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van CCT (UK)

van CCT (UK)

Testing an e-supported Illness Management & Recovery Program for People with Severe Mental Illness

- candidate number19399
- NTR NumberNTR4772
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-sep-2014
- Secondary IDsNL49693.091.14 CCMO
- Public TitleTesting an e-supported Illness Management & Recovery Program for People with Severe Mental Illness
- Scientific Titlee-supported Illness Management & Recovery Program for People with Severe Mental Illness: an early randomized controlled trial
- hypothesisA blended form of e-health contributes to the recovery process of consumers with SMI and match the consumers’ preference compared to an evidence-based face-to-face intervention.
- Healt Condition(s) or Problem(s) studiedSevere mental illness, Recovery
- Inclusion criteria• consumers with SMI
• adults, above 18 years of age
• referred to the IMR-program by their clinician.
• capable to give informed consent.
- Exclusion criteria• consumers that are overwhelmed by disability including dependence, denial, confusion, anger, or despair.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2014
- planned closingdate30-sep-2016
- Target number of participants100
- InterventionsThe standard IMR program is provided in a series of weekly face-to-face sessions in which consumers with SMI develop personalized strategies for managing their mental illness and moving forward in their lives. There is a strong emphasis on helping consumers set and pursue personal goals and helping them put strategies into action in their everyday lives. On top of the IMR participants in the intervention group will get the opportunity to enter the e-IMR intervention, e-support for self-management and recovery.
- Primary outcomeIMR-scales: illness management,
MHRM: recovery,
BSI: severity of psychiatric symptoms,
PAM-13: self-management,
MANSA: quality of life,
RAND-36: general health.
- Secondary outcomeSemi-structured qualitative interviews on:
IMR Fidelity Scales
Added value
- TimepointsAt baseline: NAW, computer literacy, IMS-scales, MHRM, BSI, PAM-13, MANSA, RAND-36, IMR fidelity scales;
At 6 months: IMR-scales, MHRM, BSI, PAM-13, MANSA, RAND-36;
At 12 months: IMS-scales, MHRM, BSI, PAM-13, MANSA, RAND-36, IMR fidelity scales, quaitative interviews on feasibilty, added value
- Trial web site
- statusplanned
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryIn the Netherlands a blended e-health application to the standard IMR-program is tested in a multi center early cluster randomized controlled trial. The objectives of this study are to evaluate the potential effectiveness, effect size, and the added value. A purposive sample of adult participants with SMI will be included when their clinician referred them to the IMR program. Participants in the care as usual group receive guideline-based treatment combined with the IMR-program. On top of this usual care participants in the intervention group receive e-IMR, which adds an e-health application to the standard IMR-program. Main study parameters/endpoints are: illness management, recovery, psychiatric symptoms severity, self-management, quality of life, and general health. The process of the IMR program will be evaluated on fidelity and feasibility in semi-structured interviews with participants and trainers.
- Main changes (audit trail)
- RECORD6-sep-2014 - 26-nov-2014

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