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

NCT06591754 | Enrolling By Invitation

• 1 other identifier: 2024-04361-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Personality Disorder

Keywords

Personality disorder; ISTDP; Intensive Short-Term Dynamic Psychotherapy

Outcome Measures

Primary Outcomes (8)

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

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

  Immediately after treatment completion

• Depression symtoms

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

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

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

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

  Immediately after treatment completion (25 weeks)

• Adverse events related to the treatment

  Adverse events related to the treatment

  From start of treatment up to. 6 month follow up.

• Number of individual sessions attended during the treatment

  Number of individual sessions attended during the treatment

  Throughout the treatment period, up to 25 weeks

• Number of group sessions attended during the treatment

  Number of group sessions attended during the treatment

  Throughout the treatment period, up to 25 weeks

• Number of dropouts

  Number of dropouts

  Throughout the treatment period, up to 25 weeks

• Total number of sessions attended during the treatment

  Total number of sessions attended during the treatment

  Throughout the treatment period, up to 25 weeks

Secondary Outcomes (10)

• Fear of negative emotions

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

• Anxiety symtoms

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

• Emotions regulation difficulties

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

• Severity of personality disorder

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

• Symtoms of Borderline Personality disorder

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

Study Arms (1)

ISTDP

EXPERIMENTAL

ISTDP combined group- and individual therapy

Behavioral: ISTDP

Interventions

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.

ISTDP

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Stockholm University: collaborator

Study Sites (1)

Affektiva, ångest och traumaprogrammet, Psykiatri Sydväst

Stockholm, 14157, Sweden

Location

MeSH Terms

Conditions

Personality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD and licensed psychologist

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)