DepressionPhase 2/3DINADEPNCT00883207
Dialogical and Narrative Processes in Couple Therapy for Depression
A Phase 2/3 study testing Psychotherapy in people with Depression, run by University of Jyvaskyla at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 65 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2006to Oct 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dialogical and Narrative Processes in Couple Therapy for Depression. Two Year Follow-up Study of the Effectiveness and Processes in Couple Therapy
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.
Read the detailed description
In each of these research centres qualified family therapists will conduct the couple therapy in case of depressed patients in a team of two therapists. To be a responsible therapist in this study the minimum criterion is three years specialist- level family therapy training and thus a qualification as psychotherapist according to Finnish law. The therapist shall have special experience and interest in dialogical and narrative processes in therapy. All the family therapists will also have taken a training program that focuses on systemic family therapy, narrative therapies and open dialogue in a family setting. No special therapy manual has been written, but the treatment processes will be analyzed after the therapy in relation to the outcome. The treatment processes are expected to last for as long as required according to the specific needs of each couple. This will allow for the focus on external validity: Clients will be recruited in the course of daily clinical practice without any selection outside the diagnosis and the therapies are taking place for as long as needed. The analyses of the treatment processes in relation to outcome, has termed as progress research by Pinsof \& Wynne (2000)
In couple therapy some guidelines are followed. Since every family therapist has training in systemic therapy, the therapy can be termed as systemic couple therapy with a special focus on dialogues and narratives. The two therapists and the couple form a system in which the first aim is to generate dialogue to increase understanding of couple's situation and the role of depression in their lives. To this end, spouses are encouraged to speak of subjects that they find most important. While one person is speaking, the other three take a reflective position in their inner dialogues and afterwards describe their thoughts about what was said. The shift between the speaking and listening positions in the topics that the couple choose is the basic element in each therapy process. In these processes a new joint language is created for experiences without words or experiences manifested in symptoms, marital problems or in problematic behaviour.
Three types of analysis will be conducted:
- The effectiveness of systemic couple therapy will be analyzed by (a) the assessment of depression by the Hamilton Depression Rating Scale inventory and the BDI and SCL self-report ratings scales; (b) the assessment of couple satisfaction by the Dyadic Adjustment Scale (DAS) self-report rating scale; and (c) the assessment of the psychological status of the patient by GAF rating. In addition to these, (e) domestic violence, use of alcohol and other psychosocial factors will be analyzed in interviews. Assessments will be conducted before the outset of the treatment, after 6 months, after 12 months and after 18 months from the beginning of the treatment. Changes in the scales between experiment and control groups will be compared. Because of the small size of the experimental group and the naturalistic design, no noteworthy differences in the results are expected as such. To test hypothetical explanatory power a prove was conducted. In the power calculation, a hypothetical sample of 35 received the value .82 in cases where the mean difference between two measurements divided by the corresponding standard deviation was 0.6. Similarly, if the difference in the means between two measurements was 0.5, the explanatory power was .66. Differences that are strong enough cannot be expected if only the group differences in the mean values between two measurements are analyzed without relating the results to the therapy processes (point 2) and to the processes of change (point 3). The explanatory power may be higher, however, after the Swedish study site has been added to the sample. The entire sample size would then consist of about 55 patients in each group.
- Treatment processes will be studied by analysing (a) video or audio recordings of the dialogues and (b) the entire treatment processes in a specific follow-up interview three months after termination of the couple therapy. This interview will be organized as a learning forum, that is, the follow-up interviews will be conducted in a way that enables the therapists to evaluate their work together with the couple and an outsider interviewer. The aim is at developing the family therapists' therapeutic skills. Reflective processes and learning on the part of the families are essential in this co-research practice (Andersen 2006). The family and all staff members included in the specific treatment process will be invited to this interview. First the therapy team will be interviewed about their experiences of the treatment, and then the family members will be interviewed about their experiences of the therapy and about their thoughts regarding the therapists' experiences. The aim of this interview is to gain information about the specific processes through which clients can perform their own psychological work with their problems.
