Short Term Therapy for Outpatients Diagnosed With Major Depressive DisorderCIPPSNCT01851915
Cognitive Behavioral Therapy and Interpersonal Psychotherapy as Treatment for Major Depressive Disorder
A study testing Cognitive Behavioral Therapy and Interpersonal Psychotherapy (IPT) in people with Short Term Therapy for Outpatients Diagnosed With Major Depressive Disorder, run by Linkoeping University at 1 site in Sweden.
Trial summary
In this study, the differential effectiveness of CBT and IPT for patients with Major Depressive Disorder, who rate their depression as mild or moderate, will be studied. Both methods are evidence based and recommended by the National Board of Health in Sweden. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Short Term Therapy for Outpatients Diagnosed With Major Depressive Disorder
- What is being tested?
- Cognitive Behavioral Therapy and Interpersonal Psychotherapy (IPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2011to Dec 2014
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -major depression
Who cannot join
- psychosis
- addiction
- bipolar disorder
- active self harm
- severe attention deficit hyperactivity syndrome
- disability pension
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Psychiatric clinic, Hospital of Sundsvall
Sundsvall, S-85186
Annika Ekeblad, +46705855746, annika.ekeblad@lvn.se
About this study
Official title: Randomized Trial of Treatment of Depression With Interpersonal Psychotherapy and Cognitive Behavioral Therapy
In this study, the differential effectiveness of CBT and IPT for patients with Major Depressive Disorder, who rate their depression as mild or moderate, will be studied. Both methods are evidence based and recommended by the National Board of Health in Sweden. They are manual based and the patients will receive 14 sessions in each therapy. Their comparative effectiveness has not been studied in Sweden, and their effectiveness with regard to work capacity has not been tested. The hypotheses in the study are that they have equal effect for depression remission, but that CBT is superior when return to work is measured. Three moderator analyses, testing effects for different subgroups, will be made. They propose that patients with attachment avoidance and lower mentalization ability and male patients will have better outcome with CBT. The study will be performed at Sundsvall Hospital, in cooperation with Linköping University. Sundsvall hospital is the only hospital in Sweden where there is a group IPT therapists large enough to make a controlled study possible. The study has a randomized design, with 16 therapists, 8 of them delivering CBT and 8 IPT. The number of patients is 96. The statistical power is .87, with a hypothesized between-groups effect size of d = .40 for return to work, and the significance level of .05 for the between-groups difference. Outcome will be measured as remission of psychiatric diagnosis, decrease in depression severity and frequency of patients who return to work. Both intent-to-treat and completers analyses will be made. The project will go over two years. The study has an effectiveness character in the sense that treatments, although manual based, will be performed in the manner that the therapists usually work, and by having broad inclusion criteria. Treatment integrity will be ascertained by therapist reports and by filming sessions.
Read the detailed description
The main purpose of the study is to analyze whether Interpersonal psychotherapy (IPT) and Cognitive Behavioural Therapy (CBT) are effective psychotherapies for depressed patients, with respect to changes in working capacity and psychiatric diagnosis. A secondary purpose is to study moderating factors in the two methods. The study has a randomized design. It will be performed at the Psychiatric Clinic in Sundsvall.
The differences in effect between different forms of psychotherapy for depression, when reduction in symptoms is used as outcome criterion, are rather small. In a recent meta-analysis, differences in efficacy between seven forms of psychotherapy were compared (Cuijpers, van Straten, Andersson \& van Oppen, 2008). The efficacy was on the whole the same.
In the guidelines from National Board of Health and Welfare in Sweden, CBT and IPT are recommended as the first hand choices for treatment of mild and moderate depression. This recommendation is based on studies from other countries. Comparative randomized studies of CBT and IPT have not been published in Sweden.
