Differential Efficacy of Guided Imagery Psychotherapy: Non-Inferiority Trial and Exploration of D… (NCT04765800) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Differential Efficacy of Guided Imagery Psychotherapy: Non-Inferiority Trial and Exploration of Differential Indication
Germany180 participantsStarted 2021-02-15
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anxiety and depression severity as measured by the PHQ-ADS
Timeframe: 12 months after the beginning of treatment