SFGT for Persistent Anxiety and Depression

NCT05942495 | Completed

• 1 other identifier: NL83423.018.22
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Anxiety Disorders; Persistent; Anxiety Depression

Keywords

schema therapy; group therapy

Outcome Measures

Primary Outcomes (1)

• 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

  From baseline to follow-up, total of 37-40 weeks. We will administrate 10 items, idiosyncratically chosen. Measured once every 4 days.

Secondary Outcomes (5)

• Early maladaptive schemas as measured with the Young Schema Questionnaire Short Form (YSQ-S3).

  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

• Experiential avoidance as measured with the Brief Experiential Avoidance Questionnaire (BEAQ).

  From baseline to follow-up, total of 37-40 weeks. BEAQ will be filled in once every 16 days

• Schema modi as measured with the Schema Modi Inventory (SMI)

  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

• Personality pathology as measured by the Level of Personality Functioning-screener brief form (LPFS-BF);

  25 weeks; before start baseline and after finishing therapy

• General psychopathology as measured by the (totalscore of the) Outcome Questionnaire (OQ-45)

  37-40 weeks; OQ-45 will be filled in 5 times during study

Study Arms (1)

SFGT

EXPERIMENTAL

Whitin subject design with one arm; SFGT groep intervention

Behavioral: short-term schema focused group therapy

Interventions

short-term schema focused group therapy 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.

SFGT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GGZ Noord-Holland-Noord: lead

Study Sites (1)

Stichting GGZ Noord-Holland-Noord

Heerhugowaard, North Holland, 1703WC, Netherlands

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Eva Velthorst, PhD

  GGZ Noord-Holland-Noord

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Case experimental design

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 12, 2023
• Study Start: July 18, 2023
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)