NCT05863637

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 27, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

April 27, 2023

Last Update Submit

May 29, 2023

Conditions

Keywords

Anxiety DisordersPrimary Care SettingPsychotherapyClinical Research

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • The Perceived Health Questionnaire (PHQ-9) scorings

    Changes in scorings from baseline scorings to scorings after 9-10 months.

  • The Panic Disorder Severity Scale (PDSS) scorings

    Changes in scorings from baseline scorings to scorings after 9-10 months.

  • The Brunnsvikens Brief Quality of Life Inventory (BBQ) scorings

    Changes in scorings from baseline scorings to scorings after 9-10 months.

Study Arms (1)

Treated

EXPERIMENTAL

Participants are their own controls when they are on the waiting list before treatment, and they will later be treated with the ISTDP.

Other: Intensive Short-Term Dynamic Psychotherapy

Interventions

A dynamic and intensive psychotherapy with eight therapeutic sessions

Treated

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Kalmar

Kalmar, 391 85, Sweden

Location

MeSH Terms

Conditions

Anxiety DisordersMood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Cecilia Fagerström, Professor

    Director of the Research Board in Region Kalmar

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Controlled study; participants (e.g. primary care patients with an anxiety disorder) will be recruited consecutively to the study, they will be put on a waiting-list for 3 months (= standard procedure) and thus be their own control person.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 18, 2023

Study Start

September 1, 2023

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations