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An online relapse prevention program based on Acceptance and Commitment Therapy for chronic pain patients and chronic fatigue patients


- candidate number15423
- NTR NumberNTR4177
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-sep-2013
- Secondary IDsP13-07 METC 
- Public TitleAn online relapse prevention program based on Acceptance and Commitment Therapy for chronic pain patients and chronic fatigue patients
- Scientific TitleUser evaluation and adherence of an online relapse prevention program based on Acceptance and Commitment Therapy for chronic pain patients and chronic fatigue patients: a pilot study
- ACRONYMRelapse prevention for chronic pain and fatigue patients
- hypothesisWe expect an improvement in psychological flexibility and a decrease in pain interference in daily life or in fatigue. Furthermore, we expect a decrease in depression and anxiety symptoms.
- Healt Condition(s) or Problem(s) studiedChronic pain, Chronic Fatigue
- Inclusion criteriaPatients are 18 years and older. Their primary complaint is chronic pain and/or fatigue. They receive an inpatient multidisciplinary group treatment at the Pain Department at the Roessingh Centre for Rehabilitation (RCR) (Enschede, the Netherlands). In addition, patients should have access to Internet at a computer and/or a smartphone.
- Exclusion criteriaThere are no exclusion criteria for including participants into the study.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 6-mei-2013
- planned closingdate1-nov-2013
- Target number of participants10
- InterventionsThe online relapse prevention program, called “NaDien”, is based on Acceptance and Commitment Therapy (ACT). The program can be downloaded as an application (“app”) on a smartphone and/or can be used as a website on a computer. The program consists of different parts that are all intended to help the patient in maintaining value-based behavior. The user can register his/her values and actions and exercises. The user can share tips with other users and fill out a diary. Furthermore, users can receive guidance by receiving SMS or email as a reminder and/or with motivational content. The patients are advised to use the program already during treatment and for two months after the treatment.
- Primary outcomeThe first objective is to evaluate the experience of an ACT relapse prevention program “NaDien” by chronic pain patients and chronic fatigue patients after the inpatient program at RCR. The primary focus of the “NaDien”-program is to support chronic pain patients and chronic fatigue patients after their treatment to persist in value-based behavior. Therefore, the first aim of the study is to examine how patients evaluate this program and whether they are satisfied with it.

User experience
-Did the online ACT relapse prevention program support the patients in maintaining value-based behavior?
-How satisfied are patients with the use of an online ACT as relapse prevention?

Furthermore, we want to examine the adherence of the ACT program. We are interested in the adherence of the program by the chronic pain patients, because this is the first time this intervention is examined. The adherence of the online ACT relapse prevention program will be registered automatically by the system. The following aspects will be monitored:
-Frequency and duration of one log in.
-Frequency and duration of page views of the different parts of the program (values and actions, diary, exercises, tips).
-Frequency of the use of the guidance by SMS and which kind of guidance.
- Secondary outcomeWe want to have an indication of the clinical benefits of psychological flexibility (Psychological inflexibility in Pain Scale), pain interference (Multidimensional Pain Inventory – subscale pain interference), fatigue (Checklist Individual Strength), depression and anxiety (Hospital Anxiety Depression Scale).
- TimepointsTo examine the patient’s experience, participants are invited for an interview two months after their pain treatment. For examining the clinical effects of the relapse program, we use questionnaires that are obtained by the standard procedures at the RCR. All patients are asked to fill out questionnaires before and after their treatment and at a three-month follow-up for examining the effects of the treatment on psychological flexibility (PIPS), pain interference (MPI) or fatigue (CIS) and psychological distress (HADS). Patients are involved in this study for duration of approximately six months from entry until they receive the three-month follow-up questionnaire.
- Trial web sitehttp://www.rrd.nl/projects/cluster__telemedicine/ACT_app
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Martine Fledderus
- CONTACT for SCIENTIFIC QUERIES Martine Fledderus
- Sponsor/Initiator Roessingh Research and Development, University of Twente
- Funding
(Source(s) of Monetary or Material Support)
Roessingh Research & Development, University of Twente
- PublicationsN/A
- Brief summaryRationale: At Roessingh Centre for Rehabilitation (RCR) in the Netherlands chronic pain patients receive an inpatient multidisciplinary 8-12 weeks group program based on Acceptance and Commitment Therapy (ACT). The main focus of ACT is enhancing acceptance and value-based behavior. For chronic pain patients acceptance means that one acknowledges the pain and gives up unproductive attempts to control pain. When these attempts are relinquished, an individual can choose or persist in behavior that is in line with important values. Patients are challenged to implement the behavior changes they learned in the treatment in daily life. However, many chronic patients find it difficult to make this transfer. Therefore, Roessingh Research and Development in collaboration with the University of Twente is currently developing a smartphone application (that also can be used as a website) as relapse prevention program based on ACT for chronic pain patients. This program, called “NaDien”, is developed for supporting the patients after treatment and for preventing relapse.

Objective: The first objective of this study is to evaluate the “NaDien”-program on user experience and adherence. The second objective of this study is to examine the clinical benefits of the program.

Study design: This study uses a non-randomized intervention design.

Study population: Patients are 18 years and older. Their primary complaint is chronic pain and/or fatigue. They receive an inpatient multidisciplinary group treatment at the Pain Department of the RCR. In addition, patients should have access to Internet at a computer and/or a smartphone

Intervention: The online program “NaDien” is based on ACT. The program can be downloaded as an application (“app”) on a smartphone and/or can be used as a website on a computer. The program consists of different parts that are all intended to help the patient in maintaining value-based behavior. The user can register his/her values and actions and exercises. The user can share tips with other users and fill out a diary. Furthermore, users can receive guidance by receiving SMS or email as a reminder and/or with motivational content.

Main study parameters/endpoints: To evaluate the user experience, semi-structured qualitative interviews will be held four weeks after treatment. The adherence of the online ACT relapse prevention program will be registered automatically by the system. The following aspects will be monitored: frequency and duration of one log in, frequency and duration of page views of the different parts of the program and frequency of the use of the guidance by SMS or email and which kind of guidance.
- Main changes (audit trail)
- RECORD16-sep-2013 - 2-okt-2013


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