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This study investigates the feasibility of a general exposure-based treatment protocol that is intended to work for a large variety of patient groups with a clinically significant preoccupation with physical symptoms. This is a prospective single-group study based at Karolinska Institutet, Stockholm, Sweden, where 40 adults with DSM-5 somatic symptom disorder are enrolled in 8 weeks of therapist-guided exposure-based treatment via the Internet. Exposure is based on general principles but tailored to suit the needs of each patient. Outcomes include patient-reported credibility and expectancy, adherence to the treatment protocol, client satisfaction, and negative events. Within-group effects will also be quantified and discussed in relation to the existing literature.
Background:
A substantial portion of patients in routine care suffer from a recurrent preoccupation with physical symptoms, which often leads to substantial suffering and impairment. Exposure-based treatment - where the patient systematically seeks out that which gives rise to unwanted sensations, cognitions, or behavior - has been found to lead to beneficial effects in several types of symptom preoccupation. Yet, this form of treatment is rarely offered in routine care. This may be partially because existing treatment protocols have been developed for specific symptom clusters (e.g., functional somatic syndromes such as irritable bowel syndrome and fibromyalgia) or specific unwanted responses to symptoms (e.g., the fear of having a severe illness), and that many clinics do not have the resources to offer all these specialized protocols in parallel. An alternative approach could be to base exposure treatment on a more general protocol that may be tailored to suit a larger variety of patient groups who suffer from a recurrent preoccupation with physical symptoms. However, it is yet unclear if the use of such a general treatment protocol for symptom preoccupation would be feasible, for example in terms of patient-reported credibility, adherence, identification with the rationale, and general client satisfaction.
Aim:
To investigate the feasibility of delivering exposure-based treatment using a general protocol for clinically significant symptom preoccupation, without selecting patients based on any specific symptom cluster (such as a functional somatic syndrome) or specific unwanted response to physical symptoms (such as a frequent fear of illness).
Design:
This is a prospective single-group feasibility study based at Karolinska Institutet, Stockholm, Sweden, where 40 adults with somatic symptom disorder according to the Diagnostic and statistical manual of mental disorders 5 (DSM-5) are enrolled in 8 weeks of therapist-guided exposure-based treatment that is delivered via the Internet. Various aspects of feasibility are assessed; most notably: patient-reported credibility and expectancy, adherence to the treatment protocol, client satisfaction, and negative events. Within-group effects are also quantified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-delivered exposure-based treatment | Experimental | Eight weeks of therapist-guided exposure-based treatment delivered via the Internet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure | Behavioral | Systematic confrontation with stimuli associated with symptom-related distress, to achieve therapeutic changes in cognitions or behavior |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility 1: Distribution of Physical Symptoms | 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) |
| Feasibility 2: Credibility/Expectancy Based on the Credibility/Expectancy Scale | Theoretical range: 0-50, higher score indicates higher credibility/expectancy | Week 3 of treatment |
| Feasibility 3: Adherence to the Protocol #1: Percentage Completed Modules in the Sample as a Whole | Preregistered target: at least 60% completed modules in the sample as a whole. In this study, all participants were enrolled in the same type of treatment and were thus offered to work with the same treatment modules. This outcome was the proportion of modules completed in total by all participants, out of the total modules available to all participants. | Adherence data collected over the entire course of the treatment, up to 8 weeks. |
| Feasibility 4: Patient-reported Adequacy of Rationale as Assessed Using a Questionnaire Developed Specifically for This Purpose (Theoretical Range: 0-10) | From 0 ("not at all relevant") to 10 ("extremely relevant"). 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) |
| Feasibility 5: Adequacy of the Measurement Strategy | Preregistered target: less than 30% missing data at post-treatment, and at least 75% finding the measurement strategy acceptable (less than 7 on a scale from 0 ["Not at all stressful/bothering"] to 10 ["Extremely stressful/bothering"]) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-15 (PHQ-15) | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erland Axelsson, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | 17165 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35854392 | Derived | Hybelius J, Gustavsson A, Af Winklerfelt Hammarberg S, Toth-Pal E, Johansson R, Ljotsson B, Axelsson E. A unified Internet-delivered exposure treatment for undifferentiated somatic symptom disorder: single-group prospective feasibility trial. Pilot Feasibility Stud. 2022 Jul 19;8(1):149. doi: 10.1186/s40814-022-01105-0. |
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We are willing to consider reasonable requests for individual participant data (IPD) and to consult the responsible parties accordingly. However, we do not expect to be granted permission to share IPD as long as, under Swedish and European Union (EU) data protection and privacy legislation, the IPD constitutes personal data meaning that it is possible to, using the study database, link the IPD to an identifiable living natural person.
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All participants were enrolled in treatment.
We originally aimed to recruit 40 participants for 80% power in two-sided tests of moderate effects (d=0.5) on efficacy outcomes measured at two time points, given a 5% alpha and 15% missing data at post-treatment. In light of the high data retention, prior to the data analysis, we ended the recruitment with 33 participants included in November 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Internet-delivered Exposure-based Treatment | Eight weeks of therapist-guided exposure-based treatment delivered via the Internet. Exposure: Systematic confrontation with stimuli associated with symptom-related distress, to achieve therapeutic changes in cognitions or behavior |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Internet-delivered Exposure-based Treatment | Eight weeks of therapist-guided exposure-based treatment delivered via the Internet. Exposure: Systematic confrontation with stimuli associated with symptom-related distress, to achieve therapeutic changes in cognitions or behavior |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility 1: Distribution of Physical Symptoms | According to the Patient Health Questionnaire-15 (PHQ-15, theoretical range: 0-30, higher score indicates more distressing physical symptoms) | Posted | Mean | Full Range | score on a scale | Pre-treatment assessment (within 2 weeks before treatment) |
|
|
8-week treatment period
We assessed adverse events using free-text items where the respondent was instructed to describe up to three adverse events and rate how much this affected them at the time it occurred and at post treatment. We also administered the 20-item Negative Efects Questionnaire (NEQ-20).
The reason why 32 (not 33) is reported as the number at risk for the "other" subtype of adverse events is that these data were derived from a post-treamtent questionnaire that was completed by 32/33 participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Internet-delivered Exposure-based Treatment | Eight weeks of therapist-guided exposure-based treatment delivered via the Internet. Exposure: Systematic confrontation with stimuli associated with symptom-related distress, to achieve therapeutic changes in cognitions or behavior |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increased anxiety, stress or distress | Psychiatric disorders | Systematic Assessment | self-reported, free text item |
The lack of a control group implies that we cannot determine if change in the efficacy outcomes were caused by participants engaging in exposure. Within-group effects were probably on the conservative side, considering the covid-19 restrictions. Another limitation is that, for pragmatic reasons, the participants were self-selected, which could indicate a highly motivated sample. Moreover, the participants were highly educated with a low average level of functional impairment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erland Axelsson | Karolinska Institutet | 0706171039 | +46 | erland.axelsson@ki.se |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2020 | Jul 19, 2021 | Prot_SAP_000.pdf |
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Prospective single-group cohort study
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Psychological intervention, patient-reported outcomes
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| Post-treatment assessment (immediately after treatment, completed within 45 days) |
| 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. | Post-treatment assessment (immediately after treatment, completed within 45 days) |
| Feasibility 7a: Adverse Events Measured Using Free-text Items #1: Total Number of Reported Events | The respondent was instructed to describe up to three adverse events. | Post-treatment assessment (immediately after treatment, completed within 45 days) |
| 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) |
| Feasibility 3: Adherence to the Protocol #2: Percentage of Participants Completing at Least 2 Exposure Exercises | Preregistered target: at least 50% of participants completing at least 2 exposure exercises | Adherence data collected over the entire course of the treatment, up to 8 weeks. |
| Feasibility 7a: Adverse Events Measured Using Free-text Items #2: Number of Participants Who Reported at Least One Adverse Event | The respondent was instructed to describe up to three adverse events. | Post-treatment assessment (immediately after treatment, completed within 45 days) |
| Somatic Symptom Disorder-B Criteria Scale (SSD-12) | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). 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 |
| Symptom Preoccupation Scale (Preliminary Scale) | Under development, higher score indicates higher degree of preoccupation with symptoms. This is to be regarded as an item pool that will be further analyzed in 2024-2025, and in conjunction with data from other clinical trials. As of September 2023, it is therefore not yet possible to provide a theoretical range for this scale, and it is also not possible to provide outcomes. | 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 |
| 14-item Health Anxiety Inventory (HAI-14) | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). 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 |
| Anxiety Sensitivity Index (ASI) | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). 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 |
| GAD-7 | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). 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 |
| Patient Health Questionnaire (PHQ-9) | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). 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 |
| 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). 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 |
| Alcohol Use Disorders Identification Test (AUDIT) | Theoretical range: 0-40, higher score indicates more problematic alcohol use | Screening only |
| Drug Use Disorders Identification Test (DUDIT) | Theoretical range: 0-44, higher score indicates more problematic substance use | Screening only |
| Working Alliance Inventory (WAI) | Theoretical range: 6-42, higher score indicates better relationship with the therapist | Week 3 of treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| University education | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| Primary | Feasibility 2: Credibility/Expectancy Based on the Credibility/Expectancy Scale | Theoretical range: 0-50, higher score indicates higher credibility/expectancy | All participants completed the week 3 assessment. | Posted | Mean | Standard Deviation | score on a scale | Week 3 of treatment |
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| Primary | Feasibility 3: Adherence to the Protocol #1: Percentage Completed Modules in the Sample as a Whole | Preregistered target: at least 60% completed modules in the sample as a whole. In this study, all participants were enrolled in the same type of treatment and were thus offered to work with the same treatment modules. This outcome was the proportion of modules completed in total by all participants, out of the total modules available to all participants. | In this study, all 33 participants were enrolled in the same type of treatment and were thus offered to work with the same five treatment modules. | Posted | Count of Units | Modules | Adherence data collected over the entire course of the treatment, up to 8 weeks. | Modules | Modules |
