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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) |
|
| Education on DGBI, psychoeducation | Active Comparator | Education on DGBI, psychoeducation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Behavioral | The 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 0: Individual videoconference meeting, introduction. Session 1: Creative hopelessness and mindfulness. Session 2: The body, acceptance, and values. Session 3: Compassion. Session 4: Cognitive defusion and committed action. Session 5-7: Personalised content (in-depth material and tasks based on individual difficulties assessed with diary). Session 8: Summary of intervention. |
| 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, min-max: 0-21, higher scores: more symptoms of general anxiety. | At pre and post treatment (0 and 8 weeks). |
| 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 the 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 second (beta) pilot study (feasibility including acceptability) in which the investigators intend to see how the intervention and overall workload (including measurements) is perceived by the participants.
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Principal Investigator, other investigators
|
| 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. Session 0: Individual session, introduction. Session 1-8: The content 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. |
|
Health-related Quality of Life, min-max 0-1 (index value), higher scores: better health-related quality of life
| At pre and post treatment (0 and 8 weeks) |
| AQoL-8D | Health-related Quality of Life, min-max -0.04-1.00, higher scores: better 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, no fixed range (reports number of contacts, costs etc.), higher scores: greater healthcare utilization/higher costs. | At pre and post treatment (0 and 8 weeks) |
| The Gastrointestinal Symptom Rating Scale (GSRS) | Symptom Severity of DGBI, min-max 19-133, higher scores: more severe gastrointestinal symptoms. | At pre and post treatment (0 and 8 weeks) |
| The Chronic Illness Shame Scale (CISS) | Shame of Chronic Illnesses, min-max 0-28, higher scores: greater shame related to chronic illness. | At pre and post treatment (0 and 8 weeks) |
| The Credibility/Expectancy Questionnaire (CEQ) | Treatment Credibility and Expectancy, min-max 0-27 credibility, 0-9 expectancy, higher scores: higher treatment credibility/expectancy. | After session 2 (2 weeks) |
| The System Usability Scale (SUS), min-max 0-100, higher scores: greater perceived usability. | Intervention Platform Usability | At post treatment (8 weeks) |
| The Negative Effects Questionnaire (NEQ-20), min-max 0-80 (depending on number of endorsed negative effects), higher scores: more negative effects/adverse events. | Negative side effects and events | At post treatment (8 weeks) |
| The Intervention Acceptability Scale | Intervention Acceptability, min-max 1-5 per item, higher scores: greater intervention acceptability. | At post treatment (8 weeks) |
| The Contextual Therapies Process Awareness Scale | Awareness of Processes, min-max 1-5 per item, higher scores: greater process awareness. | At post treatment (8 weeks) |
| The Patient Health Questionnaire-9 (PHQ-9) | Symptoms of depression, min-max 0-27, higher scores: more depressive symptoms. | At pre and post treatment (0 and 8 weeks) |
| The Multidimensional Psychological Flexibility Inventory (MPFI) | Psychological flexibility, min-max 1-6 per item, higher scores: indicate more rigidity/avoidance on negative sub scales | At pre and post treatment (0 and 8 weeks) |
| The State Self-Compassion Scale - short form (SSCS-S) | State self-compassion, min-max 6-30, higher scores: greater state self-compassion. | At pre and post treatment (0 and 8 weeks) |
| The Self-Compassion Scale - short form (SCS-SF) | Trait self-compassion, min-max 12-60, higher scores: greater trait self-compassion. | At pre and post treatment (0 and 8 weeks) |