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Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
HDT
ACDT
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Hypnotherapy; Cognitive Behavioral Therapy; Efficacy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hypnotherapeutic Treatment

Cognitive Behavioral Treatment

Arm Description

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.

ACDT (Activation-focussed Cognitive Treatment of Depression) focuses on psychoeducation, behavior activation, the use of cognitive techniques, and the improvement of social skills.

Outcomes

Primary Outcome Measures

Montgomery-Åsberg Depression Rating Scale (MADRS)
Clinician-rating of depressive symptoms, Primary outcome

Secondary Outcome Measures

QIDS: Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C16)
Clinician-rating of depressive symptoms
Patient Health Questionnaire (PHQ-9)
Self-report of depressive symptoms
Montgomery-Åsberg Depression Rating Scale (MADRS)
Incidence of response rate (symptom reduction > 60%)

Full Information

First Posted
February 24, 2015
Last Updated
September 21, 2018
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT02375308
Brief Title
Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression
Official Title
Efficacy of Activation-focussed Cognitive Treatment of Depression (ACDT) to Hypnotherapeutic Treatment of Depression (HDT) in Mild to Moderate Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
June 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Hypnotherapy; Cognitive Behavioral Therapy; Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnotherapeutic Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Behavioral Treatment
Arm Type
Experimental
Arm Description
ACDT (Activation-focussed Cognitive Treatment of Depression) focuses on psychoeducation, behavior activation, the use of cognitive techniques, and the improvement of social skills.
Intervention Type
Behavioral
Intervention Name(s)
HDT
Other Intervention Name(s)
Hypnotherapeutic Treatment of Depression
Intervention Description
20 sessions, individual psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
ACDT
Other Intervention Name(s)
Cognitive Behavioral Therapy (CBT) of Depression
Intervention Description
20 sessions, individual psychotherapy
Primary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
Clinician-rating of depressive symptoms, Primary outcome
Time Frame
Change from Baseline in MADRS to end of treatment (20 sessions in 20-24 weeks)
Secondary Outcome Measure Information:
Title
QIDS: Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C16)
Description
Clinician-rating of depressive symptoms
Time Frame
Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)
Title
Patient Health Questionnaire (PHQ-9)
Description
Self-report of depressive symptoms
Time Frame
Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
Incidence of response rate (symptom reduction > 60%)
Time Frame
six and 12 months after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Batra, Prof.
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17541109
Citation
Luty SE, Carter JD, McKenzie JM, Rae AM, Frampton CM, Mulder RT, Joyce PR. Randomised controlled trial of interpersonal psychotherapy and cognitive-behavioural therapy for depression. Br J Psychiatry. 2007 Jun;190:496-502. doi: 10.1192/bjp.bp.106.024729.
Results Reference
background
PubMed Identifier
17365072
Citation
Alladin A, Alibhai A. Cognitive hypnotherapy for depression: an empirical investigation. Int J Clin Exp Hypn. 2007 Apr;55(2):147-66. doi: 10.1080/00207140601177897.
Results Reference
background
PubMed Identifier
34676660
Citation
Fuhr K, Werle D, Batra A. How does early symptom change predict subsequent course of depressive symptoms during psychotherapy? Psychol Psychother. 2022 Mar;95(1):137-154. doi: 10.1111/papt.12370. Epub 2021 Oct 21.
Results Reference
derived
PubMed Identifier
29196478
Citation
Fuhr K, Schweizer C, Meisner C, Batra A. Efficacy of hypnotherapy compared to cognitive-behavioural therapy for mild-to-moderate depression: study protocol of a randomised-controlled rater-blind trial (WIKI-D). BMJ Open. 2017 Dec 1;7(11):e016978. doi: 10.1136/bmjopen-2017-016978.
Results Reference
derived

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Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression

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