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Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression

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ClinicalTrials.gov Identifier: NCT02375308
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Anil Batra, 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: HDT Behavioral: ACDT Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Activation-focussed Cognitive Treatment of Depression (ACDT) to Hypnotherapeutic Treatment of Depression (HDT) in Mild to Moderate Major Depression
Study Start Date : April 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : June 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypnotherapeutic Treatment
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
20 sessions, individual psychotherapy
Other Name: Hypnotherapeutic Treatment of Depression

Experimental: Cognitive Behavioral Treatment
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
20 sessions, individual psychotherapy
Other Name: Cognitive Behavioral Therapy (CBT) of Depression




Primary Outcome Measures :
  1. Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 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 :
  1. QIDS: Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C16) [ Time Frame: Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment) ]
    Clinician-rating of depressive symptoms

  2. Patient Health Questionnaire (PHQ-9) [ Time Frame: Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment) ]
    Self-report of depressive symptoms

  3. Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: six and 12 months after end of treatment ]
    Incidence of response rate (symptom reduction > 60%)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375308


Locations
Germany
Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Anil Batra, Prof. University Hospital Tuebingen

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anil Batra, Efficacy of Activation-focussed Cognitive Treatment of Depression (ACDT) to Hypnotherapeutic Treatment of Depression (HDT) in Mild to Moderate Major Depression, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02375308     History of Changes
Other Study ID Numbers: UTubingen
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

Keywords provided by Anil Batra, University Hospital Tuebingen:
Hypnotherapy; Cognitive Behavioral Therapy; Efficacy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders