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

Region Skane

Status: Active, not recruiting

Conditions: Mental Stress; Rumination - Thoughts; Mental Disorder; Mental Health Issue; Mental Depression; Anxiety

Treatments: Behavioral: RNT-ACT Protocol; Behavioral: iCBT Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05946382

2022-06465-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

RNT-ACT protocol

Experimental group

Description:

Participants randomized to RNT-ACT will receive a total of 2 sessions of 60 minutes each as well as audio files to listen to between the occasions administered via internet. Previous studies have indicated that it doesn't make much of a difference whether the temporal distance between session 1 and session 2 is between 1 week and up to 3 months. At occasion 1, the time for occasion 2 is set. The temporal distance in days will noted for each patient. The treatment is inserted into the therapist's regular diary with 60 minutes session time and appropriate break before and after the treatment (e.g. at least 5-10 minutes) for preparation and post-administration where journal writing is included.

Treatment:

Behavioral: RNT-ACT Protocol

iCBT treatment

Active Comparator group

Description:

The people randomized to Internet treatment will be offered based on M.I.N.I 7.0 a suitable iCBT program in the Stöd och Behandling (SoB) platform. The patients follow a structured self-help material which can be seen as a standard treatment option in Region Skåne, "treatment as usual". The therapist has access to the material and the patient and the therapist can communicate via a chat function. The patients are matched to iCBT programs based on whether they are most likely to show symptoms of depression or anxiety. The main component of Internet processing consists of a structured self-help program in approximately eight modules, somewhat varying depending on which program in use. The program is based on proven CBT interventions for each problem area with a strong emphasis on psychoeducation but where different intervention elements is included.

Treatment:

Behavioral: iCBT Treatment