search
Back to results

SFGT for Persistent Anxiety and Depression

Primary Purpose

Depressive Symptoms, Anxiety Disorders, Persistent

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
short-term schema focused group therapy
Sponsored by
GGZ Noord-Holland-Noord
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring schema therapy, group therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Persistent anxiety or depression symptoms (at least moderate score at the subscale depression (≥7 or anxiety ≥6 on the DASS-21). History of at least one previous evidence-based therapy focused on anxiety, depression or PTSD according to the Dutch national guidelines. Able to comprehend Dutch at a level sufficient to complete self-report. Exclusion Criteria: Clients with severe problems that need to be addressed first, including substance abuse, psychosis, anxiety disorder, PTSD or depression that not have been treated. Start of (or change in) medication which is not yet stabilized at the start of this study. Psychosocial problems such as homelessness, no income or high debts which would make the clients unable to participate in a group.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SFGT

    Arm Description

    Whitin subject design with one arm; SFGT groep intervention

    Outcomes

    Primary Outcome Measures

    Anxiety and depressive symptoms, as repeatedly measured by (an idiosyncratic set of) a self-report questionnaire; the Depression Anxiety Stress Scales-21 (DASS-21).
    The DASS-21 consists of three subscales (Depression, Anxiety, and Stress). Each item can be rated on a scale from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time"). All subscales content 7 items which makes the score range 0-21 for each subscale. Higher scores indicate the experience of more severe symptoms

    Secondary Outcome Measures

    Early maladaptive schemas as measured with the Young Schema Questionnaire Short Form (YSQ-S3).
    YSQ-S3 is a 90-item self-report questionnaire that measures 18 EMS (Young, 2005). The items are rated by a 6-point Likert scale ranging from "completely untrue" to "describes me perfectly". An average score is calculated for each EMS, with a range of 1-6. Higher scores indicate a stronger presence of the respective schema
    Experiential avoidance as measured with the Brief Experiential Avoidance Questionnaire (BEAQ).
    The BEAQ is a 15 items self-report questionnaire with a likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). Item scores are summed up making a range of 15-90; higher scores indicate more experiential avoidance.
    Schema modi as measured with the Schema Modi Inventory (SMI)
    The SMI is a self-report questionnaire that will be used to measure 14 schema modes. The 118 items are rated at a 6-point scale ranging from "never or hardly ever" to "always". An average score is calculated for each mode, with a range of 1-6. Higher scores indicate a stronger presence of the specific schema mode.
    Personality pathology as measured by the Level of Personality Functioning-screener brief form (LPFS-BF);
    The LPFS-BF 2.0 is a brief 12-items self-report questionnaire to assess severity of personality pathology. Items ar rated on a 4-point Likert-scale rating "from very false or often false" to "very true or often true". Total score (range 0-36) of LPFS-BF can be divided into two subscales; self-functioning and interpersonal functioning. Lower scores indicate better adaptive functioning, whereas higher scores are indication for personality pathology.
    General psychopathology as measured by the (totalscore of the) Outcome Questionnaire (OQ-45)
    The OQ-45 which was developed to measure three domains central to mental health: symptom distress (SD), interpersonal relations (IR) and social role (SR) functioning. The self-report questionnaire consists of 45 items to be rated on a five-point Likert scale ranging from 0 (never) to 4 (almost always). Totalscore ranges from 0-180, a high score suggests that the client is admitting to a large number of symptoms as well as difficulties in interpersonal relationships, social role, and general quality of life.

    Full Information

    First Posted
    July 4, 2023
    Last Updated
    October 10, 2023
    Sponsor
    GGZ Noord-Holland-Noord
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05942495
    Brief Title
    SFGT for Persistent Anxiety and Depression
    Official Title
    A Pilot Study on the Effectiveness of Schema Focused Group Therapy for Persistent Anxiety and Depressive Symptoms: A Single Case Experimental Design
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GGZ Noord-Holland-Noord

