NCT04254120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

February 1, 2020

Last Update Submit

August 31, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Cognitive-behavioral therapy (CBT)

ACTIVE COMPARATOR
Behavioral: Cognitive-behavioral therapy

Integrated motivational interviewing and CBT

EXPERIMENTAL
Behavioral: Integrated motivational interviewing and cognitive-behavioral therapy

Interventions

Psychological treatment focusing on changing cognitions and behaviors using information processing theory and learning theory approaches.

Cognitive-behavioral therapy (CBT)

Motivational interviewing is a psychological treatment approach focusing on increasing motivation by eliciting patient talk favoring behavior change and resolving patient ambivalence about change.

Integrated motivational interviewing and CBT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WeMind Psykiatri AB

Stockholm, SE-11357, Sweden

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Benjamin Bohman

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2020

First Posted

February 5, 2020

Study Start

February 1, 2014

Primary Completion

December 31, 2014

Study Completion

June 30, 2015

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations