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NCT Number: NCT06591754

Feasibility, Acceptability, and Preliminary Effects of ISTDP for Personality Disorders in a Specialized Psychiatric Clinic

The primary objective of this study is to evaluate the feasibility and acceptability of a 25-week combined group and individual therapy program using Intensive Short-Term Dynamic Psychotherapy (ISTDP) for patients diagnosed with personality disorders. The secondary objective is to investigate preliminary effects of the treatment in terms of reducing symtoms of depression, anxiety and emotion regulation difficulties.

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Key information

Conditions

Personality Disorder Mental Disorders Personality Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affektiva, ångest och traumaprogrammet, Psykiatri Sydväst

Stockholm, 14157, Sweden

About this study

The investigators vill investigate a 25-week treatment with ISTDP that consists of both weekly group- and individual therapy for patients diagnosed with personality disorder in a psychiatric clinic specialized on depression, anxiety and PTSD. The feasibility and acceptability and preliminary effects will be evaluated using a within-group design with repeated measures and qualitative interviews. Patients will be recruited from the clinic and the main inclusion criteria is that the patient have a personality disorder diagnosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Personality disorder diagnosis (Clinical assessment using STIP-5) Speaks Swedish fluently

Exclusion criteria

Autism or intellectual disability Borderline, antisocial or narcissistic personality disorder diagnosis Need for interpreter Urgent social misery Psychotic disorder High suicidality

Treatment and study plan

ISTDP

Behavioral

Both the individual therapy and the group therapy is based on ISTDP (Intensive Short-Term Dynamic Psychotherapy), an affect-focused psychodynamic therapy method. The therapy focus on the relationship between feelings, anxiety and dysfunctional emotion regulation (i.e. defenses). The purpose is to increase the capacity of anxiety regulation in the patient and to help the patient identify the dysfunctional patterns developed to avoid internal stress and then gradually approach previously warded of feelings. The individual therapy consists of 25 weekly sessions. The group treatment consists of 18 weekly sessions and is structured in three phases. Phase one: Psychoeducation about anxiety and exercises in anxiety regulation. Phase two: patients takes turn to observe their own anxiety and defenses together with a therapist. Phase three: Every session two patients will work with a chosen problem and identify defenses, anxiety and feelings together with a therapist in front of the group.

Primary outcomes

  1. Patients experience of, and satisfaction with, the treatment assessed through qualitative interviews

    Time frame: Immediately after treatment completion

    Patients experience of, and satisfaction with, the treatment assessed through qualitative interviews

  2. Depression symtoms

    Time frame: Baseline, weekly throughout treatment, immediately after treatment completion and 6-month follow-up

    Depression symtoms will be measured with Patient Health Questionnaire (PHQ-9; (Kroenke et al., 2001)

  3. Participants satisfaction with treatment assessed with the Client Satisfaction Questionnaire (CSQ-8)

    Time frame: Immediately after treatment completion (25 weeks)

    Participants satisfaction with treatment assessed with the Client Satisfaction Questionnaire (CSQ-8)

  4. Adverse events related to the treatment

    Time frame: From start of treatment up to. 6 month follow up.

    Adverse events related to the treatment

  5. Number of individual sessions attended during the treatment

    Time frame: Throughout the treatment period, up to 25 weeks

    Number of individual sessions attended during the treatment

  6. Number of group sessions attended during the treatment

    Time frame: Throughout the treatment period, up to 25 weeks

    Number of group sessions attended during the treatment

  7. Number of dropouts

    Time frame: Throughout the treatment period, up to 25 weeks

    Number of dropouts

  8. Total number of sessions attended during the treatment

    Time frame: Throughout the treatment period, up to 25 weeks

    Total number of sessions attended during the treatment

Secondary outcomes

  1. Fear of negative emotions

    Time frame: Change from baseline to post-treatment (25 weeks) and follow up 6 months after treatment.

    Fear of negative emotion scale (Gilbert et al., 2014) for assessing fear and avoidance of negative feelings.

  2. Anxiety symtoms

    Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.

    Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006) for assessing anxiety symtoms.

  3. Emotions regulation difficulties

    Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.

    Difficulties in Emotion Regulation Scale (DERS-16; Bjureberg et al., 2016) for assessing difficulties with emotions regulation.

  4. Severity of personality disorder

    Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.

    The Standardized Assessment of Severity of Personality Disorders (SASPD; Olajide et al., 2018) for assessing degree of personality disorder.

  5. Symtoms of Borderline Personality disorder

    Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.

    Borderline Symtom List (BLS-23; Bohus et al., 2008) for assessing symtoms of Borderline personality disorder.

  6. Severity of personality disorder

    Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.

    Levels of Personality Functioning Brief Form (LPFS-BF; Weekers et al., 2019) for assessing degree of personality disorder.

  7. Quality of life

    Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.

    Brunnsviken Brief Quality of life (Lindner et al., 2016) for assessing quality of life.

  8. Quality of life

    Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.

    EuroQol-5D (EQ5D; Balestroni, Gianluigi, & Bertolotti, 2015) for assessing quality of life.

  9. Working alliance

    Time frame: Weekly throughout treatment , up to 25 weeks

    Session Alliance Inventory (SAI; Falkenström et al., 2015) for assessing the working alliance with the therapist

  10. Emotional activation during therapy

    Time frame: Weekly throughout treatment, up to 25 weeks

    Emotional Experience Self Report (Fisher et al., 2016) for assessing the degree of emotional activation during the session.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm
  • Stockholm University

Registry information

Official study title

A Pilotstudy Investigating Feasability, Acceptability and Preliminary Effects of ISTDP (Intensive Short Term Dynamic Psychotherapy) for Patients with Personality Disorder in a Psychiatric Clinic Specialized on Depression, Anxiety and PTSD

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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