DepressionNCT02542618
The Efficacy of Inquiry Based Stress Reduction (IBSR) for Depression, a Clinical Trial
A study testing Inquiry Based Stress Reduction (IBSR) and Cognitive Behavioral Therapy (CBT) in people with Depression, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Background: Major depression is a common mental disorder with serious consequences. The societal costs of depression are high. Despite the existence of empirically-supported psychological therapies, many patients do not benefit from these treatments and relapse and recurrence percentages are high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Inquiry Based Stress Reduction (IBSR) and Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2015to Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years and older,
- Not making use of other treatment for depression at the time,
- No history of psychotherapy in the last year,
- No medication for depression or unchanged dosage of medication during the last two months ,
- All participants must be willing to refrain from engaging in additional psychological treatments or making changes to their medication status during the course of the trial. (changes in medication dosage will result in dropout),
- All participants must have at least a low average level of intelligence (IQ above 80). During regular intakes a clinical judgment is made. This is in accordance with the standard protocols used within the FortaGroep.
- All participants are required to have sufficient knowledge of the Dutch language.
Who cannot join
- Active suicidal intent (which is asked during the interviews and further operationalized with help of the ninth item in the BDI-II at pre-treatment: If patients marked the statement ''I would kill myself if I could'', they are classified as being at risk of suicide)
- If the DSM-IV criteria for severe major depressive disorder, psychotic disorder, or bipolar disorder are met
- A mental impairment or neurocognitive disorders such as Alzheimer
- Substance abuse requiring specialist treatment
- No time for homework.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Inquiry Based Stress Reduction (IBSR) for Depression, a Randomized Clinical Trial
Background: Major depression is a common mental disorder with serious consequences. The societal costs of depression are high. Despite the existence of empirically-supported psychological therapies, many patients do not benefit from these treatments and relapse and recurrence percentages are high. Improvement of existing treatments or development of new and better treatments is badly needed. Inquiry Based Stress Reduction (IBSR) is a promising verbal therapy focusing on the inquiry of thoughts and could be a next step in improving psychotherapy for depression.
Objective: The objective of the current study is to assess the effectiveness of IBSR. Research to date has shown that IBSR is effective in reducing symptoms of anxiety and depression. The investigators want to know if IBSR is more effective in reducing symptoms of depression than the best psychotherapeutic treatment for depression at this moment, cognitive behavioural therapy (CBT). The investigators' secondary objective is to know more about the underlying mechanisms of change of these therapies.
Read more
Study design: A randomized controlled intervention study.
Study population: 88 patients with a mild to moderate depression as their principal diagnosis.
Intervention: IBSR or CBT
- Conditions
- Depression
- Being tested
- Inquiry Based Stress Reduction (IBSR), Cognitive Behavioral Therapy (CBT)
- Keywords
- Depression, Treatment, IBSR, CBT
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inquiry Based Stress Reduction (IBSR)Behavioural
Also called The Work
Cognitive Behavioral Therapy (CBT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Inquiry Based stress Reduction (IBSR) | Experimental | IBSR intervention is the clinical implementation of a mindful-process, named "The Work" developed by Byron Katie. It teaches the individual to identify and question the thoughts that causes stress and suffering through four questions and turnarounds. Receives: Behavioral: Inquiry Based Stress Reduction (IBSR) |
| Cognitive Behavioral Therapy (CBT) | Active comparator | CBT is a psychological treatment method, focusing on a structured way to identify and modify unhelpful thinking patterns, underlying assumptions and idiosyncratic cognitive schemes about the self, the world (including other people) and the future. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (BDI-II) to measure change from baseline self-reported symptoms of depression at the endpoint of the therapy (after completing 16 sessions) and follow-ups.
The BDI-II is a self-report questionnaire which measures the severity of depression in 21 statements, with four levels of increasing severity each. The investigators use the BDI-II to measure self-reported symptoms of depression.
Measured: At pre (baseline) and session 16 (post) and follow-up (after 1 and 2 years) measurements.
Secondary outcomes (8)
Symptom Questionnaire (SQ-48) to measure change in self-reported general psychological distress from baseline at session 8, session 16 (end of therapy) and follow-ups
The SQ-48 is a self-report questionnaire which measures general psychological distress, vitality/optimism and work functioning. The subscales of this questionnaire include: Depression, Anxiety, Somatization, Agoraphobia, Aggression, Cognitive problems, Social Phobia, Work functioning and Vitality. The investigators use the SQ-48 to measure general psychological distress.
