Department of Clinical Psychology and Psychotherapy

Babes-Bolyai University

Archive for July, 2008

A “Platform for Advanced Imaging – fMRI/EEG – in Clinical Cognitive Sciences/Psychotherapy” will be developed at the Babes-Bolyai University, Department of Clinical Psychology and Psychotherapy/International Institute for the Advanced Studies of Psychotherapy and Applied Mental Health, based on a grant from the European Union through the Romanian Government – National Authority for Research. The Platform will be composed of a Center for Advanced Imaging – fMRI/EEG – in Clinical Cognitive Sciences, which has two Laboratories: (1) Advanced fMRI Lab.; and (2) Advanced EEG Lab. Thus, the Platform will make use of an advanced technology, consisting of fMRI (3T) and EEG technologies, and it will be fully operational in 2009.

 

Building on our international expertise in evidence based assessment and psychotherapy (see our Web of Science indexed publications), this new development will help us complement our advanced research at the computational and algorithmic-representational levels (e.g., large randomized clinical trials comparing psychotherapy and medication for various clinical conditions by outcome, mechanism of change and cost-effectiveness, virtual reality therapy) with research at the implementational level (brain level) to facilitate the understanding and integration of  the mechanisms and processes of psychotherapy and other psychological interventions intended for the treatment of various clinical conditions and/or for health promotion.

(R) GAD CLINICAL TRIAL – A BRIEF DESCRIPTION

TO START: FALL 2008

I. TITLE

·     Cognitive Therapy vs. Rational Emotive Behavior Therapy vs. Acceptance & Commitment Therapy in the Treatment of Generalized Anxiety Disorder. A Randomized Clinical Trial: Outcomes, Theory of Change, and Cost-Effectiveness.

 

II. LOCATION

·     The International Institute for the Advanced Studies of Psychotherapy and Applied Mental Health at  Babes-Bolyai University, Cluj-Napoca, Romania (see for details and for the expertise of the Institute in running large scale randomized clinical trials: www.psychotherapy.ro). The trial is funded internationally.

 

III. OBJECTIVES

·     To investigate, in a randomized clinical trial, the efficacy, the mechanisms of change, and the cost-effectiveness of Cognitive Therapy (reference treatment) vs. Rational Emotive Behavior Therapy vs. Acceptance & Commitment Therapy in the treatment of generalized anxiety disorder (GAD).

o    Theoretical implications: (1) a better understanding of the mechanisms involved in GAD and (2) a better integration of the diverse cognitive pathogenetic mechanisms of GAD into (a) a coherent cognitive-behavior theory and (b) a rigorous and integrative psychological assessment strategy (measures/scales).

o    Practical Implications: New clinical protocols and guidelines for the evidence-based assessment and therapy of GAD.

 

IV. INTERNATIONAL COORDINATING TEAM

·     Principal Investigator (PI): Dr. Daniel David, Professor, Ph.D., Babes-Bolyai University, Romania, Director of the International Institute for the Advanced Studies of Psychotherapy and Applied Mental Health (see his expertise at: www.psychotherapy.ro) & Co-PI: Dr. Aurora Szentagotai, Associate Professor, Ph.D., Babes-Bolyai University.

·     External Research Consultant:  Dr. Douglas Mennin, Ph.D., Associate Professor, Yale University, USA, Director of Yale Anxiety & Mood Services at Yale University.

·     Psychiatric Components Consultants: Dr. Doina Cosman, MD, Professor, Ph.D., and Dr. Viorel Lupu, MD, Professor, Ph.D., “Iuliu Haţieganu” University of Medicine and Pharmacy, Romania.

 

1. Cognitive Therapy (CT) Coordinating Group

·     Coordinator: Ramona Moldovan, Assistant Professor, MA, Babes-Bolyai University, Clinical Psychologist (trained in CT by the Romanian Association of Cognitive and Behavioral Psychotherapies with international CT supervisors).

·     Clinical Consultant: Dr. Robert Leahy, Clinical Professor, Ph.D., Department of Psychiatry, Weill-Cornell University Medical College, USA (President of the Academy of Cognitive Therapy (ACT); President of the Association for Behavioral and Cognitive Therapies (ABCT)).

·     Research Consultant: Dr. Stefan G. Hoffman, Professor, Ph.D., Boston University, USA, Director of the Psychotherapy and Emotion Research Laboratory at Boston University.

