NCT03625024

Brief Summary

The study examines associations between competence in cognitive-behavioral therapy (CBT) and adherence to evidence-based generic CBT in therapists and treatment outcome in patients with depression or an anxiety disorder in psychiatric outpatient care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

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

First Submitted

Initial submission to the registry

June 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

3.3 years

First QC Date

June 28, 2018

Last Update Submit

August 23, 2022

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (1)

  • Disorder-specific self-reported symptoms change instruments

    Symptoms measures of depression or an anxiety disorder

    Change from baseline symptoms at 18 weeks

Interventions

Cognitive-behavioral therapyBEHAVIORAL

Individual cognitive-behavioral therapy, including homework and behavioral change methods.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients in psychiatric outpatient care with depression or anxiety disorder.

You may qualify if:

  • Primary diagnosis of major depression or an anxiety disorder (panic disorder, agoraphobia, social anxiety, generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder)

You may not qualify if:

  • Psychosis, bipolar disorder, eating disorder, substance use disorder, high risk of suicide, any simultaneous psychological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WeMind Psykiatri

Stockholm, Sweden

Location

Related Publications (1)

  • Bergvall H, Linde J, Alfonsson S, Sunnhed R, Barber JP, Lundgren T, Andersson G, Bohman B. Quality of cognitive-behavioural therapy in routine psychiatric care: therapist adherence and competence, and patient outcomes for depression and anxiety disorders. BMC Psychiatry. 2024 Dec 4;24(1):887. doi: 10.1186/s12888-024-06328-4.

    PMID: 39633319DERIVED

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Benjamin Bohman, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 28, 2018

First Posted

August 10, 2018

Study Start

August 1, 2018

Primary Completion

November 22, 2021

Study Completion

November 22, 2021

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)