Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice

NCT ID: NCT01388231

Last Updated: 2011-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-06-30

Brief Summary

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The study aims at examining the effects of additional training in manualized cognitive-behavioral therapy (CBT) on outcome in routine psychotherapy for social phobia. The investigators will investigate how CBT, specifically the treatment procedures and manuals proposed by Clark and Wells (1995), can be transferred from controlled trials into the less structured setting of routine clinical care, and whether the health care system benefits from such developments. Private practitioners (N=36) will be randomized to one of two treatment conditions (i.e., training in manualized CBT vs. treatment as usual without specific training). The investigators plan to enroll 160 patients (80 per condition) to be able to detect differences of d=.50 between conditions at 1-beta=.80, given the drop-out rate of 25% (N=116 completers; N=58 per condition). The study is genuinely designed to promote faster and more widespread dissemination of effective interventions. The following research questions can be examined: (1) Can manualized CBT be successfully implemented into routine outpatient care? (2) Will the new methods lead to an improvement of treatment courses aned outcomes? (3) Will treatment effects in routine psychotherapeutic treatments be comparable to those of the controlled, strictly manualized treatment of the main study?

Detailed Description

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Conditions

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Social Phobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Manualized CBT Group

The present group is comprised of clinical practitioners performing cognitive-behavioral therapy (CBT) on social phobic patients after receiving structured clinical training on the treatment of social phobia based on the Clark and Wells (1995) model.

Group Type ACTIVE_COMPARATOR

CBT-Manualized Intervention

Intervention Type BEHAVIORAL

Cognitive-behavioral therapy (CBT) for social phobia following the Clark and Wells (1995) model of social phobia.

CBT Group -Treatment as Usual

The present group is comprised of clinical practitioners performing cognitive-behavioral therapy (CBT) on social phobic patients, while receiving no structured training in the treatment of social phobia.

Group Type ACTIVE_COMPARATOR

CBT-Treatment as Usual

Intervention Type BEHAVIORAL

Cognitive-behavioral therapy for social phobia following no specific model.

Interventions

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CBT-Manualized Intervention

Cognitive-behavioral therapy (CBT) for social phobia following the Clark and Wells (1995) model of social phobia.

Intervention Type BEHAVIORAL

CBT-Treatment as Usual

Cognitive-behavioral therapy for social phobia following no specific model.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* primary diagnosis of Social Phobia (SCID-I)
* Liebowitz Social Anxiety Inventory Scale (LSAS) equal to or greater than 30
* age between 18 and 70 years

Exclusion Criteria

* psychotic disorder, risk of self-harm, acute substance related disorders, personality disorders except for Cluster C (SCID-II)
* organic mental disorder
* severe medical conditions
* ongoing psychotherapy or initiation
* psychopharmacological treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goethe University

OTHER

Sponsor Role collaborator

University of Göttingen

OTHER

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Dresden University of Technology

Principal Investigators

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Juergen Hoyer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Technische Universität Dresden

Locations

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Outpatient clinical services and day clinic center Technical University Dresden (IAP-TUD)

Dresden, Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Juergen Hoyer, Prof. Dr.

Role: CONTACT

35146336986 ext. +49

Stephen C Crawcour, Dr.

Role: CONTACT

35146336964 ext. +49

Facility Contacts

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Juergen Hoyer, Prof. Dr.

Role: primary

35146336986 ext. +49

Stephen C Crawcour, Dr.

Role: backup

35146336964 ext. +49

References

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Leichsenring F, Hoyer J, Beutel M, Herpertz S, Hiller W, Irle E, Joraschky P, Konig HH, de Liz TM, Nolting B, Pohlmann K, Salzer S, Schauenburg H, Stangier U, Strauss B, Subic-Wrana C, Vormfelde S, Weniger G, Willutzki U, Wiltink J, Leibing E. The social phobia psychotherapy research network. The first multicenter randomized controlled trial of psychotherapy for social phobia: rationale, methods and patient characteristics. Psychother Psychosom. 2009;78(1):35-41. doi: 10.1159/000162299. Epub 2008 Oct 14.

Reference Type BACKGROUND
PMID: 18852500 (View on PubMed)

Crawcour S, Leibing E, Ginzburg D, Stangier U, Wiltink J, Hoyer J. Transfer of manualized CBT for social phobia into clinical practice (SOPHO-PRAX): a study protocol for a cluster-randomized controlled trial. Trials. 2012 May 30;13:70. doi: 10.1186/1745-6215-13-70.

Reference Type DERIVED
PMID: 22647314 (View on PubMed)

Other Identifiers

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01GV1001

Identifier Type: -

Identifier Source: org_study_id

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