Group Intervention for Interpersonal Skills

NCT ID: NCT06170801

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-03
• Study Completion Date: 2026-10-31

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.

Conditions

Depressive Disorder; Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Kiesler Circle Training (KCT)

Intervention Type: BEHAVIORAL

Kiesler Circle Training is a transdiagnostic modular group treatment, which comprises a baseline module and four additional independent modules (nonverbal communication, verbal communication, conflict training and empathy and corrective interpersonal experiences). KCT is based on a heuristic model to explain and anticipate interactions developed by Donald Kiesler and other representatives of the interpersonal theory. The circumplex model arranges the variety of interpersonal behaviors in terms of a circular continuum allocated on two orthogonal axes: The vertical axis addresses interpersonal control (agency), the horizontal axis addresses interpersonal communion. The model further allows illustrating complementary action tendencies to anticipate other's reactions and to guide own behavior to achieve interpersonal goals. KCT is designed for increasing the awareness of such interpersonal action tendencies and for improving interpersonal behavioral flexibility.

Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy is based on the interrelationships of thoughts, actions and feelings. Presumably, individual CBT will address intrapersonal therapeutic foci such as behavioral activation, identification of dysfunctional thoughts, overcoming fears by exposure, etc. Individual CBT may also include interpersonal functioning as therapeutic foci. Disorder-specific treatment manuals are available for all diagnoses included in the study. Of note, state-of-the-art CBT does not necessarily mean, that individual CBT-sessions strictly adhere to a manual. However, because both study sites are CBT training institutes, which guarantee supervision at least every four hours, it can be estimated that state-of-the-art CBT is realized.

Cognitive Behavioral Therapy (CBT)

The patients receive weekly individual state-of-the-art CBT sessions (50 minutes each).

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy is based on the interrelationships of thoughts, actions and feelings. Presumably, individual CBT will address intrapersonal therapeutic foci such as behavioral activation, identification of dysfunctional thoughts, overcoming fears by exposure, etc. Individual CBT may also include interpersonal functioning as therapeutic foci. Disorder-specific treatment manuals are available for all diagnoses included in the study. Of note, state-of-the-art CBT does not necessarily mean, that individual CBT-sessions strictly adhere to a manual. However, because both study sites are CBT training institutes, which guarantee supervision at least every four hours, it can be estimated that state-of-the-art CBT is realized.

Interventions

Kiesler Circle Training (KCT)

Kiesler Circle Training is a transdiagnostic modular group treatment, which comprises a baseline module and four additional independent modules (nonverbal communication, verbal communication, conflict training and empathy and corrective interpersonal experiences). KCT is based on a heuristic model to explain and anticipate interactions developed by Donald Kiesler and other representatives of the interpersonal theory. The circumplex model arranges the variety of interpersonal behaviors in terms of a circular continuum allocated on two orthogonal axes: The vertical axis addresses interpersonal control (agency), the horizontal axis addresses interpersonal communion. The model further allows illustrating complementary action tendencies to anticipate other's reactions and to guide own behavior to achieve interpersonal goals. KCT is designed for increasing the awareness of such interpersonal action tendencies and for improving interpersonal behavioral flexibility.

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

Cognitive Behavioral Therapy is based on the interrelationships of thoughts, actions and feelings. Presumably, individual CBT will address intrapersonal therapeutic foci such as behavioral activation, identification of dysfunctional thoughts, overcoming fears by exposure, etc. Individual CBT may also include interpersonal functioning as therapeutic foci. Disorder-specific treatment manuals are available for all diagnoses included in the study. Of note, state-of-the-art CBT does not necessarily mean, that individual CBT-sessions strictly adhere to a manual. However, because both study sites are CBT training institutes, which guarantee supervision at least every four hours, it can be estimated that state-of-the-art CBT is realized.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

University of Greifswald

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Anne Guhn

Dr. rer. nat.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Guhn, Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Eva-Lotta Brakemeier, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Greifswald

Locations

Charité

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Anne Guhn, Dr.

Role: CONTACT

anne.guhn@charite.de

+49 30 450 517456

Karen Ollrogge

Role: CONTACT

karen-anna.ollrogge@charite.de

+49 30 450 517456

Facility Contacts

Karen Ollrogge, M.Sc.

Role: primary

karen-anna.ollrogge@charite.de

+49 30 450 517 456

References

Ollrogge K, Schulze D, Sterzer P, Kohler S, Friedel E, Romanczuk-Seiferth N, Siegerist AL, Brakemeier EL, Guhn A. Cognitive behavioural therapy plus Kiesler Circle Training (CBT+) versus CBT only for patients with interpersonal problems: study protocol for a randomised controlled feasibility trial. BMJ Open. 2025 Feb 11;15(2):e098466. doi: 10.1136/bmjopen-2024-098466.

Reference Type: DERIVED

PMID: 39933819 (View on PubMed)

Other Identifiers

457376358

Identifier Type: -

Identifier Source: org_study_id