Clinical trial NCT02542618: The Efficacy of Inquiry Based Stress Reduction (IBSR) for Depression, a Clinical Trial
Official title: The Efficacy of Inquiry Based Stress Reduction (IBSR) for Depression, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Depression
Treatment
IBSR
CBT
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: FortaGroep
First posted: 2015-09-07
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
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.
timeFrame: At pre (baseline) and session 16 (post) and follow-up (after 1 and 2 years) measurements.
Secondary outcomes:
measure: 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
timeFrame: At pre (baseline), session 8 and 16 (post) and follow-up (after 1 and 2 years) measurements.
measure: 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
timeFrame: At pre (baseline), session 16 (post) and follow-up (after 1 and 2 years) measurements.
measure: 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
timeFrame: At pre (baseline), session 16 (post) and follow-up (after 1 and 2 years) measurements.
measure: 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
timeFrame: At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.
measure: 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
timeFrame: At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.
measure: 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
timeFrame: At pre (baseline), session 4,8, 12 and 16 (post) and follow-up (after 1 and 2 years) measurements.
measure: State-Trait Anxiety Inventory, version: Y (STAI-form Y) to measure the level of anxiety at baseline
timeFrame: At pre (baseline)
measure: Beck Depression Inventory (BDI-II) to measure change from baseline self-reported symptoms of depression at every fourth therapy session
timeFrame: At pre (baseline), session 4,8, 12 and 16 (post).
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: FortaGroep
state: Zuid-Holland
Study officials:
References: