Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression

September 21, 2018 updated by: Anil Batra, University Hospital Tuebingen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Cognitive Behavioral Therapy (CBT) of Depression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)
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
Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: six and 12 months after end of treatment
Incidence of response rate (symptom reduction > 60%)
six and 12 months after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

June 28, 2018

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 21, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTubingen

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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