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Microtuning a Bonafide Treatment for GAD Patients - A Randomized Controlled Trial.

NCT02039193 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2015-12-03

No results posted yet for this study

Summary

Background: Psychotherapy is an effective treatment for generalized anxiety disorder in comparison to no-treatment controls. Instead of creating more and more new overall treatment-packets within a medical meta-model, a complementary approach to investigate clinical research designs may lie into the understanding of already effective psychotherapies. Treatment manuals and protocols allow a relatively high degree of freedom of therapists' behaviors on how to implement the overall treatment manuals. There is a lack of systematical knowledge of how therapists have to customize these overall protocols. The present design experimentally examines 3 types of conducting a 15 session time-limited cognitive-behavioral therapy (CBT) protocol and its relation to the therapists' protocol adherence and treatment efficacy.

Methods/design: This trial investigates 3 different types of how to customize a well-introduced CBT-protocol using dyadic peer tutoring methodology (primings). The individuals with GAD are randomly assigned to 3 priming conditions (resource priming vs. supportive resource priming vs. adherence priming). Participants' treatment allocation is performed randomly, therapist's assignment to the peer tutoring partner and the priming condition is based on mutual agreement. Treatment outcomes are assessed at following levels: Observer based in-session outcomes, post-session outcomes from session 1 to 15, treatment outcome at post assessment and at 6-months follow-up assessments.

Conditions

  • Dyadic Peer-tutoring
  • Adherence Priming
  • Resource Priming

Interventions

BEHAVIORAL

Cognitive behavioral therapy

CBT-manual (Zinbarg et al., 2006): Traditional cognitive-behavioral therapy (CBT) for GAD typically consists of psycho education of generalized anxiety disorder, relaxation training (RT), cognitive restructuring (CR) and with some in-vivo situational exposure for patients with overt behavioral avoidance (e.g., Barlow, Rapee, \& Brown, 1992; Borkovec \& Costello, 1993). Furthermore, imagery exposure as a GAD-specific form of in-sensu exposition will be applied to reduce experiential avoidance based on a well-introduced CBT-manual (Zinbarg et al., 2006). The manualized therapy follows an usual treatment format of 14 sessions to 50 minutes and a booster session after 6-months.

Sponsors & Collaborators

  • Swiss National Science Foundation

    collaborator OTHER

  • University of Zurich

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-05-31
Completion
2015-08-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02039193 on ClinicalTrials.gov