AzTrials
AzTrials

Depressive DisorderGRIPSNCT06170801

Group Intervention for Interpersonal Skills

A study testing Kiesler Circle Training (KCT) and Cognitive Behavioral Therapy (CBT) in people with Depressive Disorder and Anxiety Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Depressive Disorder, Anxiety Disorder
What is being tested?
Kiesler Circle Training (KCT) and Cognitive Behavioral Therapy (CBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteGermany
Study dates
3 Jul 2024to 13 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Charité

    Berlin

Other trials in Germany

About this study

Official title: Efficacy and Feasibility of a Transdiagnostic Augmentation Therapy for Improving Interpersonal Skills Using the Kiesler Circle Training (KCT)

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.

Read the 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.

Being tested
Kiesler Circle Training (KCT), Cognitive Behavioral Therapy (CBT)
Keywords
Psychotherapy, Depression, Anxiety, Outpatient Treatment, Group Therapy, Childhood Maltreatment, Moderator, Mediator, Daily Social Contacts, Electronical Momentary Assessment, Efficacy, Feasibility
Medical subject headings
Depressive Disorder, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kiesler Circle Training (KCT)Behavioural

    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)Behavioural

    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.

Study groups in NCT06170801
Study groupRoleWhat they receive
Kiesler Circle Training (KCT) + Cognitive Behavioral Therapy (CBT)ExperimentalThe 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).
Receives: Behavioral: Kiesler Circle Training (KCT); Behavioral: Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy (CBT)Active comparatorThe patients receive weekly individual state-of-the-art CBT sessions (50 minutes each).
Receives: Behavioral: Cognitive Behavioral Therapy (CBT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Weeks 1, 14

Secondary outcomes (14)
  1. Inventory for Interpersonal Problems (IIP-32; Horowitz et al., 1988, German: Thomas et al., 2011)

    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.

    Measured: Baseline, Weeks 1, 9, 14, 26

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

    As key secondary endpoint, observer-rated changes in interpersonal functioning from Time 1 (week 1) to Time 2 (week 14) will be investigated with the IMI-R. The IMI-R will be conducted by blinded study raters. The IMI-R uses 64 items (8 items for each Kiesler Circle position) to capture covert reactions that a patient evokes in a blinded-rater. Through this assessment, it is possible to create an individual Kiesler Circle profile for each patient. The assessment of each behavior is conducted on a 4-point scale (1 = strongly disagree; 4 = strongly agree), so that higher values mean a higher expression of the Kiesler Circle position.

    Measured: Weeks 1, 14, 26

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

    The HAMD is a semi-structured interview, which measures the severity of depressive symptoms experienced in the last week. Blinded study raters will assess the severity of symptoms for each of the 24 items using a scale ranging from 0-2, 0-3, or 0-4. The total score ranges from 0-75, with higher scores indicating a higher severity of depression.

    Measured: Weeks 1, 9, 14, 26

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

    The BDI-V is a self-report questionnaire designed to assess the severity of depressive symptoms. Patients rate the severity of 20 depression symptoms on a 6-point scale (0 = never, 5 = almost always). The total score ranges from 0 to 100, with higher scores indicating a higher severity of depression.

    Measured: Weeks 1, 9, 14, 26

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

    The HAM-A is a clinician-rating to assess the severity of anxiety symptoms experienced in the last week. Blinded raters will assess the severity of symptoms for each of 14 items using a 5-point scale ranging from 0 to 4. The total score ranges from 0 to 56, with higher scores indicating a higher severity of anxiety.

    Measured: Weeks 1, 9, 14, 26

  6. Questionnaire on panic-related Anxieties, Cognitions and Avoidance (ACA; Chambless et al., 1984; German: Ehlers et al., 2001)

    The ACA is a self-report questionnaire of which we assess two subdomains in our study: the Body Sensations Questionnaire (BSQ) and the Agoraphobic Cognitions Questionnaire (ACQ). The BSQ asks about anxiety regarding 17 physical symptoms and the ACQ about 14 catastrophizing thoughts that can occur during anxiety. Answers are given on a 5-point scale, with higher scores indicating higher levels of anxiety (1 = not anxious/never, 5 = extremely anxious/always). A mean value is calculated for each of the two subdomains.

    Measured: Weeks 1, 9, 14, 26

  7. Short Emotional Disorder Inventory (SEDI; adopted short version of the MEDI by Kaiser et al., unsubmitted)

    The SEDI is a short form of the Multidimensional Emotional Disorder Inventory (MEDI; Rosellini \& Brown, 2019), which represents a dimensional approach to classify emotional disorders. The SEDI is a self-report questionnaire comprising 15 items that are answered on a 4-point scale (1 = completely untrue or slightly true, 4 = completely true). A mean value is calculated over all items, with higher values indicating a higher level of emotional disorder traits.

