Motivational Interviewing and Cognitive Behavioural Therapy for Generalized Anxiety Disorder

NCT01488799 | Completed DMC

• 1 other identifier: MOP114909
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anxiety Disorders; Generalized Anxiety Disorder

Keywords

Anxiety; Generalized Anxiety Disorder; Motivational Interviewing; Cognitive Behavioural Therapy; Psychotherapy

Outcome Measures

Primary Outcomes (1)

• Penn State Worry Questionnaire (PSWQ)

  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).

  up to 4 years

Secondary Outcomes (3)

• Satisfaction with Life Scale (SWLS)

  up to 4 years

• Inventory of Interpersonal Problems (IIP)

  up to 4 years

• Depression Anxiety Stress Scale (DASS)

  up to 4 years

Study Arms (2)

MI-CBT

ACTIVE COMPARATOR

Behavioral: Motivational Interviewing and Cognitive Behavioural Therapy

CBT alone

ACTIVE COMPARATOR

Behavioral: Motivational Interviewing and Cognitive Behavioural Therapy

Interventions

Motivational Interviewing and Cognitive Behavioural Therapy BEHAVIORAL

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.

Also known as: Motivational Interviewing, Cognitive Behavioral Therapy

CBT alone; MI-CBT

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• York University: lead
• Toronto Metropolitan University: collaborator
• University of Massachusetts, Amherst: collaborator

Study Sites (2)

York University

Toronto, Ontario, M3J 1P3, Canada

Location

Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder

Interventions

Motivational Interviewing; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy

Study Officials

• Henny A Westra, Ph.D.

  York University

  PRINCIPAL INVESTIGATOR

• Martin M Antony, Ph.D.

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

• Michael J Constantino, Ph.D.

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist, Associate Professor (York University)

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 8, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

CA (2)