Development of Transdiagnostic Single-session Treatment

NCT ID: NCT05784259

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-01-31

Brief Summary

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The goal of this clinical trial is to test a single session treatment program in primary care patients with anxiety and/or depression and/or stress-related issues. The main questions it aims to answer is:

* Will the transdiagnostic treatment program decrease symptoms of depression/anxiety/stress?
* Will the transdiagnostic treatment program decrease transdiagnostic risk factors?
* Will the transdiagnostic treatment program decrease the measured risk factors equally?
* Will the transdiagnostic treatment program impact patients with anxiety, depression or stress disorders equally?
* Will the transdiagnostic treatment program have long term (6 months post-treatment) effect on transdiagnostic risk factors?
* Will the transdiagnostic treatment program have long term (6 months post-treatment) effect on anxiety, depression, or stress-symptoms?
* Have the participants been able to generalize the skills taught in the program(qualitative)?
* Within group that were treated with single-session treatment and recieved additional care before follow-up, was there a difference in outcome?

Detailed Description

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The study investigates the effect of a single-session, 4 hour, transdiagnostic treatment for primary care patientst with depression, anxiety or stress.

The treatment includes, interoceptive exposure, behavioral activation, mindfulness, defusion and psycho-education about emotions.

The study is conducted in a clinical setting in northern sweden and follows up results at 3 weeks and 6 months post treatment.

Conditions

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Anxiety Disorders Depression Stress Disorder

Keywords

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transdiagnostic single-session

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment group

Transdiagnostic single-session treatment

Group Type EXPERIMENTAL

Transdiagnostic single-session treatment

Intervention Type BEHAVIORAL

Administered over 4 hour in group of 10 patients. Interventions are: Psychoeducation of emotions, De-fusion exercise, Mindfulness exercise, Interoceptive exposure, Behavioral activation

Interventions

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Transdiagnostic single-session treatment

Administered over 4 hour in group of 10 patients. Interventions are: Psychoeducation of emotions, De-fusion exercise, Mindfulness exercise, Interoceptive exposure, Behavioral activation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Meet the criteria for anxiety, mood disorder, or stress diagnosis
* Symptoms are mild to moderate in severity

Exclusion Criteria

* Already in ongoing psychotherapy
* Within a month commenced pharmaceutical treatment that will likely impact mood or psychological functioning and is not deemed to be on a stable dose
* Has a comorbid personality disorder
* Has a risk of suicide deemed other than low
* Has other severe psychological disorders outside the scope of primary care
* Is in a severely stressful social situation deemed incompatible with psychotherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Norrbotten

UNKNOWN

Sponsor Role collaborator

Luleå Tekniska Universitet

OTHER

Sponsor Role lead

Responsible Party

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John Näsling

Lic. psychologist / Doctoral student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Näsling, Master

Role: PRINCIPAL_INVESTIGATOR

Luleå tekniska universitet/Region Norrbotten

Locations

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Region Norrbotten, Primary care

Luleå, Norrbotten County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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John Näsling, Master

Role: CONTACT

Phone: +4673 080 77 67

Email: [email protected]

Facility Contacts

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John Näsling

Role: primary

Other Identifiers

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275863

Identifier Type: -

Identifier Source: org_study_id