Blended Care Versus Face-to-Face Therapy for Depression

NCT04337242 | Active Not Recruiting

• 1 other identifier: S59765
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 6

Brief Summary

Depression is a severe mental disorder that affects 5-7% of Belgians each year. Unfortunately, many individuals with depression do not seek professional help, and if they do seek professional help, waiting lists for psychotherapy are typically very long. To help resolve this problem, this study aims to investigate whether blended therapies, i.e. therapies that consist of a mixture of face-to-face sessions and online sessions, are (cost-)effective as a treatment for depression, and whether they are as (cost-)effective as traditional treatments which consist of face-to-face sessions alone. Should this be the case, then blended therapy can be implemented on a large scale in mental health care, as it could provide a more cost-effective means of helping individuals with depression. This study also aims to investigate whether certain patient features, such as the severity of depression and personality traits, may influence the efficacy of (blended) psychotherapy for depression. Finally, we will also investigate patients' attitudes towards and experience of blended therapy.

Conditions

Major Depressive Disorder

Keywords

depression; psychotherapy; blended; cognitive behavioral; psychodynamic

Outcome Measures

Primary Outcomes (1)

• Changes in depressive symptoms assessed by the Beck Depression Inventory (BDI-II) at 6-month follow-up (12 months after the start of treatment)

  Severity of depression as measured by the BDI-II (range 0-63, with higher scores reflecting worse outcome)

  From baseline to 6 months follow-up (12 months after the start of treatment)

Secondary Outcomes (5)

• Partial and full recovery

  From baseline to treatment termination (6 months after the start of treatment), and 6-month, and one- and two-year follow-up

• Quality of Life

  From baseline to treatment termination(6 months after the start of treatment), and 6-month, and one- and two-year follow-up

• Treatment Expectancy

  Baseline, and (with a modified version) at treatment termination (6 months after the start of treatment) and 6-month follow-up

• Satisfaction with treatment

  Baseline, treatment termination (6 months after the start of treatment), and at 6-month, and one- and two-year follow-up

• Cost-effectiveness

  Baseline, treatment termination (6 months after the start of treatment), and at 6-month, and one- and two-year follow-up

Other Outcomes (2)

• Predictors of treatment response and mechanisms of change

  Baseline

• Feasibility and acceptability of blended psychotherapy

  Baseline, treatment termination (6 months after the start of treatment), and at 6-month, and one- and two-year follow-up

Study Arms (4)

Blended Dynamic Interpersonal Therapy (B-DIT)

EXPERIMENTAL

B-DIT is based on the same treatment principles as face-to-face Dynamic Interpersonal Therapy (DIT) and has the same structure of treatment consisting of three phases: (a) an exploration and engagement phase, (b) a middle or working through phase, and (c) an ending phase. B-DIT consists of 8 online modules that are alternated with up to 8 fortnightly face-to-face sessions.

Behavioral: B-DIT

Blended Cognitive Behavioral Therapy (B-CBT)

EXPERIMENTAL

B-CBT is based on the same treatment principles as face-to-face Cognitive Behavioral Therapy (CBT). These include (a) psycho-education about depression, (b) cognitive restructuring (i.e., identifying and challenging maladaptive thoughts and beliefs, fostering problem solving capacities), (c) mindfulness and acceptance based approaches, and (d) relapse prevention. B-CBT in this trial consists of 8 online modules that are alternated with up to 8 fortnightly face-to-face sessions.

Behavioral: B-CBT

Dynamic Interpersonal Therapy (DIT)

ACTIVE COMPARATOR

DIT is a short-term, integrative psychodynamic, 16 weekly sessions individual therapy for depression. DIT formulates the presenting symptoms of depression as responses to interpersonal difficulties or perceived threats to attachments (loss/separation) and hence also as threats to the self.

Behavioral: DIT

Cognitive Behavioral Therapy (CBT)

ACTIVE COMPARATOR

CBT is a brief talking therapy that consists of a maximum of 16 sessions, offered over 4 to 6 months. CBT is based on the assumption that depression is directly related to patterns of thinking. Specifically, dysfunctional and often automatic patterns of thinking are assumed to be related to the onset and maintenance of depression.

Behavioral: Cognitive Behavioral Therapy

Interventions

B-DIT BEHAVIORAL

Blended Dynamic Interpersonal Therapy

Blended Dynamic Interpersonal Therapy (B-DIT)

B-CBT BEHAVIORAL

Blended Cognitive Behavioral Therapy

Blended Cognitive Behavioral Therapy (B-CBT)

DIT BEHAVIORAL

Dynamic Interpersonal Therapy

Dynamic Interpersonal Therapy (DIT)

Cognitive Behavioral Therapy BEHAVIORAL

CBT

Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Current diagnosis of major depressive disorder with or without dysthymic disorder according to DSM 5 criteria.
• PHQ score ≥ 10.
• Note: Use of pharmacotherapy for depression and other psychiatric disorders during the intervention is allowed (with the exception of antipsychotic medication for psychotic disorder), as this reflects routine clinical care. Of note, in routine clinical care, it is not uncommon that antipsychotic medication is prescribed for symptoms in the depressive-anxious cluster rather than for primary psychotic symptoms.

You may not qualify if:

• Current psychotic symptoms or bipolar disorder.
• Current use of antipsychotic medication specifically for the treatment of primary psychotic disorder.
• Severe Personality Disorder (e.g., borderline personality disorder).
• Historic or current self-injury/parasuicide of such extent and/or severity that may substantially interfere with the ability to engage in brief psychotherapy.
• Current excessive use of drugs/alcohol.
• Not fluent in Dutch.
• Clinical contra-indication to brief psychotherapy (e.g., attachment history - multiple separations, serious ongoing trauma in childhood, multiple caregivers - suggesting the need for longer-term psychotherapy).
• Evidence of pervasive use of help.
• Highly unstable or insecure life arrangements.
• No access to computer/internet or computer illiteracy.
• Participation in another depression clinical trial within the last year where the participant has received CBT or PDT.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Belgium Health Care Knowledge Centre: collaborator
• Erasmus University Rotterdam: collaborator

Study Sites (6)

CGG Andante

Berchem, 2600, Belgium

Location

CGG Vagga

Berchem, 2600, Belgium

Location

CGG Mandel & Leie

Kortrijk, 8500, Belgium

Location

CGG VBO

Leuven, 3000, Belgium

Location

CGG De Pont

Mechelen, 2800, Belgium

Location

CGG Kempen

Turnhout, 2300, Belgium

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Patrick Luyten, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: April 7, 2020
• Study Start: March 29, 2019
• Primary Completion: December 31, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the publication of results focusing on primary and secondary outcomes/endpoints, anonymous data will be made available.
• Access Criteria: Only researchers who provide a methodologically sound research proposal can ask for access to the data.

Locations

BE (6)