NCT05946382

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Mental Disorder
• Mental Health Issue
• Mental Depression
• Anxiety
• Mental Stress
• Rumination - Thoughts

Interventions

Type	Name	Description
BEHAVIORAL	RNT-ACT Protocol	Swedish Translation of the 2\*60 minute Acceptance and Commitment Protocol for Repetitive Negative Thinking.
BEHAVIORAL	iCBT Treatment	Internet-based Cognitive Behavioral Therapy as mandatory routine care in Swedish Primary care and therefore considered Treatment as usual.

Timeline

• Start date: 2024-02-07
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-07-14
• Last updated: 2025-04-09

Locations

1 site across 1 country: Sweden