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| Primary | Feasibility 4: Patient-reported Adequacy of Rationale as Assessed Using a Questionnaire Developed Specifically for This Purpose (Theoretical Range: 0-10) | From 0 ("not at all relevant") to 10 ("extremely relevant"). Was originally intended to be administered at week 3, but was administered post-treatment due to an administrative error | Posted | Mean | Standard Deviation | score on a scale | Post-treatment assessment (immediately after treatment, completed within 45 days) |
|
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| Primary | Feasibility 5: Adequacy of the Measurement Strategy | Preregistered target: less than 30% missing data at post-treatment, and at least 75% finding the measurement strategy acceptable (less than 7 on a scale from 0 ["Not at all stressful/bothering"] to 10 ["Extremely stressful/bothering"]) | Because the question about the measurement strategy was administered at the post-treatment assessment, which was completed by 32/33 participants, 32 was the denominator for this outcome. | Posted | Count of Participants | Participants | Post-treatment assessment (immediately after treatment, completed within 45 days) |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Post-treatment assessment (immediately after treatment, completed within 45 days) |
|
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| Primary | Feasibility 7a: Adverse Events Measured Using Free-text Items #1: Total Number of Reported Events | The respondent was instructed to describe up to three adverse events. | Posted | Number | adverse events | Post-treatment assessment (immediately after treatment, completed within 45 days) |
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| 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 | Posted | Mean | Standard Deviation | score on scale | Post-treatment assessment (immediately after treatment, completed within 45 days) |
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| Primary | Feasibility 3: Adherence to the Protocol #2: Percentage of Participants Completing at Least 2 Exposure Exercises | Preregistered target: at least 50% of participants completing at least 2 exposure exercises | Posted | Count of Participants | Participants | Adherence data collected over the entire course of the treatment, up to 8 weeks. |
|
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| Primary | Feasibility 7a: Adverse Events Measured Using Free-text Items #2: Number of Participants Who Reported at Least One Adverse Event | The respondent was instructed to describe up to three adverse events. | Posted | Count of Participants | Participants | Post-treatment assessment (immediately after treatment, completed within 45 days) |
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| Secondary | Patient Health Questionnaire-15 (PHQ-15) | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-30, higher score indicates more distressing physical symptoms | Posted | Mean | 95% Confidence Interval | units on a scale | 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 |
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| Secondary | Somatic Symptom Disorder-B Criteria Scale (SSD-12) | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-48, higher score indicates higher degree of preoccupation with symptoms | Posted | Mean | 95% Confidence Interval | Likert scale units | 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 |
|
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| Secondary | Symptom Preoccupation Scale (Preliminary Scale) | Under development, higher score indicates higher degree of preoccupation with symptoms. This is to be regarded as an item pool that will be further analyzed in 2024-2025, and in conjunction with data from other clinical trials. As of September 2023, it is therefore not yet possible to provide a theoretical range for this scale, and it is also not possible to provide outcomes. | Not Posted | Jun 2025 | 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 | Participants |
| Secondary | 14-item Health Anxiety Inventory (HAI-14) | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-42, higher score indicates more health anxiety | Posted | Mean | 95% Confidence Interval | Likert scale units | Screening, pre-treatment assessment (within 2 weeks before treatment), Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment |
|
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| Secondary | Anxiety Sensitivity Index (ASI) | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-64, higher score indicates more anxiety sensitivity | Posted | Mean | 95% Confidence Interval | Likert scale units | 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 |
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| Secondary | GAD-7 | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-21, higher score indicates more general anxiety | Posted | Mean | 95% Confidence Interval | Likert scale units | 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 |
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| Secondary | Patient Health Questionnaire (PHQ-9) | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-27, higher score indicates more symptoms of depression | Posted | Mean | 95% Confidence Interval | units on a scale | 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 |
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| Secondary | 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) | Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-100, higher score indicates more disability | Posted | Mean | 95% Confidence Interval | units on a scale | Screening, pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment |
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| Secondary | Alcohol Use Disorders Identification Test (AUDIT) | Theoretical range: 0-40, higher score indicates more problematic alcohol use | Posted | Mean | Standard Deviation | score on a scale | Screening only |
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| Secondary | Drug Use Disorders Identification Test (DUDIT) | Theoretical range: 0-44, higher score indicates more problematic substance use | Posted | Mean | Standard Deviation | score on a scale | Screening only |
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| Secondary | Working Alliance Inventory (WAI) | Theoretical range: 6-42, higher score indicates better relationship with the therapist | Posted | Mean | Standard Deviation | score on a scale | Week 3 of treatment |
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| 0 |
| 33 |
| 0 |
| 33 |
| 5 |
| 32 |
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| a negative outlook on the future caused by poor treatment outcome | Psychiatric disorders | Systematic Assessment | self-reported, free text item |
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| distress caused by conflicting information on how to optimise the effect of meditation | Psychiatric disorders | Systematic Assessment | self-reported, free text item |
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