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van CCT (UK)

van CCT (UK)

Goal management training for patients with arthritis.

- candidate number13305
- NTR NumberNTR3606
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-sep-2012
- Secondary IDsNL40257.044.12/P12-17 METC Twente
- Public TitleGoal management training for patients with arthritis.
- Scientific Title"Doelbewust!" Goal management training for patients with arthritis: A randomized controlled trial.
- hypothesisThe main objective is to evaluate the goal management training in terms of the effect on depressive symptoms. It is expected that people with arthritis will experience lower levels of depressive symptoms after participation in the group training, compared to the control group.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis, Psychosocial, Cognitive behavior therapy, Depression, Rheumatic diseases
- Inclusion criteria1. Age: 18 years and older;
2. Diagnosed with polyarthritis;
3. Score on depression subscale of Hospital Anxiety and Depression Scale.
- Exclusion criteria1. Severe distress (screening with HADS);
2. Insufficient Dutch language skills;
3. Enrolment in psychotherapeutic treatment at moment of study entry.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2012
- planned closingdate30-apr-2014
- Target number of participants200
- InterventionsThe new training aims to teach patients to recognize personal goals which are threatened by arthritis and learn to apply beneficial goal management strategies to improve adaptation to arthritis. The training is to be delivered by specialized nurses in hospital settings to groups with 8-10 participants. The training consists of 6 group meetings, based on informing, learning, and practicing goal management strategies. In addition to the group sessions, participants work individually on a personal goal. This individual trajectory is discussed within the group.

Control condition: Participant in the control condition recieve care-as-usual and fill in the same questionnaires as the intervention condition.
- Primary outcomeEffect of the intervention on depressive symptoms.
- Secondary outcome1. Adaptation outcomes: Anxiety symptoms, positive affect, purpose in life, participation;
2. Goal management: Broadening, use and flexibility of goal management strategies;
3. Disease related outomes: Self-efficacy, pain and fatigue;
4. Cost-effectiveness: Medical and non-medical costs. Cost-utility.
- TimepointsT0: Baseline (all measures);
T1: Post-intervention (all measures);
T2: Only cost-effectiveness measures;
T3: Only cost-effectiveness measures;
T4: Follow-up (all measures).

Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983). The depression subscale of the HADS is used to measure our primary outcome depressive symptoms.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator University of Twente, Dept. of Psychology, Health & Technology (PHT)
- Funding
(Source(s) of Monetary or Material Support)
Stichting ReumaOnderzoek Twente
- PublicationsN/A
- Brief summaryExisting self-management programs try to improve coping with rheumatic disease but revealed very limited effects and low participation rates. These programs narrowly focus on illness-related aspects. However, adaptation problems are more complex and include various domains of life. The new program starts from personal goals of the patients which are threatened by arthritis. It aims to broaden and improve patients competencies to manage these threatened personal goals in order to improve adaptation to arthritis.

The main objective of the study is to evaluate the goal management training in terms of the effect on depressive symptoms. Secondary objectives of the intervention are to study the effect of the intervention on the secondary outcome measures: anxiety symptoms, positive affect, purpose in life and social participation; use of and preference for goal management strategies; and disease related outcomes. Furthermore the cost-effectiveness and cost utility of the goal management intervention will be evaluated from a societal perspective.
- Main changes (audit trail)27-3-2014: 22-10-2012: Gelderse Vallei Hospital (Ede) is added as a participating center. 01-11-2012: Inclusion started at Medisch Spectrum Twente (Enschede). 29-01-2013: Streekziekenhuis Koningin Beatrix (Winterswijk) and St. Elisabeth Ziekenhuis (Tilburg) are added as participating centers. 16-07-2013: Changes to the design. A number of changes have been made, since the recruitment of participants went slow. Randomization is not performed and the waiting list control condition lapses. The intervention group will be compared to an existing cohort that ran from 2010 to 2011. The cohort exists of 330 patients with polyarthritis that participated in an observational study. Patients in the cohort will be selected based on the baseline criteria from the intervention study. These patients did not participate in an intervention at the time of the study, making it possible to compare the natural course of adaptation to the intervention group. New time point in the intervention group: 4 months follow-up after intervention (was 6 months). Scientific title changed to: “Doelbewust!” Goal management training for patients with arthritis. Planned closing date is delayed to 30-04-2014 (was 01-10-2013). - AB
- RECORD11-sep-2012 - 27-mrt-2014

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