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A combined group and individual functional remediation blended care program for patients with unipolar recurrent depression or bipolar-I disorder; A pilot study.

A combined group and individual functional remediation blended care program for patients with unipolar recurrent depression or bipolar-I disorder; A pilot study. - FRMD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52514
Enrollment
30
Registered
2019-11-12
Start date
2020-02-28
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cognitive impairment in mood disorders impairment of memory and attention in depression and mania

Interventions

The intervention consists of a functional remediation program, based on strategies for the treatment of patients with acquired brain injury (Sohlberg en Mateer, 2001, Wilson, 2003, Haskins, 2012). T

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: o Age: 18-60 o Bipolar I Disorder or recurrent Major Depression according to DSM 5 as diagnosed by a psychiatrist and verified by MINI-Plus o Subjective cognitive complaints o At least moderate levels of functional impairments, Functioning Assessment Short Test (FAST) interview > 18 o NLV (Dutch National Adult Reading Test) IQ > 85 o Informed consent signed by patient before participation o Availability of a computer with internet and sufficient computer skills o Being able to read and write in Dutch o Mentally competent as documented in the formal treatment plan.

Exclusion criteria

Exclusion criteria: oCurrent mania or severe depression (defined by scores > 5 on the Altman Self-Rating Mania Rating Scale and >15 on the Quick Inventory of Depressive Symptoms) o Substance or alcohol abuse within the last 3 months (de*ned as more than 2 units/day for men, and more than 1 unit/day for women). o A history of neurological disease or traumatic brain injury o Electroconvulsive treatment (ECT) within the last 12 months o Currently participating in a group-treatment, or planning to participate within 3 months after the intervention. oPrior participation in the study *A pilot study of a combined group and individual functional remediation program for patients with bipolar I disorder*.

Design outcomes

Primary

MeasureTime frame
The main study parameter will be the feasibility of the program as defined by the evaluations of the participants on closed and open ended questions and the non-compliance and drop-out rate and reasons for dropout and non-compliance. The two variants, fully offered online and blended, will be compared to each other on these variabels. In addition the experiences with the online application " Niet rennen maar plannen" will be evaluated through ratings on closed questions.

Secondary

MeasureTime frame
The secondary study parameters will be the indication of change in subjective cognitive complaints, functional improvement and change expressed in QALYs.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)