
Participants will receive 4 sessions of individual therapy focused on imagery-based cognitive work and behavioural experiments.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Social Phobia Inventory
Tidsramme: This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Measures social anxiety symptoms
This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Vividness of Visual Imagery Questionnaire
Tidsramme: This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Measures the ability to visualize several visual images
This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Homework Adherence Scale
Tidsramme: This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Measures the quality of homework completion
This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Treatment Satisfaction Scale
Tidsramme: This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Measures the participant's satisfaction with their treatment
This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Brief Fear of Negative Evaluation Scale
Tidsramme: This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Measures fears about being negatively evaluated by others
This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Illness Intrusiveness Rating Scale
Tidsramme: This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
Measures how much anxiety interferes with functioning
This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Karen Rowa, Ph. D, St. Joseph's Healthcare Hamilton

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.

Generelle publikasjoner

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

1. januar 2016

Primær fullføring (Faktiske)

1. desember 2016

Studiet fullført (Faktiske)

1. desember 2016

Datoer for studieregistrering

Først innsendt

14. januar 2016

Først innsendt som oppfylte QC-kriteriene

15. januar 2016

Først lagt ut (Anslag)

20. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

29. desember 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. desember 2016

Sist bekreftet

1. desember 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 0986

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. .

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