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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 acceptability, feasibility, and usability of the iACTforDGBI intervention among patients with Disorders of Gut-Brain Interaction (DGBI). The main question it aims to answer are:
What are the perceptions of patients with DGBI and healthcare practitioners regarding the acceptability, feasibility, and usability of the iACTforDGBI intervention?
Participants will be asked to:
Complete the iACTforDGBI intervention prototype, consisting of self-guided online sessions.
Participate in online interviews and fill out online questionnaires to evaluate the intervention concerning acceptability, feasibility, usability and preliminary effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | Acceptance and Commitment Therapy (ACT) |
|
| Psychoeducation | Active Comparator | Psychoeducation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Behavioral | The self-guided Online version of Acceptance and Commitment Therapy (iACTforDGBI) intervention will include 8 weekly sessions of around 20 minutes each, and will comprise ACT-consistent informative texts, audio exercises, and videos. The intervention is expected to have the following overall structure: Session 1: Introduction to the intervention and promotion of creative hopelessness, Awareness of bodily sensations, Values clarification Session 2: Committed action, Acceptance, Cognitive defusion Session 3: Self as context, Conclusions Session 4-8: personalised content (in-depth material and tasks based on individual difficulties assessed with diary) |
| Measure | Description | Time Frame |
|---|---|---|
| Individual Interviews | Feasibility and Acceptability of intervention | At post treatment (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| The Generalized Anxiety Disorder scale-7 (GAD-7) | Symptoms of general anxiety | At pre and post treatment (0 and 8 weeks), 6-month follow-up (FU1), and 12-month follow-up (FU2) assessments |
| EQ-5D-5L |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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This is a pilot study (feasibility including acceptability) in which we intend to see how the prototype intervention and overall workload (including measurements) is perceived by the participants.
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| Psychoeducation | 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 a similar 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. The content of the education course will be based on the IBS school intervention (e.g., Ringström et al., 2009), in particular its online version (Lindfors et al., 2021), developed by members of the current research team. This education intervention was based on the biopsychosocial model of DGBI and was originally developed and tested as a face-to-face group intervention with six 2-h sessions held weekly. IBS school generally aims at increasing disease knowledge in people with IBS and covers a wide spectrum of issues related to IBS, such as disease pathophysiological me |
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Health-related Quality of Life
| At pre and post treatment (0 and 8 weeks) |
| AQoL-8D | Health-related Quality of Life | At pre and post treatment (0 and 8 weeks) |
| The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) | Healthcare Utilization | At pre and post treatment (0 and 8 weeks) |
| The Gastrointestinal Symptom Rating Scale (GSRS) | Symptom Severity of DGBI | At pre and post treatment (0 and 8 weeks) |
| The Chronic Illness Shame Scale (CISS) | Shame of Chronic Illnesses: | At pre and post treatment (0 and 8 weeks) |
| The Credibility / Expectancy Questionnaire (CEQ) | Treatment Credibility and Expectancy | After session 2 (2 weeks) |
| The System Usability Scale (SUS) | Intervention Platform Usability | At post treatment (8 weeks) |
| The Negative Effects Questionnaire (NEQ-20) | Negative Side Effects and Events | At post treatment (8 weeks) |
| The Intervention Acceptability Scale | Intervention Acceptability | At post treatment (8 weeks) |
| The Contextual Therapies Process Awareness Scale | Awareness of Processes | At post treatment (8 weeks) |
| The Patient Health Questionnaire-9 (PHQ-9) | symptoms of depression | At pre and post treatment (0 and 8 weeks) |
| The Multidimensional Psychological Flexibility Inventory (MPFI) | Psychological flexibility | At pre and post treatment (0 and 8 weeks) |
| The State Self-Compassion Scale - short Form (SSCS-S) | state self-compassion | At pre and post treatment (0 and 8 weeks) |
| The Self-Compassion Scale - short Form (SCS-SF) | trait self-compassion | At pre and post treatment (0 and 8 weeks) |