Hypotheses The main hypotheses in this study is that CBT and IPT are both effective treatments for Major Depressive Disorder, and that they have equal effects with regard to remission from depression, but that CBT is more effective than IPT when return to employment is the outcome measure. Three moderator hypotheses will be tested. The first moderator hypothesis is that patients with attachment avoidance get better results with CBT, whereas patients with attachment anxiety get better results with IPT. The second hypothesis is that patients with higher RF get better results with IPT than with CBT. The third moderator hypothesis is that women respond better to IPT and men to CBT, particularly if relational functioning is considered. In the moderator hypotheses, both remission from depression and return to work will be outcome criteria.
Method Participants Patients who seek treatment with the diagnosis Major Depressive Disorder (MDD), and who indicate mild or moderate depression on Beck's Depression Inventory will be asked to participate. The inclusion criterion is thus Major depressive disorder with mild or moderate severity. Exclusion criteria are psychosis, ongoing drug abuse, serious neuropsychiatric disorder, personality disorder cluster B. Patients with severe depression will also be excluded. We will also exclude patients who have used the disability pension and only include patients who have sickness benefit, as it is improbable the psychotherapy with 14 sessions will be enough for patients with disability pension. There will be no treatment arm with only medication. Ongoing medication is no obstacle for participation, but changes in medication will be avoided if possible. Medication will be registered. The patients will be randomized to the treatment alternatives. In all, 96 patients will take part in the study.
Sixteen therapists will participate in the study. Eight of them will give CBT and eight will give IPT. The therapists have at least the basic level of psychotherapy training according to Swedish norms. They are psychologists, social workers, and psychiatric nurses. They have been trained in their respective methods, have experience in it and have ongoing supervision, which will continue during the study.
Treatments Interpersonal therapy (IPT) will be delivered according to the standard manual (Weissman, Klerman \& Markowitz, 2000). IPT is a manualized, problem-focused treatment, originally created for depression treatment but now also using manuals for other disorders. The working mechanism of the treatment is supposed to be the patient's increased ability to connect the mood with interpersonal events, thus enabling him or her to influence the mood by solving interpersonal problems. Four distinct problem areas have been defined as associated with depression. The patient and the therapist start the treatment with identifying the patient's psychiatric and interpersonal problems. At the end of the introductory phase, a problem area is selected as the main focus. The remaining sessions, up to the termination phase, are devoted to helping the patient to find ways of handling the selected problem. The therapy will include 14 sessions.
Cognitive behavior therapy will be delivered according to the manuals of a) behavior activation during 14 sessions (Jacobson, Martell \& Dimidjian 2001) and b) Cognitive therapy for depression according to Beck et al. Behavior activation is based on a contextual model of depression, where the link between avoidant behavior and depression is the focus and the change mechanism is supposed to be activation strategies aiming to undermine punishment and increase positive reinforcement from the environment. The conceptualization of depression emphasizes the relationship between activity and mood and the role of contextual changes which may lead to decreased access to reinforcers associated with depression. The model underlines the importance of patterns of avoidance and withdrawal (e.g., of interpersonal situations, occupational or daily-life routine demands, distressing thoughts or feelings). Contacting potential antidepressant reinforcers may often be experienced as initially punishing, and thus avoidance of contact minimizes distress in the short term but is associated with greater long-term difficulty, both by reducing opportunities to contact potentially antidepressant environmental reinforcers and by creating or exacerbating new problems secondary to the decreased activity. Increased activation is presented as a strategy to break this cycle (Martell, Addis \& Jacobson, 2001). Some therapist are going to include mindfulness in their CBT as well.
The design has effectiveness character in the sense that the exclusion criteria are few and the therapies, although manual based, will be carried out in the manner that they are usually carried out at this clinic. We will endeavour to ascertain that the therapies are performed with accuracy, by having supervision on each therapy form. Adherence will be rated by the therapists after each session and by filming a limited number of therapies from each therapist, in order to ascertain treatment integrity. The Collaborative Study Psychotherapy Rating Scale-6 (CSPRS-6; Markowitz, Spielman, Scarvalone \& Perry, 2000), which is the standard scale for rating adherence to CBT and IPT, will be used.
In both therapy forms, the treatments last for 14 sessions. Outcome will be evaluated at treatment termination.
