Clinical trial NCT02375308: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Hypnotherapy; Cognitive Behavioral Therapy; Efficacy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Change from Baseline in MADRS to end of treatment (20 sessions in 20-24 weeks)
Secondary outcomes:
measure: QIDS: Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C16)
timeFrame: Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: six and 12 months after end of treatment
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie
Study officials:
affiliation: University Hospital Tuebingen
name: Anil Batra, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.