NCT00883207

Brief Summary

The main aim of the project is to develop couple therapy for depression with special interest in dialogical and narrative processes in therapy. Parenthood, and different psychosocial phenomena, such as domestic violence, suicidal behaviour and alcohol abuse in relation to the client's specific depressive state will be analysed. The second main aim of the study is to analyse the effectiveness couple therapy for depression as a real world study. The good and poor outcome of different therapy processes will be compared and thus information about precise change processes will be reached. Owing to the real world setting, the inclusion criterion is a broad one: a primary diagnosis of depression (F32 and F33 in ICD-10). The project will be conducted as a multicentre study so that in each centre the included patients will be randomized into experiment and control groups. The study centres are (1) Pohjois-Savon sairaanhoitopiiri in Kuopio, (2) Länsi-Pohjan sairaanhoitopiiri in Tornio and Kemi and (3) HUS/ Jorvin sairaala regional psychiatric polyclinics in Espoo. In each province the entire adult population has free access to the psychiatric outpatient clinics in their specific catchment area and thus no selection for the patients is done.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_2 depression

Timeline
Completed

Started Feb 2006

Typical duration for phase_2 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

1.4 years

First QC Date

April 16, 2009

Last Update Submit

August 15, 2023

Conditions

Keywords

Depressionfamily therapydialogical processesDeveloping couple therapy for depression

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale; BDI and SCL-90 Dyadic Adjustment Scale (DAS)for couples -domestic violence, use of alcohol

    6, 12, 18 and 24 months

Secondary Outcomes (1)

  • Outcome Ratings Scale and Session Rating Scale video recordings co-research interviews

    3 months after termination

Interventions

PsychotherapyBEHAVIORAL

Narrative and dialogical approach for couples

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A primary diagnosis of depression (F32 and F33 in ICD-10);
  • Under 65 years of age, living in a heterosexual couple relationship;
  • Contacting the study centres either by oneself or by a referral because of depression (F32 or F33 in ICD-10) rating at least 14 on the Hamilton Rating Scale.

You may not qualify if:

  • Violence;
  • Drug abuse;
  • Clear psychotic symptoms, organic brain disorder or severe suicidal behaviour that prevents participation in therapy discussions;
  • Earlier family or couple therapy due to depression during the two years before the index treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of psychology

Jyväskylä, 40014, Finland

Location

Related Links

MeSH Terms

Conditions

Depression

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 17, 2009

Study Start

February 1, 2006

Primary Completion

July 1, 2007

Study Completion

October 1, 2009

Last Updated

August 16, 2023

Record last verified: 2023-08

Locations