Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Feasibility 1: distribution of physical symptoms |
Primarily according to the Patient Health Questionnaire-15 (PHQ-15, theoretical range: 0-30, higher score indicates more distressing physical symptoms) |
Pre-treatment assessment (within 2 weeks before treatment) |
|
Primary |
Feasibility 2: credibility/expectancy based on the Credibility/Expectancy scale |
Theoretical range: 0-50, higher score indicates higher credibility/expectancy |
Week 3 of treatment |
|
Primary |
Feasibility 3: adherence to the protocol in terms of at least 60% completed modules and at least 50% of participants completing at least 2 exposure exercises |
|
Post-treatment assessment (immediately after treatment, completed within 45 days) |
|
Primary |
Feasibility 4: patient-reported adequacy of rationale as assessed using a questionnaire developed specifically for this purpose (theoretical range: 0-10) |
Was originally intended to be administered at week 3, but was administered post-treatment due to an administrative error |
Post-treatment assessment (immediately after treatment, completed within 45 days) |
|
Primary |
Feasibility 5: adequacy of the measurement strategy in terms of less than 30% missing data at post-treatment, and at least 75% finding the measurement strategy acceptable |
|
Post-treatment assessment (immediately after treatment, completed within 45 days) |
|
Primary |
Feasibility 6: satisfaction with treatment as indicated by a mean Client Satisfaction Questionnaire (CSQ-8) score of at least 22 |
Theoretical range: 8-32, higher score indicates higher satisfaction. This sum score is based on 8 items, each scored 1-4. The original preregistered range of 7-28 was an erratum. |
Post-treatment assessment (immediately after treatment, completed within 45 days) |
|
Primary |
Feasibility 7a: adverse events measured using free-text items, primarily reported as the total number of reported events |
|
Post-treatment assessment (immediately after treatment, completed within 45 days) |
|
Primary |
Feasibility 7b: adverse events measured using the 20-item Negative Effects Questionnaire (NEQ-20) |
Theoretical range: 0-80, higher score indicates more severe adverse events |
Post-treatment assessment (immediately after treatment, completed within 45 days) |
|
Secondary |
Patient Health Questionnaire-15 (PHQ-15) |
Theoretical range: 0-30, higher score indicates more distressing physical symptoms |
Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment |
|
Secondary |
Somatic Symptom Disorder-B Criteria Scale (SSD-12) |
Theoretical range: 0-48, higher score indicates higher degree of preoccupation with symptoms |
Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment |
|
Secondary |
Symptom Preoccupation Scale (preliminary scale) |
Under development, higher score indicates higher degree of preoccupation with symptoms |
Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment |
|
Secondary |
14-item Health Anxiety Inventory (HAI-14) |
Theoretical range: 0-42, higher score indicates more health anxiety |
Screening, pre-treatment assessment (within 2 weeks before treatment), Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment |
|
Secondary |
Anxiety Sensitivity Index (ASI) |
Theoretical range: 0-64, higher score indicates more anxiety sensitivity |
Screening, pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment |
|
Secondary |
GAD-7 |
Theoretical range: 0-21, higher score indicates more general anxiety |
Pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment |
|
Secondary |
Patient Health Questionnaire (PHQ-9) |
Theoretical range: 0-27, higher score indicates more symptoms of depression |
Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatments (suicidality), post-treatment assesment (immediately after treatment, completed within 45 days), 3 months after treatment |
|
Secondary |
12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) |
Theoretical range: 0-100, higher score indicates more disability |
Screening, pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment |
|
Secondary |
Alcohol Use Disorders Identification Test (AUDIT) |
Theoretical range: 0-40, higher score indicates more problematic alcohol use |
Screening only |
|
Secondary |
Drug Use Disorders Identification Test (DUDIT) |
Theoretical range: 0-44, higher score indicates more problematic substance use |
Screening only |
|
Secondary |
Working Alliance Inventory (WAI) |
Theoretical range: 6-42, higher score indicates better relationship with the therapist |
Week 3 of treatment |
|