Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: HDT; Behavioral: ACDT

• Registration Number: NCT02375308
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

The purpose of the study is to compare the efficacy of an Hypnotherapeutic Treatment of Depression to Cognitive Behavioral Treatment of Depression in patients with mild to moderate Major Depressive Episodes.

Detailed Description

Cognitive Behavioral Therapy (CBT) is considered to be an effective psychological treatment of mild to moderate Major Depressive Episodes. Effective treatments, however, show a reduction of depressive symptoms only up to 50 % (Luty et al., 2007) which is one reason for the modification of the well-established CBT in the last years. Following the 'third wave' approaches of CBT, e.g. Emotion-Focussed Therapy or Mindfulness-Based Cognitive Therapy, techniques like meditation or the use of systemic or Gestalt techniques within CBT has been applied. Within this context, Hypnotherapy-based strategies can also show an improvement of the current state of the art in depression psychotherapy. However, only few studies conducted randomised controlled trials to study the efficacy of hypnosis for depression as e.g. the comparison of cognitive hypnotherapy to CBT-alone (e.g. Alladin and Alibhai, 2007). With the present study, the efficacy of the Hypnotherapeutic Treatment of Depression (HDT) will be compared to the CBT-based Activation-focussed Cognitive Treatment of Depression (ACDT). Both treatments are individually administered and includes 20 sessions. We expect HDT not being inferior to ACDT in the reduction of depressive symptoms after six months of treatment.

Study Timeline

• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-02
• Study Start: 2015-04
• Primary Completion: 2017-07
• Study Completion: 2018-06-28
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• DSM-5 (Diagnostic and Statistical Manual) criteria for current mild to moderate Major Depressive Episode (MDE)
• Informed consent
• Fluent in German
• Time for weekly therapy sessions
• Stable antidepressant medication since three months

Exclusion Criteria

• A history of lifetime bipolar disorder, psychotic symptoms
• A diagnosis of a chronic Major Depressive Disorder (total duration of two years and more)
• Fulfilling the DSM-5 criteria for current severe MDE or scores in MADRS >/= 35 or QIDSC16 (Quick Inventory of Depressive Symptomatology) >/= 16
• Remission of current MDE since more than four weeks prior to inclusion assessment
• Acute risk for suicide
• Severe cognitive impairment (confirmed suspicion with Mini-Mental-State-Test > 25)
• A dominating primary diagnosis of another axis I disorder including anxiety disorders (e.g. Panic disorder, Posttraumatic Stress Disorder, Anorexia nervosa, Borderline personality disorder), or any severe substance-related abuse or dependence disorder
• A physical illness which would interfere with regular psychotherapy sessions
• Outpatient psychotherapy during the last 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnotherapeutic Treatment	HDT	HDT (Hypnotherapeutic Treatment of Depression) focuses on the hypnotic activation and strengthening of individual resources, the use of regression techniques to rebuild positive and negative experiences and the development of positive imaginations for the future.
Cognitive Behavioral Treatment	ACDT	ACDT (Activation-focussed Cognitive Treatment of Depression) focuses on psychoeducation, behavior activation, the use of cognitive techniques, and the improvement of social skills.

Primary Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale (MADRS)	Change from Baseline in MADRS to end of treatment (20 sessions in 20-24 weeks)	Clinician-rating of depressive symptoms, Primary outcome

Secondary Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale (MADRS)	six and 12 months after end of treatment	Incidence of response rate (symptom reduction \> 60%)
QIDS: Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C16)	Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)	Clinician-rating of depressive symptoms
Patient Health Questionnaire (PHQ-9)	Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)	Self-report of depressive symptoms

Trial Locations

Locations (1)

Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie; 🇩🇪 Tuebingen, Germany