Measured: At pre (baseline), session 8 and 16 (post) and follow-up (after 1 and 2 years) measurements.
Short Form Health Survey (SF-36) to measure change from baseline self-reported quality of life at the endpoint of the therapy (after completing 16 sessions) and follow-ups
The SF-36 is a self-report questionnaire which measures quality of life. It consists of 36 items on well-being and functional, mental and physical health. The investigators use the SF-36 to measure quality of life.
Measured: At pre (baseline), session 16 (post) and follow-up (after 1 and 2 years) measurements.
The Structured Clinical Interview for Diagnostic and Statistical Manual-IV (DSM-IV) Axis I Disorders (SCID-I) Dutch version to screen for Diagnostic and Statistical Manual of Mental Disorder (DSM-IV) diagnoses
This structured interview is used to determine DSM-IV Axis I disorders. The investigators use the SCID-I to check in- and exclusion criteria, and to determine change in diagnosis after therapy.
Measured: At pre (baseline), session 16 (post) and follow-up (after 1 and 2 years) measurements.
Acceptance and Action Questionnaire-II (AAQ-II) to measure change in self-reported level of general psychological acceptance from baseline at every fourth therapy session and follow-ups
The AAQ-II is a self-report questionnaire which measures the psychological acceptance component of psychological flexibility. The investigators use the AAQ-II to measure the level of general psychological acceptance.
Measured: At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.
Dysfunctional Attitude Scale, 17-item Dutch version (DAS-A-17) to measure change in self-reported level of dysfunctional thinking from baseline at every fourth therapy session and follow-ups
The DAS-A-17 is a self-report scale designed to measures the respondent's use of typical depressive assumptions. The investigators use the DAS-A-17 to measure the level of dysfunctional thinking.
Measured: At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.
Behavioral activation for depression scale (BADS) to measure change in self-reported level of activation from baseline at every fourth therapy session and follow-ups
The short version of the BADS is a self-report questionnaire which measures the amount of activation in the past week. The investigators use the BADS to measure the level of activation.
Measured: At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.
State-Trait Anxiety Inventory, version: Y (STAI-form Y) to measure the level of anxiety at baseline
The STAI assesses current and trait anxiety symptoms. The investigators use the STAI to measure anxiety at baseline.
Measured: At pre (baseline)
Beck Depression Inventory (BDI-II) to measure change from baseline self-reported symptoms of depression at every fourth therapy session
Measured: At pre (baseline), session 4,8, 12 and 16 (post).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2018 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- FortaGroep
- Responsible party
- Principal investigator, Ingmar Franken, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542618
- Sponsor's protocol ID
- NL51699.078.15
- Status last verified
- Sep 2018
- First submitted
- 2 Sep 2015
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Inquiry Based Stress Reduction (IBSR) for Depression, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02542618
- Acronym / sponsor ID
- NL51699.078.15
- Conditions
- Depression
- Keywords
- Depression, Treatment, IBSR, CBT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- FortaGroep
- Study start
- Oct 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 7 Sep 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.
Background: Major depression is a common mental disorder with serious consequences. The societal costs of depression are high. Despite the existence of empirically-supported psychological therapies, many patients do not benefit from these treatments and relapse and recurrence percentages are high. Improvement of existing treatments or development of new and better treatments is badly needed. Inquiry Based Stress Reduction (IBSR) is a promising verbal therapy focusing on the inquiry of thoughts and could be a next step in improving psychotherapy for depression.
Objective: The objective of the current study is to assess the effectiveness of IBSR. Research to date has shown that IBSR is effective in reducing symptoms of anxiety and depression. The investigators want to know if IBSR is more effective in reducing symptoms of depression than the best psychotherapeutic treatment for depression at this moment, cognitive behavioural therapy (CBT). The investigators' secondary objective is to know more about the underlying mechanisms of change of these therapies.
Study design: A randomized controlled intervention study.
Study population: 88 patients with a mild to moderate depression as their principal diagnosis.
