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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05863637
Other study ID # LinnaeusUSP
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date December 2025

Study information

Verified date May 2023
Source Linnaeus University
Contact Annika Lundmark, MSc
Phone +46480445274
Email annika.lundmark@regionkalmar.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Other:
Intensive Short-Term Dynamic Psychotherapy
A dynamic and intensive psychotherapy with eight therapeutic sessions

Locations

Country Name City State
Sweden Region Kalmar Kalmar

Sponsors (2)

Lead Sponsor Collaborator
Linnaeus University Kalmar County Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Generalized Anxiety Disorder-7 (GAD-7) scorings 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.
Secondary The Perceived Health Questionnaire (PHQ-9) scorings 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. Changes in scorings from baseline scorings to scorings after 9-10 months.
Secondary The Panic Disorder Severity Scale (PDSS) scorings 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. Changes in scorings from baseline scorings to scorings after 9-10 months.
Secondary The Brunnsvikens Brief Quality of Life Inventory (BBQ) scorings 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. Changes in scorings from baseline scorings to scorings after 9-10 months.
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