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

28. december 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

9

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

St. Joseph's Healthcare Hamilton

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2016

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

14. januar 2016

Først indsendt, der opfyldte QC-kriterier

15. januar 2016

Først opslået (Skøn)

20. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0986

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Social angst

Kliniske forsøg med Verbal-linguistic CBT

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