Major Depressive DisorderDAPPeRNCT03594773

Modeling Multi-level Dyadic Behavior to Transform the Science and Practice of Psychotherapy Process and Outcome.

A study testing Cognitive Behavioral Therapy and Interpersonal Psychotherapy in people with Major Depressive Disorder, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a short-term longitudinal study of psychotherapy process. Participants will be treated with 8 sessions of psychotherapy over the course of 8 to 12 weeks. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Cognitive Behavioral Therapy and Interpersonal Psychotherapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 1 siteUnited States
Study dates: 8 Jul 2018to 31 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Age 18-65
Meet DSM-5 criteria for major depressive disorder (MDD), current episode, based on the Mini International Neuropsychiatric Interview (MINI)
Hamilton Rating Scale for Depression (HRSD-17) score ≥ 14 consistent with at least moderate depressive symptoms
If currently on antidepressant medication, must be on a stable dose for at least one month at the time of study entry and agree to remain on that dose for study duration
Fluent in English
Capacity to understand and give informed consent

Who cannot join

At high risk for suicide, that, in the clinical opinion of the investigator, would warrant a higher level of care such as hospitalization or intensive outpatient programs
Current depressive episode has psychotic features
Current depressive episode has been present for > 104 weeks
Meets criteria for substance use disorders, as defined by DSM-5, in the past 3 months, except for caffeine or nicotine. (Limited substance use, not meeting criteria for substance use disorders, is not exclusionary).
Meets DSM-5 criteria for prior manic or hypomanic episode (bipolar I or II disorder) or a psychotic disorder including schizoaffective disorder or schizophrenia
Meets DSM-5 criteria for antisocial personality disorder (MINI)

Show all 10Show fewer

Significant, unstable, psychiatric co-morbidity that, in the opinion of the investigators, requires an alternative treatment approach (i.e., unstable eating disorder, unstable borderline personality disorder)
Significant unstable medical illness that may explain depressive symptoms such as epilepsy, autoimmune disorder, chronic pain, or unstable endocrine disorder
Cognitive deficits that would preclude completion of study questionnaires or participation in psychotherapy
Unable to unwilling to comply with study requirements (i.e., complete forms, attend sessions)

Trial locations and contacts

1 site in 1 country.

United States1 site

WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Dyadic Behavior Informatics for Psychotherapy Process and Outcome

This is a short-term longitudinal study of psychotherapy process. Participants will be treated with 8 sessions of psychotherapy over the course of 8 to 12 weeks.

Read the detailed description

Enrolled participants were randomized to one of two psychotherapy conditions: 8 sessions of Brief Cognitive Behavior Therapy or Brief Interpersonal Psychotherapy (IPT) over a 12 week protocol.

In response to the COVID-19 pandemic, we completed the study in two phases. Phase 1 procedures were conducted entirely in-person and Phase 2 procedures were conducted via telehealth. Phase 1 recruitment began July 2018 and concluded in February 2020. Recruitment for Phase 2 began July 2020 and concluded March 2021.

This project aims to model the dynamics of individual and dyadic behavior on a moment-by-moment basis within each therapy session and over the course of treatment. These models will be used to test hypotheses about multimodal behavior dynamics, psychotherapy process, type of treatment, and treatment outcome.

Conditions: Major Depressive Disorder
Being tested: Cognitive Behavioral Therapy, Interpersonal Psychotherapy
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
Also called CBT
Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
Interpersonal PsychotherapyBehavioural
Also called IPT
Participants will receive 8 one-on-one sessions over 8 to 12 weeks.

Study groups in NCT03594773
Study group	Role	What they receive
Interpersonal Psychotherapy	Experimental	Participants randomized to this arm will be treated with 8 sessions over the course of 8 to 12 weeks by a therapist trained in IPT. Participants will complete brief questionnaires before and after treatment sessions. Before each session, they will report on their psychological distress. Following each session, participants and therapists will both complete assessments of the working alliance and rate their own and the other person's affective and interpersonal behavior. Receives: Behavioral: Interpersonal Psychotherapy
Cognitive Behavioral Therapy	Experimental	Participants randomized to this arm will be treated with 8 sessions over the course of 8 to 12 weeks by a therapist trained in CBT. Participants will complete brief questionnaires before and after treatment sessions. Before each session, they will report on their psychological distress. Following each session, participants and therapists will both complete assessments of the working alliance and rate their own and the other person's affective and interpersonal behavior. Receives: Behavioral: Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Depression Severity
Our primary outcome measure of depression symptom severity was based on the Hamilton Rating Scale for Depression (HRSD-17) obtained at the final study visit (12 weeks). The HRSD-17 consists of 17 items with Likert scale of either 0 to 4 or 0 to 2. Scores can range from 0(min) to 54(max), with higher scores indicating higher depression symptoms.
Clinical interpretation of scale ranges of the HRSD-17 are as follows:
0-7= Normal 8-13= Mild Depression 14-18= Moderate Depression 19-22= Severe Depression >=23 = Very Severe Depression
Measured: 12 weeks

