A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress.

Last updated: April 7, 2025
Sponsor: Region Skane
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Depression

Anxiety Disorders

Panic Disorders

Treatment

iCBT Treatment

RNT-ACT Protocol

Clinical Study ID

NCT05946382
2022-06465-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial is to compare the effect and time consumption of the Swedish translation of the protocol for RNT-ACT with the internet administrated self-help treatment with therapist support (iCBT) for patients seeking medical care for depression, anxiety or stress at their primary care unit. The trial consists of a feasibility study and a randomized controlled trial with 3- and 12-month follow ups.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • DASS-21 >25

  • Ability to communicate in Swedish orally and in writing

Exclusion

Exclusion Criteria:

  • Routine blood tests are carried out including blood count, thyroid hormone, liverstatus and fluid balance in order to be able to differentially diagnose any physicalillness.

In addition to physical illness are exclusion criteria

  • Other psychological or psychiatric treatment,

  • Suicidality, substance abuse, Anorexia Nervosa, psychosis, bipolar disorder,attention deficit hyperactivity disorder (ADHD) and antisocial personality disorder (as verified based on M.I.N.I 7.0).

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: iCBT Treatment
Phase:
Study Start date:
February 07, 2024
Estimated Completion Date:
December 31, 2026

Study Description

The main question it aims to answer are: Is the Swedish translation of a psychological treatment protocol targeting Repetitive Negative Thinking (RNT) based on Acceptance and Commitment therapy (ACT), RNT-ACT, an effective treatment in Swedish primary care for the treatment of people with a high proportion of negative repetitive thoughts, who meet diagnostic criteria for depression and/or anxiety? The question is planned to be elaborated into the following parts:

A feasibility study in which the material and the system are tested at a single care center.

A randomized controlled trial conducted at several health centers where the comparison group is patients who are actualized for traditional psychological treatment in the form of iCBT for either anxiety or depression programs and where they are offered the second treatment arm after 3- and 12-month follow-ups.

A follow-up study where time consumption and patient satisfaction are evaluated in both branches.

Participants will be given either RNT-ACT or iCBT as treatment. The group who are given RNT-ACT will receive 2*60 minutes of therapy along with mindfulness files to listen to daily between sessions. The group who are given iCBT will receive internet-based Cognitive Behavioral Therapy, one of the forms of delivering Cognitive behavioral therapy that is implemented in Region Skåne and can thus be seen as treatment as usual. Patients will access the treatment through a secure website and communicate with their therapist by text when needed. Researchers will compare the RNT-ACT and iCBT groups to see if there are differences in depressive, anxiety- and stress- related symptoms, rumination, psychological flexibility, client satisfaction and therapist-rated time consumption. In the feasibility study researchers will also evaluate drop-out and recruitment rate.

Connect with a study center

  • Vårdcentralen Laröd

    Helsingborg, Skåne 254 83
    Sweden

    Site Not Available

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