Efficacy and Feasibility of a Transdiagnostic Augmentation Therapy for Improving Interpersonal Skills Using the Kiesler Circle Training (KCT)
Overview
- Phase
- Not Applicable
- Intervention
- Kiesler Circle Training (KCT)
- Conditions
- Depressive Disorder
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Inventory for Interpersonal Problems (IIP-32; Horowitz et al., 1988, German: Thomas et al., 2011)
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
Brief Summary
The purpose of this study is to compare an individual state-of-the-art cognitive behavioral therapy (CBT) with CBT augmented by a group intervention for improving interpersonal skills, the Kiesler Circle Training (CBT+KCT), in patients with a depressive or anxiety disorder.
Detailed Description
This study aims to test the effectiveness and feasibility of a transdiagnostic group psychotherapy to improve interpersonal skills, the Kiesler Circle Training (KCT). For this purpose, a prospective, bicentre, randomised clinical trial (RCT) blinded by evaluators and statisticians will be conducted on outpatients with diagnoses of anxiety and/or depressive disorders according to DSM-5. An individual state-of-the-art cognitive behavioral therapy (CBT) will be compared with CBT augmented by Kiesler Circle Training (CBT + KCT) in a sample of 156 patients (CBT: 78 patients, CBT + KCT: 78 patients). All participants will be assessed four times, at baseline (T1, week 2), at mid-treatment (T2, week 9), at post-treatment (T3, week 14) and at 3-months follow-up (T4, week 26). Outcome measurements include interpersonal problems as well as symptom change in regard to both the categorical approach (primary diagnosis) and the transdiagnostic approach. The two main hypotheses are: 1. the improvement of interpersonal problems in the experimental group (CBT + KCT) will be greater than the improvement in the control group (CBT). 2. the improvement of interpersonal problems will be associated with decreasing symptom severity related to the primary diagnosis, so that patients in the conjoint CBT+KCT treatment will reach higher symptom change scores than patients in the CBT only condition. Furthermore, we assume that the course of interpersonal problems is moderated by childhood maltreatment and mediated by the quality and quantity of daily social contacts.
Investigators
Anne Guhn
Dr. rer. nat.
Charite University, Berlin, Germany
Eligibility Criteria
Inclusion Criteria
- •Sufficient knowledge of the German language (B2 level)
- •Primary diagnosis of either depressive disorder or anxiety disorder according to DSM-5 at time of screening
- •Interpersonal distress above average (IIP-32 \> 1.81) at time of screening
- •Ongoing individual CBT at time of screening
- •Signed informed consent regarding the study protocol
Exclusion Criteria
- •Acute suicidality at time of screening
- •Active substance abuse at time of screening
- •Borderline, antisocial, schizoid or schizotypic personality disorder at time of screening
- •Inability to participate in outpatient treatment with additional weekly group appointment at time of screening
- •Any kind of additional group treatment (including self-help groups) besides individual CBT during the entire study period
Arms & Interventions
Kiesler Circle Training (KCT) + Cognitive Behavioral Therapy (CBT)
The Kiesler Circle Training (KCT) consists of 12 weekly group sessions of 100 minutes each (in a group of max. 10 patients). In addition, all patients receive weekly individual state-of-the-art CBT sessions (50 minutes each).
Intervention: Kiesler Circle Training (KCT)
Kiesler Circle Training (KCT) + Cognitive Behavioral Therapy (CBT)
The Kiesler Circle Training (KCT) consists of 12 weekly group sessions of 100 minutes each (in a group of max. 10 patients). In addition, all patients receive weekly individual state-of-the-art CBT sessions (50 minutes each).
Intervention: Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy (CBT)
The patients receive weekly individual state-of-the-art CBT sessions (50 minutes each).
Intervention: Cognitive Behavioral Therapy (CBT)
Outcomes
Primary Outcomes
Inventory for Interpersonal Problems (IIP-32; Horowitz et al., 1988, German: Thomas et al., 2011)
Time Frame: Weeks 1, 14
Change in interpersonal functioning, measured with the IIP-32 from baseline (Time 1) to week 14 (Time 2), represents the primary outcome measure. The IIP-32 is a self-assessment questionnaire for interpersonal problems, i.e., difficulties in interacting with other individuals, based on Horowitz's Circumplex Model. It consists of 32 items that are answered on a 5-point scale (0= not at all, 4 = very much). For evaluation, a mean score is calculated across all items, with a higher score indicating a higher severity of interpersonal problems.
Secondary Outcomes
- Impact Message Inventory, revised version (IMI-R; Kiesler et al., 2006; German: Caspar et al., 2016)(Weeks 1, 14, 26)
- Beck Depression Inventory, simplified (BDI-V; Beck, 1961; German version: Schmitt et al., 2000)(Weeks 1, 9, 14, 26)
- Inventory for Interpersonal Problems (IIP-32; Horowitz et al., 1988, German: Thomas et al., 2011)(Baseline, Weeks 1, 9, 14, 26)
- Hamilton Depression Rating Scale, 24 items version (HAM-D, Hamilton, 1967)(Weeks 1, 9, 14, 26)
- Questionnaire on panic-related Anxieties, Cognitions and Avoidance (ACA; Chambless et al., 1984; German: Ehlers et al., 2001)(Weeks 1, 9, 14, 26)
- Hamilton Anxiety Rating Scale (HAM-A; Hamilton, 1959)(Weeks 1, 9, 14, 26)
- Short Emotional Disorder Inventory (SEDI; adopted short version of the MEDI by Kaiser et al., unsubmitted)(Weeks 1, 14, 26)
- Generalized Anxiety Disorder 7 (GAD-7; Spitzer et al., 2006)(Weeks 1, 14, 26)
- World Health Organization Quality of Life (WHOQoL-BREF; The WHOQOL Group, 1998)(Weeks 1, 14, 26)
- Level of Personality Functioning Scale-Brief Form 2.0 (LPFS-BF; Spitzer et al., 2021)(Weeks 1, 14, 26)
- Patient Health Questionnaire-15 (PHQ-15; Kroenke et al., 2002)(Weeks 1, 14, 26)
- Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001)(Weeks 1, 14, 26)
- Interpersonal Needs Questionnaire (INQ; Forkmann, T. & Glaesmer, H., 2013)(Weeks 1, 14, 26)
- Personality Inventory for DSM-5 Brief Form Plus (PID5BF+M; Bach et al., 2020)(Weeks 1, 14, 26)