Secondary outcomes (2)

Working Alliance Inventory--Short Revised Client Version (WAI-SR-C)
The Working Alliance Inventory-Short Revised (WAI-SR), client version, is a 12-item scale that measures three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Each subscale score for the WAI-SR ranges from 5(min) to 20(max), for a total score range of 15(min) to 60(max). Higher scores represent better alliance. The secondary outcome measure is based on the WAI-SR mean of the total scores measured at the final therapy visit (visit 8).
Measured: 12 weeks
Working Alliance Inventory--Short Revised Therapist Version (WAI-SRT)
The Working Alliance Inventory-Short Revised (WAI-SRT), therapist version, is a 12-item scale that measures three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Each subscale score for the WAI-SR ranges from 5(min) to 20(max), for a total score range of 15(min) to 60(max). Higher scores represent better alliance. The secondary outcome measure is based on the WAI-SRT mean of the total scores measured at the final therapy visit (visit 8).
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 201831 Jul 2021

First posted20 Jul 2018
Study start8 Jul 2018
Primary completion31 Mar 2021
Study completion31 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by University of PittsburghThe 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: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03594773
Sponsor's protocol ID: PRO17110528
Other IDs: 171722822
Acronym: DAPPeR
Status last verified: Jun 2024
First submitted: 11 Jul 2018
Last updated: 22 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Swartz HA, Bylsma LM, Fournier JC, Girard JM, Spotts C, Cohn JF, Morency LP. Randomized trial of brief interpersonal psychotherapy and cognitive behavioral therapy for depression delivered both in-person and by telehealth. J Affect Disord. 2023 Jul 15;333:543-552. doi: 10.1016/j.jad.2023.04.092. Epub 2023 Apr 28.
PubMed 37121279
Girard JM, Yermol DA, Bylsma LM, Cohn JF, Fournier JC, Morency LP, Swartz HA. Dynamic and dyadic relationships between facial behavior, working alliance, and treatment outcomes during depression therapy. J Consult Clin Psychol. 2025 Nov;93(11):749-760. doi: 10.1037/ccp0000980.
PubMed 41182707

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dyadic Behavior Informatics for Psychotherapy Process and Outcome
ClinicalTrials.gov ID: NCT03594773
Acronym / sponsor ID: DAPPeR / PRO17110528
Conditions: Major Depressive Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: Carnegie Mellon University
Study start: 8 Jul 2018 (actual)
Primary completion: 31 Mar 2021 (actual)
Study completion: 31 Jul 2021 (actual)
First posted: 20 Jul 2018 (actual)
Results: Posted 22 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a short-term longitudinal study of psychotherapy process. Participants will be treated with 8 sessions of psychotherapy over the course of 8 to 12 weeks.

Detailed description

Enrolled participants were randomized to one of two psychotherapy conditions: 8 sessions of Brief Cognitive Behavior Therapy or Brief Interpersonal Psychotherapy (IPT) over a 12 week protocol.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Interpersonal Psychotherapy	Experimental	Behavioral: Interpersonal PsychotherapyParticipants randomized to this arm will be treated with 8 sessions over the course of 8 to 12 weeks by a therapist trained in IPT. Participants will complete brief questionnaires before and after treatment sessions. Before each session, they will report on their psychological distress. Following each session, participants and therapists will both complete assessments of the working alliance and rate their own and the other person's affective and interpersonal behavior.
Cognitive Behavioral Therapy	Experimental	Behavioral: Cognitive Behavioral TherapyParticipants randomized to this arm will be treated with 8 sessions over the course of 8 to 12 weeks by a therapist trained in CBT. Participants will complete brief questionnaires before and after treatment sessions. Before each session, they will report on their psychological distress. Following each session, participants and therapists will both complete assessments of the working alliance and rate their own and the other person's affective and interpersonal behavior.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age 18-65
Meet DSM-5 criteria for major depressive disorder (MDD), current episode, based on the Mini International Neuropsychiatric Interview (MINI)
Hamilton Rating Scale for Depression (HRSD-17) score ≥ 14 consistent with at least moderate depressive symptoms
If currently on antidepressant medication, must be on a stable dose for at least one month at the time of study entry and agree to remain on that dose for study duration
Fluent in English