The inclusion of participants started in January 2011 and continues throughout the fall 2013.
- Being tested
- Cognitive Behavioral Therapy, Interpersonal Psychotherapy (IPT)
- Keywords
- Major depression, Interpersonal psychotherapy, Cognitive Behavioral Therapy, Alliance, Return to Work
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
14 sessions psychological treatment for depression
Interpersonal Psychotherapy (IPT)Behavioural
14 sessions psychological treatment for depression
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral therapy (CBT) | Active comparator | Short term therapy for treatment of depression Receives: Behavioral: Cognitive Behavioral Therapy |
| Interpersonal Psychotherapy (IPT) | Experimental | Interpersonal short term therapy for treatment of depression Receives: Behavioral: Interpersonal Psychotherapy (IPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale (MADRS) ( Montgomery SA & Åsberg M. Br J Psychiatry 1979; 134:382-9)
Clinician-rated depression symptoms before and after therapy
Measured: Change from before treatment to after termination (14-15 weeks)
Return to Work
Sick leave will be measured by medical records and by checking the insurance system
Measured: Change from before treatment and after termination (14-15 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Short Term Therapy for Outpatients Diagnosed With Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- REHSAM, Västernorrland County Council, Sweden, Psychiatric clinic, Hospital of Sundsvall, Sweden
- Responsible party
- Principal investigator, Annika Ekeblad, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851915
- Sponsor's protocol ID
- RS2010/013
- Acronym
- CIPPS
- Status last verified
- May 2013
- First submitted
- 11 Mar 2013
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Alexandersson K, Wagberg M, Ekeblad A, Holmqvist R, Falkenstrom F. Session-to-session effects of therapist adherence and facilitative conditions on symptom change in CBT and IPT for depression. Psychother Res. 2023 Jan;33(1):57-69. doi: 10.1080/10503307.2022.2025626. Epub 2022 Jan 23.
PubMed 35068364Falkenstrom F, Ekeblad A, Holmqvist R. Improvement of the working alliance in one treatment session predicts improvement of depressive symptoms by the next session. J Consult Clin Psychol. 2016 Aug;84(8):738-51. doi: 10.1037/ccp0000119. Epub 2016 May 23.
PubMed 27213493
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Treatment of Depression With Interpersonal Psychotherapy and Cognitive Behavioral Therapy
- ClinicalTrials.gov ID
- NCT01851915
- Acronym / sponsor ID
- CIPPS / RS2010/013
- Keywords
- Major depression, Interpersonal psychotherapy, Cognitive Behavioral Therapy, Alliance, Return to Work
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- REHSAM, Västernorrland County Council, Sweden, Psychiatric clinic, Hospital of Sundsvall, Sweden
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 13 May 2013 (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.
In this study, the differential effectiveness of CBT and IPT for patients with Major Depressive Disorder, who rate their depression as mild or moderate, will be studied. Both methods are evidence based and recommended by the National Board of Health in Sweden. They are manual based and the patients will receive 14 sessions in each therapy. Their comparative effectiveness has not been studied in Sweden, and their effectiveness with regard to work capacity has not been tested. The hypotheses in the study are that they have equal effect for depression remission, but that CBT is superior when return to work is measured. Three moderator analyses, testing effects for different subgroups, will be made. They propose that patients with attachment avoidance and lower mentalization ability and male patients will have better outcome with CBT. The study will be performed at Sundsvall Hospital, in cooperation with Linköping University. Sundsvall hospital is the only hospital in Sweden where there is a group IPT therapists large enough to make a controlled study possible. The study has a randomized design, with 16 therapists, 8 of them delivering CBT and 8 IPT. The number of patients is 96. The statistical power is .87, with a hypothesized between-groups effect size of d = .40 for return to work, and the significance level of .05 for the between-groups difference. Outcome will be measured as remission of psychiatric diagnosis, decrease in depression severity and frequency of patients who return to work. Both intent-to-treat and completers analyses will be made. The project will go over two years. The study has an effectiveness character in the sense that treatments, although manual based, will be performed in the manner that the therapists usually work, and by having broad inclusion criteria. Treatment integrity will be ascertained by therapist reports and by filming sessions.
