Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression

• ClinicalTrials.gov Identifier: NCT02375308
• Recruitment Status: Completed
• First Posted: March 2, 2015
• Last Update Posted: September 25, 2018
• Sponsor: University Hospital Tuebingen
• Information provided by (Responsible Party): Anil Batra, University Hospital Tuebingen

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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Behavioral: HDT; Behavioral: ACDT	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Activation-focussed Cognitive Treatment of Depression (ACDT) to Hypnotherapeutic Treatment of Depression (HDT) in Mild to Moderate Major Depression
• Study Start Date: April 2015
• Actual Primary Completion Date: July 2017
• Actual Study Completion Date: June 28, 2018

Arms and Interventions

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 Name: 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 Name: Cognitive Behavioral Therapy (CBT) of Depression

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: six and 12 months after end of treatment ]
   Incidence of response rate (symptom reduction > 60%)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Germany

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

Tuebingen, Germany, 72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

• Principal Investigator: Anil Batra, Prof.; University Hospital Tuebingen

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• 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, University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT02375308
• Other Study ID Numbers: UTubingen
• First Posted: March 2, 2015
• Last Update Posted: September 25, 2018
• Last Verified: September 2018

Keywords provided by Anil Batra, University Hospital Tuebingen:

Hypnotherapy; Cognitive Behavioral Therapy; Efficacy

Additional relevant MeSH terms:

Depression; Depressive Disorder; Depressive Disorder, Major; Behavioral Symptoms; Mood Disorders; Mental Disorders