Clincosm LogoSign in Get a demo

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

Sponsor
Region Skane (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05946382
Collaborator
Lund University (Other)
124
Enrollment
2
Arms
40.8
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: RNT-ACT Protocol
  • Behavioral: iCBT Treatment
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Masking Description:
Patients are made aware of the study through information material at the primary care unit in the waiting room and on the therapists door. There they can notify the contact person about their interest. Letter with information about the study will be sent out to the interested patient. If the patient chooses to participate by answering positively on the information letter, they will be contacted by telephone by a psychologist at the respective primary care unit for the opportunity to ask questions and to book an appointment for a baseline measurement at the unit. After the baseline measurement the patient is randomly assigned to one of the treatment arms. Measurements with all self-assessment scales are carried out at week 0, at the end of treatment and 3 months after the end of treatment. The participants are then offered the opportunity for a follow-up 12 months after completion of treatment using the same scales as the 3-month follow-up.
Primary Purpose:
Treatment
Official Title:
A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress: a Randomized Controlled Trial.
Anticipated Study Start Date :
Aug 7, 2023
Anticipated Primary Completion Date :
Dec 31, 2026
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: RNT-ACT protocol

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.

Behavioral: RNT-ACT Protocol
Swedish Translation of the 2*60 minute Acceptance and Commitment Protocol for Repetitive Negative Thinking.
Other Names:
  • Acceptance and Commitment Therapy (ACT)

    		•
    Active Comparator: iCBT treatment

    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.

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

    Outcome Measures

    Primary Outcome Measures

    1. DASS-21 [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 Outcome Measures

    1. Drop Out rate [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 [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 [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 [Up to three months.]

      Self-registered time consumption for therapists.

    5. WAI [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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Region Skane
    • Lund University

    Investigators

    • Principal Investigator: Veronica Milos Nymberg, PhD, Lund University/Region Skåne

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Region Skane
    ClinicalTrials.gov Identifier:
    NCT05946382
    Other Study ID Numbers:
    • 2022-06465-01
    First Posted:
    Jul 14, 2023
    Last Update Posted:
    Jul 14, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Anxiety Disorders
    Mental Disorders
    Stress, Psychological

    Study Results

    No Results Posted as of Jul 14, 2023