Condition: Major Depressive Disorder (MDD) Clinical Trial
Official title:
The Modulatory Role of Communicated Treatment Rationale on Treatment Expectation Effects in Depression.
| Verified date | November 2023 |
| Source | Philipps University Marburg Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Placebo groups in clinical trials on depression show impressive improvements. Yet, there is little research on the mechanism underlying this effect. The aim of this study is to assess how patients' treatment expectations modulate the placebo treatment effects. We expect that patients' treatment expectation determines placebo responses and treatment outcomes, and that this expectation is influenced by the disorder explanations (information about the illness models) typically provided during the initial medical encounters that precede treatment. In the study we aim to manipulate depressed patients' expectations by providing two different clinician-delivered illness and treatment rationales (biological/ psychological). Patients will then receive placebo treatment (pharmacological/ psychological), that is either congruent or incongruent with the previously communicated treatment rationale. Hypotheses: 1. Providing a treatment-congruent treatment rationale leads to a better outcome than providing treatment-incongruent rationales. 2. Treatment-congruent explanations reduce the risk of side effect development, in particular in the medication arm. 3. Inter-individual differences in the effect of provided treatment rationale are associated with pre-treatment experiences and expectations, depression severity and comorbid anxiety.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | September 12, 2023 |
| Est. primary completion date | September 12, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Diagnosis of major depression according to the 'Structured Clinical Interview for DSM-V' (SCID) - Age>17 - Comorbidity is allowed if major depression is the dominant clinical problem - Concordant medication is allowed if kept constant for the four weeks before and until the end of the trial (with the exception of benzodiazepines and if not contraindicated together with Buscopan) - Fluency in German - Informed consent Exclusion Criteria: - Severe depression (BDI> 30) or suicidality - Psychosis - Significant neurological diseases - Other mental or physical disorder with substantial influence on disability - Benzodiazepine intake - Any intolerance against Buscopan and sucrose or any medical condition/treatment conflicting with Buscopan intake |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg | Marburg |
| Lead Sponsor | Collaborator |
|---|---|
| Philipps University Marburg Medical Center | Psychotherapie-Ambulanz Marburg e.V. |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Treatment adherence | Count of remaining pills per week; participation in weekly therapy sessions | Once per week (during the 4-week treatment period) | |
| Other | Common biological stress markers | Salivary Alpha-Amylase and cortisol levels | Baseline | |
| Other | Current treatment effects after 4 weeks of treatment | Generic questions to assess perceived treatment effects; 3 items, each rated on a 0(no improvement) - 10(most improvement imaginable) numeric scale; total scores range from 0-30 (higher scores indicate better treatment expectations) | post-treatment (4 weeks after start of treatment) | |
| Other | Current treatment effects at follow-up | Generic questions to assess perceived treatment effects; 3 items, each rated on a 0(no improvement) - 10(most improvement imaginable) numeric analogue scale; total scores range from 0-30 (higher scores indicate better treatment expectations) | at follow-up (1 week after end of treatment) | |
| Other | Change in generic expectations about antidepressants at the start of treatment | Generic questions assess pre-existing expectations about antidepressants; 3 items; items are rated on a 0(no expectation of improvement) - 10(most improvement imaginable) numeric analogue scale; total scores range from 0-30 (higher scores indicate better antidepressant treatment expectations) | Baseline; pre-treatment (2-7 days after baseline) | |
| Other | Change in generic expectations about psychotherapy at the start of treatment | Generic questions to assess pre-existing expectations about psychotherapy; 3 items; items are rated on a 0(no expectation of improvement) - 10(most improvement imaginable) numeric analogue scale; total scores range from 0-30 (higher scores indicate better psychotherapy treatment expectations) | Baseline, pre-treatment (2-7 days after baseline) | |
