PsychotherapyNCT05863637
Intensive Short-Term Dynamic Psychotherapy (ISTDP) for Anxiety Diagnoses in a Primary Care Setting
A study testing Intensive Short-Term Dynamic Psychotherapy in people with Psychotherapy and Anxiety Disorders, run by Linnaeus University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psychotherapy, Anxiety Disorders, Psychiatric &or Mood Disorder
- What is being tested?
- Intensive Short-Term Dynamic Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2023to Dec 2025
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Region Kalmar
Kalmar, 391 85
Suzanne IM Petersson, PhD, +46738019547, suzanne.petersson@regionkalmar.se
Hanna Franzén, MSc, +46480445274, hanna.franzen1@regionkalmar.se
About this study
Official title: 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.
- Being tested
- Intensive Short-Term Dynamic Psychotherapy
- Keywords
- Anxiety Disorders, Primary Care Setting, Psychotherapy, Clinical Research
- Medical subject headings
- Anxiety Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Short-Term Dynamic PsychotherapyOther
A dynamic and intensive psychotherapy with eight therapeutic sessions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intensive Short-Term Dynamic Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Changes in scorings from baseline scorings to scorings after 9-10 months.
Secondary outcomes (3)
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.
Measured: Changes in scorings from baseline scorings to scorings after 9-10 months.
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.
Measured: Changes in scorings from baseline scorings to scorings after 9-10 months.
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.
Measured: Changes in scorings from baseline scorings to scorings after 9-10 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study startSep 2023 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychotherapyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linnaeus University
- Sponsor type
- University, hospital or other
- Collaborators
- Kalmar County Hospital
- Responsible party
- Principal investigator, Suzanne Petersson, Linnaeus University
- Investigators
- Cecilia Fagerström, Professor, Study director, Director of the Research Board in Region Kalmar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863637
- Sponsor's protocol ID
- LinnaeusUSP
- Status last verified
- May 2023
- First submitted
- 27 Apr 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety Treatment in Primary Care: an Evaluation of Intensive Dynamic Short-term Therapy
- ClinicalTrials.gov ID
- NCT05863637
- Acronym / sponsor ID
- LinnaeusUSP
- Keywords
- Anxiety Disorders, Primary Care Setting, Psychotherapy, Clinical Research
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Linnaeus UniversityUniversity, hospital or other
- Collaborators
- Kalmar County Hospital
- Study start
- Sep 2023 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 May 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treated | Experimental | Other: Intensive Short-Term Dynamic PsychotherapyParticipants are their own controls when they are on the waiting list before treatment, and they will later be treated with the ISTDP. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Intensive Short-Term Dynamic PsychotherapyA dynamic and intensive psychotherapy with eight therapeutic sessions | Other | Treated |
Primary outcome
The Generalized Anxiety Disorder-7 (GAD-7) scorings
Time frame: Changes in scorings from baseline scorings to scorings after 9-10 months.
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
3 secondary outcomes
The Perceived Health Questionnaire (PHQ-9) scorings
Time frame: Changes in scorings from baseline scorings to scorings after 9-10 months.
The Panic Disorder Severity Scale (PDSS) scorings
Time frame: Changes in scorings from baseline scorings to scorings after 9-10 months.
The Brunnsvikens Brief Quality of Life Inventory (BBQ) scorings
Time frame: Changes in scorings from baseline scorings to scorings after 9-10 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- 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.
Cecilia Fagerström, Professor study director
Director of the Research Board in Region Kalmar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Short-Term Dynamic Psychotherapy in people with Psychotherapy and Anxiety Disorders, run by Linnaeus University 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 2 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: status not confirmed, as of the sponsor's last update on 31 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annika Lundmark, MSc (+46480445274, annika.lundmark@regionkalmar.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Generalized Anxiety Disorder-7 (GAD-7) scorings (time frame: Changes in scorings from baseline scorings to scorings after 9-10 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2023.