Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression

NCT ID: NCT02375308

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-06-28

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

HDT

Intervention Type: BEHAVIORAL

20 sessions, individual psychotherapy

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.

Group Type: EXPERIMENTAL

ACDT

Intervention Type: BEHAVIORAL

20 sessions, individual psychotherapy

Interventions

HDT

20 sessions, individual psychotherapy

Intervention Type: BEHAVIORAL

ACDT

20 sessions, individual psychotherapy

Intervention Type: BEHAVIORAL

Other Intervention Names

Hypnotherapeutic Treatment of Depression; Cognitive Behavioral Therapy (CBT) of Depression

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anil Batra, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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

Tübingen, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 17541109 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17365072 (View on PubMed)

Fuhr K, Meisner C, Batra A. Long-Term Outcomes of Depression Treatment With Hypnotherapy or Cognitive Behavioral Therapy. J Nerv Ment Dis. 2023 Jul 1;211(7):519-524. doi: 10.1097/NMD.0000000000001647. Epub 2023 Mar 15.

Reference Type: DERIVED

PMID: 36928627 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34676660 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29196478 (View on PubMed)

Other Identifiers

UTubingen

Identifier Type: -

Identifier Source: org_study_id