title: A randomized clinical trial on the effectiveness of an intervention to treat psychological distress and improve quality of life after autologous stem cell transplantation.
abstract: Psychological distress contributes to impaired quality of life in hematological cancer patients. Stepped care treatment, in which patients start with the least intensive treatment most likely to work and only receive more intensive interventions if needed, could improve distress. We aimed to evaluate the outcome of stepped care treatment on psychological distress and physical functioning in patients treated with autologous stem cell transplantation for hematological malignancies. In the present study, we performed a randomized clinical trial with two treatment arms: stepped care and care as usual. Baseline assessment and randomization occurred during pre-transplant hospitalization. Stepped care was initiated after 6 weeks, consisting of (1) watchful waiting, (2) Internet-based self-help intervention, and (3) face-to-face counseling/ psychopharmacological treatment/ referral. Follow-up measurements were conducted at 13, 30, and 42 weeks after transplantation. Stepped care (n = 47) and care as usual (n = 48) were comparable on baseline characteristics. The uptake of the intervention was low: 24 patients started with step 1, 23 with step 2, and none with step 3. Percentages of distressed patients ranged from 4.1 to 9.7 %. Ten percent of patients received external psychological or psychiatric care. No statistically significant differences were found between stepped care and care as usual on psychological distress or physical functioning in intention to treat analyses, nor in per protocol analyses. The stepped care program was not effective in decreasing psychological distress. The low intervention uptake, probably related to the low levels of psychological distress, offers an explanation for this outcome. Future research should take into account patients' specific care needs. Netherlands Trial Registry identifier: NTR1770.
authors.affiliation: Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, A.J.Ernststraat 1187, Amsterdam, 1081 HL, Netherlands. a.braamse@vumc.nl.|Department of Health, Sports & Welfare/Cluster Nursing, Inholland University of Applied Sciences, Amsterdam, Netherlands. a.braamse@vumc.nl.
authors.forename: Annemarie M J
authors.initials: AMJ
authors.lastname: Braamse
authors.affiliation: Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, A.J.Ernststraat 1187, Amsterdam, 1081 HL, Netherlands.|Department of Health, Sports & Welfare/Cluster Nursing, Inholland University of Applied Sciences, Amsterdam, Netherlands.|Parnassia Psychiatric Institute, The Hague, Netherlands.
authors.forename: B
authors.initials: B
authors.lastname: van Meijel
authors.affiliation: Department of Hematology, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: O J
authors.initials: OJ
authors.lastname: Visser
authors.affiliation: Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, A.J.Ernststraat 1187, Amsterdam, 1081 HL, Netherlands.
authors.forename: A D
authors.initials: AD
authors.lastname: Boenink
authors.affiliation: Department of Clinical Psychology, VU University, Amsterdam, Netherlands.
authors.forename: P
authors.initials: P
authors.lastname: Cuijpers
authors.affiliation: Department of Hematology, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: C E
authors.initials: CE
authors.lastname: Eeltink
authors.affiliation: Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, A.J.Ernststraat 1187, Amsterdam, 1081 HL, Netherlands.
authors.forename: A W
authors.initials: AW
authors.lastname: Hoogendoorn
authors.affiliation: Department of Oncology/Hematology, Isala Clinics, Zwolle, Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: van Marwijk Kooy
authors.affiliation: Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, A.J.Ernststraat 1187, Amsterdam, 1081 HL, Netherlands.
authors.forename: P
authors.initials: P
authors.lastname: van Oppen
authors.affiliation: Department of Hematology, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: P C
authors.initials: PC
authors.lastname: Huijgens
authors.affiliation: Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, A.J.Ernststraat 1187, Amsterdam, 1081 HL, Netherlands.
authors.forename: A T F
authors.initials: ATF
authors.lastname: Beekman
authors.affiliation: Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, A.J.Ernststraat 1187, Amsterdam, 1081 HL, Netherlands.|Department of Rehabilitation Medicine, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Dekker
mesh_terms: D000328:Adult; D005260:Female; D019337:Hematologic Neoplasms / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy*; D018380:Hematopoietic Stem Cell Transplantation / Q000639:trends; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life / Q000523:psychology*; D013315:Stress, Psychological / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy*; D014182:Transplantation, Autologous / Q000639:trends; D016896:Treatment Outcome
keywords: Anxiety; Depression; Hematological neoplasms; Hematopoietic stem cell transplantation; Quality of life