Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression

NCT02375308 | Completed DMC

• 1 other identifier: UTubingen
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Hypnotherapy; Cognitive Behavioral Therapy; Efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• QIDS: Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C16)

  Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)

• Patient Health Questionnaire (PHQ-9)

  Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  six and 12 months after end of treatment

Study Arms (2)

Hypnotherapeutic Treatment

EXPERIMENTAL

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

Cognitive Behavioral Treatment

EXPERIMENTAL

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

Interventions

HDT BEHAVIORAL

20 sessions, individual psychotherapy

Also known as: Hypnotherapeutic Treatment of Depression

Hypnotherapeutic Treatment

ACDT BEHAVIORAL

20 sessions, individual psychotherapy

Also known as: Cognitive Behavioral Therapy (CBT) of Depression

Cognitive Behavioral Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

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

Tübingen, 72076, Germany

Location

Related Publications (5)

• 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.

  PMID: 17541109 BACKGROUND

• 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.

  PMID: 17365072 BACKGROUND

• 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.

  PMID: 36928627 DERIVED

• 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.

  PMID: 34676660 DERIVED

• 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.

  PMID: 29196478 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anil Batra, Prof.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Efficacy of Activation-focussed Cognitive Treatment of Depression (ACDT) to Hypnotherapeutic Treatment of Depression (HDT) in Mild to Moderate Major Depression

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 2, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: June 28, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Locations

DE (1)