Intervention: IBSR or CBT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inquiry Based stress Reduction (IBSR) | Experimental | Behavioral: Inquiry Based Stress Reduction (IBSR)IBSR intervention is the clinical implementation of a mindful-process, named "The Work" developed by Byron Katie. It teaches the individual to identify and question the thoughts that causes stress and suffering through four questions and turnarounds. |
| Cognitive Behavioral Therapy (CBT) | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT)CBT is a psychological treatment method, focusing on a structured way to identify and modify unhelpful thinking patterns, underlying assumptions and idiosyncratic cognitive schemes about the self, the world (including other people) and the future. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years and older,
- Not making use of other treatment for depression at the time,
- No history of psychotherapy in the last year,
- No medication for depression or unchanged dosage of medication during the last two months ,
- All participants must be willing to refrain from engaging in additional psychological treatments or making changes to their medication status during the course of the trial. (changes in medication dosage will result in dropout),
Key exclusion criteria (5 listed)
- Active suicidal intent (which is asked during the interviews and further operationalized with help of the ninth item in the BDI-II at pre-treatment: If patients marked the statement ''I would kill myself if I could'', they are classified as being at risk of suicide)
- If the DSM-IV criteria for severe major depressive disorder, psychotic disorder, or bipolar disorder are met
- A mental impairment or neurocognitive disorders such as Alzheimer
- Substance abuse requiring specialist treatment
- No time for homework.
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 |
|---|---|---|
| Inquiry Based Stress Reduction (IBSR)Also: The Work | Behavioural | Inquiry Based stress Reduction (IBSR) |
| Cognitive Behavioral Therapy (CBT) | Behavioural | Cognitive Behavioral Therapy (CBT) |
Primary outcome
Beck Depression Inventory (BDI-II) to measure change from baseline self-reported symptoms of depression at the endpoint of the therapy (after completing 16 sessions) and follow-ups.
Time frame: At pre (baseline) and session 16 (post) and follow-up (after 1 and 2 years) measurements.
The BDI-II is a self-report questionnaire which measures the severity of depression in 21 statements, with four levels of increasing severity each. The investigators use the BDI-II to measure self-reported symptoms of depression.
8 secondary outcomes
Symptom Questionnaire (SQ-48) to measure change in self-reported general psychological distress from baseline at session 8, session 16 (end of therapy) and follow-ups
Time frame: At pre (baseline), session 8 and 16 (post) and follow-up (after 1 and 2 years) measurements.
Short Form Health Survey (SF-36) to measure change from baseline self-reported quality of life at the endpoint of the therapy (after completing 16 sessions) and follow-ups
Time frame: At pre (baseline), session 16 (post) and follow-up (after 1 and 2 years) measurements.
The Structured Clinical Interview for Diagnostic and Statistical Manual-IV (DSM-IV) Axis I Disorders (SCID-I) Dutch version to screen for Diagnostic and Statistical Manual of Mental Disorder (DSM-IV) diagnoses
Time frame: At pre (baseline), session 16 (post) and follow-up (after 1 and 2 years) measurements.
Acceptance and Action Questionnaire-II (AAQ-II) to measure change in self-reported level of general psychological acceptance from baseline at every fourth therapy session and follow-ups
Time frame: At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.
Dysfunctional Attitude Scale, 17-item Dutch version (DAS-A-17) to measure change in self-reported level of dysfunctional thinking from baseline at every fourth therapy session and follow-ups
Time frame: At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.
Behavioral activation for depression scale (BADS) to measure change in self-reported level of activation from baseline at every fourth therapy session and follow-ups
Time frame: At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.
State-Trait Anxiety Inventory, version: Y (STAI-form Y) to measure the level of anxiety at baseline
Time frame: At pre (baseline)
Beck Depression Inventory (BDI-II) to measure change from baseline self-reported symptoms of depression at every fourth therapy session
Time frame: At pre (baseline), session 4,8, 12 and 16 (post).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inquiry Based Stress Reduction (IBSR) and Cognitive Behavioral Therapy (CBT) in people with Depression, run by Erasmus Medical Center at 1 site in Netherlands.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 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 Netherlands. 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?
Results are not available in the source record.
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?
Beck Depression Inventory (BDI-II) to measure change from baseline self-reported symptoms of depression at the endpoint of the therapy (after completing 16 sessions) and follow-ups. (time frame: At pre (baseline) and session 16 (post) and follow-up (after 1 and 2 years) measurements.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2018.