Intersession Processes in Psychotherapeutic Treatments Using an Ecological Momentary Assessment Approach (ISA-Bell)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The effects of a monitoring intervention as an add-on to face-to-face Cognitive Behavioral Therapy (CBT) for depression are assessed in this randomised trial. Monitoring consists of Ecological Momentary Assessment (EMA) of symptoms and inter-session processes via mobile phones. Twenty sessions of face-to-face CBT + EMA are compared to twenty sessions of face-to-face CBT (treatment as usual, TAU). 84 patients with mild to moderate depression will be randomised to CBT + EMA or to TAU.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Self-monitoring and Reflection's Impact on Psychotherapy Outcomes: A Trial Protocol.

NCT06038747

Psychotherapy Therapeutic Alliance Psychological

COMPLETED NA

Efficacy of Internet-delivered Cognitive-behavior Therapy for PTSD

NCT05934162

Post Traumatic Stress Disorder

RECRUITING NA

Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial

NCT00329992

Chronic Posttraumatic Stress Disorder

COMPLETED PHASE3

Blended Treatment för PTSD: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy

NCT05758987

PTSD CBT

RECRUITING NA

Reflective Function as a Mediator of Interpersonal Psychotherapy (IPT)

NCT02645929

PTSD

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

As mobile technologies advance, healthcare is increasingly utilising mobile interventions to accompany traditional interventions such as psychotherapy. Mobile assessments of symptoms and other processes are also used as low-level interventions and are believed to lead to symptom improvements in patients with symptoms of depression, for example. However, robust evidence on the health benefits of monitoring interventions in patients with depression is lacking.

The investigators are interested in the potential benefits of a monitoring intervention as an add-on to face-to-face Cognitive Behavioral Therapy (CBT) for depression. Therefore, the investigators will conduct a randomised trial to investigate the effects of a monitoring intervention consisting of Ecological Momentary Assessment (EMA) of symptoms and inter-session processes via mobile phones. Twenty sessions of face-to-face CBT + EMA will be compared to twenty sessions of face-to-face CBT (treatment as usual, TAU). Participants in the CBT + EMA group will be asked to answer monitoring questions twice daily for two four-week blocks during the CBT treatment. A total of 84 participants with mild to moderate depression will be randomized. Of these, 48 participants will be randomized to CBT + EMA and 36 participants will be randomized to TAU. The primary outcome of interest is change in the Patient Health Questionnaire (PHQ-9) score at four-month follow-up assessment.

Throughout the study, there will be five assessment timepoints: Baseline (before the first therapy session), four weeks after the fourth therapy session, four weeks after the twelfth therapy session, after the last session (post-treatment) and the 4-month follow-up (four months after the last therapy session).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4/7 of participants will be randomised to CBT + EMA and 3/7 to TAU. This randomisation ratio is chosen to foster longitudinal analyses in the CBT + EMA group. Randomisation is stratified by pre-treatment severity of depressive symptoms. Participants with PHQ-9 scores 5-9 will be randomised separately from participants with PHQ-9 scores 10-20.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

As is common in psychotherapy research, participants and care providers cannot be blinded to the intervention. Only subjective outcomes (i.e., participant-rated) are assessed.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive Behavior Therapy + Ecological Momentary Assessment (CBT + EMA)

Cognitive Behavior Therapy + Ecological Momentary Assessment

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy (CBT)

Intervention Type BEHAVIORAL

20 sessions of face-to-face, individual CBT

Ecological Momentary Assessment (EMA)

Intervention Type OTHER

Two four-week blocks of twice daily ecological momentary assessment (EMA) of symptoms and inter-session processes

Treatment as Usual (TAU)

Cognitive Behavioural Therapy (Treatment as Usual)

Group Type ACTIVE_COMPARATOR

Cognitive Behavioural Therapy (CBT)

Intervention Type BEHAVIORAL

20 sessions of face-to-face, individual CBT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive Behavioural Therapy (CBT)

20 sessions of face-to-face, individual CBT

Intervention Type BEHAVIORAL

Ecological Momentary Assessment (EMA)

Two four-week blocks of twice daily ecological momentary assessment (EMA) of symptoms and inter-session processes

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ICD-10 diagnosis of mild or moderate depression, first or recurrent episode (F32.0, F32.1, F33.0, F33.1)
* PHQ-9 ≥ 5
* Possession of smartphone with internet access
* Signed informed consent

Exclusion Criteria

* Acute or past suicidality; self-reported
* Acute addiction (F10 - F19)
* Dysthymia (F34.1), postpartum depression, or severe depression (F32.3; F33.3)
* PHQ-9 \> 20
* Depression not main mental health concern
* Planned onset or planned change in antidepressant medication
* History of psychotic symptoms, bipolar disorder, personality disorders, or organic brain disorders
* Cognitive impairment or physical disability that would hinder psychotherapy or the use of a smartphone

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No