- Processes of changes will be studied by conducting (a) a Outcome Ratings Scale among clients before each session and a Session Rating Scale among both clients and therapists after each therapy session and; and by (b) analyzing the qualities of the couple therapies by Psychotherapy Q-Sort (PQS) categories (Jones \& Jones, 1985). In the PQS 100 characteristics in 9 categories will be analyzed for one therapy session. The characteristics describe 1) attitude, behaviour and explicative experience of the patient; 2) actions and attitudes of the therapists; and 3) the nature of the therapeutic relationship, environment and atmosphere of the session (Sirigatti, 2004). Although the PQS has mostly been used in analysing manualized psychotherapies (Ablon \& Jones, 2002), implications has recently been developed for non-prescriptive therapies (Ablon et al., 2005) and systemic therapy (Sirigatti, 2004). Both analyses will be related to the outcome of the couple therapies and thus systematic information will be obtained as to which type of dialogues are connected with good outcomes.
Control group is formed in each of the three centres. These clients will not have family therapy sessions during the first 12 months; instead, according to the manner usual in each centre they will visit a psychiatrist or other therapists. Clients will be randomly assigned to the experimental and control groups after the doctor admitting them has assessed their inclusion by diagnosis and the Hamilton Rating Scale and after the first research interview has been conducted.
The inclusion period started in February 2006 and lasted until summer 2007. The first follow-up interviews will continue until the end of 2009. In this specific project the analysis of the data will begin in 2007 and continue to the end of 2010 concerning this specific project. Thereafter the data will be available for post graduate and doctoral students under the supervision of the principal investigators.
Department of Psychology at the University of Jyväskylä is the study site, in which all the data will be gathered. In each centre the research data will be stored outside of patient records. Information of the ratings scales can be added to specific patient records.
- Conditions
- Depression
- Being tested
- Psychotherapy
- Keywords
- Depression, family therapy, dialogical processes, Developing couple therapy for depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Narrative and dialogical approach for couples
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale; BDI and SCL-90 Dyadic Adjustment Scale (DAS)for couples -domestic violence, use of alcohol
Measured: 6, 12, 18 and 24 months
Secondary outcomes (1)
Outcome Ratings Scale and Session Rating Scale video recordings co-research interviews
Measured: 3 months after termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startFeb 2006
- Primary completionJul 2007
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883207
- Sponsor's protocol ID
- DINADEP
- Acronym
- DINADEP
- Status last verified
- Aug 2023
- First submitted
- 16 Apr 2009
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialogical and Narrative Processes in Couple Therapy for Depression. Two Year Follow-up Study of the Effectiveness and Processes in Couple Therapy
- ClinicalTrials.gov ID
- NCT00883207
- Acronym / sponsor ID
- DINADEP / DINADEP
- Conditions
- Depression
- Keywords
- Depression, family therapy, dialogical processes, Developing couple therapy for depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- Feb 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In each of these research centres qualified family therapists will conduct the couple therapy in case of depressed patients in a team of two therapists. To be a responsible therapist in this study the minimum criterion is three years specialist- level family therapy training and thus a qualification as psychotherapist according to Finnish law. The therapist shall have special experience and interest in dialogical and narrative processes in therapy. All the family therapists will also have taken a training program that focuses on systemic family therapy, narrative therapies and open dialogue in a family setting. No special therapy manual has been written, but the treatment processes will be analyzed after the therapy in relation to the outcome. The treatment processes are expected to last for as long as required according to the specific needs of each couple. This will allow for the focus on external validity: Clients will be recruited in the course of daily clinical practice without any selection outside the diagnosis and the therapies are taking place for as long as needed. The analyses of the treatment processes in relation to outcome, has termed as progress research by Pinsof \& Wynne (2000)
In couple therapy some guidelines are followed. Since every family therapist has training in systemic therapy, the therapy can be termed as systemic couple therapy with a special focus on dialogues and narratives. The two therapists and the couple form a system in which the first aim is to generate dialogue to increase understanding of couple's situation and the role of depression in their lives. To this end, spouses are encouraged to speak of subjects that they find most important. While one person is speaking, the other three take a reflective position in their inner dialogues and afterwards describe their thoughts about what was said. The shift between the speaking and listening positions in the topics that the couple choose is the basic element in each therapy process. In these processes a new joint language is created for experiences without words or experiences manifested in symptoms, marital problems or in problematic behaviour.