Detailed description
The main purpose of the study is to analyze whether Interpersonal psychotherapy (IPT) and Cognitive Behavioural Therapy (CBT) are effective psychotherapies for depressed patients, with respect to changes in working capacity and psychiatric diagnosis. A secondary purpose is to study moderating factors in the two methods. The study has a randomized design. It will be performed at the Psychiatric Clinic in Sundsvall.
The differences in effect between different forms of psychotherapy for depression, when reduction in symptoms is used as outcome criterion, are rather small. In a recent meta-analysis, differences in efficacy between seven forms of psychotherapy were compared (Cuijpers, van Straten, Andersson \& van Oppen, 2008). The efficacy was on the whole the same.
In the guidelines from National Board of Health and Welfare in Sweden, CBT and IPT are recommended as the first hand choices for treatment of mild and moderate depression. This recommendation is based on studies from other countries. Comparative randomized studies of CBT and IPT have not been published in Sweden.
Hypotheses The main hypotheses in this study is that CBT and IPT are both effective treatments for Major Depressive Disorder, and that they have equal effects with regard to remission from depression, but that CBT is more effective than IPT when return to employment is the outcome measure. Three moderator hypotheses will be tested. The first moderator hypothesis is that patients with attachment avoidance get better results with CBT, whereas patients with attachment anxiety get better results with IPT. The second hypothesis is that patients with higher RF get better results with IPT than with CBT. The third moderator hypothesis is that women respond better to IPT and men to CBT, particularly if relational functioning is considered. In the moderator hypotheses, both remission from depression and return to work will be outcome criteria.
Method Participants Patients who seek treatment with the diagnosis Major Depressive Disorder (MDD), and who indicate mild or moderate depression on Beck's Depression Inventory will be asked to participate. The inclusion criterion is thus Major depressive disorder with mild or moderate severity. Exclusion criteria are psychosis, ongoing drug abuse, serious neuropsychiatric disorder, personality disorder cluster B. Patients with severe depression will also be excluded. We will also exclude patients who have used the disability pension and only include patients who have sickness benefit, as it is improbable the psychotherapy with 14 sessions will be enough for patients with disability pension. There will be no treatment arm with only medication. Ongoing medication is no obstacle for participation, but changes in medication will be avoided if possible. Medication will be registered. The patients will be randomized to the treatment alternatives. In all, 96 patients will take part in the study.
Sixteen therapists will participate in the study. Eight of them will give CBT and eight will give IPT. The therapists have at least the basic level of psychotherapy training according to Swedish norms. They are psychologists, social workers, and psychiatric nurses. They have been trained in their respective methods, have experience in it and have ongoing supervision, which will continue during the study.
Treatments Interpersonal therapy (IPT) will be delivered according to the standard manual (Weissman, Klerman \& Markowitz, 2000). IPT is a manualized, problem-focused treatment, originally created for depression treatment but now also using manuals for other disorders. The working mechanism of the treatment is supposed to be the patient's increased ability to connect the mood with interpersonal events, thus enabling him or her to influence the mood by solving interpersonal problems. Four distinct problem areas have been defined as associated with depression. The patient and the therapist start the treatment with identifying the patient's psychiatric and interpersonal problems. At the end of the introductory phase, a problem area is selected as the main focus. The remaining sessions, up to the termination phase, are devoted to helping the patient to find ways of handling the selected problem. The therapy will include 14 sessions.
