Clinical trial NCT05942495: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Anxiety Disorders
Persistent
Anxiety Depression
Keywords: schema therapy
group therapy
Lead sponsor: GGZ Noord-Holland-Noord
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Case experimental design
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Anxiety and depressive symptoms, as repeatedly measured by (an idiosyncratic set of) a self-report questionnaire; the Depression Anxiety Stress Scales-21 (DASS-21).
timeFrame: From baseline to follow-up, total of 37-40 weeks. We will administrate 10 items, idiosyncratically chosen. Measured once every 4 days.
Secondary outcomes:
measure: Early maladaptive schemas as measured with the Young Schema Questionnaire Short Form (YSQ-S3).
timeFrame: 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
measure: Experiential avoidance as measured with the Brief Experiential Avoidance Questionnaire (BEAQ).
timeFrame: From baseline to follow-up, total of 37-40 weeks. BEAQ will be filled in once every 16 days
measure: Schema modi as measured with the Schema Modi Inventory (SMI)
timeFrame: 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
measure: Personality pathology as measured by the Level of Personality Functioning-screener brief form (LPFS-BF);
timeFrame: 25 weeks; before start baseline and after finishing therapy
measure: General psychopathology as measured by the (totalscore of the) Outcome Questionnaire (OQ-45)
timeFrame: 37-40 weeks; OQ-45 will be filled in 5 times during study
Other outcomes:
Locations:
city: Heerhugowaard
country: Netherlands
facility: Stichting GGZ Noord-Holland-Noord
state: North Holland
Study officials:
affiliation: GGZ Noord-Holland-Noord
name: Eva Velthorst, PhD
role: PRINCIPAL_INVESTIGATOR
References: