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Study halted before recruitment started due to data integrity issues from the previous pilot studies. Decision made by PI, with support from the host institution.
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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
| Göteborg University | OTHER |
| Uppsala University | OTHER |
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The goal of this clinical trial is to assess the efficacy and cost-effectiveness of the iACTforDGBI intervention among adults with Disorders of Gut-Brain Interaction (DGBI) and psychological distress. The main questions it aims to answer are: What is the efficacy of iACTforDGBI vs DGBI School? What is the cost-effectiveness of iACTforDGBI vs DGBI School? Who are the responders of each intervention? What are the moderators and mechanisms of change of the interventions? Participants will be asked to: Complete one of the two interventions (to which they will be randomly allocated to). Both interventions are 8-session online programs, delivered via an interactive platform and tailored for Swedish-speaking adults with symptoms compatible with a DGBI and psychological distress. Both interventions are theory-based and expected to be beneficial. Participants will be asked to fill out online questionnaires for screening of study eligibility, and baseline, post-treatment and follow-up outcome measures to evaluate the intervention. A subsample will also be interviewed post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and Commitment Therapy with explicit self-compassion training | Experimental | Acceptance and Commitment Therapy with explicit self-compassion training |
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| Education about DGBI and distress | Active Comparator | Education |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy with explicit self-compassion training | Behavioral | The self-guided Online version of Acceptance and Commitment Therapy with explicit self-compassion components (iACTforDGBI) intervention will include 8 weekly sessions of around 20-30 minutes each, and will comprise ACT-consistent informative texts, audio exercises, and videos. |
| Measure | Description | Time Frame |
|---|---|---|
| The Gastrointestinal Symptom Rating Scale (GSRS) | Symptom Severity of DGBI, minimum 15, maximum 105, higher = worse gastrointestinal symptoms | T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up). T3 (6 month follow-up), T4 (12 month follow-up) |
| The Generalized Anxiety Disorder scale-7 (GAD-7) | Symptoms of general anxiety, total score 0-21, higher = worse anxiety symptoms | T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) |
| The Patient Health Questionnaire-9 (PHQ-9) | symptoms of depression, total score 0-27, higher = worse depressive symptoms | T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol 5-Dimension 5-Level (EQ-5D-5L), EQ Vas 0-100, higher = better health-related quality of life | Health-related Quality of Life | T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) |
| Assessment of Quality of Life - 8 dimensions (AQoL-8D) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inês A Trindade, Phd | Örebro University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro University | Örebro | Sweden |
This question is under investigation. Some of our data contain sensitive information on health, and the main priority is participants integrity which need to be balanced against basic scientific principles on scrutiny. However, any personal data that can be shared without compromising participants integrity to a reasonable degree will be shared upon reasonable request.
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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This is a randomized controlled trial in which we intend to compare the efficacy and cost-effectiveness of the iACTforDGBI intervention compared to the active control group (DGBI School).
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Researcher responsible for randomization and allocation
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| Education | Other | Participants in the active control group will be asked to complete 8 weekly 20-minute sessions of an online course for education on DGBIs. This course will be delivered through the same platform than the one delivering the online ACT for DGBI intervention, via the same website. The intervention platform will have similar designs and structure, and will be developed by the same web development company. This intervention is based on the IBS school program (e.g., Ringström et al., 2009), in particular its online version (Lindfors et al., 2021), developed by members of the current research team. |
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Health-related Quality of Life, Utility score -0.04 - 1.00, higher = better quality of life |
| T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) |
| The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) | Healthcare Utilization, no single fixed min/max, higher = worse/more costly outcome | T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) |
| The Chronic Illness Shame Scale (CISS) | Shame of Chronic Illnesses, total score 0-28, higher = worse shame related to chronic illness | T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) |
| The Credibility / Expectancy Questionnaire (CEQ) | Treatment Credibility and Expectancy, total score 3-27 each, higher = better treatment credibility/expectancy | T0 (week 0, only expectancy sub scale), Tmid (week 4, both subscales) |
| The System Usability Scale (SUS) | Intervention Platform Usability, total score 0-100, higher = better usability | T1 (week 8) |
| The Negative Effects Questionnaire (NEQ-20) | Negative Side Effects and Events, total score 0-80, higher = worse negative effects | T1 (week 8) |
| Global Impression of Change Scale | Impression of change, a single global change item, higher = worse | Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) |
| Awareness of Processes Post-Intervention Scale | Awareness of Processes, higher = more awareness | T1 (week 8) |
| The Multidimensional Psychological Flexibility Inventory (MPFI) | Psychological flexibility, composites scored as means, higher = worse for inflexibility | T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) |
| Self-Compassion Scale | Self-compassion, higher = better self-compassion | T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) |
| Insomnia Severity Index | Insomnia symptoms, total score 0-28, higher = worse insomnia severity | T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) |
| Major Life Events | Past 12 months. Questions about psychological/physical diagnoses, usually more events/greater burden = worse stress exposure | T0 (week 0), T3 (6 month follow-up) |