Depressive SymptomsNCT05942495
SFGT for Persistent Anxiety and Depression
A study testing short-term schema focused group therapy in people with Depressive Symptoms and Anxiety Disorders, run by GGZ Noord-Holland-Noord at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Symptoms, Anxiety Disorders, Persistent
- What is being tested?
- short-term schema focused group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jul 2023to 2 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Stichting GGZ Noord-Holland-Noord
Heerhugowaard, North Holland, 1703WC
About this study
Official title: A Pilot Study on the Effectiveness of Schema Focused Group Therapy for Persistent Anxiety and Depressive Symptoms: a Single Case Experimental Design
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.
Read the detailed description
Study design: A Single Case Experimental Design (SCED), using repeated measures over four different phases.
- Conditions
- Depressive Symptoms, Anxiety Disorders, Persistent, Anxiety Depression
- Being tested
- short-term schema focused group therapy
- Keywords
- schema therapy, group therapy
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short-term schema focused group therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SFGT | Experimental | Whitin subject design with one arm; SFGT groep intervention Receives: Behavioral: short-term schema focused group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
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
Measured: 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).
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.
Measured: 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)
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.
Measured: 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);
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.
Measured: 25 weeks; before start baseline and after finishing therapy
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.
Measured: 37-40 weeks; OQ-45 will be filled in 5 times during study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start18 Jul 2023
- Primary completion2 Feb 2025
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Case experimental design
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- GGZ Noord-Holland-Noord
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Velthorst, PhD, Principal investigator, GGZ Noord-Holland-Noord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942495
- Sponsor's protocol ID
- NL83423.018.22
- Status last verified
- Mar 2025
- First submitted
- 4 Jul 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Effectiveness of Schema Focused Group Therapy for Persistent Anxiety and Depressive Symptoms: a Single Case Experimental Design
- ClinicalTrials.gov ID
- NCT05942495
- Acronym / sponsor ID
- NL83423.018.22
- Conditions
- Depressive Symptoms, Anxiety Disorders, Persistent, Anxiety Depression
- Keywords
- schema therapy, group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GGZ Noord-Holland-NoordUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Case experimental design
| Arm | Type | Receives |
|---|---|---|
| SFGT | Experimental | Behavioral: short-term schema focused group therapyWhitin subject design with one arm; SFGT groep intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persistent anxiety or depression symptoms (at least moderate score at the subscale depression (≥7 or anxiety ≥6 on the DASS-21).
Key exclusion criteria (3 listed)
- Clients with severe problems that need to be addressed first, including substance abuse, psychosis, anxiety disorder, PTSD or depression that not have been treated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short-term schema focused group therapyThere 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. | Behavioural | SFGT |
Primary outcome
Anxiety and depressive symptoms, as repeatedly measured by (an idiosyncratic set of) a self-report questionnaire; the Depression Anxiety Stress Scales-21 (DASS-21).
Time frame: From baseline to follow-up, total of 37-40 weeks. We will administrate 10 items, idiosyncratically chosen. Measured once every 4 days.
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
5 secondary outcomes
Early maladaptive schemas as measured with the Young Schema Questionnaire Short Form (YSQ-S3).
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
Experiential avoidance as measured with the Brief Experiential Avoidance Questionnaire (BEAQ).
Time frame: 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)
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
Personality pathology as measured by the Level of Personality Functioning-screener brief form (LPFS-BF);
Time frame: 25 weeks; before start baseline and after finishing therapy
General psychopathology as measured by the (totalscore of the) Outcome Questionnaire (OQ-45)
Time frame: 37-40 weeks; OQ-45 will be filled in 5 times during study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Velthorst, PhD principal investigator
GGZ Noord-Holland-Noord
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short-term schema focused group therapy in people with Depressive Symptoms and Anxiety Disorders, run by GGZ Noord-Holland-Noord at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: From baseline to follow-up, total of 37-40 weeks. We will administrate 10 items, idiosyncratically chosen. Measured once every 4 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.