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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04254120
Other study ID # KI-2013/1566-31/3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2014
Est. completion date June 30, 2015

Study information

Verified date August 2021
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date June 30, 2015
Est. primary completion date December 31, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Cognitive-behavioral therapy
Psychological treatment focusing on changing cognitions and behaviors using information processing theory and learning theory approaches.
Integrated motivational interviewing and cognitive-behavioral therapy
Motivational interviewing is a psychological treatment approach focusing on increasing motivation by eliciting patient talk favoring behavior change and resolving patient ambivalence about change.

Locations

Country Name City State
Sweden WeMind Psykiatri AB Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Index measure of aggregated psychiatric symptoms Symptoms of principal anxiety disorder or principal depression, expressed as z scores; higher scores indicate more severe symptoms 12 weeks
Primary 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 12 weeks
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