Key exclusion criteria (10 listed)

At high risk for suicide, that, in the clinical opinion of the investigator, would warrant a higher level of care such as hospitalization or intensive outpatient programs
Current depressive episode has psychotic features
Current depressive episode has been present for > 104 weeks
Meets criteria for substance use disorders, as defined by DSM-5, in the past 3 months, except for caffeine or nicotine. (Limited substance use, not meeting criteria for substance use disorders, is not exclusionary).
Meets DSM-5 criteria for prior manic or hypomanic episode (bipolar I or II disorder) or a psychotic disorder including schizoaffective disorder or schizophrenia

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 TherapyAlso: CBTParticipants will receive 8 one-on-one sessions over 8 to 12 weeks.	Behavioural	Cognitive Behavioral Therapy
Interpersonal PsychotherapyAlso: IPTParticipants will receive 8 one-on-one sessions over 8 to 12 weeks.	Behavioural	Interpersonal Psychotherapy

Primary outcome

Depression Severity
Time frame: 12 weeks
Our primary outcome measure of depression symptom severity was based on the Hamilton Rating Scale for Depression (HRSD-17) obtained at the final study visit (12 weeks). The HRSD-17 consists of 17 items with Likert scale of either 0 to 4 or 0 to 2. Scores can range from 0(min) to 54(max), with higher scores indicating higher depression symptoms. Clinical interpretation of scale ranges of the HRSD-17 are as follows: 0-7= Normal 8-13= Mild Depression 14-18= Moderate Depression 19-22= Severe Depression >=23 = Very Severe Depression

2 secondary outcomes

Working Alliance Inventory--Short Revised Client Version (WAI-SR-C)
Time frame: 12 weeks
Working Alliance Inventory--Short Revised Therapist Version (WAI-SRT)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 22 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Interpersonal Psychotherapy (IPT)	42	36
Cognitive Behavioral Therapy (CBT)	35	29

Primary outcome: Depression Severity

Time frame: 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Interpersonal Psychotherapy n = 31	Cognitive Behavioral Therapy n = 27
Value	11.9 (6.34)	11.41 (5.41)

Interpersonal Psychotherapy vs Cognitive Behavioral Therapy: Mean Difference (Final Values): -.496 (95% CI -3.62 to 2.63), p = .752, t-test, 2 sided

Population analysed: These analyses only include those who completed the final 12-week post-treatment assessment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks per participant. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Interpersonal Psychotherapy	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Cognitive Behavioral Therapy	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Limitations and caveats (from the sponsor): Limitations include the small sample size for each group and COVID-19 pandemic related restrictions necessitated that we conduct the 2nd half of the study virtually: delivery format for both intervention groups consisted of in person for the first phase of the trial (N=49) and virtual for the second phase of the trial (N=26). One participant for CBT and 3 for IPT were active in the study at the time of pandemic lockdown and had to be discontinued because of COVID-19 related safety requirements.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37121279Swartz HA, Bylsma LM, Fournier JC, Girard JM, Spotts C, Cohn JF, Morency LP. Randomized trial of brief interpersonal psychotherapy and cognitive behavioral therapy for depression delivered both in-person and by telehealth. J Affect Disord. 2023 Jul 15;333:543-552. doi: 10.1016/j.jad.2023.04.092. Epub 2023 Apr 28.
Derived from this study: PubMed 41182707Girard JM, Yermol DA, Bylsma LM, Cohn JF, Fournier JC, Morency LP, Swartz HA. Dynamic and dyadic relationships between facial behavior, working alliance, and treatment outcomes during depression therapy. J Consult Clin Psychol. 2025 Nov;93(11):749-760. doi: 10.1037/ccp0000980.
Individual participant dataSharing planned: No

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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.

Jeffrey F Cohn, Ph.D. principal investigator

University of Pittsburgh

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 in people with Major Depressive Disorder, run by University of Pittsburgh at 1 site in United States.

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 6 inclusion and 10 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 22 Jul 2024. 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 United States. 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?

Yes. Results are posted in the registry (first posted 22 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Depression Severity (time frame: 12 weeks). 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 NCT03594773, 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 22 Jul 2024.