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The efficacy of Inquiry Based Stress Reduction (IBSR) for depression, a randomized clinical trial.

The efficacy of Inquiry Based Stress Reduction (IBSR) for depression, a randomized clinical trial. - IBSR for depression

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47093
Enrollment
88
Registered
2018-09-18
Start date
2015-10-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Melancholy Sadness

Interventions

The intervention in the experimental group is IBSR. In the control group the intervention is treatment as usual, CBT. The IBSR intervention consists of psycho-education on depression and the influe
Depression
IBSR

Sponsors

FortaGroep
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Patients will be eligible to participate if they meet the DSM-IV (APA, 2000) criteria for a major depressive disorder, mild to moderate, as the principal diagnosis on the Structured Clinical Interview for DSM-IV Axis I Disorders * Dutch version (SCID-I; van Groenestijn, et al., 1998). 2. Aged 18 years and older 3. Not making use of other treatment for depression at the time 4. No history of psychotherapy in the last year 5. No medication for depression or unchanged dosage of medication during the last two months 6. 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) 7. All participants are required to have sufficient knowledge of the Dutch language

Exclusion criteria

Exclusion criteria: Patients will only be excluded if they: 1. have active suicidal intent (which is asked during the interviews and further operationalized with help of the ninth item in the BDI-II-NL at pre-treatment: If patients marked the statement **I would kill myself if I could**, they are classified as being at risk of suicide), 2. meet the DSM-IV-TR criteria for severe major depressive disorder, psychotic disorder, or bipolar disorder, 3. suffer from mental impairment or neurocognitive disorders such as Alzheimer, 4. have substance abuse requiring specialist treatment, 5. have no time for homework.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure of this study is the severity of the depressive symptoms measured with the BDI-II-NL. The score-range of this 21-item questionnaire is 0 to 63. Higher scores reflect more severe depressive symptoms. Several studies have shown that the BDI-II is a strong screening measure for depression (Beck, Steer, & Brown, 1996; van der Does, 2002; Whisman, Perez, & Ramel, 2000). It is a widely used instrument measuring the severity of depression. In 1998 the BDI had already been used in over 2000 studies (Richter, Werner, Heerlein, Kraus, & Sauer, 1998).

Secondary

MeasureTime frame
Secondary outcome measures (see the research proposal in the appendix for more information on the listed questionnaires): General psychological distress SQ-48: Symptom Questionnaire 48 (Carlier, Schulte-Van Maaren, Wardenaar, Giltay, Van Noorden, Vergeer, & Zitman,2012). 48 multiple choice items Quality of life SF-36: Short Form Health Survey (Ware & Sherbourne, 1992). Dutch version by Aaronson, et al. (1998). 36 multiple choice items Acceptatie AAQ-II: Dutch version (Jacobs, Kleen, de Groot, & A-Tjak, 2008) of the Acceptance and Action Questionnaire-II (Bond, et al., 2011). 10 multiple choice items Dysfunctional Attitudes DAS-A-17: The 17-item Dutch version (Leefregelvragenlijst; de Graaf, Roelofs, & Huibers, 2009) of the Dysfunctional Attitude Scale (DAS-A; Weissman, 1978) 17 multiple choice items Stait and trait anxiety ZBV: Zelfbeoordelingsvragenlijst (van der Ploeg, 2000). 40 multiple choice items Presence of an Axis I disorder (DSM-IV-TR: APA, 2000) SCID-I: The Structured Clinical Interview for DSM-IV Axis I Disorders (Dutch version: van Groenestijn, et al., 1998). Completion time variable Paralingual aspects of speech Analysis with PRAAT (Boersma & Weenink, 2018) of the recordings of the therapy sessions: Pitch, pitch variability and speech rate

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)