Depression/Anxiety, DGBI
Conditions
Brief summary
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.
Interventions
BEHAVIORALAcceptance and Commitment Therapy with explicit self-compassion training
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.
OTHEREducation
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.
Sponsors
Örebro University, Sweden
Sahlgrenska University Hospital
Göteborg University
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Researcher responsible for randomization and allocation
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 75 years 2. Meeting clinical symptom levels for least one DGBI diagnosis (assessed with the Rome IV Diagnostic Questionnaire for Functional Gastrointestinal Disorders in Adults (Palsson et al., 2016)) 3. Clinically meaningful levels of depressive symptoms or anxiety: score ≥ 13 on the Montgomery Åsberg Depression Rating Scale (Svanborg \& Åsberg, 1994; (MADRS-S; depressive symptoms), or score ≥ 10 on the Generalized Anxiety Disorder scale-7 (GAD-7; anxiety symptoms; Spitzer et al., 2006) 4. Stable medication for psychiatric symptoms including anxiety, depression and sleep problems for at least two months prior to intervention. 5. Ability to read and write Swedish 6. Have access to a device (like computer, tablet or smartphone with) with access to the internet and that can be used to attend video conferences and preview the intervention platform (i.e., have a microphone and speakers or headphones).
Exclusion criteria
1. Currently undergoing any form of psychological intervention. 2. Increased risk of suicide (≥4 points on MADRS item 9). 3. Ongoing or previously diagnosed severe psychiatric disorder, such as schizophrenia spectrum disorders or bipolar disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Gastrointestinal Symptom Rating Scale (GSRS) | T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up). T3 (6 month follow-up), T4 (12 month follow-up) | Symptom Severity of DGBI, minimum 15, maximum 105, higher = worse gastrointestinal symptoms |
| The Generalized Anxiety Disorder scale-7 (GAD-7) | T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) | Symptoms of general anxiety, total score 0-21, higher = worse anxiety symptoms |
| The Patient Health Questionnaire-9 (PHQ-9) | T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) | symptoms of depression, total score 0-27, higher = worse depressive symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol 5-Dimension 5-Level (EQ-5D-5L), EQ Vas 0-100, higher = better 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) | Health-related Quality of Life |
| Assessment of Quality of Life - 8 dimensions (AQoL-8D) | T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) | Health-related Quality of Life, Utility score -0.04 - 1.00, higher = better quality of life |
| The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) | T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) | Healthcare Utilization, no single fixed min/max, higher = worse/more costly outcome |
| The Chronic Illness Shame Scale (CISS) | T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) | Shame of Chronic Illnesses, total score 0-28, higher = worse shame related to chronic illness |
| The Credibility / Expectancy Questionnaire (CEQ) | T0 (week 0, only expectancy sub scale), Tmid (week 4, both subscales) | Treatment Credibility and Expectancy, total score 3-27 each, higher = better treatment credibility/expectancy |
| The System Usability Scale (SUS) | T1 (week 8) | Intervention Platform Usability, total score 0-100, higher = better usability |
| The Negative Effects Questionnaire (NEQ-20) | T1 (week 8) | Negative Side Effects and Events, total score 0-80, higher = worse negative effects |
| Global Impression of Change Scale | Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) | Impression of change, a single global change item, higher = worse |
| Awareness of Processes Post-Intervention Scale | T1 (week 8) | Awareness of Processes, higher = more awareness |
| The Multidimensional Psychological Flexibility Inventory (MPFI) | T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) | Psychological flexibility, composites scored as means, higher = worse for inflexibility |
| Self-Compassion Scale | 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, higher = better self-compassion |
| Insomnia Severity Index | T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up) | Insomnia symptoms, total score 0-28, higher = worse insomnia severity |
| Major Life Events | T0 (week 0), T3 (6 month follow-up) | Past 12 months. Questions about psychological/physical diagnoses, usually more events/greater burden = worse stress exposure |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORInês A Trindade, Phd
Örebro University, Sweden
Outcome results
None listed