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Completed

NCT Number: NCT02375308

Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HDT

Behavioral

20 sessions, individual psychotherapy

Other names: Hypnotherapeutic Treatment of Depression

ACDT

Behavioral

20 sessions, individual psychotherapy

Other names: Cognitive Behavioral Therapy (CBT) of Depression

Primary outcomes

  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 outcomes

  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%)

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Mar 2, 2015
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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