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Motivational Interviewing and Cognitive Behavioural Therapy for Generalized Anxiety Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01488799
First Posted: December 8, 2011
Last Update Posted: December 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ryerson University
University of Massachusetts, Amherst
Information provided by (Responsible Party):
Henny Westra, York University
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adding Motivational Interviewing to Cognitive Behavioural Therapy for Severe Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Henny Westra, York University:

Primary Outcome Measures:
  • Penn State Worry Questionnaire (PSWQ) [ Time Frame: up to 4 years ]
    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 ]
    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 ]
    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 ]
    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).


Enrollment: 85
Study Start Date: January 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (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

  Hide Detailed Description

Detailed Description:

The proposed study builds on the findings of the clinical trial by Westra, Arkowitz and Dozois (2009), and aims to: (1) provide a powerful test of the value of adding MI to CBT for high severity GAD (as pilot data has indicated that individuals with severe GAD may preferentially benefit from the addition of MI to CBT), (2) employ treatment procedures generalizable to clinical practice, and (3) examine the mechanisms underlying any additive treatment benefit. 106 individuals with a principal diagnosis of GAD and of high worry severity will be randomly assigned to receive either 4 sessions of MI followed by 11 sessions of CBT (MI-CBT arm) or 15 sessions of CBT (CBT alone arm). Both groups will also receive 2 follow-up CBT treatment sessions at 1 and 3 months post-treatment. Each therapist will deliver all treatment components, treatments will appear seamless to clients, and therapists will be nested within treatment group to control for allegiance effects and avoid cross-contamination of the therapies. 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. Anxiety and related symptoms, motivation, and treatment engagement will be assessed at various points during treatment, and at 6 and 12 months post-treatment. A multi-method approach to assessment will be used, including self-report, clinician-report, clinician-administered, observer-rated, and interview-based measures. Importantly, we will include not only traditional outcome measures, but also process measures (e.g., observer-coded interpersonal behavior, interview-based derivation of client experiences) to investigate possible mechanisms underlying any additive treatment benefit. In addition, all therapy sessions will be videotaped and assessed by independent raters for protocol adherence.

The specific hypotheses are as followed:

Hypothesis 1: Worry, Anxiety, & Related Symptoms. The MI-CBT arm will show greater reductions in worry, anxiety, and related symptoms (depression, disability, maladaptive beliefs about worry, life satisfaction) and a greater percentage of treatment responders (using clinical significance criteria) across the treatment period and at follow-up (FU), compared to the CBT alone arm.

Hypothesis 2: Motivation and Resistance. Over the course of early treatment (i.e., sessions 1 to 4), the MI-CBT arm will demonstrate greater increases in motivation compared to the CBT alone arm. In addition, the MI-CBT arm will exhibit lower in-session resistance during early (sessions 5 & 7), middle (sessions 10 & 12), and late (sessions 15 & 17) phases of treatment.

Hypothesis 3: Homework Compliance. The MI-CBT arm will show greater client- and therapist-rated homework compliance throughout CBT treatment compared to the CBT alone arm.

Hypothesis 4a: Interpersonal Processes between Clients and Therapists. Compared to CBT alone clients, MI-CBT clients and therapists will report higher working alliance quality during both the initial MI sessions and subsequent phases of CBT. Furthermore, moment-to-moment interpersonal processes between client and therapist during early, middle, and late treatment are expected to be characterized by more adaptive processes (e.g., higher affiliation and less hostility) in the MI-CBT vs. CBT alone arms.

Hypothesis 4b. Interpersonal Processes During Resistance. During episodes of client resistance (identified with resistance coding), therapist and client exchanges in MI-CBT are expected to be characterized by more adaptive processes (i.e., higher affiliation, less hostility, and greater client autonomy-preservation) compared to CBT alone. Further, when a small subset of clients (5 per treatment group) are interviewed about their experiences of resistance episodes, we expect client accounts in the MI-CBT arm to be characterized more positively (e.g., more supportive of client autonomy, more conducive to increased engagement vs. disengagement with treatment) compared to CBT alone.

Hypothesis 5: Mediation of Therapeutic Outcomes. We expect that increased motivation and reduced resistance in MI-CBT, compared to CBT alone, will lead to higher levels of engagement in the CBT (better homework compliance and therapeutic alliance), which will result in greater worry reduction.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488799


Locations
Canada, Ontario
York University
Toronto, Ontario, Canada, M3J 1P3
Ryerson University
Toronto, Ontario, Canada, M5B 2K3
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

Responsible Party: Henny Westra, Clinical Psychologist, Associate Professor (York University), York University
ClinicalTrials.gov Identifier: NCT01488799     History of Changes
Other Study ID Numbers: MOP114909
First Submitted: December 6, 2011
First Posted: December 8, 2011
Last Update Posted: December 29, 2015
Last Verified: December 2015

Keywords provided by Henny Westra, York University:
Anxiety
Generalized Anxiety Disorder
Motivational Interviewing
Cognitive Behavioural Therapy
Psychotherapy

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders