NCT01388231

Brief Summary

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 8, 2011

Status Verified

July 1, 2011

Enrollment Period

2.8 years

First QC Date

June 8, 2011

Last Update Submit

July 7, 2011

Conditions

Social Phobia

Keywords

social phobia, cognitive-behavioral therapy, treatment

Outcome Measures

Primary Outcomes (1)

  • Severity of Social Phobia Symptoms

    Symptom severity will be assessed via the Liebowitz Social Anxiety Scale (LSAS).

    Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.

Secondary Outcomes (10)

  • Diagnostic Status of Social Phobia

    Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.

  • Assessment of Symptoms of Social Anxiety (Performance Anxiety)

    Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.

  • Assessment of Symptoms of Social Anxiety (Social Phobic Cognitions)

    Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.

  • Assessment of a Change in Safety Behaviors in Social Anxiety

    Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.

  • Assessment of Other Social Anxiety Symptoms

    Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.

  • +5 more secondary outcomes

Study Arms (2)

Manualized CBT Group

ACTIVE COMPARATOR

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.

Behavioral: CBT-Manualized Intervention

CBT Group -Treatment as Usual

ACTIVE COMPARATOR

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.

Behavioral: CBT-Treatment as Usual

Interventions

CBT-Manualized InterventionBEHAVIORAL

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

Manualized CBT Group
CBT-Treatment as UsualBEHAVIORAL

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

CBT Group -Treatment as Usual

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Dresden, Saxony, 01187, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 18852500BACKGROUND

  • 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.

    PMID: 22647314DERIVED

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Juergen Hoyer, Prof. Dr.

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juergen Hoyer, Prof. Dr.

CONTACT

35146336986hoyer@psychologie.tu-dresden.de

Stephen C Crawcour, Dr.

CONTACT

35146336964crawcour@psychologie.tu-dresden.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2011

First Posted

July 6, 2011

Study Start

September 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 8, 2011

Record last verified: 2011-07

Locations

DE(1)