Clinical trial NCT06170801: Group Intervention for Interpersonal Skills
Official title: Efficacy and Feasibility of a Transdiagnostic Augmentation Therapy for Improving Interpersonal Skills Using the Kiesler Circle Training (KCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Disorder
Anxiety Disorder
Keywords: Psychotherapy
Depression
Anxiety
Outpatient Treatment
Group Therapy
Childhood Maltreatment
Moderator
Mediator
Daily Social Contacts
Electronical Momentary Assessment
Efficacy
Feasibility
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: University of Greifswald
First posted: 2023-12-14
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, bicenter, evaluator- and statistician-blinded, randomized clinical trial with an active control condition
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Inventory for Interpersonal Problems (IIP-32; Horowitz et al., 1988, German: Thomas et al., 2011)
timeFrame: Weeks 1, 14
Secondary outcomes:
measure: Inventory for Interpersonal Problems (IIP-32; Horowitz et al., 1988, German: Thomas et al., 2011)
timeFrame: Baseline, Weeks 1, 9, 14, 26
measure: Impact Message Inventory, revised version (IMI-R; Kiesler et al., 2006; German: Caspar et al., 2016)
timeFrame: Weeks 1, 14, 26
measure: Hamilton Depression Rating Scale, 24 items version (HAM-D, Hamilton, 1967)
timeFrame: Weeks 1, 9, 14, 26
measure: Beck Depression Inventory, simplified (BDI-V; Beck, 1961; German version: Schmitt et al., 2000)
timeFrame: Weeks 1, 9, 14, 26
measure: Hamilton Anxiety Rating Scale (HAM-A; Hamilton, 1959)
timeFrame: Weeks 1, 9, 14, 26
measure: Questionnaire on panic-related Anxieties, Cognitions and Avoidance (ACA; Chambless et al., 1984; German: Ehlers et al., 2001)
timeFrame: Weeks 1, 9, 14, 26
measure: Short Emotional Disorder Inventory (SEDI; adopted short version of the MEDI by Kaiser et al., unsubmitted)
timeFrame: Weeks 1, 14, 26
measure: Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001)
timeFrame: Weeks 1, 14, 26
measure: Patient Health Questionnaire-15 (PHQ-15; Kroenke et al., 2002)
timeFrame: Weeks 1, 14, 26
measure: Generalized Anxiety Disorder 7 (GAD-7; Spitzer et al., 2006)
timeFrame: Weeks 1, 14, 26
measure: World Health Organization Quality of Life (WHOQoL-BREF; The WHOQOL Group, 1998)
timeFrame: Weeks 1, 14, 26
measure: Personality Inventory for DSM-5 Brief Form Plus (PID5BF+M; Bach et al., 2020)
timeFrame: Weeks 1, 14, 26
measure: Level of Personality Functioning Scale-Brief Form 2.0 (LPFS-BF; Spitzer et al., 2021)
timeFrame: Weeks 1, 14, 26
measure: Interpersonal Needs Questionnaire (INQ; Forkmann, T. & Glaesmer, H., 2013)
timeFrame: Weeks 1, 14, 26
Other outcomes:
measure: Childhood Trauma Questionnaire (CTQ; Original: Bernstein & Fink, 1998; German: Wingenfeld et al., 2010)
timeFrame: Baseline
measure: Quality and quantity of daily social contacts
timeFrame: Three one-week EMA surveys (3 weeks in total: week 1-2, week 8-9, week 15-16)
measure: Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig et al., 2014)
timeFrame: Weeks 1, 14, 26
measure: Questionnaire for the Assessment of Side Effects and Negative Experiences in Group Therapy (NUGE- 24; Strauß & Drobinskaya, 2018)
timeFrame: Weekly during the weeks 3-14
Locations:
city: Berlin
country: Germany
facility: Charité
Study officials:
affiliation: Charite University, Berlin, Germany
name: Anne Guhn, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Greifswald
name: Eva-Lotta Brakemeier, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: