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

Technische Universität Dresden

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Social Phobia

Treatments: Behavioral: CBT-Treatment as Usual; Behavioral: CBT-Manualized Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01388231

01GV1001

Details and patient eligibility

About

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?

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups

Manualized CBT Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: CBT-Manualized Intervention

CBT Group -Treatment as Usual

Active Comparator group

Description:

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.

Treatment:

Behavioral: CBT-Treatment as Usual