Depression, AnxietyNCT03625024
Quality Assurance of Cognitive-behavioral Therapy
An observational study of Depression, Anxiety, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 89 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2018to 22 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients in psychiatric outpatient care with depression or anxiety disorder.
Who may be able to join
- Primary diagnosis of major depression or an anxiety disorder (panic disorder, agoraphobia, social anxiety, generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder)
Who cannot join
- Psychosis, bipolar disorder, eating disorder, substance use disorder, high risk of suicide, any simultaneous psychological treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality Assurance of Cognitive-behavioral Therapy: Adherence and Competence in Therapists and Treatment Outcome in Patients With Depression and Anxiety
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.
- Conditions
- Depression, Anxiety
- Being tested
- Cognitive-behavioral therapy
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapyBehavioural
Individual cognitive-behavioral therapy, including homework and behavioral change methods.
What is being measured
The primary outcome is the main question the study is designed to answer.
Disorder-specific self-reported symptoms change instruments
Symptoms measures of depression or an anxiety disorder
Measured: Change from baseline symptoms at 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Aug 2018
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Bohman, Karolinska Institutet
- Investigators
- Benjamin Bohman, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625024
- Sponsor's protocol ID
- KI-2018/472-31/5
- Status last verified
- Aug 2022
- First submitted
- 28 Jun 2018
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39633319
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Assurance of Cognitive-behavioral Therapy: Adherence and Competence in Therapists and Treatment Outcome in Patients With Depression and Anxiety
- ClinicalTrials.gov ID
- NCT03625024
- Acronym / sponsor ID
- KI-2018/472-31/5
- Conditions
- Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients in psychiatric outpatient care with depression or anxiety disorder.
Key inclusion criteria (1 listed)
- Primary diagnosis of major depression or an anxiety disorder (panic disorder, agoraphobia, social anxiety, generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder)
Key exclusion criteria (1 listed)
- Psychosis, bipolar disorder, eating disorder, substance use disorder, high risk of suicide, any simultaneous psychological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapyIndividual cognitive-behavioral therapy, including homework and behavioral change methods. | Behavioural | – |
Primary outcome
Disorder-specific self-reported symptoms change instruments
Time frame: Change from baseline symptoms at 18 weeks
Symptoms measures of depression or an anxiety disorder
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Derived from this study: PubMed 39633319Bergvall 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Bohman, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Anxiety, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disorder-specific self-reported symptoms change instruments (time frame: Change from baseline symptoms at 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03625024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.