Social Phobia Intervention Study of Mannheim

NCT00434759 | Completed Results DMC

• 1 other identifier: SP-32000
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: The purpose of this study is to examine efficacy and efficiency of a Stepped Care Program (SCP) for patients with Social Phobia in comparison to the standard cognitive therapy for Social Phobia according to D.M. Clark. Secondary objective: Further, it is intended to identify mechanisms of change which mediate treatment outcome and to identify differential predictors for therapy success for the two treatment conditions.

Conditions

Social Phobia

Keywords

randomized controlled trial; stepped-care program; cognitive therapy of social phobia according to D.M. Clark

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Social Interaction Anxiety Scale (SIAS)

  This scale measures interaction anxiety on a 5-point scale (range of scores is 0-4); the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.

  baseline to post-treatment (on average 24 weeks)

• Change From Baseline in Social Phobia Scale (SPS)

  The scale measures social anxiety on a 5-point scale (range of score is 0-4) ; the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.

  baseline to post-treatment (on average 24 weeks)

• Change From Baseline in Liebowitz Social Anxiety Scale (LSAS)

  The scale measures social anxiety and avoidance on a 4-point-scale (range of scores is 0-3). Blinded raters assessed social anxiety and avoidance behaviour relating to 24 social situations. Minimum for all 24 situations is 0, maximum for all 24 situations including the assessments for anxiety and avoidance is 144). Lower scores consider better outcome.

  baseline to post-treatment (on average 24 weeks)

Secondary Outcomes (2)

• Change From Baseline in Brief Symptom Inventory (BSI)

  baseline to post-treatment (on average 24 weeks)

• Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)

  baseline to post-treatment (on average 24 weeks)

Study Arms (2)

SCP

ACTIVE COMPARATOR

SCP is a stepped-care program with a self-help module with minimal therapist contact (8 sessions) as first step, followed by therapist-guided intervention depending on status of remission (8 sessions up to a maximum of 16 sessions).

Behavioral: stepped care program based on cognitive therapy

ST

ACTIVE COMPARATOR

A standard therapy which means a therapist-guided intervention with 16 sessions face-to-face therapy.

Behavioral: cognitive therapy

Interventions

cognitive therapy BEHAVIORAL

changing safety behaviors, self-focused attention, and automatic negative thoughts in anxiety-provoking situations via cognitive techniques, for example role plays and behavioral experiments

Also known as: cognitive therapy of social phobia according to D.M. Clark

ST

stepped care program based on cognitive therapy BEHAVIORAL

starting with a digital-video-disk-based (DVD-based) self-help module (8 Sessions) followed by face-to-face-therapy including 8 or 16 sessions depending on remission status; including: changing safety behaviors, self-focused attention, and automatic negative thoughts in anxiety-provoking situations via cognitive techniques, for example role plays and behavioral experiments

Also known as: based on cognitive therapy for social phobie by Clark & Wells (1995)

SCP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Social Phobia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV)
• Duration of the disorder at least 1 year
• Severity of symptomatology according to at least one of two self-report measures for social anxiety above Cut-Off: Social Interaction Anxiety Scale (SIAS: value of 26 or more) and / or Social Phobia Scale (SPS: value of 17 or more)
• Age: 18-60
• Written Informed Consent

You may not qualify if:

• Social Phobia is not the main diagnosis
• Mental Retardation
• Lifetime Diagnoses: Schizophreniform Disorder, Bipolar Affective Disorder
• Acute Diagnoses: severe Major Depression Episode, severe Anorexia Nervosa, Substance-, Drug - or Alcohol-Dependence, life-threatening suicidal crisis
• Psychotropic medication (except stable treatment with antidepressant since 3 months before study start: medication and dosage has to be stable during the entire study duration)

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead
• German Research Foundation: collaborator

Study Sites (1)

Central Institute of Mental Health

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Behavioral Therapy; Water Wells

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Water Supply; Sanitary Engineering; Engineering; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Prof. Martin Bohus
• Organization: Central Institute of Mental Health, Mannheim, Germany

martin.bohus@zi-mannheim.de

+49 621 1703 4002

Study Officials

• Martin Bohus, MD

  Central Institute of Mental Health in Mannheim

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2007
• First Posted: February 13, 2007
• Study Start: September 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2011
• Last Updated: November 28, 2012
• Results First Posted: November 28, 2012

Record last verified: 2012-10

Locations

DE (1)