Differential Efficacy of Guided Imagery Psychotherapy: Non-Inferiority Trial and Exploration of Differential Indication

NCT04765800 | Active Not Recruiting

• 1 other identifier: DiW-KIP
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The DE-GIP study compares the efficacy and differential efficacy of two manualized psychodynamic psychotherapies for emotional disorders. The study therefore has two independent aims: A) The first aim is to test the hypothesized non-inferiority (NI margin: 5 points in PHQ-ADS, requiring N = 152 for a one-sided α = 0.025 and 1-ß = 0.80) of Guided Imagery Psychotherapy for Emotional Disorders (GIP-EMO) to the established Unified Psychodynamic Protocol for Emotional Disorders (UPP-EMO). The primary outcome is anxiety and depression severity (as measured by the PHQ-ADS) 12 months after the beginning of treatment. B) The second aim is to assess whether GIP-EMO is more effective for patients meeting the GIP suitability criteria (as measured by the Suitability Questionnaire for Guided Imagery Psychotherapy) than for patients who do not meet these criteria. Furthermore, it will be tested whether GIP-EMO is more effective than UPP-EMO for patients who meet the GIP suitability criteria.

Conditions

Emotional Disorders

Keywords

depression; anxiety

Outcome Measures

Primary Outcomes (1)

• Anxiety and depression severity as measured by the PHQ-ADS

  German version of the Patient Health Questionnaire Anxiety and Depression Scale \[range: 0-48\]; higher scores indicate more symptom distress through anxiety and/or depression; non-inferiority margin: d = 0.46 = 5 points in the PHQ-ADS (s. NI specifications in the study description)

  12 months after the beginning of treatment

Secondary Outcomes (10)

• Somatic symptom severity as measured by the PHQ-15

  12 and 48 months after the beginning of treatment

• Quality of life as measured by the WHOQOL-BREF

  12 and 48 months after the beginning of treatment

• Severity of interpersonal problems as measured by the IIP-32

  12 and 48 months after the beginning of treatment

• Levels of personality functioning as measured by the LPFS-BF

  12 and 48 months after the beginning of treatment

• Levels of Structural integration as measured by the OPD-SQS

  12 and 48 months after the beginning of treatment

Study Arms (2)

Unified Psychodynamic Protocol for Emotional Disorders (UPP-EMO)

ACTIVE COMPARATOR

manualized treatment with a focus on core psychodynamic treatment principles; no use of imagery-based interventions.

Behavioral: weekly, biweekly, or twice a week sessions of face-to-face outpatient psychotherapy

Guided Imagery Psychotherapy for Emotional Disorders (GIP-EMO)

EXPERIMENTAL

manualized treatment with regular applications (every 4-5 sessions) of guided affective imagery; the therapeutic work is explicitly focused on the patient's guided imagery.

Behavioral: weekly, biweekly, or twice a week sessions of face-to-face outpatient psychotherapy

Interventions

weekly, biweekly, or twice a week sessions of face-to-face outpatient psychotherapy BEHAVIORAL

according to the German Psychotherapy Guidelines (Richtlinie des Gemeinsamen Bundesausschusses über die Durchführung der Psychotherapie)

Guided Imagery Psychotherapy for Emotional Disorders (GIP-EMO); Unified Psychodynamic Protocol for Emotional Disorders (UPP-EMO)

Eligibility Criteria

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

You may qualify if:

• depressive disorder, anxiety disorder or somatic symptom disorder (with comorbid depressive or anxiety disorder) according to German version of the DSM-5 (SCID-5-CV, Beesdo-Baum et al., 2019) as main diagnosis
• informed consent to participate voluntarily in the study
• sufficient German language skills to understand the patient-report questionnaires

You may not qualify if:

• acute suicidality
• diagnosis of schizophrenia, schizophreniform, schizoaffective disorders, and/or psychosis NOS
• bipolar disorder
• depressive disorder with mood-incongruent psychotic features
• paranoid/ schizotypal/ borderline/ or antisocial personality disorder
• severe neurological disorder
• PTSD with intrusive re-experiencing
• clinically relevant substance dependence
• psychopharmacological treatment other than antidepressants
• other simultaneous psychological treatments
• organic cause of depression/anxiety or drug-induced depression/anxiety

Sponsors & Collaborators

• University of Kassel: lead
• Deutsche Gesellschaft für Katathym Imaginative Psychotherapie (DGKIP): collaborator
• International Psychoanalytic University Berlin: collaborator

Study Sites (1)

University of Kassel

Kassel, Hesse, 34127, Germany

Location

Related Publications (18)

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MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Christian Sell, Prof.

  International Psychoanalytic University Berlin

  PRINCIPAL INVESTIGATOR

• Cord Benecke, Prof.

  University of Kassel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-Inferiority Trial (NI margin: d = 0.46, required N = 152, α = 0.025, 1-β = 0.80)

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 21, 2021
• Study Start: February 15, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2029
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)