Is it feasible to run a clinical trial of online acceptance and commitment therapy (ACT) for chronic abdominal pain?

Feasibility randomised controlled trial of online acceptance and commitment therapy (ACT) for chronic abdominal pain

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19023898

Enrollment

Registered

2019-08-29

Start date

2019-08-29

Completion date

Unknown

Last updated

2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic abdominal pain Signs and Symptoms

Interventions

Participants will be randomly allocated (1:1 ratio) to the intervention or treatment-as-usual (TAU) condition. This will be done using computer-generated random numbers (http://www.random.org). Sealed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Outpatient aged at least 18 years 2. Presence of continuous or intermittent abdominal pain or discomfort for the last 6 months or more 3. Has reported interference of pain with daily activities over the past 6 months of >4 on scale ranging from 0 (no interference) to 10 (unable to carry out any activities) 4. Has reported at least moderate symptoms of depression in the past 2 weeks, as indicated by a score of >10 on the PHQ-9 5. Willing and able to take part

Exclusion criteria

Exclusion criteria: 1. Unable to participate due to limits in communicating in English 2. Conditions including: 2.1. Severe depression (as indicated by a PHQ-9 score of >23) 2.2. Suicidal ideation 2.3. Psychiatric disorders (e.g. schizophrenia, bipolar disorder, post-traumatic stress disorder, psychosis, manic episode, and anorexia) 2.4. Cognitive impairment 3. Currently receiving another form of regular psychotherapy weekly

Design outcomes

Primary

Measure	Time frame
1. Feasibility, calculated using the following measures: 1.1. Recruitment rate calculated by the researcher at completion of data collection 1.2. Retention rate calculated by the researcher at completion of data collection 1.3. Treatment completion rate calculated by the researcher at completion of data collection 1.4. Appropriateness of measures chosen to examine treatment effect calculated from the proportion of missing questionnaire responses 1.5. Credibility of treatment measured by asking participants to rate (on a 1 to 9 scale) in a treatment evaluation questionnaire how logical the therapy seems to them, how successful they think the treatment will be in improving their functioning, and how confident they are in recommending this treatment The treatment will be considered feasible if 85 participants are recruited and 60 retained at follow-up, a treatment completion rate of 70% is achieved, a rate of <10% missing questionnaire data is achieved, and the majority of the participants in the treatment arm describe the treatment as acceptable.	—

Measure

Time frame

1. Feasibility, calculated using the following measures: 1.1. Recruitment rate calculated by the researcher at completion of data collection 1.2. Retention rate calculated by the researcher at completion of data collection 1.3. Treatment completion rate calculated by the researcher at completion of data collection 1.4. Appropriateness of measures chosen to examine treatment effect calculated from the proportion of missing questionnaire responses 1.5. Credibility of treatment measured by asking participants to rate (on a 1 to 9 scale) in a treatment evaluation questionnaire how logical the therapy seems to them, how successful they think the treatment will be in improving their functioning, and how confident they are in recommending this treatment The treatment will be considered feasible if 85 participants are recruited and 60 retained at follow-up, a treatment completion rate of 70% is achieved, a rate of <10% missing questionnaire data is achieved, and the majority of the participants in the treatment arm describe the treatment as acceptable.

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Secondary

Measure	Time frame
1. Pain intensity assessed using 0-10 numerical ratings in a questionnaire at baseline and 12 weeks 2. Patient-reported gastrointestinal symptoms assessed using the Gastrointestinal Symptom Rating Scale (GSRS) at baseline and 12 weeks 3. Patient's belief of efficacy of treatment assessed using the Patients’ Impression of Change (PIC) at 12 weeks 4. Depression assessed using the Patient Health Questionnaire (PHQ-9) at baseline and 12 weeks 5. Gastrointestinal symptom-specific anxiety assessed using the Visceral Sensitivity Index (VSI) at baseline and 12 weeks 6. Severity of pain and level of interference of pain in daily life assessed using the Brief Pain Inventory (BPI) at baseline and 12 weeks 7. Functional impairment assessed using the Work and Social Adjustment Scale (WSAS) at baseline and 12 weeks	—

Measure

Time frame

1. Pain intensity assessed using 0-10 numerical ratings in a questionnaire at baseline and 12 weeks 2. Patient-reported gastrointestinal symptoms assessed using the Gastrointestinal Symptom Rating Scale (GSRS) at baseline and 12 weeks 3. Patient's belief of efficacy of treatment assessed using the Patients’ Impression of Change (PIC) at 12 weeks 4. Depression assessed using the Patient Health Questionnaire (PHQ-9) at baseline and 12 weeks 5. Gastrointestinal symptom-specific anxiety assessed using the Visceral Sensitivity Index (VSI) at baseline and 12 weeks 6. Severity of pain and level of interference of pain in daily life assessed using the Brief Pain Inventory (BPI) at baseline and 12 weeks 7. Functional impairment assessed using the Work and Social Adjustment Scale (WSAS) at baseline and 12 weeks

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026