Clinical trial NCT05946382: A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress.
Official title: A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Disorder
Mental Health Issue
Mental Depression
Anxiety
Mental Stress
Rumination - Thoughts
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2023-07-14
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After assessment the participant receives either the RNT-ACT arm or the iCBT arm.

When the treatment is finished, the patient is called to an evaluation visit. If the person still needs care, we are faced with two choices. Either the patient is offered usual care and is thus removed from the three-month follow-up.Or it will wait for three-month follow up.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: DASS-21
timeFrame: From assessment to 3 month follow up.
Secondary outcomes:
measure: Drop Out rate
timeFrame: Up to three months.
measure: Recruitment rate
timeFrame: one month.
measure: CSQ-8
timeFrame: From assessment to 3 month follow up.
measure: Self registered time consumption
timeFrame: Up to three months.
measure: WAI
timeFrame: From assessment to 3 month follow up.
measure: RRS-BR
timeFrame: From assessment to 3 month follow up.
measure: BSRI
timeFrame: From assessment to 3 month follow up.
measure: SAAQ
timeFrame: From assessment to 3 month follow up.
measure: AFQ-Y8
timeFrame: From assessment to 3 month follow up.
measure: CFQ-7
timeFrame: From assessment to 3 month follow up.
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Vårdcentralen Laröd
state: Skåne
Study officials:
affiliation: Lund University/Region Skåne
name: Veronica Milos Nymberg, PhD
role: PRINCIPAL_INVESTIGATOR
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