Group Intervention for Interpersonal Skills

NCT06170801 | Active Not Recruiting DMC

• 1 other identifier: 457376358
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Inventory for Interpersonal Problems (IIP-32; Horowitz et al., 1988, German: Thomas et al., 2011)

  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.

  Weeks 1, 14

Secondary Outcomes (14)

• Inventory for Interpersonal Problems (IIP-32; Horowitz et al., 1988, German: Thomas et al., 2011)

  Baseline, Weeks 1, 9, 14, 26

• Impact Message Inventory, revised version (IMI-R; Kiesler et al., 2006; German: Caspar et al., 2016)

  Weeks 1, 14, 26

• Hamilton Depression Rating Scale, 24 items version (HAM-D, Hamilton, 1967)

  Weeks 1, 9, 14, 26

• Beck Depression Inventory, simplified (BDI-V; Beck, 1961; German version: Schmitt et al., 2000)

  Weeks 1, 9, 14, 26

• Hamilton Anxiety Rating Scale (HAM-A; Hamilton, 1959)

  Weeks 1, 9, 14, 26

Other Outcomes (4)

• Childhood Trauma Questionnaire (CTQ; Original: Bernstein & Fink, 1998; German: Wingenfeld et al., 2010)

  Baseline

• Quality and quantity of daily social contacts

  Three one-week EMA surveys (3 weeks in total: week 1-2, week 8-9, week 15-16)

• Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig et al., 2014)

  Weeks 1, 14, 26

Study Arms (2)

Kiesler Circle Training (KCT) + Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

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).

Behavioral: Kiesler Circle Training (KCT); Behavioral: Cognitive Behavioral Therapy (CBT)

Cognitive Behavioral Therapy (CBT)

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy (CBT)

Interventions

Kiesler Circle Training (KCT) 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.

Kiesler Circle Training (KCT) + Cognitive Behavioral Therapy (CBT)

Cognitive Behavioral Therapy (CBT) 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); Kiesler Circle Training (KCT) + Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• German Research Foundation: collaborator
• University of Greifswald: collaborator

Study Sites (1)

Charité

Berlin, Germany

Location

Related Publications (1)

• 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.

  PMID: 39933819 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anne Guhn, Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Eva-Lotta Brakemeier, Prof. Dr.

  University of Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of interventions, blinding of patients/therapists concerning the treatment is impossible, but all assessments as well as data analysis will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. rer. nat.

Model Details: prospective, bicenter, evaluator- and statistician-blinded, randomized clinical trial with an active control condition

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 14, 2023
• Study Start: July 3, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: We will make the outcome data and then the covariate data freely available after our respective publications, but not before 01.06.2026.
• Access Criteria: Data will be shared with the public; data will be made available for all what types of analyses; the mechanism by which the data will be made available will be determined soon.

Locations

DE (1)