- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05863637
Intensive Short-Term Dynamic Psychotherapy (ISTDP) for Anxiety Diagnoses in a Primary Care Setting
May 29, 2023 updated by: Suzanne Petersson, Linnaeus University
Anxiety Treatment in Primary Care: an Evaluation of Intensive Dynamic Short-term Therapy
Living with anxiety often means great suffering for the person affected.
The trend points to a continued increase in anxiety problems in the population, especially in the 18-44 age group.
Inadequate treatment of this condition can lead to long-term sick leave, isolation, exclusion and, in the worst case, to death.
The treatment methods that are available in primary care today help some but far from all.
Therefore, the investigators want to scientifically evaluate a shorter version of a proven emotion-focused psychotherapy in order to increase the treatment range for this patient group.
The aim of this project is to, in a primary care setting, test and evaluate an intensive, emotion-focused short-term therapy, ISTDP (Intensive Short-Term Dynamic Psychotherapy) for patients with an anxiety diagnosis.
The method is well-proven on patients with more severe mental conditions (personality disorders) with good results, but the treatment has only been tested to a limited extent on patients with anxiety symptoms.
The investigators want to investigate the effectiveness of treating various anxiety states for primary care patients.
The treatment is expected to provide an addition to today's methods, which overall will provide better treatment results for this, increasing in number, group of patients who often seek primary care.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Annika Lundmark, MSc
- Phone Number: +46480445274
- Email: annika.lundmark@regionkalmar.se
Study Locations
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-
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Kalmar, Sweden, 391 85
- Region Kalmar
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Contact:
- Suzanne IM Petersson, PhD
- Phone Number: +46738019547
- Email: suzanne.petersson@regionkalmar.se
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Contact:
- Hanna Franzén, MSc
- Phone Number: +46480445274
- Email: hanna.franzen1@regionkalmar.se
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Primary Care patients with primary anxiety diagnoses at a Health Care clinic in Sweden. Sufficient language competence in Swedish is required of the participants to understand, read, speak and write.
Exclusion Criteria:
- Major reading-writing and learning difficulties, severe psychiatric problems such as psychosis, eating disorder, current major depression, recurrent depression, severe trauma, acute crisis reaction, exhaustion, acute risk of suicide (assessed according to the suicide scale), addiction.
- Diagnosed specific phobia or obsessive-compulsive disorder that must be primarily treated with CBT. Concurrent psychological treatment, anxiety-relieving medication such as benzodiazepines, or recently started antidepressant treatment (< 3 months of treatment) are also exclusion criteria for participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treated
Participants are their own controls when they are on the waiting list before treatment, and they will later be treated with the ISTDP.
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A dynamic and intensive psychotherapy with eight therapeutic sessions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Generalized Anxiety Disorder-7 (GAD-7) scorings
Time Frame: Changes in scorings from baseline scorings to scorings after 9-10 months.
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Self-report measure. The GAD-7 consists of 7 items which are scored 0-3, with a total score ranging from 0-21. Higher scores correspond to worse outcome. measures |
Changes in scorings from baseline scorings to scorings after 9-10 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Perceived Health Questionnaire (PHQ-9) scorings
Time Frame: Changes in scorings from baseline scorings to scorings after 9-10 months.
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Self-report measure.
The PHQ-9 consists of 9 items, which are scored from 0-3 and a total score ranging from 0-27.
Higher scores correspond to worse outcome.
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Changes in scorings from baseline scorings to scorings after 9-10 months.
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The Panic Disorder Severity Scale (PDSS) scorings
Time Frame: Changes in scorings from baseline scorings to scorings after 9-10 months.
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Self-report measure.
The PDSS consists of 7 items, which are scored from 0-4, with a total score ranging from 0-28.
Higher scores correspond to worse outcome.
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Changes in scorings from baseline scorings to scorings after 9-10 months.
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The Brunnsvikens Brief Quality of Life Inventory (BBQ) scorings
Time Frame: Changes in scorings from baseline scorings to scorings after 9-10 months.
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Self-report measure.
The BBQ has a total of 12 items covering 6 life areas.
Possible total score range is 0-96.
Higher scores correspond to a better outcome.
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Changes in scorings from baseline scorings to scorings after 9-10 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Cecilia Fagerström, Professor, Director of the Research Board in Region Kalmar
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2023
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
April 27, 2023
First Submitted That Met QC Criteria
May 8, 2023
First Posted (Actual)
May 18, 2023
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 29, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LinnaeusUSP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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