SFGT for Persistent Anxiety and Depression

NCT ID: NCT05942495

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-18

Study Completion Date

2025-02-02

Brief Summary

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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

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Study design: A Single Case Experimental Design (SCED), using repeated measures over four different phases.

Conditions

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Depressive Symptoms Anxiety Disorders Persistent Anxiety Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Case experimental design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SFGT

Whitin subject design with one arm; SFGT groep intervention

Group Type EXPERIMENTAL

short-term schema focused group therapy

Intervention Type BEHAVIORAL

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.

Interventions

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short-term schema focused group therapy

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GGZ Noord-Holland-Noord

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eva Velthorst, PhD

Role: PRINCIPAL_INVESTIGATOR

GGZ Noord-Holland-Noord

Locations

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Stichting GGZ Noord-Holland-Noord

Heerhugowaard, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL83423.018.22

Identifier Type: -

Identifier Source: org_study_id

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