Cognitive behavior therapy will be delivered according to the manuals of a) behavior activation during 14 sessions (Jacobson, Martell \& Dimidjian 2001) and b) Cognitive therapy for depression according to Beck et al. Behavior activation is based on a contextual model of depression, where the link between avoidant behavior and depression is the focus and the change mechanism is supposed to be activation strategies aiming to undermine punishment and increase positive reinforcement from the environment. The conceptualization of depression emphasizes the relationship between activity and mood and the role of contextual changes which may lead to decreased access to reinforcers associated with depression. The model underlines the importance of patterns of avoidance and withdrawal (e.g., of interpersonal situations, occupational or daily-life routine demands, distressing thoughts or feelings). Contacting potential antidepressant reinforcers may often be experienced as initially punishing, and thus avoidance of contact minimizes distress in the short term but is associated with greater long-term difficulty, both by reducing opportunities to contact potentially antidepressant environmental reinforcers and by creating or exacerbating new problems secondary to the decreased activity. Increased activation is presented as a strategy to break this cycle (Martell, Addis \& Jacobson, 2001). Some therapist are going to include mindfulness in their CBT as well.
The design has effectiveness character in the sense that the exclusion criteria are few and the therapies, although manual based, will be carried out in the manner that they are usually carried out at this clinic. We will endeavour to ascertain that the therapies are performed with accuracy, by having supervision on each therapy form. Adherence will be rated by the therapists after each session and by filming a limited number of therapies from each therapist, in order to ascertain treatment integrity. The Collaborative Study Psychotherapy Rating Scale-6 (CSPRS-6; Markowitz, Spielman, Scarvalone \& Perry, 2000), which is the standard scale for rating adherence to CBT and IPT, will be used.
In both therapy forms, the treatments last for 14 sessions. Outcome will be evaluated at treatment termination.
The inclusion of participants started in January 2011 and continues throughout the fall 2013.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral therapy (CBT) | Active comparator | Behavioral: Cognitive Behavioral TherapyShort term therapy for treatment of depression |
| Interpersonal Psychotherapy (IPT) | Experimental | Behavioral: Interpersonal Psychotherapy (IPT)Interpersonal short term therapy for treatment of depression |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -major depression
Key exclusion criteria (6 listed)
- psychosis
- addiction
- bipolar disorder
- active self harm
- severe attention deficit hyperactivity syndrome
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 |
|---|---|---|
| Cognitive Behavioral Therapy14 sessions psychological treatment for depression | Behavioural | Cognitive Behavioral therapy (CBT) |
| Interpersonal Psychotherapy (IPT)14 sessions psychological treatment for depression | Behavioural | Interpersonal Psychotherapy (IPT) |
Primary outcome
Montgomery Asberg Depression Rating Scale (MADRS) ( Montgomery SA & Åsberg M. Br J Psychiatry 1979; 134:382-9)
Time frame: Change from before treatment to after termination (14-15 weeks)
Clinician-rated depression symptoms before and after therapy
Return to Work
Time frame: Change from before treatment and after termination (14-15 weeks).
Sick leave will be measured by medical records and by checking the insurance system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
- Derived from this study: PubMed 35068364Alexandersson K, Wagberg M, Ekeblad A, Holmqvist R, Falkenstrom F. Session-to-session effects of therapist adherence and facilitative conditions on symptom change in CBT and IPT for depression. Psychother Res. 2023 Jan;33(1):57-69. doi: 10.1080/10503307.2022.2025626. Epub 2022 Jan 23.
- Derived from this study: PubMed 27213493Falkenstrom F, Ekeblad A, Holmqvist R. Improvement of the working alliance in one treatment session predicts improvement of depressive symptoms by the next session. J Consult Clin Psychol. 2016 Aug;84(8):738-51. doi: 10.1037/ccp0000119. Epub 2016 May 23.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Interpersonal Psychotherapy (IPT) in people with Short Term Therapy for Outpatients Diagnosed With Major Depressive Disorder, run by Linkoeping University at 1 site in Sweden.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 May 2013. 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 Sweden. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annika Ekeblad, PhD student (46705855746, annika.ekeblad@lvn.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery Asberg Depression Rating Scale (MADRS) ( Montgomery SA & Åsberg M. Br J Psychiatry 1979; 134:382-9) (time frame: Change from before treatment to after termination (14-15 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01851915, which also lists 2 linked publications.
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 13 May 2013.