## Protocol Section
### Identification Module
**NCT ID:** NCT00184379

**Brief Title:** Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness

**Official Title:** Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness

#### Organization Study ID Info
**ID:** 4.2005.389
#### Organization
**Class:** OTHER
**Full Name:** Norwegian University of Science and Technology
### Status Module
#### Completion Date
**Date:** 2010-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-08-28

**Type:** ACTUAL

**Last Update Submit Date:** 2017-08-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-06

**Type:** ACTUAL

#### Start Date
**Date:** 2005-04

**Status Verified Date:** 2017-08

#### Study First Post Date
**Date:** 2005-09-16
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-13
**Study First Submit QC Date:** 2005-09-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** St. Olavs Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Norwegian University of Science and Technology

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to determine the effects of psychoeducation for relatives to patients with serious mental illness.

**Detailed Description:** The main aim of the study is to compare the effects of group psychoeducation for relatives to patients with serious mental illness with a waiting list control group. The main hypothesis is whether psychoeducation in groups has effects on the stress experience and coping style in the relatives. The relatives will receive group education in 6 weekly sessions. We will measure stress experience, coping style and the relatives' health condition before the sessions, after the sessions and at one year follow-up.

### Conditions Module

**Conditions:**

- Mental Disorder

- Depressive Disorder

- Schizophrenia

**Keywords:**

- Family

- Coping Skills

- Psychoeducation

- Stress, Psychological

- Health Education

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Relatives of patients with schizophrenia, who receive education

**Intervention Names:**

- Behavioral: Psychoeducation

**Label:** 1 S+E

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Relatives of patients with schizophrenia, who do not receive education

**Label:** 2 S-E

**Type:** NO_INTERVENTION

#### Arm Group 3

**Description:** Relatives of patients with bipolar disorder, who receive education

**Intervention Names:**

- Behavioral: Psychoeducation

**Label:** 3 B+E

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Relatives of patients with bipolar disorder, who do not receive education

**Label:** 4 B-E

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1 S+E

- 3 B+E

**Description:** Structured disorder-related educational program for relatives

**Name:** Psychoeducation

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Measure:** ECI (Experience of Caregiving Inventory) (Smuckler et al,1994)

**Time Frame:** 0-6 months

**Measure:** COOP/WONCA (Bowling, 1995)

**Time Frame:** 0-6 months

**Measure:** Selection of questions from COPE (Carver et al. 1989)

**Time Frame:** 0-6 months

**Measure:** Evaluation-questions

**Time Frame:** 0-6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Relatives to patients having a psychotic or bipolar disorder
* Good Norwegian language skills
* Consent to participate
* The patients' consent for their relatives to participate

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Trondheim

**Country:** Norway

**Facility:** Østmarka Psychiatric Department, St. Olavs Hospital, University Hospital of Trondheim

#### Overall Officials

**Official 1:**

**Affiliation:** Norwegian University of Science and Technology

**Name:** Olav M Linaker, MD Prof

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Moller T, Gudde CB, Folden GE, Linaker OM. The experience of caring in relatives to patients with serious mental illness: gender differences, health and functioning. Scand J Caring Sci. 2009 Mar;23(1):153-60. doi: 10.1111/j.1471-6712.2008.00605.x. Epub 2009 Jan 21.

**PMID:** 19192243

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019967

- Term: Schizophrenia Spectrum and Other Psychotic Disorders

- ID: D000019964

- Term: Mood Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M15376

- Name: Schizophrenia

- Relevance: HIGH

- As Found: Schizophrenia

- ID: M4815

- Name: Mental Disorders

- Relevance: HIGH

- As Found: Mental Disorders

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M16105

- Name: Stress, Psychological

- Relevance: LOW

- As Found: Unknown

- ID: M21838

- Name: Schizophrenia Spectrum and Other Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012559

- Term: Schizophrenia

- ID: D000003866

- Term: Depressive Disorder

- ID: D000001523

- Term: Mental Disorders

### Misc Info Module

- Version Holder: 2024-05-24