    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
    Rationale: Although there are effective treatments available for anxiety and depression, there is a large group of clients that does not benefit sufficiently from first-choice treatment. For this group of clients, no suitable alternative exists yet. One of the main hypothesis about maintaining factors is that there are underlying personality features that impede recovery. Schema focused therapy (SFT) is a transdiagnostic therapy focusing on underlying personality features. It has been proven to be an effective therapy for people with personality disorders and there are initial indications that SFT is also an effective treatment for anxiety and depressive symptoms. A short-term schema focused group therapy (SFGT) has been developed within GGZ-NHN, which is expected to benefit clients with persistent anxiety and depressive symptoms, but has not yet been studied. Objective of the study: In the present study the effectiveness of short-term SFGT (protocol of De Jager, Burger & Groot) on (1) persistent anxiety and depressive symptoms, and (2) early maladaptive schemas (EMS), experiential avoidance and the mode of the healthy adult will be investigated.
    Detailed Description
    Study design: A Single Case Experimental Design (SCED), using repeated measures over four different phases.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depressive Symptoms, Anxiety Disorders, Persistent, Anxiety Depression
    Keywords
    schema therapy, group therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single Case experimental design
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SFGT
    Arm Type
    Experimental
    Arm Description
    Whitin subject design with one arm; SFGT groep intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    short-term schema focused group therapy
    Intervention Description
    There are two intervention phases. The first concerns the pre-treatment phase, which consists of five online sessions and three face-to-face sessions. The second intervention phase is the short-term SFGT. The SFGT consists of 17 weekly group sessions.
    Primary Outcome Measure Information:
    Title
    Anxiety and depressive symptoms, as repeatedly measured by (an idiosyncratic set of) a self-report questionnaire; the Depression Anxiety Stress Scales-21 (DASS-21).
    Description
    The DASS-21 consists of three subscales (Depression, Anxiety, and Stress). Each item can be rated on a scale from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time"). All subscales content 7 items which makes the score range 0-21 for each subscale. Higher scores indicate the experience of more severe symptoms
    Time Frame
    From baseline to follow-up, total of 37-40 weeks. We will administrate 10 items, idiosyncratically chosen. Measured once every 4 days.
    Secondary Outcome Measure Information:
    Title
    Early maladaptive schemas as measured with the Young Schema Questionnaire Short Form (YSQ-S3).
    Description
    YSQ-S3 is a 90-item self-report questionnaire that measures 18 EMS (Young, 2005). The items are rated by a 6-point Likert scale ranging from "completely untrue" to "describes me perfectly". An average score is calculated for each EMS, with a range of 1-6. Higher scores indicate a stronger presence of the respective schema
    Time Frame
    From baseline to follow-up, total of 37-40 weeks. Complete YSQ will be filled in 5 times during study. Two early maladpative schema's, 10 items, idiosyncratically chosen will be measured once every 16 days
    Title
    Experiential avoidance as measured with the Brief Experiential Avoidance Questionnaire (BEAQ).
    Description
    The BEAQ is a 15 items self-report questionnaire with a likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). Item scores are summed up making a range of 15-90; higher scores indicate more experiential avoidance.
    Time Frame
    From baseline to follow-up, total of 37-40 weeks. BEAQ will be filled in once every 16 days
    Title
    Schema modi as measured with the Schema Modi Inventory (SMI)
    Description
    The SMI is a self-report questionnaire that will be used to measure 14 schema modes. The 118 items are rated at a 6-point scale ranging from "never or hardly ever" to "always". An average score is calculated for each mode, with a range of 1-6. Higher scores indicate a stronger presence of the specific schema mode.
    Time Frame
    From baseline to follow-up, total of 37-40 weeks. Complete SMI will be filled in 5 times during study. Mode of the healthy parent, 10 items, will be measured once every 16 days
    Title
    Personality pathology as measured by the Level of Personality Functioning-screener brief form (LPFS-BF);
    Description
    The LPFS-BF 2.0 is a brief 12-items self-report questionnaire to assess severity of personality pathology. Items ar rated on a 4-point Likert-scale rating "from very false or often false" to "very true or often true". Total score (range 0-36) of LPFS-BF can be divided into two subscales; self-functioning and interpersonal functioning. Lower scores indicate better adaptive functioning, whereas higher scores are indication for personality pathology.
    Time Frame
    25 weeks; before start baseline and after finishing therapy
    Title
    General psychopathology as measured by the (totalscore of the) Outcome Questionnaire (OQ-45)
    Description
    The OQ-45 which was developed to measure three domains central to mental health: symptom distress (SD), interpersonal relations (IR) and social role (SR) functioning. The self-report questionnaire consists of 45 items to be rated on a five-point Likert scale ranging from 0 (never) to 4 (almost always). Totalscore ranges from 0-180, a high score suggests that the client is admitting to a large number of symptoms as well as difficulties in interpersonal relationships, social role, and general quality of life.
    Time Frame
    37-40 weeks; OQ-45 will be filled in 5 times during study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Persistent anxiety or depression symptoms (at least moderate score at the subscale depression (≥7 or anxiety ≥6 on the DASS-21). History of at least one previous evidence-based therapy focused on anxiety, depression or PTSD according to the Dutch national guidelines. Able to comprehend Dutch at a level sufficient to complete self-report. Exclusion Criteria: Clients with severe problems that need to be addressed first, including substance abuse, psychosis, anxiety disorder, PTSD or depression that not have been treated. Start of (or change in) medication which is not yet stabilized at the start of this study. Psychosocial problems such as homelessness, no income or high debts which would make the clients unable to participate in a group.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elizabeth Groot
    Phone
    06-13049091
    Email
    ellen.groot2@ggz-nhn.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eva Velthorst
    Phone
    0618644345
    Email
    e.velthorst@ggz-nhn.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eva Velthorst, PhD
    Organizational Affiliation
    GGZ Noord-Holland-Noord
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    SFGT for Persistent Anxiety and Depression

    We'll reach out to this number within 24 hrs