Vårdcentralen Laröd
Helsingborg, Skåne County, 254 83, Sweden
NCT Number: NCT05946382
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Helsingborg, Skåne County, 254 83, Sweden
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In addition to physical illness are exclusion criteria
Swedish Translation of the 2*60 minute Acceptance and Commitment Protocol for Repetitive Negative Thinking.
Other names: Acceptance and Commitment Therapy (ACT)
Internet-based Cognitive Behavioral Therapy as mandatory routine care in Swedish Primary care and therefore considered Treatment as usual.
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.
Time frame: Up to three months.
Percentage of patients who for any reason fails to continue in the trial until the end of intervention.
Time frame: one month.
How many patients were recruited on average for one month in the primary care unit responsible for the feasibility study.
Time frame: From assessment to 3 month follow up.
Client Satisfaction Questionnaire (CSQ-8). Min 8, Max 32 with higher values indicating higher satisfaction.
Time frame: Up to three months.
Self-registered time consumption for therapists.
Time frame: From assessment to 3 month follow up.
Working Alliance Inventory (WAI). Min 7, Max 84 with higher values indicating better working alliance.
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.
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.
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.
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.
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.
Region Skane
Other
A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress: a Randomized Controlled Trial.
Acronym: RNTACTSweden
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.
Published trials that share one or more normalized conditions with this study.
NCT05074901
Anxiety, Anxiety Disorders
Bordeaux, France
View Trial DetailsNCT06600139
Anxiety, Anxiety Disorders
View Trial DetailsNCT04842461
Anxiety, Anxiety Disorders
Ciudad Real, Castellón, Spain
View Trial DetailsNCT06005961
Anxiety Disorders, Anxiety Symptoms
Hong Kong
View Trial Details