|- candidate number||13305|
|- NTR Number||NTR3606|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-sep-2012|
|- Secondary IDs||NL40257.044.12/P12-17 METC Twente|
|- Public Title||Goal management training for patients with arthritis.|
|- Scientific Title||"Doelbewust!" Goal management training for patients with arthritis: A randomized controlled trial.|
|- hypothesis||The 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) studied||Rheumatoid arthritis, Psychosocial, Cognitive behavior therapy, Depression, Rheumatic diseases|
|- Inclusion criteria||1. Age: 18 years and older;|
2. Diagnosed with polyarthritis;
3. Score on depression subscale of Hospital Anxiety and Depression Scale.
|- Exclusion criteria||1. Severe distress (screening with HADS);|
2. Insufficient Dutch language skills;
3. Enrolment in psychotherapeutic treatment at moment of study entry.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2012|
|- planned closingdate||30-apr-2014|
|- Target number of participants||200|
|- Interventions||The 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 outcome||Effect of the intervention on depressive symptoms.|
|- Secondary outcome||1. 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.
|- Timepoints||T0: 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 site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| R.Y. Arends|
|- CONTACT for SCIENTIFIC QUERIES|| R.Y. Arends|
|- Sponsor/Initiator ||University of Twente, Dept. of Psychology, Health & Technology (PHT)|
(Source(s) of Monetary or Material Support)
|Stichting ReumaOnderzoek Twente|
|- Brief summary||Existing 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
New time point in the intervention group: 4 months follow-up after intervention (was 6
Scientific title changed to: “Doelbewust!” Goal management training for patients with
Planned closing date is delayed to 30-04-2014 (was 01-10-2013).
|- RECORD||11-sep-2012 - 27-mrt-2014|