| Other | 'Somatosensory Amplification Scale' (SSAS) | Self-report questionnaire to assess amount of somatosensory amplification tendencies; 10 items; items are rated on a 5-point scale from 1(not at all true) - 5(extremely true); total scores range from 10-50 (higher scores indicate more somatosensory amplification) | Baseline | |
| Other | 'Behavioral Inhibition/Behavioral Approach System' Scale (BIS/BAS) | Self-report questionnaire to assess sensitivity to approach or avoidance goals; 24 items; each item is rated on a 4-point scale from 1(not at all true for me) to 4(very true for me) | Baseline | |
| Other | Generic screening pre-experiences with antidepressants | Generic questions to assess pre-existing experiences with antidepressants; 4 items; if experience with antidepressants is indicated in item 1, the following 3 items are rated on a 0(no improvement) - 10(most improvement imaginable) numeric analogue scale; total scores range from 0-30 (higher scores indicate better past experiences with antidepressants) | Baseline | |
| Other | Generic screening pre-experiences with psychotherapy | Generic questions to assess pre-existing experiences with psychotherapy; 4 items; if experience with psychotherapy is indicated in item 1, the following 3 items are rated on a 0 (no improvement)-10(most improvement imaginable) numeric analogue scale; total scores range from 0-30 (higher scores indicate better past experiences with psychotherapy) | Baseline | |
| Primary | Change in depression severity scores after 4 weeks of treatment - 'Montgomery Asberg Depression Scale' (MADRS) | Expert rating to assess depression severity; 10 items; each item is rated on a 7-point scale (0-6); total scores range between 0-60 (higher scores indicate more severe depression) | Baseline, post-treatment (4 weeks after start of treatment) | |
| Secondary | Change in depressive symptom scores after 4 weeks of treatment- 'Beck Depression Inventory' (BDI-II) | Self-report questionnaire to assess subjective depression symptomatology; 21 items (each item response is scored 0-3); total scores range from 0 - 63 (higher scores indicate more depressiveness) | Baseline, post-treatment (4 weeks after start of treatment), and at follow-up (1 week later) | |
| Secondary | Change in subjective disability scores after 4 weeks of treatment - adaptation of 'Pain Disability Index' (PDI) | Self-report questionnaire to assess illness burden; 7 items; each item rated on a 0 (no disability)-10(maximum disability) standardized numerical analogue scale; total scores range from 0-70 (higher scores indicate more disability) | Pre-treatment (2-7 days after baseline), post-treatment (4 weeks after start of treatment), and at follow-up (1 week later) | |
| Secondary | Change in 'Generic Assessment of Side-Effects' scores (GASE) after 4 weeks of treatment | Self-report questionnaire to assess experience of side effects; 36 items; each item describes a side-effect symptom which is rated on a 4-point scale from 0 (not present)-3 (strong experience); total scores range from 0-108 (higher scores indicate stronger experience of side effects) | Pre-treatment (2-7 days after baseline), post-treatment (4 weeks after start of treatment), and at follow-up (1 week later) | |
| Secondary | Change in treatment expectations at the start of treatment - 'Treatment Expectation Questionnaire' (TEX-Q) | Self-report questionnaire to assess expectations about treatment outcomes; 15 items; each rated on a 0 (no expectation of improvement)- 10(most improvement imaginable) numeric scale; total scores range from 0-150 (higher scores indicate better treatment expectations) | Baseline, pre-treatment (2-7 days after baseline) | |
| Secondary | Change in subjective stress scores after 4 weeks of treatment - 'Perceived Stress Scale' (PSS-10) | Self-report questionnaire to assess subjective stress experience; 10 items; each item is rated on a 5-point scale from 0(never) to 4(very often); total scores range between 0 and 40 (higher scores indicate more subjective stress) | pre-treatment (2-7 days after baseline), post-treatment (4 weeks after start of treatment), and at follow-up (1 week later) | |
| Secondary | Change in anxiety scores after 4 weeks of treatment - 'State-Trait-Anxiety- Depression-Inventory' (STADI) | Self-report questionnaire to assess state and trait anxiety and depression; 40 (20 state scale; 20 trait scale) items; each item is rated on a 4-point scale from 1(not at all) to 4(very much); total scores per scale range between 20 and 80 (higher scores indicate more anxiety) | State scale: Baseline; pre-treatment (2-7 days after baseline), post-treatment (4 weeks after start of treatment) and at follow-up (1 week later); Trait scale only measured at baseline |