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

Primary Purpose

Mental Disorder, Mental Health Issue, Mental Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RNT-ACT Protocol
iCBT Treatment
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    RNT-ACT protocol

    iCBT treatment

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Drop Out rate
    Percentage of patients who for any reason fails to continue in the trial until the end of intervention.
    Recruitment rate
    How many patients were recruited on average for one month in the primary care unit responsible for the feasibility study.
    CSQ-8
    Client Satisfaction Questionnaire (CSQ-8). Min 8, Max 32 with higher values indicating higher satisfaction.
    Self registered time consumption
    Self-registered time consumption for therapists.
    WAI
    Working Alliance Inventory (WAI). Min 7, Max 84 with higher values indicating better working alliance.
    RRS-BR
    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.
    BSRI
    Brief State Rumination Inventory (BSRI). Min 0, Max 80. A higher value indicates higher degree of ongoing ruminative cognitive responses.
    SAAQ
    Swedish Acceptance and Action Questionnaire (SAAQ). Min 6, Max 42. A higher value indicates lower psychological flexibility which indicates a worse value.
    AFQ-Y8
    Avoidance and Fusion Questionnaire for Youth (AFQ-Y8). Min 0, Max 32. A higher value indicates lower psychological flexibility which indicates a worse value.
    CFQ-7
    Cognitive Fusion Questionnaire - 7 items (CFQ-7). Min 1, Max 49. A higher value indicates higher cognitive fusion which indicates a worse value.

    Full Information

    First Posted
    June 22, 2023
    Last Updated
    July 6, 2023
    Sponsor
    Region Skane
    Collaborators
    Lund University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05946382
    Brief Title
    A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress.
    Acronym
    RNTACTSweden
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 7, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2026 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Region Skane
    Collaborators
    Lund University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Disorder, Mental Health Issue, Mental Depression, Anxiety, Mental Stress, Rumination - Thoughts

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    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.
    Allocation
    Randomized
    Enrollment
    124 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RNT-ACT protocol
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    iCBT treatment
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    RNT-ACT Protocol
    Other Intervention Name(s)
    Acceptance and Commitment Therapy (ACT)
    Intervention Description
    Swedish Translation of the 2*60 minute Acceptance and Commitment Protocol for Repetitive Negative Thinking.
    Intervention Type
    Behavioral
    Intervention Name(s)
    iCBT Treatment
    Intervention Description
    Internet-based Cognitive Behavioral Therapy as mandatory routine care in Swedish Primary care and therefore considered Treatment as usual.
    Primary Outcome Measure Information:
    Title
    DASS-21
    Description
    Depression, Anxiety and Stress Scale-21 (DASS-21); Min 0, Max 63 with high values associated with more Depression/Anxiety/Stress.
    Time Frame
    From assessment to 3 month follow up.
    Secondary Outcome Measure Information:
    Title
    Drop Out rate
    Description
    Percentage of patients who for any reason fails to continue in the trial until the end of intervention.
    Time Frame
    Up to three months.
    Title
    Recruitment rate
    Description
    How many patients were recruited on average for one month in the primary care unit responsible for the feasibility study.
    Time Frame
    one month.
    Title
    CSQ-8
    Description
    Client Satisfaction Questionnaire (CSQ-8). Min 8, Max 32 with higher values indicating higher satisfaction.
    Time Frame
    From assessment to 3 month follow up.
    Title
    Self registered time consumption
    Description
    Self-registered time consumption for therapists.
    Time Frame
    Up to three months.
    Title
    WAI
    Description
    Working Alliance Inventory (WAI). Min 7, Max 84 with higher values indicating better working alliance.
    Time Frame
    From assessment to 3 month follow up.
    Title
    RRS-BR
    Description
    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.
    Title
    BSRI
    Description
    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.
    Title
    SAAQ
    Description
    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.
    Title
    AFQ-Y8
    Description
    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.
    Title
    CFQ-7
    Description
    Cognitive Fusion Questionnaire - 7 items (CFQ-7). Min 1, Max 49. A higher value indicates higher cognitive fusion which indicates a worse value.
    Time Frame
    From assessment to 3 month follow up.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Thor Bengtsson, MD
    Phone
    +46 (0)424060850
    Email
    thor.bengtsson@skane.se
    First Name & Middle Initial & Last Name or Official Title & Degree
    Veronica Milos Nymberg, PhD
    Phone
    46 (0)733565679
    Email
    veronica.milos_nymberg@med.lu.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Veronica Milos Nymberg, PhD
    Organizational Affiliation
    Lund University/Region Skåne
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress.

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