Integrating Motivational Interviewing With Cognitive-behavioral Therapy
Primary Purpose
Anxiety Disorders and Symptoms, Depression, Life Style
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive-behavioral therapy
Integrated motivational interviewing and cognitive-behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders and Symptoms
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- A principal diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) of panic disorder, social anxiety disorder, obsessive-compulsive disorder, generalized anxiety disorder, posttraumatic stress disorder, or major depressive disorder
- At least one of the following unhealthy lifestyle behaviors: unhealthy eating habits, hazardous use of alcohol, insufficient physical activity, or tobacco use, according to screening criteria suggested by the National Board of Health and Welfare
Exclusion Criteria:
- Psychotic symptoms
- DSM-IV-TR criteria for substance abuse other than alcohol
- DSM-IV-TR criteria for substance dependence including alcohol
- Moderate to severe suicide risk according to the Mini-International Neuropsychiatric Interview or a score of 2 or above on item 9 on the Patient Health Questionnaire 9
- Another simultaneous psychological treatment
Sites / Locations
- WeMind Psykiatri AB
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Cognitive-behavioral therapy (CBT)
Integrated motivational interviewing and CBT
Arm Description
Outcomes
Primary Outcome Measures
Index measure of aggregated psychiatric symptoms
Symptoms of principal anxiety disorder or principal depression, expressed as z scores; higher scores indicate more severe symptoms
Index measure of aggregated unhealthy lifestyle behaviors
Unhealthy lifestyle behaviors related to diet, physical activity, alcohol, or tobacco, expressed as z scores; higher scores indicate more problematic behaviors
Secondary Outcome Measures
Full Information
NCT ID
NCT04254120
First Posted
February 1, 2020
Last Updated
August 31, 2021
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT04254120
Brief Title
Integrating Motivational Interviewing With Cognitive-behavioral Therapy
Official Title
Integrating Motivational Interviewing With Cognitive-behavioral Therapy for Anxiety Disorders, Depression, and Unhealthy Lifestyle Behaviors: a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2014 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
June 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cognitive-behavioral therapy (CBT) is efficacious for anxiety disorders and depression, but not all patients achieve remission, and dropout is considerable. Motivational interviewing (MI) may strengthen motivation to change, and influence non-response and dropout. Research shows that MI as a pretreatment to CBT produces moderate effects compared to CBT alone. Studies integrating MI with CBT (MI-CBT) throughout treatment are scarce. The present study explored the feasibility of MI-CBT in routine psychiatric care, and compared CBT alone to MI-CBT for anxiety disorders, depression, and unhealthy lifestyle behaviors. The Anxiety, Depression, Diet, Alcohol, Physical activity, and Tobacco (ADDAPT) feasibility study had a randomized controlled design, and data were analyzed using hierarchical regression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders and Symptoms, Depression, Life Style
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-behavioral therapy (CBT)
Arm Type
Active Comparator
Arm Title
Integrated motivational interviewing and CBT
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Intervention Description
Psychological treatment focusing on changing cognitions and behaviors using information processing theory and learning theory approaches.
Intervention Type
Behavioral
Intervention Name(s)
Integrated motivational interviewing and cognitive-behavioral therapy
Intervention Description
Motivational interviewing is a psychological treatment approach focusing on increasing motivation by eliciting patient talk favoring behavior change and resolving patient ambivalence about change.
Primary Outcome Measure Information:
Title
Index measure of aggregated psychiatric symptoms
Description
Symptoms of principal anxiety disorder or principal depression, expressed as z scores; higher scores indicate more severe symptoms
Time Frame
12 weeks
Title
Index measure of aggregated unhealthy lifestyle behaviors
Description
Unhealthy lifestyle behaviors related to diet, physical activity, alcohol, or tobacco, expressed as z scores; higher scores indicate more problematic behaviors
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
A principal diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) of panic disorder, social anxiety disorder, obsessive-compulsive disorder, generalized anxiety disorder, posttraumatic stress disorder, or major depressive disorder
At least one of the following unhealthy lifestyle behaviors: unhealthy eating habits, hazardous use of alcohol, insufficient physical activity, or tobacco use, according to screening criteria suggested by the National Board of Health and Welfare
Exclusion Criteria:
Psychotic symptoms
DSM-IV-TR criteria for substance abuse other than alcohol
DSM-IV-TR criteria for substance dependence including alcohol
Moderate to severe suicide risk according to the Mini-International Neuropsychiatric Interview or a score of 2 or above on item 9 on the Patient Health Questionnaire 9
Another simultaneous psychological treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Bohman
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
WeMind Psykiatri AB
City
Stockholm
ZIP/Postal Code
SE-11357
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Integrating Motivational Interviewing With Cognitive-behavioral Therapy
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