Motivational Interviewing and Cognitive Behavioural Therapy for Generalized Anxiety Disorder - Full Text View

Purpose

The current study examines whether change-readiness, and consequently treatment outcome, can be enhanced in Cognitive Behavioral Therapy (CBT) for severe Generalized Anxiety Disorder (GAD) by adding a brief course of Motivational Interviewing (MI adapted for anxiety, Westra & Dozois, 2003) before and during CBT when motivation wanes. 106 individuals with severe GAD will be randomly assigned to receive an equal number of sessions of either MI and CBT (MI-CBT arm) or CBT alone (CBT alone arm). It is expected that the MI-CBT arm relative to the CBT alone arm will show lower levels of resistance in CBT, higher levels of homework compliance and therapeutic alliance, better moment-to-moment interpersonal process, and consequently superior outcomes - both post-treatment and at 6 and 12 month follow-ups.

Condition	Intervention
Anxiety Disorders Generalized Anxiety Disorder	Behavioral: Motivational Interviewing and Cognitive Behavioural Therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Adding Motivational Interviewing to Cognitive Behavioural Therapy for Severe Generalized Anxiety Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by York University:

Primary Outcome Measures:

Penn State Worry Questionnaire (PSWQ) [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
The Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990) is a widely used measure of worry in GAD treatment outcome studies. It is a 16-item scale assessing trait worry. The PSWQ has been found to possess high internal consistency and temporal stability, as well as good convergent and discriminant validity. It also differentiates individuals with GAD from those with other anxiety disorders (Brown et al., 1992).

Secondary Outcome Measures:

Satisfaction with Life Scale (SWLS) [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
The Satisfaction with Life Scale (SWLS; Diener et al., 1985)is a 5-item scale that is a widely used as a measure of life satisfaction with high internal validity, temporal stability, and sensitivity to change, as well as good convergent and divergent validity.
Inventory of Interpersonal Problems (IIP) [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
The Inventory of Interpersonal Problems (IIP; Horowitz, Rosenberg, Baer, Ureño, & Villaseñor, 1988), scale has been shown to discriminate among different categories of personality disorders and reliably tap into three dimensions of the the interpersonal relational field (Gude, Moum, Kaldestad, & Friis, 2000).
Depression Anxiety Stress Scale (DASS) [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
The Depression Anxiety Stress Scale (DASS; Lovibond & Lovibond, 1995) is a set of three self-report scales designed to define, measure and understand depression, anxiety and stress. Each scale contains 14 items, for a total of 42 items, and each scale is divided into sub-scales of 2-5 items based on content. The DASS shows strong consistent reliability in distinguishing between features of depression, anxiety and stress (Antony, Bieling, Cox, Enns, Murray & Swinson, 1998).

Estimated Enrollment:	106
Study Start Date:	January 2012
Estimated Study Completion Date:	October 2016
Estimated Primary Completion Date:	October 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: MI-CBT	Behavioral: Motivational Interviewing and Cognitive Behavioural Therapy Participants with a diagnosis of severe Generalized Anxiety Disorder will be randomly assigned to receive either 4 weekly sessions of MI followed by 11 weekly sessions of CBT (MI-CBT arm) or 15 weekly sessions of CBT (CBT alone arm). Both groups will also receive 2 follow-up CBT treatment sessions at 1 and 3 months post-treatment. In order to increase generalizability to clinical practice, in the CBT phase for the MI-CBT arm, therapists will shift to MI in the presence of empirically derived markers of resistance and shift back to CBT when resistance has diminished. In the CBT alone arm therapists will respond to resistance using manualized recommendations derived from leading CBT theorists for the management of resistance. Other Names: Motivational Interviewing Cognitive Behavioral Therapy
Active Comparator: CBT alone	Behavioral: Motivational Interviewing and Cognitive Behavioural Therapy Participants with a diagnosis of severe Generalized Anxiety Disorder will be randomly assigned to receive either 4 weekly sessions of MI followed by 11 weekly sessions of CBT (MI-CBT arm) or 15 weekly sessions of CBT (CBT alone arm). Both groups will also receive 2 follow-up CBT treatment sessions at 1 and 3 months post-treatment. In order to increase generalizability to clinical practice, in the CBT phase for the MI-CBT arm, therapists will shift to MI in the presence of empirically derived markers of resistance and shift back to CBT when resistance has diminished. In the CBT alone arm therapists will respond to resistance using manualized recommendations derived from leading CBT theorists for the management of resistance. Other Names: Motivational Interviewing Cognitive Behavioral Therapy

