Group Intervention for Interpersonal Skills (GRIPS)

Charité University Medicine Berlin

Status: Enrolling

Conditions: Anxiety Disorder; Depressive Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06170801

457376358

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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156 participants in 2 patient groups

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

Experimental group

Description:

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).

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

Behavioral: Kiesler Circle Training (KCT)

Cognitive Behavioral Therapy (CBT)

Active Comparator group

Description:

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

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)