Microtuning a Bonafide Treatment for GAD Patients - A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 57
- Locations
- 2
- Primary Endpoint
- Change of Beck Anxiety Inventory (BAI)
Study Overview
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.
Detailed Description
Aims of the trial. This trial investigates 3 different types of how to customize a well-introduced CBT-protocol (Zinbarg, Craske, & Barlow, 2006) using dyadic peer tutoring methodology (primings). The participants are randomly assigned to 3 priming conditions: (a) Resource priming (Flückiger, Wüsten et al., 2010; Flückiger & Grosse Holtforth, 2008a); (b) Supportive resource priming and (c) Adherence priming.
The main research questions are:
- In-session outcomes. Using the videotapes, observer-based videoanalyses will be conducted: (a) Do the resource priming conditions show comparable observer-based therapist's adherence in comparison to the adherence priming condition (Zinbarg et al., 2007)? (b) Do the resource priming conditions show more resource activating micro interventions than the adherence priming condition (ROMA; Flückiger & Grosse Holtforth, 2008a/b)? (c) Are the in-session processes predictors and mediators of session and therapy outcomes (Flückiger et al., 2009; Flückiger et al., 2013)?
- Post-session outcomes. Are there differences in the post-session outcomes of the 3 priming conditions? Furthermore: Are the post-session outcomes along with symptom change predictors and mediators of therapy outcome (Flückiger et al., 2009; Flückiger et al., 2012)?
- Treatment outcomes. Do show the resource priming conditions comparable efficacy on GAD outcomes, general outcomes and dropout rates in comparison to the adherence priming condition?
Methods/Design. This study is a randomized controlled trial with three active treatment arms. This trial is conducted at the Swiss psychotherapy outpatient clinic from the Department of Psychology at the University of Zürich. The treatments are based on the same treatment protocol (Zinbarg et al., 2006). Overall, a 3 x 4 design with one between-subject factor (resource priming vs. supportive resource priming vs. problem priming) and one within-subject factor (time: pre, mid (session 6), post (session 14), 6-months follow-up).
Participants. Inclusion/Exclusion Criteria. Participants will be included in the study if they: (a) are 18 years or older; (b) agree to the informed consent, (c) have sufficient knowledge of German; and (d) fulfill the diagnostic criteria of GAD DSM-IV criteria. Participants will be excluded if they have: (a) 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, (b) a current medication of psychotic or bipolar disorder, (c) a current treatment by a professional psychotherapist. Further, prescribed medications for anxiety or depressive disorders do not lead to exclusion if the dosage has remained constant for at least one month. The presence of a comorbidity does not result in exclusion if GAD is in the foreground according to the severity rating of the Diagnostic Interview for DSM-diagnoses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •are 18 years or older
- •agree to the informed consent,
- •have sufficient knowledge of German
- •fulfill the diagnostic criteria of GAD DSM-IV criteria
Exclusion Criteria
- •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,
- •a current treatment by a professional psychotherapist. (Further, prescribed medications for anxiety or depressive disorders do not lead to exclusion if the dosage has remained constant for at least one month. The presence of a comorbidity does not result in exclusion if GAD is in the foreground according to the severity rating of the Diagnostic Interview for DSM-diagnoses.)
Outcomes
Primary Outcomes
Change of Beck Anxiety Inventory (BAI)
Time Frame: Change from intake, sessions 1-15, 6-month follow-up (HLM slope-estimate)
Self-report measure of the anxiety status
Secondary Outcomes
- 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)
- Change of Inventory of Interpersonal Problems (IIP-64)(change from intake, session 6 and 14, 6-months follow-up)
- Change of Inventory of Interpersonal Strengths (IIS-64)(change from intake, session 6 and 14, 6-months follow-up)
- Change of Penn State Worry Questionnaire (PSWQ)(change from intake, session 6 and 14, 6 months follow-up)
- Change of Resource potential questionnaire (RES)(change from intake, session 6 and 14, 6-months follow-up)