Three types of analysis will be conducted:
- The effectiveness of systemic couple therapy will be analyzed by (a) the assessment of depression by the Hamilton Depression Rating Scale inventory and the BDI and SCL self-report ratings scales; (b) the assessment of couple satisfaction by the Dyadic Adjustment Scale (DAS) self-report rating scale; and (c) the assessment of the psychological status of the patient by GAF rating. In addition to these, (e) domestic violence, use of alcohol and other psychosocial factors will be analyzed in interviews. Assessments will be conducted before the outset of the treatment, after 6 months, after 12 months and after 18 months from the beginning of the treatment. Changes in the scales between experiment and control groups will be compared. Because of the small size of the experimental group and the naturalistic design, no noteworthy differences in the results are expected as such. To test hypothetical explanatory power a prove was conducted. In the power calculation, a hypothetical sample of 35 received the value .82 in cases where the mean difference between two measurements divided by the corresponding standard deviation was 0.6. Similarly, if the difference in the means between two measurements was 0.5, the explanatory power was .66. Differences that are strong enough cannot be expected if only the group differences in the mean values between two measurements are analyzed without relating the results to the therapy processes (point 2) and to the processes of change (point 3). The explanatory power may be higher, however, after the Swedish study site has been added to the sample. The entire sample size would then consist of about 55 patients in each group.
- Treatment processes will be studied by analysing (a) video or audio recordings of the dialogues and (b) the entire treatment processes in a specific follow-up interview three months after termination of the couple therapy. This interview will be organized as a learning forum, that is, the follow-up interviews will be conducted in a way that enables the therapists to evaluate their work together with the couple and an outsider interviewer. The aim is at developing the family therapists' therapeutic skills. Reflective processes and learning on the part of the families are essential in this co-research practice (Andersen 2006). The family and all staff members included in the specific treatment process will be invited to this interview. First the therapy team will be interviewed about their experiences of the treatment, and then the family members will be interviewed about their experiences of the therapy and about their thoughts regarding the therapists' experiences. The aim of this interview is to gain information about the specific processes through which clients can perform their own psychological work with their problems.
- Processes of changes will be studied by conducting (a) a Outcome Ratings Scale among clients before each session and a Session Rating Scale among both clients and therapists after each therapy session and; and by (b) analyzing the qualities of the couple therapies by Psychotherapy Q-Sort (PQS) categories (Jones \& Jones, 1985). In the PQS 100 characteristics in 9 categories will be analyzed for one therapy session. The characteristics describe 1) attitude, behaviour and explicative experience of the patient; 2) actions and attitudes of the therapists; and 3) the nature of the therapeutic relationship, environment and atmosphere of the session (Sirigatti, 2004). Although the PQS has mostly been used in analysing manualized psychotherapies (Ablon \& Jones, 2002), implications has recently been developed for non-prescriptive therapies (Ablon et al., 2005) and systemic therapy (Sirigatti, 2004). Both analyses will be related to the outcome of the couple therapies and thus systematic information will be obtained as to which type of dialogues are connected with good outcomes.
Control group is formed in each of the three centres. These clients will not have family therapy sessions during the first 12 months; instead, according to the manner usual in each centre they will visit a psychiatrist or other therapists. Clients will be randomly assigned to the experimental and control groups after the doctor admitting them has assessed their inclusion by diagnosis and the Hamilton Rating Scale and after the first research interview has been conducted.
The inclusion period started in February 2006 and lasted until summer 2007. The first follow-up interviews will continue until the end of 2009. In this specific project the analysis of the data will begin in 2007 and continue to the end of 2010 concerning this specific project. Thereafter the data will be available for post graduate and doctoral students under the supervision of the principal investigators.
Department of Psychology at the University of Jyväskylä is the study site, in which all the data will be gathered. In each centre the research data will be stored outside of patient records. Information of the ratings scales can be added to specific patient records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychotherapyNarrative and dialogical approach for couples | Behavioural | – |
Primary outcome
Hamilton Depression Rating Scale; BDI and SCL-90 Dyadic Adjustment Scale (DAS)for couples -domestic violence, use of alcohol
Time frame: 6, 12, 18 and 24 months
1 secondary outcome
Outcome Ratings Scale and Session Rating Scale video recordings co-research interviews
Time frame: 3 months after termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- http://www.jyu.fi/ytk/laitokset/psykologia/psykoterapiaklinikka/en/Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Psychotherapy in people with Depression, run by University of Jyvaskyla at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale; BDI and SCL-90 Dyadic Adjustment Scale (DAS)for couples -domestic violence, use of alcohol (time frame: 6, 12, 18 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.