Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375308
• Other study ID #: UTubingen
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: June 28, 2018

Study information

• Verified date: September 2018
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 28, 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• HDT
20 sessions, individual psychotherapy
• ACDT
20 sessions, individual psychotherapy

Locations

Country	Name	City	State
Germany	Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Alladin A, Alibhai A. Cognitive hypnotherapy for depression: an empirical investigation. Int J Clin Exp Hypn. 2007 Apr;55(2):147-66. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	QIDS: Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C16)	Clinician-rating of depressive symptoms	Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)
Secondary	Patient Health Questionnaire (PHQ-9)	Self-report of depressive symptoms	Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)
Secondary	Montgomery-Åsberg Depression Rating Scale (MADRS)	Incidence of response rate (symptom reduction > 60%)	six and 12 months after end of treatment