Primary: to determine whether an early psychological intervention poststroke in order to reduce symptoms of anxiety and depression, is feasible.Secondary: To evaluate if an early individual psychological intervention in patients independent in…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility outcome measures:
- Patient satisfaction
- Response rates, the number of drop-outs and reasons.
- Evaluation the characteristics of respondent versus non-participants.
Secondary outcome
Anxiety and depression as measured with the Hospital Anxiety and Depression
scale (HADS)
Perceived quality of life measured with the Shortform 36 (SF-36)
Fatigue with the Fatigue severity scale (FSS)
Risk factors for anxiety and depression:
Coping style Utrecht Coping List (UCL)
Illness cognitions Illness Cognition questionnaire (ICQ)
Posttraumatic stress Impact of Event Scale (IES)
Social support Social support List (SSL)
Background summary
Stroke frequently affects mood and behaviour. The negative impact of mood and
adjustment disorders on recovery and reintegration has been recognized. Major
improvement in stroke prognosis has been achieved by the implementation of
stroke units in the hospital and increased use of thrombolysis. Therefore the
proportion of patients with favorable outcome has been rising. Patients with
mild stroke (hemorrhagic or ischemic, subarachnoid hemorrhages) or Transient
Ischemic Attack (TIA) are expected to return to their normal pre-stroke status
relatively quick and are mostly discharged directly to their home environment,
often without follow-up consultation by a rehabilitation physician. These
patients however, often struggle to regain their pre-morbid functional status
despite little or no physical disabilities. Anxiety and depression are thought
to be of influence on functional outcome in patients with mild stroke and TIA.
There are only few studies regarding these subjects in the general stroke
population, and even less evidence can be found in the mild stroke group.
We believe that early detection and treatment of anxiety and depression in mild
stroke and TIA patients may improve functional outcome. Thereby reducing the
needs for intensive and expensive rehabilitation diagnostics and treatment in a
later phase when patients get stuck in their work and social life. Therefore we
have developed an early individual psychological intervention aimed at reducing
symptoms of anxiety and depression. This prospective cohort study in minor
stroke patients is designed to examine the feasibility of such a psychological
intervention in an early phase.
Study objective
Primary: to determine whether an early psychological intervention poststroke
in order to reduce symptoms of anxiety and depression, is feasible.
Secondary: To evaluate if an early individual psychological intervention in
patients independent in activities of daily living poststroke leads to a
reduction of symptoms of anxiety and depression after 6 months poststroke.
Study design
The study is designed as a prospective cohort study.
Intervention
Four to six weeks after discharge home the patients will visit a psychologist
at the department of rehabilitation. At the first visit, symptoms of anxiety
and depression will be analysed using questionnaires and also the potential
risk factors for anxiety and depression will be assessed; psychiatric history,
coping-strategies, the patient*s cognitions to disease processes and the amount
of social support that is perceived will be assessed. The influence of possible
cognitions and misconceptions to the disease and occurrence of anxiety and
depression after TIA/minor stroke are examined. In the second and third visit
the psychologist will educate the patient about general brain functioning and
the influence of stroke; also the possible development of anxiety after stroke
is discussed with patient and caregiver. Active coping strategies will be
promoted and illness perceptions will be reviewed. These sessions are tailored
to the patients* needs and questions. If, after 3 visits, the psychologist
finds continuation of psychological support advisable, the patient will be
referred for further treatment.
Study burden and risks
Burden: All patients will receive questionnaires to fill out at home and return
back to the investigators. The total duration of completing the questionnaires
is estimated at 1.0 to 1.5 hours. Travelling costs for the outcome assessments
will be reimbursed. Questionnaires will be send back in envelopes with a
freepost number.
Potential risks: No risks are associated with psychological counselling.
Potential benefits for the patients: Considering the positive effects of
psychological counselling known from preliminary research it can be concluded
that the benefits outweigh the burden associated with this study.
Meibergdreef 9 A01-420
Amsterdam 1100 DD
NL
Meibergdreef 9 A01-420
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
Consecutive patients who are admitted to the AMC hospital Amsterdam, from august 2012 tuntil december 2013 with a stroke (ischemic or hemorrhagic, subarachnoid hemorrhage) or TIA, independent in activities of daily living at the moment of discharge of the hospital (modified Rankin Scale 0-1) and discharged home without multidisciplinary rehabilitation treatment are eligible for this study.
Exclusion criteria
Age younger than 18 years old, difficulty comprehending the Dutch language, a history of anxiety disorder, major depression or psychiatric diseases.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL39971.018.12 |