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

NCT02039193 | Completed Phase 4 DMC

• 2 other identifiers: PZ00P1_136973 / 12011- 0475
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Generalized anxiety disorder; cognitive behavior therapy; adherence

Outcome Measures

Primary Outcomes (1)

• Change of Beck Anxiety Inventory (BAI)

  Self-report measure of the anxiety status

  Change from intake, sessions 1-15, 6-month follow-up (HLM slope-estimate)

Secondary Outcomes (8)

• Change of Penn State Worry Questionnaire (PSWQ)

  change from intake, session 6 and 14, 6 months follow-up

• Change of State -Trait Anxiety (STAI)

  change from intake, session 6 and 14, 6-months follow-up

• Change of Beck Depression Inventory (BDI)

  change from intake, session 6 and 14, 6-months-follow-up

• Change of Brief Symptom Inventory (BSI)

  change from intake, session 6 and 14, 6-months-follow-up

• Change of BIS/BAS scale

  change from intake, session 6 and 14, 6-months-follow-up

Other Outcomes (1)

• dropout rate

  intake, sessions 1-15, 6-months follow-up

Study Arms (3)

adherence priming

EXPERIMENTAL

To investigate various types of how to conduct a standardized CBT-protocol, all therapists are tutored in peer dyads (tandem peer tutoring). Immediate before sessions 1 to 5, the therapists are required to contact the tandem-partner face-to-face or via self-phone to deliberate the forthcoming session by a 5 to 10 minute brief communication (primings; comparable to Flückiger \& Grosse-Holtforth, 2008). Adherence priming: Immediately before sessions 1 to 5, therapists have a five-minute conversation about how to implement the disorderspecific interventions that are described in the treatment protocol. These communications are focused on therapists' understanding of patients GAD and the related comorbidities and how these issues can be addressed in the prescriptive treatment protocol.

Behavioral: Cognitive behavioral therapy

resource priming

EXPERIMENTAL

Resource priming: Immediately before sessions 1 to 5, therapists have a five-minute conversation about how to implement strengths-based micro-interventions in the forthcoming session. Strengths-based micro-interventions addresses therapists explicit focus on patients' preexisting strengths and abilities, subtle changes and improvements during therapy (potential recources) as well as motivational preparedness, readiness and goals (motivational resources; Grawe, 2006; Flückiger, et al., 2010).

Behavioral: Cognitive behavioral therapy

supportive resource priming

EXPERIMENTAL

Supportive resource priming: The supportive resource priming condition has the very same protocol as the resource priming condition (5 brief tandem peer tutorings). The only difference in the procedure is that the therapists are allowed to integrate a helpful significant person of the patients (such as the partners or the best friends) around session 1 and 7 to encourage and support the patient to realize their treatment plans (active integration of interpersonal resources). However, the integration of a significant other person does not touch the CBT-treatment protocol.

Behavioral: Cognitive behavioral therapy

Interventions

Cognitive behavioral therapy BEHAVIORAL

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.

Also known as: CBT-manual

adherence priming; resource priming; supportive resource priming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are 18 years or older
• agree to the informed consent,
• have sufficient knowledge of German
• fulfill the diagnostic criteria of GAD DSM-IV criteria

You may not qualify if:

• a score of 2 or higher on the suicide item of the BDI and/or with active suicidal plans according to the diagnostic screening interview,
• a current medication of psychotic or bipolar disorder,

Sponsors & Collaborators

• University of Zurich: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

University of Zürich, Department of Psychology

Zurich, Canton of Zurich, 8050, Switzerland

Location

Related Publications (3)

• Fluckiger C. The adherence/resource priming paradigm--a randomised clinical trial conducting a bonafide psychotherapy protocol for generalised anxiety disorder. BMC Psychiatry. 2014 Feb 20;14:49. doi: 10.1186/1471-244X-14-49.

  PMID: 24552307 BACKGROUND

• Fluckiger C, Horvath AO, Brandt H. The evolution of patients' concept of the alliance and its relation to outcome: A dynamic latent-class structural equation modeling approach. J Couns Psychol. 2022 Jan;69(1):51-62. doi: 10.1037/cou0000555. Epub 2021 Jul 1.

  PMID: 34197151 DERIVED

• Fluckiger C, Forrer L, Schnider B, Battig I, Bodenmann G, Zinbarg RE. A Single-blinded, Randomized Clinical Trial of How to Implement an Evidence-based Treatment for Generalized Anxiety Disorder [IMPLEMENT]--Effects of Three Different Strategies of Implementation. EBioMedicine. 2015 Nov 27;3:163-171. doi: 10.1016/j.ebiom.2015.11.049. eCollection 2016 Jan.

  PMID: 26870827 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 17, 2014
• Study Start: August 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

CH (1)