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NCT Number: NCT05946382

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vårdcentralen Laröd

Helsingborg, Skåne County, 254 83, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DASS-21 >25
  • Ability to communicate in Swedish orally and in writing

Exclusion criteria

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

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).

Treatment and study plan

RNT-ACT Protocol

Behavioral

Swedish Translation of the 2*60 minute Acceptance and Commitment Protocol for Repetitive Negative Thinking.

Other names: Acceptance and Commitment Therapy (ACT)

iCBT Treatment

Behavioral

Internet-based Cognitive Behavioral Therapy as mandatory routine care in Swedish Primary care and therefore considered Treatment as usual.

Primary outcomes

  1. DASS-21

    Time frame: From assessment to 3 month follow up.

    Depression, Anxiety and Stress Scale-21 (DASS-21); Min 0, Max 63 with high values associated with more Depression/Anxiety/Stress.

Secondary outcomes

  1. Drop Out rate

    Time frame: Up to three months.

    Percentage of patients who for any reason fails to continue in the trial until the end of intervention.

  2. Recruitment rate

    Time frame: one month.

    How many patients were recruited on average for one month in the primary care unit responsible for the feasibility study.

  3. CSQ-8

    Time frame: From assessment to 3 month follow up.

    Client Satisfaction Questionnaire (CSQ-8). Min 8, Max 32 with higher values indicating higher satisfaction.

  4. Self registered time consumption

    Time frame: Up to three months.

    Self-registered time consumption for therapists.

  5. WAI

    Time frame: From assessment to 3 month follow up.

    Working Alliance Inventory (WAI). Min 7, Max 84 with higher values indicating better working alliance.

  6. RRS-BR

    Time frame: From assessment to 3 month follow up.

    Ruminative Responses Scale - Brooding and Reflection (RRS-BR). Min 5, Max 20. A higher value indicates a higher extent of ruminative response style and self-reflection.

  7. BSRI

    Time frame: From assessment to 3 month follow up.

    Brief State Rumination Inventory (BSRI). Min 0, Max 80. A higher value indicates higher degree of ongoing ruminative cognitive responses.

  8. SAAQ

    Time frame: From assessment to 3 month follow up.

    Swedish Acceptance and Action Questionnaire (SAAQ). Min 6, Max 42. A higher value indicates lower psychological flexibility which indicates a worse value.

  9. AFQ-Y8

    Time frame: From assessment to 3 month follow up.

    Avoidance and Fusion Questionnaire for Youth (AFQ-Y8). Min 0, Max 32. A higher value indicates lower psychological flexibility which indicates a worse value.

  10. CFQ-7

    Time frame: From assessment to 3 month follow up.

    Cognitive Fusion Questionnaire - 7 items (CFQ-7). Min 1, Max 49. A higher value indicates higher cognitive fusion which indicates a worse value.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University

Registry information

Official study title

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

Acronym: RNTACTSweden

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2023
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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