2. Rational Emotive Behavior Therapy (REBT) Coordinating Group

·     Coordinator: Bianca Macavei, Assistant Professor, MA, Babes-Bolyai University, Clinical Psychologist (trained in REBT by the Romanian Association of Cognitive and Behavioral Psychotherapies with international REBT supervisors; supervisor in REBT at the Albert Ellis Institute, USA).

·     Clinical Consultant: Dr. Windy Dryden, Professor, Ph.D., University of London, UK, Supervisor in REBT at the Albert Ellis Institute.

·     Research Consultant: Dr. Raymond DiGiuseppe, Professor, Ph.D., St. John University, USA, Director of Professional Education at the Albert Ellis Institute (Past President of the ABCT).

3. Acceptance & Commitment Therapy (ACT) Coordinating Group

·     Coordinator: Ioana Cristea, Assistant Professor, MA, Babes-Bolyai University, Clinical Psychologist (trained in ACT by the Romanian Association of Cognitive and Behavioral Psychotherapies with international ACT supervisors).

·     Clinical Consultant: Dr. Kelly G. Wilson, Associate Professor, Ph.D., University of Mississippi, USA, ACT Supervisor.

·     Research Consultant: Dr. Steven Hayes, Professor, Ph.D., University of Nevada, USA; Founder of ACT (Past president of ABCT).

 

V. DESIGN

A rigorous randomized clinical trial, following the model implemented in one of our previous studies on major depressive disorder (MDD) (see the below cited study), will be designed for this study.

·          David, D., Szentagotai, A., Lupu, V., & Cosman, D. (2008). Rational emotive behavior therapy, Cognitive therapy and Medication in the treatment of major depressive disorder: A randomized clinical trial, post-treatment outcomes, and six month follow-up. Journal of Clinical Psychology, 64, 728-746.

All the methodological components (e.g., treatment integrity, allegiance effect, missing data analysis, attrition/power calculation etc.) of this trial on GAD will be implemented similar to the ones in the MDD trial (mentioned above). Each treatment will consist of about 20 sessions, delivered over a 14-week period.

 

1. Outcome measures

a. General:

·     OQR 45.2 – (Adult outcome measure; age 18+)

·     POMS (Profile of Mood States; includes: (a) functional and dysfunctional negative feelings scores and (b) positive affect)

·     SF-37 (Quality of Life)

b. Specific:

·         HRSA (Hamilton Rating Scale for Anxiety)

·         BAI (Beck Anxiety Inventory)

·         GAD-Q-IV (the Generalized Anxiety Disorders Questionnaire 4th Edition)

SCID-RV will be used for categorical diagnoses (based on DSM-IV)

Note: All outcome measures will be administered pre- mid- and post-treatment. The BAI will be administered each session.

 

2. Hypothesized mediating (i.e., mechanisms of change) variables

·             ATQ (Automatic Thoughts Questionnaire) (related to CT)

·         DAS (Dysfunctional Attitudes Scale) (related to CT)

·         ABS-II (Attitudes and Beliefs Scale – II) (related to REBT)

·         USA (Unconditional Self-Acceptance) (related to REBT)

·         AAQ (Acceptance and Action Questionnaire) (related to ACT)

·         EAS (Experiential Avoidance Scale) (related to ACT)

·         RE (Response Expectancies for Non-volitional Outcomes [i.e., anxiety, relaxation]; VAS type      scales) (not specifically related to any of the investigated forms of therapy)

·         PSWQ (Penn State Worry Questionnaire) (not specifically related to any of the forms of therapy)

·         DERS (Difficulties in Emotional Regulation Scale) (not specifically related to any of the investigated forms of therapy)

·         AIM (Affect Intensity Measure) (not specifically related to any of the investigated forms of therapy)

Note: All mediating variable measures will be administered pre-, mid-, and post-treatment. The ATQ and RE will be administered each session.

 

3. Hypothesized moderator variables

·         LOT (Level of Optimism and Pessimism)

·         Brief-Cope (Coping Mechanisms)

Note: All hypothesized moderating variables measures will be administered pre-, mid-, and post-treatment.

 

Other measures will include demographics and relevant medical data. Some cognitive tasks (e.g., cognitive inhibition/interference) and psychophysiological measures will be also employed (to be established) to complement the self-report measures.

 

 

 

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