Arms

Assigned Interventions

Active Comparator: MI-CBT

Behavioral: Motivational Interviewing and Cognitive Behavioural Therapy

Participants with a diagnosis of severe Generalized Anxiety Disorder will be randomly assigned to receive either 4 weekly sessions of MI followed by 11 weekly sessions of CBT (MI-CBT arm) or 15 weekly sessions of CBT (CBT alone arm). Both groups will also receive 2 follow-up CBT treatment sessions at 1 and 3 months post-treatment. In order to increase generalizability to clinical practice, in the CBT phase for the MI-CBT arm, therapists will shift to MI in the presence of empirically derived markers of resistance and shift back to CBT when resistance has diminished. In the CBT alone arm therapists will respond to resistance using manualized recommendations derived from leading CBT theorists for the management of resistance.

Other Names:

Motivational Interviewing
Cognitive Behavioral Therapy

Active Comparator: CBT alone

Behavioral: Motivational Interviewing and Cognitive Behavioural Therapy

Participants with a diagnosis of severe Generalized Anxiety Disorder will be randomly assigned to receive either 4 weekly sessions of MI followed by 11 weekly sessions of CBT (MI-CBT arm) or 15 weekly sessions of CBT (CBT alone arm). Both groups will also receive 2 follow-up CBT treatment sessions at 1 and 3 months post-treatment. In order to increase generalizability to clinical practice, in the CBT phase for the MI-CBT arm, therapists will shift to MI in the presence of empirically derived markers of resistance and shift back to CBT when resistance has diminished. In the CBT alone arm therapists will respond to resistance using manualized recommendations derived from leading CBT theorists for the management of resistance.

Other Names:

Motivational Interviewing
Cognitive Behavioral Therapy

Show Detailed Description

Eligibility

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Between 16 & 65 years of age
Proficient use of English
A principle diagnosis of Generalized Anxiety Disorder (GAD)
Severe GAD (as measured by clinician severity ratings and PSWQ)
Willingness to either remain on stable dosage of psychotropic medication or remain unmedicated throughout their involvement in the clinical trial

Exclusion Criteria:

Current of history of psychotic spectrum disorder or bipolar mood disorder
Cognitive impairment such as neurodegenerative illness or head injury
Current substance abuse and or dependance
Concurrent psychotherapy, either individual or group.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488799

Contacts

Contact: Henny A Westra, Ph.D.	416-736-2100 ext 33706	hwestra@yorku.ca
Contact: Martin M Antony, Ph.D.	416-979-5000 ext 2631	mantony@psych.ryerson.ca

Locations

Canada, Ontario
York University	Recruiting
Toronto, Ontario, Canada, M3J 1P3
Contact: Henny A Westra, Ph.D. 416-736-2100 ext 33706 hwestra@yorku.ca
Principal Investigator: Henny A Westra, Ph.D.
Ryerson University	Recruiting
Toronto, Ontario, Canada, M5B 2K3
Contact: Martin M Antony, Ph.D. 416-979-5000 ext 2631 mantony@psych.ryerson.ca
Principal Investigator: Martin M Antony, Ph.D.

Sponsors and Collaborators

York University

Ryerson University

University of Massachusetts, Amherst

Investigators

Principal Investigator:	Henny A Westra, Ph.D.	York University
Principal Investigator:	Martin M Antony, Ph.D.	Ryerson University
Principal Investigator:	Michael J Constantino, Ph.D.	University of Massachusetts, Worcester

More Information

No publications provided

Responsible Party:	Henny Westra, Clinical Psychologist, Associate Professor (York University), York University
ClinicalTrials.gov Identifier:	NCT01488799 History of Changes
Other Study ID Numbers:	MOP114909
Study First Received:	December 6, 2011
Last Updated:	August 22, 2012
Health Authority:	Canada: Canadian Institutes of Health Research

Keywords provided by York University:

Anxiety
Generalized Anxiety Disorder
Motivational Interviewing
Cognitive Behavioural Therapy
Psychotherapy

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013