- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02659436
Imagery-based CBT for Social Anxiety Disorder: Piloting a Treatment Augmentation Protocol
Studieoversikt
Status
Forhold
Intervensjon / Behandling
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
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
Sponsor
Etterforskere
- Hovedetterforsker: Karen Rowa, Ph. D, St. Joseph's Healthcare Hamilton
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Moscovitch DA, Gavric DL, Merrifield C, Bielak T, Moscovitch M. Retrieval properties of negative vs. positive mental images and autobiographical memories in social anxiety: outcomes with a new measure. Behav Res Ther. 2011 Aug;49(8):505-17. doi: 10.1016/j.brat.2011.05.009. Epub 2011 May 26.
- American Psychiatric Association (2013). Diagnostic and statistical manual of mental disorders (5th edition). Washington, DC: APA.
- Antony MM, Roth D, Swinson RP, Huta V, Devins GM. Illness intrusiveness in individuals with panic disorder, obsessive-compulsive disorder, or social phobia. J Nerv Ment Dis. 1998 May;186(5):311-5. doi: 10.1097/00005053-199805000-00008.
- Bieling, P.J., Rowa, K., Antony, M.M., Summerfeldt, L.J., & Swinson, R.P. (2001). Factor structure of the Illness Intrusiveness Ratings Scale in patients diagnosed with anxiety disorders. Journal of Psychopathology and Behavioral Assessment, 23, 223-230. doi: 10.1023/A:1012723318964
- Carleton RN, Collimore KC, Asmundson GJ. Social anxiety and fear of negative evaluation: construct validity of the BFNE-II. J Anxiety Disord. 2007;21(1):131-41. doi: 10.1016/j.janxdis.2006.03.010. Epub 2006 May 3. Erratum In: J Anxiety Disord. 2007;21(4):600-1.
- Devins GM. Illness intrusiveness and the psychosocial impact of lifestyle disruptions in chronic life-threatening disease. Adv Ren Replace Ther. 1994 Oct;1(3):251-63. doi: 10.1016/s1073-4449(12)80007-0.
- Devins GM, Dion R, Pelletier LG, Shapiro CM, Abbey S, Raiz LR, Binik YM, McGowan P, Kutner NG, Beanlands H, Edworthy SM. Structure of lifestyle disruptions in chronic disease: a confirmatory factor analysis of the Illness Intrusiveness Ratings Scale. Med Care. 2001 Oct;39(10):1097-104. doi: 10.1097/00005650-200110000-00007.
- Hackmann A, Clark DM, McManus F. Recurrent images and early memories in social phobia. Behav Res Ther. 2000 Jun;38(6):601-10. doi: 10.1016/s0005-7967(99)00161-8.
- Hirsch CR, Clark DM, Mathews A, Williams R. Self-images play a causal role in social phobia. Behav Res Ther. 2003 Aug;41(8):909-21. doi: 10.1016/s0005-7967(02)00103-1.
- Holmes EA, Lang TJ, Shah DM. Developing interpretation bias modification as a "cognitive vaccine" for depressed mood: imagining positive events makes you feel better than thinking about them verbally. J Abnorm Psychol. 2009 Feb;118(1):76-88. doi: 10.1037/a0012590.
- Leary, M. R. (1983). A brief version of the Fear of Negative Evaluation Scale. Personality and Social Psychology Bulletin, 9, 371-376. doi: 10.1177/0146167283093007
- McEvoy PM, Saulsman LM. Imagery-enhanced cognitive behavioural group therapy for social anxiety disorder: a pilot study. Behav Res Ther. 2014 Apr;55:1-6. doi: 10.1016/j.brat.2014.01.006. Epub 2014 Feb 7.
- McEvoy PM, Erceg-Hurn DM, Saulsman LM, Thibodeau MA. Imagery enhancements increase the effectiveness of cognitive behavioural group therapy for social anxiety disorder: a benchmarking study. Behav Res Ther. 2015 Feb;65:42-51. doi: 10.1016/j.brat.2014.12.011. Epub 2014 Dec 27.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0986
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