Ehde 2015.
Methods |
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Participants |
Population source: recruited from University of Washington Department of Rehabilitation Medicine Research. Registry and advertisements through National MS organisations. Flyers and referrals from University of Washington Multiple Sclerosis Centre. Numbers: randomised 163, telephone self‐management 75, control (telephone education) 88 Inclusion criteria: >18 years, self‐reported physician diagnosis of MS and 1 or more of the following: (1) moderate depressive symptoms indicated by a score of 10 to 14 on the PHQ‐9, presence of chronic pain (average pain intensity 3 in the past week) or significant fatigue symptoms, defined as a score 10 on the 5‐item (MFIS) Exclusion criteria: cognitive impairment (1 error on 6‐item Cognitive Screener), psychotherapy more than once a month, had participated in another study for fatigue, depression, or pain, moderate‐severe to severe depressive symptoms (PHQ‐9 score 15) Age: treatment group (mean age 51 years,range 25‐76), control group (mean age 53.2 years, range 26‐76) Gender: treatment group (women 67, men 8), control group (women 75, men 13) Type of MS: treatment group (relapsing remitting 46, progressive 29), control group (relapsing remitting 45, progressive 43) Pain type: chronic pain |
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Interventions |
Treatment: telephone self‐management skills training Control: education on MS symptoms Duration: 8 weekly individual telephone calls delivered, 45‐60 minute sessions |
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Outcomes |
Primary
Secondary
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Notes |
Funding: not described Conflicts of interest: not described |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers were generated by computer software |
Allocation concealment (selection bias) | Low risk | The allocation sequence was concealed from the research assistants who enrolled participants via a limited access database program |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | On 2 occasions research assistants became aware of a participant’s allocation |
Blinding of outcome assessment (detection bias) All outcomes | High risk | On 2 occasions research assistants became aware of a participant’s allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | For the telephone self‐management group there were 10 withdrawals during sessions and 4 during assessments. For the control group there were 6 withdrawals during sessions and 2 withdrawals during assessments |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No other bias detected |