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Clinical Trials/NCT06591754
NCT06591754
Enrolling By Invitation
Not Applicable

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

Karolinska Institutet1 site in 1 country34 target enrollmentSeptember 9, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Personality Disorder
Sponsor
Karolinska Institutet
Enrollment
34
Locations
1
Primary Endpoint
Patients experience of, and satisfaction with, the treatment assessed through qualitative interviews
Status
Enrolling By Invitation
Last Updated
last year

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 9, 2024
End Date
December 31, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria Bragesjo

PhD and licensed psychologist

Karolinska Institutet

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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)

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)

Adverse events related to the treatment

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

Adverse events related to the treatment

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

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

Number of dropouts

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

Number of dropouts

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

  • 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.)
  • Symtoms of Borderline Personality disorder(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.)
  • Quality of life(Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.)
  • Working alliance(Weekly throughout treatment , up to 25 weeks)
  • Emotional activation during therapy(Weekly throughout treatment, up to 25 weeks)

Study Sites (1)

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