Background and aim 
Depressive symptoms, anxiety, and social isolation are prevalent after stroke. Psychosocial difficulties may influence long-term functioning and quality of life, reduce the effects of rehabilitation services, and lead to higher mortality rates. This study aimed to evaluate the effect of a dialogue-based intervention to promote psychosocial well-being at 12 months post-stroke.

Methods
Trial design and participants
This is a multicenter prospective randomized controlled trial with two parallel groups. Inclusion criteria: aged >=18, acute stroke within the last month, medically stable, sufficient cognitive functioning, able to understand and speak Norwegian before stroke onset, able to give informed consent. Patients with moderate to severe dementia or other serious somatic or psychiatric diseases, significant impressive or expressive aphasia were excluded. Eleven hospitals in South-Eastern Norway enrolled patients from November 2014 to November 2016. All participants were assessed at baseline (1-month post-stroke) and at 6- and 12-months post-stroke.

Usual care
All participants received evidence-based comprehensive stroke treatment in the acute phase and stroke rehabilitation in accordance with the Norwegian guideline for treatment and rehabilitation of stroke. 

Dialogue-based intervention
In addition to standard care, the intervention group was offered a dialogue-based intervention. The intervention was based on Antonovsky’s sense of coherence theory, narrative theory, and ideas from the guided self-determination method. The intervention consisted of eight individual 1-1 ½-hour sessions between the participant and a specially certified nurse or occupational therapist during the period of 1-month post-stroke to 6 months post-stroke. The intervention was delivered in the participant’s home. 

Outcomes
The primary outcome was psychological distress and depressive and anxiety symptoms at 12 months post-stroke measured by the General Health Questionnaire-28 (GHQ-28). Secondary outcomes included the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39g), Sense of coherence (SOC-13), and depression (Yale-Brown single-item questionnaire). 

Statistical analyses
Logistic regression, independent samples t-tests, and paired samples t-tests were used to assess within- and between group differences. A generalized linear mixed model (GLMM) was used to model the repeated measures at 6 and 12 months with fixed and random predictors.

Results 
In total, 322 patients were randomized into the intervention (n=166) and the control group (n=156). Baseline demographics and clinical characteristics were similar in both groups with the exception of depression. Relative to baseline, both groups improved significantly on the primary outcome, GHQ-28, and the secondary outcome, SAQOL-39g, at 12 months. There were no significant changes in SOC-13 or depression at 12 months relative to baseline in either group. There was no between-group difference in psychosocial well-being at 12 months post-stroke. The results of the GLMM are still pending and will be presented at the conference.

Conclusions
The dialogue-based intervention did not improve psychosocial well-being compared with standard care at 12 months post-stroke.

The effect of a dialogue-based intervention on psychosocial well-being 12 months after stroke: A multicentre prospective randomized controlled trial.