NCT03299127

Brief Summary

Depression is among the world's leading causes of disability. To fill the existing treatment gap, psychological online interventions (POIs) and Internet-based treatment, including bibliotherapy with PDF manuals (POIs), are increasingly recommended as they are easily accessible and deemed an initial alternative approach. The present trial aims to evaluate imagery rescripting. With the help of various techniques, the approach aims to edit negative memories and rewrite a "happy end". To the best of our knowledge, imagery rescripting has never been tested as a self-help intervention. A large sample of patients with primary or secondary depression (N = 120) will be recruited and randomly allocated to either the intervention group or a wait-list control group. The intervention group consists of two subgroups that will receive either a full or brief version of a manual teaching them imagery rescripting. Participants will be assessed at baseline and six weeks later. A follow-up assessment will be completed six months later. The primary outcome measure is the Beck Depression Inventory II.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

June 13, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

September 27, 2017

Last Update Submit

June 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory II

    Beck Depression Inventory II (BDI II) (Beck, Steer, \& Brown, 1996). The BDI-II is a self-report scale that contains 21 Items that tap into cognitive, behavioral and somatic symptoms of depression. A follow-up assessment after six month serves as secondary outcome.

    Change in BDI-II from pre- to post-intervention (i.e. 6 week interval)

Secondary Outcomes (4)

  • Patient Health Questionnaire (PHQ-9)

    Change from pre- to post-intervention (i.e. 6 week interval)

  • Rosenberg Self-Esteem Scale (RSE)

    Change from pre- to post-intervention (i.e. 6 week interval)

  • Generalized Anxiety Disorders 7 (GAD-7)

    Change from pre- to post-intervention (i.e. 6 week interval)

  • Global item of the WHO Quality of Life scale (WHOQOL-BREF)

    Change from pre- to post-intervention (i.e. 6 week interval)

Study Arms (2)

imagery rescripting

EXPERIMENTAL

bibliotherapy, intervention is provided by pdf-manual (either short or long version, i.e. 2 active arms, each 1/3 of sample receives either short or long version)

Behavioral: imagery rescripting

wait-list control

NO INTERVENTION

wait-list control, participants receive intervention manual upon completion of post-assessment (1/3 of sample)

Interventions

The long version of the manual contained 4,959 words, the brief version had 3,369 words. Individuals were encouraged patients to time travel to negative personal events, enter the scene and protect or comfort their younger-ego. The participant should bring the negative event to a "happy end. This could also be a fictive, compassionate person and may violate the laws of physics (e.g., a person may fly). Readers were encouraged to embellish the scenes as much as possible so that it competed with the original scene. This technique was then applied to future events. For the last technique, patients were asked to seek a corresponding mood-congruent metaphor, creature or symbol; for example, a small bird that has fallen out of its nest. Using their mind's eye, these images may be transformed into something of beauty or pride.

imagery rescripting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Electronic informed consent
  • Internet access
  • Adequate command of the German language
  • Diagnosis of depression (primary or secondary)

You may not qualify if:

  • Acute suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

  • Moritz S, Ahlf-Schumacher J, Hottenrott B, Peter U, Franck S, Schnell T, Peter H, Schneider BC, Jelinek L. We cannot change the past, but we can change its meaning. A randomized controlled trial on the effects of self-help imagery rescripting on depression. Behav Res Ther. 2018 May;104:74-83. doi: 10.1016/j.brat.2018.02.007. Epub 2018 Feb 26.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Steffen Moritz, PhD

    UKE Hamburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
self-report serves as outcomes, patients are not masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized-controlled trial, wait-list control condition
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 2, 2017

Study Start

April 1, 2017

Primary Completion

July 30, 2017

Study Completion

December 15, 2017

Last Updated

June 13, 2018

Record last verified: 2018-06

Locations