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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

About this trial

This is an interventional treatment trial for Anxiety Disorders and Symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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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