search
Back to results

Intensive Short-Term Dynamic Psychotherapy (ISTDP) for Anxiety Diagnoses in a Primary Care Setting

Primary Purpose

Psychotherapy, Anxiety Disorders, Psychiatric &or Mood Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intensive Short-Term Dynamic Psychotherapy
Sponsored by
Linnaeus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotherapy focused on measuring Anxiety Disorders, Primary Care Setting, Psychotherapy, Clinical Research

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Region Kalmar

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 27, 2023
Last Updated
May 29, 2023
Sponsor
Linnaeus University
Collaborators
Kalmar County Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05863637
Brief Title
Intensive Short-Term Dynamic Psychotherapy (ISTDP) for Anxiety Diagnoses in a Primary Care Setting
Official Title
Anxiety Treatment in Primary Care: an Evaluation of Intensive Dynamic Short-term Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linnaeus University
Collaborators
Kalmar County Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotherapy, Anxiety Disorders, Psychiatric &or Mood Disorder
Keywords
Anxiety Disorders, Primary Care Setting, Psychotherapy, Clinical Research

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treated
Arm Type
Experimental
Arm Description
Participants are their own controls when they are on the waiting list before treatment, and they will later be treated with the ISTDP.
Intervention Type
Other
Intervention Name(s)
Intensive Short-Term Dynamic Psychotherapy
Intervention Description
A dynamic and intensive psychotherapy with eight therapeutic sessions
Primary Outcome Measure Information:
Title
The Generalized Anxiety Disorder-7 (GAD-7) scorings
Description
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
Time Frame
Changes in scorings from baseline scorings to scorings after 9-10 months.
Secondary Outcome Measure Information:
Title
The Perceived Health Questionnaire (PHQ-9) scorings
Description
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.
Time Frame
Changes in scorings from baseline scorings to scorings after 9-10 months.
Title
The Panic Disorder Severity Scale (PDSS) scorings
Description
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.
Time Frame
Changes in scorings from baseline scorings to scorings after 9-10 months.
Title
The Brunnsvikens Brief Quality of Life Inventory (BBQ) scorings
Description
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.
Time Frame
Changes in scorings from baseline scorings to scorings after 9-10 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annika Lundmark, MSc
Phone
+46480445274
Email
annika.lundmark@regionkalmar.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia Fagerström, Professor
Organizational Affiliation
Director of the Research Board in Region Kalmar
Official's Role
Study Director
Facility Information:
Facility Name
Region Kalmar
City
Kalmar
ZIP/Postal Code
391 85
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne IM Petersson, PhD
Phone
+46738019547
Email
suzanne.petersson@regionkalmar.se
First Name & Middle Initial & Last Name & Degree
Hanna Franzén, MSc
Phone
+46480445274
Email
hanna.franzen1@regionkalmar.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intensive Short-Term Dynamic Psychotherapy (ISTDP) for Anxiety Diagnoses in a Primary Care Setting

We'll reach out to this number within 24 hrs