Major Depressive DisorderNCT02375308
Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression
A study testing HDT and ACDT in people with Major Depressive Disorder, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- HDT and ACDT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to 28 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie
Tübingen, 72076
About this study
Official title: Efficacy of Activation-focussed Cognitive Treatment of Depression (ACDT) to Hypnotherapeutic Treatment of Depression (HDT) in Mild to Moderate Major 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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- HDT, ACDT
- Keywords
- Hypnotherapy; Cognitive Behavioral Therapy; Efficacy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDTBehavioural
Also called Hypnotherapeutic Treatment of Depression
20 sessions, individual psychotherapy
ACDTBehavioural
Also called Cognitive Behavioral Therapy (CBT) of Depression
20 sessions, individual psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: ACDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Clinician-rating of depressive symptoms, Primary outcome
Measured: 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)
Clinician-rating of depressive symptoms
Measured: Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)
Patient Health Questionnaire (PHQ-9)
Self-report of depressive symptoms
Measured: Change from Baseline to end of therapy and follow-ups (six and 12 months after end of treatment)
Montgomery-Åsberg Depression Rating Scale (MADRS)
Incidence of response rate (symptom reduction > 60%)
Measured: six and 12 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2017
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Batra, University Hospital Tuebingen
- Investigators
- Anil Batra, Prof., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375308
- Sponsor's protocol ID
- UTubingen
- Status last verified
- Sep 2018
- First submitted
- 24 Feb 2015
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 17541109Alladin 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.
PubMed 17365072Fuhr 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.
PubMed 36928627Fuhr 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.
PubMed 34676660Fuhr 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.
PubMed 29196478
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Activation-focussed Cognitive Treatment of Depression (ACDT) to Hypnotherapeutic Treatment of Depression (HDT) in Mild to Moderate Major Depression
- ClinicalTrials.gov ID
- NCT02375308
- Acronym / sponsor ID
- UTubingen
- Conditions
- Major Depressive Disorder
- Keywords
- Hypnotherapy; Cognitive Behavioral Therapy; Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnotherapeutic Treatment | Experimental | Behavioral: HDTHDT (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. |
| Cognitive Behavioral Treatment | Experimental | Behavioral: ACDTACDT (Activation-focussed Cognitive Treatment of Depression) focuses on psychoeducation, behavior activation, the use of cognitive techniques, and the improvement of social skills. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDTAlso: Hypnotherapeutic Treatment of Depression20 sessions, individual psychotherapy | Behavioural | Hypnotherapeutic Treatment |
| ACDTAlso: Cognitive Behavioral Therapy (CBT) of Depression20 sessions, individual psychotherapy | Behavioural | Cognitive Behavioral Treatment |
Primary outcome
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
3 secondary outcomes
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)
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)
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: six and 12 months after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Background: PubMed 17541109Luty 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.
- Background: PubMed 17365072Alladin 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.
- Derived from this study: PubMed 36928627Fuhr 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.
- Derived from this study: PubMed 34676660Fuhr 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.
- Derived from this study: PubMed 29196478Fuhr 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Batra, Prof. principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HDT and ACDT in people with Major Depressive Disorder, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: Change from Baseline in MADRS to end of treatment (20 sessions in 20-24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375308, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.