    Measured: Weeks 1, 14, 26

  8. Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001)

    The PHQ-9 is part of the Patient Health Questionnaire and measures depressive symptoms using 9 items. The rating scale is 4-point (0 = never, 3 = almost daily) and a total score ranging from 0-24 is calculated.

    Measured: Weeks 1, 14, 26

  9. Patient Health Questionnaire-15 (PHQ-15; Kroenke et al., 2002)

    The PHQ-15 is part of the Patient Health Questionnaire and measures the 15 most common somatic symptoms of outpatients. The rating scale is 3-point (0 = not affected, 2 = severely affected) and a total score ranging from 0-30 is calculated.

    Measured: Weeks 1, 14, 26

  10. Generalized Anxiety Disorder 7 (GAD-7; Spitzer et al., 2006)

    The GAD-7 was integrated into the patient health questionnaire in 2006 as a validated scale for measuring generalized anxiety disorder using 7 items. The rating scale is 4-point (0 = never, 3 = almost daily) and a total score ranging from 0-21 is calculated.

    Measured: Weeks 1, 14, 26

  11. World Health Organization Quality of Life (WHOQoL-BREF; The WHOQOL Group, 1998)

    The WHOQoL-BREF is a self-report measure and assesses the subjective quality of life across physical, psychological, social, and environmental domains using 26 items. These domains are rated by patients on a 5-point scale and a mean score for each domain is calculated by multiplying the mean value of all items of the respective domain by four. The possible values for all domain scores therefore range from 4-20.

    Measured: Weeks 1, 14, 26

  12. Personality Inventory for DSM-5 Brief Form Plus (PID5BF+M; Bach et al., 2020)

    The PID5BF+M is a self-report questionnaire designed to assess maladaptive personality traits in alignment with the DSM-5 and ICD-11. The questionnaire comprises 36 items, which are answered on a 4-point scale (0 = completely untrue, 3 = completely true) and captures six personality trait domains (negative affectivity, detachment, antagonism/dissociality, disinhibition, anankastia, and psychoticism). A mean value is calculated for each domain, with higher scores indicating higher expression of that personality domain.

    Measured: Weeks 1, 14, 26

  13. Level of Personality Functioning Scale-Brief Form 2.0 (LPFS-BF; Spitzer et al., 2021)

    The LPFS-BF is a self-report questionnaire designed to assess personality functioning in alignment with the DSM-5 and ICD-11. The questionnaire comprises 12 items, which are answered on a 4-point scale (1 = completely untrue, 4 = completely true) and captures two personality functioning domains (self and interpersonal pathology). A mean value is calculated for each domain, with higher scores indicating higher expression of that personality functioning domain.

    Measured: Weeks 1, 14, 26

  14. Interpersonal Needs Questionnaire (INQ; Forkmann, T. & Glaesmer, H., 2013)

    The Interpersonal Needs Questionnaire (INQ) measures interpersonal needs using two subscales: thwarted belongingness and perceived burdensomeness. The questionnaire consists of 15 items, that are answered on a 7-point scale (1 = completely untrue, 7 = completely true). After reversing the polarity of 6 items, a mean value is calculated for each of the two subscales, with higher scores indicating higher levels of thwarted belongingness and perceived burdensomeness.

    Measured: Weeks 1, 14, 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2023
  2. Study start3 Jul 2024
  3. Primary completion13 Aug 2026
  4. Study completion13 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, bicenter, evaluator- and statistician-blinded, randomized clinical trial with an active control condition
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06170801
Sponsor's protocol ID
457376358
Acronym
GRIPS
Status last verified
Aug 2026
First submitted
4 Dec 2023
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Following the Open Science guidelines of the German Psychological Association (DGPS), anonymized data will be made available via the Open Data portal of the Open Science Foundation (www.osf.io). The data will be stored after the completion of data collection, but not before 01.06.2026. This practice enables external parties to replicate the analyses mentioned in scientific publications and to perform ad hoc analyses. The data is permanently stored on servers located in Germany. Once uploaded and published, these anonymized data cannot be deleted and are exempt from deletion even if a study participant later decides to revoke their participation.

Publications

  • 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.

    PubMed 39933819

Questions about this trial

What is this clinical trial studying?

A study testing Kiesler Circle Training (KCT) and Cognitive Behavioral Therapy (CBT) in people with Depressive Disorder and Anxiety Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inventory for Interpersonal Problems (IIP-32; Horowitz et al., 1988, German: Thomas et al., 2011) (time frame: Weeks 1, 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06170801, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Group Intervention for Interpersonal Skills | AzTrials