Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Activation-focussed Cognitive Treatment of Depression (ACDT) to Hypnotherapeutic Treatment of Depression (HDT) in Mild to Moderate Major Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: HDT
* Behavioral: ACDT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnotherapeutic Treatment<br>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. | Behavioral: HDT<br>* 20 sessions, individual psychotherapy<br>* Other names: Hypnotherapeutic Treatment of Depression;|
| Experimental: Cognitive Behavioral Treatment<br>ACDT (Activation-focussed Cognitive Treatment of Depression) focuses on psychoeducation, behavior activation, the use of cognitive techniques, and the improvement of social skills. | Behavioral: ACDT<br>* 20 sessions, individual psychotherapy<br>* Other names: Cognitive Behavioral Therapy (CBT) of Depression;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypnotherapy; Cognitive Behavioral Therapy; Efficacy